FDA MedWatch- Cardinal Health Alcohol-Free Mouth- Product Recalled Because Of the Presence Of Burkholderia Cepacia
Hydrox Labs issued a voluntary recall of Cardinal Health labeled alcohol-free mouthwash because the product was found to contain Burkholderia cepacia (B. cepacia). The affected product lot number is 26228. B. cepacia poses little medical risk to healthy individuals. However, people who have certain health problems such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with this organism. Consumers and facilities with the recalled alcohol-free mouthwash should stop using the product and contact Cardinal Health for instructions on how to return the product.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Cardinal POSTED 5/8/2008

FDA MedWatch - The May 2008 FDA Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the May 2008 edition include:
FDA Licenses New Hemophilia Treatment
Xyntha is produced without additives from human or animal material, which can further minimize the risk of infection...
Unsafe Use of Extended-Release Tussionex Suspension
Overdose of long-acting hydrocodone cough suppressant can result in respiratory depression and death...
Liver Injury with Tysabri (natalizumab)
Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury...
Updated Labeling Changes for Tamiflu (oseltamivir phosphate) and Relenza (zanamivir)
Patients with influenza should be closely monitored for signs of abnormal behavior...
New Instructions for Using Talecris IG Syringes
How to use HyperRAB S/D and GamaSTAN S/D 2 mL syringes properly in certain circumstances...
Hepatotoxicity with Prezista (darunavir)
Appropriate laboratory testing should be conducted before starting treatment and patients should also be monitored during treatment...
Information on Mortality Rates with the AneuRx Stent Graft System
Patients should meet the appropriate risk-benefit profile...
Mistakenly Swallowing Inhaler Capsules
Respiratory problems will not be treated if patients mistakenly take the capsules orally rather than with an inhaler...
Choosing the Correct Test Strip for a Blood Glucose Meter
Using the wrong strip in any brand of blood glucose meter could result in erroneous readings or no readings at all...
For more FDA Patient Safety News, visit http://www.fda.gov/psn .  Please send any comments, questions or suggestions about the program to PSNews@fda.gov POSTED 5/7/2008

FDA MedWatch- Enbrel (etanercept)-Prescribing Information Revised To Include A Boxed Warning Regarding The Risk Of Infection, Including Tuberculosis
Amgen and Wyeth Pharmaceuticals informed healthcare professionals of revisions to prescribing information for Enbrel. The revisions include a BOXED WARNING about infections, including serious infections leading to hospitalization or death that have been observed in patients treated with Enbrel. Infections have included bacterial sepsis and tuberculosis. The ADVERSE REACTIONS section of the label was updated to include information regarding global clinical studies and the rate of occurrence of tuberculosis in patients treated with Enbrel. Healthcare professionals should screen patients for latent tuberculosis infection before beginning Enbrel. Patients should be educated about the symptoms of infection and closely monitored for signs and symptoms of infection during and after treatment with the drug. Patients who develop an infection should be evaluated for appropriate antimicrobial treatment and, in patients who develop a serious infection, Enbrel should be discontinued.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:  
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Enbrel POSTED 5/2/2008

FDA MedWatch- Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Digitek POSTED 5/2/2008

MedWatch - January 2008 Drug Safety Labeling Changes for 41 drugs now available on web
The January 2008 posting includes 41 drug products with safety labeling changes to the following sections: BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/SAFETY/2008/jan08_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/SAFETY/2008/jan08.htm
In January 2008, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
EstroGel 0.06% (estradiol gel)
Herceptin (trastuzumab) Intravenous Infusion
Rituxan (rituximab) Injection For Intravenous Use
Alesse 28 Tablets (levonorgestrel and ethinyl estradiol tablets)
Janumet (sitagliptin/metformin HCl) Tablets
Mycamine (micafungin sodium) For Injection
Omnitrope [somatropin (rDNA origin) injection] For Subcutaneous Use
Tysabri (natalizumab) Injection For Intravenous Use
WelChol (colesevelam hydrochloride) Tablets
Azactam (aztreonam for injection, USP)
Azactam (aztreonam injection) in GALAXY Plastic Container (PL 2040) For Intravenous Use
Chantix (varenicline) Tablets
Cialis (tadalafil) Tablets
E.E.S. (erythromycin ethylsuccinate)
Ery-Ped (erythromycin ethylsuccinate, USP)
Humira (adalimumab) Injection, Solution For Subcutaneous Use
Lunesta (eszopiclone) Tablets
Ortho Evra (norelgestromin/ethinyl estradiol transdermal system)
PCE (erythromycin particles in tablets) Dispertab Tablets
Rapamune (sirolimus) Oral Solution and Tablets POSTED 4/28/2008

FDA MedWatch- CellCept (mycophenolate mofetil) and Myfortic (mycophenolate acid)-Possible Development Of Progressive Multifocal Leukoencephalopathy
FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information.  FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.  FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information.  As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public.
Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.
Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Communication About an Ongoing Safety Review regarding this issue and prior MedWatch alerts regarding these products at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#mycophenolate POSTED 4/10/2008

FDA MedWatch-Exubera (insulin human rDNA origin) Inhalation Powder-Prescribing Information Updated To Include Information About Primary Lung Malignancies In Patients In Clinical Trials
Pfizer informed healthcare professionals and patients of updated safety information in the WARNINGS section of prescribing information for Exubera, a short-acting insulin you breathe in through your mouth using the Exubera inhaler that helps to control high blood sugar in adults with diabetes. There have been 6 newly diagnosed cases of primary lung malignancies in clinical trials among Exubera-treated patients, and 1 newly diagnosed case among comparator treated patients. There has also been 1 post-marketing report of a primary lung malignancy in an Exubera-treated patient. There were too few cases to determine whether the emergence of these events is related to Exubera. All patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Because of the limited availability of Exubera, healthcare professionals should seek alternative treatment options to maintain patients' glycemic control.
Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and Dear Patient Letter regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#exubera POSTED 4/9/2008

FDA MedWatch - Heparin Sodium USP - Voluntary Nationwide Recall Because Two Lots Had Heparin-like Contaminant
Covidien notified healthcare professionals of a voluntary recall of certain lots of Heparin Sodium USP because two lots of the product acquired by Covidien had a heparin-like contaminant. To date, Covidien has not received any adverse event reports related to this issue. See the manufacturer's press release for the list of specific lots of the product affected by the recall. Use of the recalled product should be discontinued immediately. Patients should contact their physician if they experience any problems associated with the use of the product.Read the complete MedWatch 2008 safety summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#heparinsodium POSTED 4/2/2008

FDA MedWatch- Relenza (zanamivir) Changes To The WARNINGS AND PRECAUTIONS Sections Of Prescribing Information For Relenza About Postmarketing Reports Of Neurologic And Behavioral Symptoms
GlaxoSmithKline informed healthcare professionals of changes to the WARNINGS AND PRECAUTIONS sections of prescribing information for Relenza regarding information from postmarketing reports (mostly from Japan) of delirium and abnormal behavior leading to injury in patients with influenza who are receiving neuraminidase inhibitors, including Relenza. These events were reported primarily among pediatric patients and often had an abrupt onset and rapid resolution. The contribution of Relenza to these events has not been established. Influenza can be associated with a variety of neurologic and behavioral symptoms which can include seizures, hallucinations, delirium, and abnormal behavior, in some cases resulting in fatal outcomes. These events may occur in the setting of encephalitis or encephalopathy but can occur without obvious severe disease.
Patients with influenza should be closely monitored for signs of abnormal behavior. If neuropsychiatric symptoms occur, the risks and benefits of continuing treatment should be evaluated for each patient.Read the entire 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:     http://www.fda.gov/medwatch/safety/2008/safety08.htm#Relenza POSTED 4/2/2008

FDA MedWatch - The April 2008 FDA Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the A[pril 2008 edition include:
Decellularized Allograft Heart Valve Approved
FDA has cleared for marketing the first allograft heart valve from which cells and cellular debris have been removed…
Fentanyl (Duragesic) Patches Recalled
Gel leaks from defective patches may cause respiratory depression and death…
New Safety Warnings about Chantix
Possible neuropsychiatric problems and changes in behavior linked to Chantix (varenicline), a smoking-cessation drug…
Early Communication on Adverse Events from Botox and Myobloc
Botulinum toxin may have spread beyond injection site and cause symptoms associated with botulism, including dysphagia and respiratory insufficiency…
New Data on Thromboembolic Events with Ortho Evra Contraceptive Patch
Results of new study found women aged 15-44 who used the patch were at higher risk of developing venous thromboembolism than women using birth control pills…
Remembering to Re-Activate a Patients’s Defibrillator
A recent FDA article in Nursing2008 about a patient who died, possibly of ventricular fibrillation, following elective surgery because his ICD wasn't reactivated…
Mixups between Insulin U-100 and U-500
ISMP describes medication errors could result in dangerous hyper or hypo-glycemia… 
Caution Giving Children Cough and Cold Medicines
Ongoing evaluation of cough and cold medicines for children two and older…
For more FDA Patient Safety News, visit http://www.fda.gov/psn .  Please send any comments, questions or suggestions about the program to PSNews@fda.gov POSTED 4/1/2008

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FDA MedWatch- Regranex (becaplermin) Gel- Study Data Suggests Possible Increased Risk Of Death From Cancer In Diabetic Patients Using The Product
The FDA is conducting a safety review based on study data suggesting there may be an increased risk of death from cancer in diabetic patients using Regranex (becaplermin) Gel, a skin product used to heal leg and foot ulcers. While the review is ongoing, the FDA recommends health care professionals discuss the potential risks and benefits of using Regranex with their patients.
This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public.
Read the complete 2008 Safety Summary, including a link to the FDA Early Communication About An Ongoing Safety Review regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Regranex POSTED 3/29/2008

MedWatch - December 2007 Monthly Safety Labeling Changes Posted on MedWatch Website
The December 2007 posting includes 43 drug products with safety labeling changes to the following sections:  BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2007/dec07_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2007/dec07.htm
In December 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Carbatrol (carbamazepine) Extended-Release Capsules
Equetro (carbamazepine) Extended-Release Capsules
Omniscan (gadodiamide) Injection for Intravenous Use
Tegretol (carbamazepine) USP, Chewable Tablets and Oral Suspension
Tegretol-XR (carbamazepine extended-release tablets)
Ambien CR (zolpidem tartrate extended-release) Tablets
AndroGel (testosterone gel) 1%
Dostinex (cabergoline) Tablets
Aredia (pamidronate disodium for injection)
Biaxin Filmtab (clarithromycin tablets, USP)
Biaxin XL Filmtab (clarithromycin extended-release tablets)
Biaxin Granules (clarithromycin for oral suspension, USP)
DepoDur (morphine sulfate extended-release liposome injection)
Derma-Smoothe/FS (fluocinolone acetonide) Topical Oil 0.01% (Body Oil)
Doryx (doxycycline hyclate) Capsule, Delayed Release Pellets
Effexor XR (venlafaxine hydrochloride) Extended-Release Capsules
Exjade (deferasirox) Tablets for Oral Suspension
Heparin Sodium Injection, USP
Heparin Sodium Injection, USP (porcine) 5,000 U/mL
Hepsera (adefovir dipivoxil) Tablets
Invega (paliperidone) Extended-Release Tablets
Levaquin (levofloxacin) Tablets and Oral Solution
Levaquin (levofloxacin) Injection, for Intravenous Use
Levaquin (levofloxacin in 5% dextrose) Injection, for Intravenous Use
Monodox (doxycycline monohydrate) Capsules
Sonata (zaleplon) Capsules POSTED 3/24/2008

MedWatch - Medtronic Neuromodulation Implantable Infusion Pumps: Class I recall - Reports of inflammatory mass formations
FDA and Medtronic notified healthcare professionals of the Class 1 recall of Medtronic Neuromodulation Implantable Infusion Pumps, implantable devices for administering drugs to a specific site in the body to treat pain, spasticity and cancer. The company updated the labeling for the devices to include current patient management and treatment recommendations. The company received reports of inflammatory mass formations at or near the distal tip of intrathecal catheters which infuse opioids, baclofen, or chemotherapy drugs into patients. On January 28, 2008, Medtronic sent a letter to doctors who implant these devices and/or provide care to patients with the implanted device. The letter described the problem, patient risks, patient management, recommendations and next steps. Medtronic’s representatives will complete a reply card to document their communication with each doctor regarding this recall, as well as asking the doctors to sign and return a reply card.
Read the complete MedWatch safety summary, including links to the Recall Notice and the "Dear Healthcare Professional" letter, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation POSTED 3/24/2008

MedWatch - B. Braun Heparin Sodium Injection Solutions - Recall due to heparin-like contaminant
B. Braun Medical Inc. was notified by its supplier, Scientific Protein Laboratories LLC (SPL) of a nationwide recall of Heparin Sodium USP active pharmaceutical ingredient (API). The voluntary recall affects 23 Finished Product lots manufactured and distributed by B. Braun Medical Inc. nationwide and to Canada. This product recall was initiated due to a notification received from SPL, disclosing that one lot of Heparin Sodium, USP API acquired by B. Braun has a heparin-like contaminant. FDA has received reports of serious injuries and/or deaths in patients who have been administered Heparin injectable products of other companies containing this contaminant.
Read the complete MedWatch 2008 safety summary, including a link to the Press Release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#BBraun POSTED 3/24/2008

MedWatch - FDA Drug Safety Newsletter: new online issue available
The new quarterly issue of FDA's online Drug Safety Newsletter [DSN] has been published today. DSN highlights safety issues related to FDA-approved drug products, based on an assessment of the importance and timeliness of these issues to patient care and the seriousness of the adverse events. The current issue includes an article on 'Pharmacogenomics and Drug Safety" and  postmarket safety reviews of Exenatide/acute pancreatitis, PDE5 inhibitors/sudden hearing loss, and TNF-alpha antagonists/serious skin reactions.
The entire online newsletter can be found at
http://www.fda.gov/cder/dsn/2008_winter/toc.htm POSTED 3/18/2008

MedWatch - Medtronic AneuRx Stent Graft System: Updated information on mortality risks
FDA issued a Public Health Notification to inform healthcare professionals of an update to earlier FDA safety information on this product. The notification re-emphasizes the need for continued surveillance of patients treated with endovascular grafts, and provides updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture.Read the complete MedWatch 2008 safety summary, including a link to the Public Health Notification and previous MedWatch alerts, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#AneuRx POSTED 3/18/2008

FDA MedWatch- Erythropoiesis Stimulating Agents- Studies Indicate Increased Mortality And More Rapid Tumor Progression In Patients With Cancer Receiving ESAs
Amgen and FDA notified healthcare professionals of changes to the Boxed Warnings/WARNINGS: Increased Mortality and/or Tumor Progression section of the Aranesp and EPOGEN/PROCRIT labeling to update information describing the results of two additional studies showing increased mortality and more rapid tumor progression in patients with cancer receiving ESAs. Based on the results of these studies, the prescribing information has been revised as follows: ESAs shortened overall survival and/or time to tumor progression in clinical studies in patients with breast, non-small cell lung, head and neck, lymphoid, and cervical cancers when dosed to target a hemoglobin of ≥ 12 g/dL.
Read the complete 2008 MedWatch Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ESA POSTED 3/12/2008

FDA MedWatch - Prezista (darunavir)- Reports Of Drug Induced Hepatitis In Patients Receiving Prezista/Ritonavir
FDA and Tibotec Therapeutics notified healthcare professionals of changes to the WARNINGS section of the prescribing information for Prezista (darunavir) tablets regarding the risk of hepatotoxicity. In clinical trials and postmarketing experience, drug induced hepatitis has been reported in patients receiving combination therapy with Prezista/ritonavir. Appropriate laboratory testing should be conducted prior to initiating therapy with Prezista/ritonavir and patients should be monitored during treatment. Increased AST/ALT monitoring should be considered in patients with underlying chronic hepatitis, cirrhosis, or in patients who have pretreatment elevations of transaminases, especially during the first several months of Prezista/ritonavir treatment.
Read the complete 2008 MedWatch Safety Summaries including a link to the manufacturer's Dear Healthcare Professional Letter and Prescribing Information for Prezista concerning this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Prezista POSTED 3/12/2008

FDA MedWatch - Tussionex: Reports of life-threatening events and deaths in patients including children
FDA informed healthcare professionals of life-threatening adverse events and death in patients, including children, who have received Tussionex Pennkinetic Extended-Release Suspension (Tussionex). The reports indicate that healthcare professionals have prescribed Tussionex for patients younger than the approved age group of 6 years old and older, and more frequently than the labeled dosing interval of every 12 hours. Tussionex is contraindicated for use in patients less than 6 years of age because of their susceptibility to life-threatening and fatal respiratory depression.
Patients have administered the incorrect dose due to misinterpretation of the dosing directions, and have used inappropriate devices to measure the suspension. Overdose of Tussionex in older children, adolescents, and adults has also been associated with life-threatening and fatal respiratory depression. Prescribers should be familiar with the dosing recommendations of Tussionex before prescribing. In addition, patients and caregivers should use a properly marked measuring device to measure Tussionex to prevent overdose.
Read the complete 2008 MedWatch Safety Summary, including links to the Public Health Advisory, Information for Healthcare Professionals, and the Prescribing Information at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tussionex POSTED 3/12/2008

FDA MedWatch - The March 2008 Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
First Drug to Treat PKU Approved
Kuvan (sapropterin dihydrochloride) increases the activity of phenylalanine hydroxylase in those PKU patients who have some residual functioning of this enzyme…
Recall of Heparin and Saline Flush Syringes
Some Sierra Pre-filled, Inc. and B. Braun syringes could be contaminated with the bacteria Serratia marcescens…
Severe Pain with Osteoporosis Drugs
Incapacitating musculoskeletal pain can occur in patients taking certain bisphosphonate drugs such as Fosamax, Actonel, Reclast and Boniva…
Warning on Exjade and Liver Failure
Patients’ liver function should be monitored monthly due to reported cases of hepatic failure…
Dangerous Skin Reactions from Carbamazepine
These reactions are significantly more common in patients of Asian ancestry…
Potentially Fatal Hyponatremia from Desmopressin
Patients or their caregivers should watch for circumstances that could lead to excessive fluid intake…
Alaris (Medley) Infusion Pumps Recalled
Pump occluder springs may have been misassembled, which can lead to overinfusion and result in serious injury or death…
Preventing Burns from Electric Dental Handpieces
Third degree burns can occur when poorly maintained electric dental handpieces are used…
MedWatch: Reporting Adverse Events
FDA's MedWatch program relies on health care professionals and consumers to report to serious problems with the medical products they prescribe, dispense, or use…
For more FDA Patient Safety News, visit http://www.fda.gov/psn .  Please send any comments, questions or suggestions about the program to PSNews@fda.gov .  POSTED 3/4/2008

FDA MedWatch - Heparin Sodium Injection: Recall of Multi-dose And Single-dose Vials
UPDATE - Baxter Healthcare and FDA informed healthcare professionals of a voluntary recall of all Heparin multi-dose and single-use vials, and Heparin lock flush solutions.
Read the MedWatch 2008 safety summary, including links to the Public Health Update, press release, and the previous safety alert information, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2 POSTED 3/3/2008

FDA MedWatch - November 2007 Monthly Safety Labeling Changes Posted on MedWatch Website
The November 2007 posting includes 39 drug products with safety labeling changes to the following sections:  BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
http://www.fda.gov/medwatch/safety/2007/nov07_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a bref summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/safety/2007/nov07.htm
In November 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Abilify (aripiprazole) Tablets, Abilify Discmelt (aripiprazole) Orally Disintegrating Tablets, Abilify (aripiprazole) Oral Solution, Abilify (aripiprazole) Injection For Intramuscular Use Only
Aranesp (darbepoetin alfa) For Injection
Avandia (rosiglitazone maleate) Tablets
Epogen (epoetin alfa) For Injection
Myfortic (mycophenolic acid) Delayed-Release Tablets
Optison (Perflutren Protein-Type A Microspheres Injectable Suspension, USP)
Sarafem (fluoxetine hydrochloride tablets)
Crestor (rosuvastatin calcium) Tablets
Cymbalta (duloxetine hydrochloride) Delayed-Release Capsules
Kaletra (Iopinavir/ritonavir) Tablets and Solution
Lac-Hydrin (ammonium lactate) Lotion, 12%
Zometa (zoledronic acid) Injection - Concentrate for Intravenous Infusion
Arava (leflunomide) Tablets
Avalide (irbesartan-hydrochlorothiazide) Tablets
Celebrex (celecoxib capsules)
Eligard (leuprolide acetate for injectable suspension)
Invanz (ertapenem for injection)
Motrin IB (200 mg ibuprofen) Tablets
Nexavar (sorafenib) Tablets
Sprycel (dasatinib) Tablet For Oral Use
Toradol (ketorolac tromethamine tablets)
Vectibix (panitumumab) For Intravenous Use Only POSTED 3/3/2008

FDA MedWatch - FDA MedWatch - Tysabri (natalizumab) - Reports Of Clinically Significant Liver Injury
Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.
Read the complete 2008 MedWatch Safety Summary, including a link to the manufacturer's Dear Healthcare Professional Letter and prescribing information for Tysabri at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tysabri POSTED 2/28/2008

FDA MedWatch - Avandia (rosiglitazone maleate): new Medication Guide issued
FDA and GlaxoSmithKline notified pharmacists and physicians of a new Medication Guide for Avandia (rosiglitazone maleate). The FDA regulation 21CFR 208 requires a Medication Guide to be provided with each prescription that is dispensed for products that FDA determines pose a serious and significant public health concern. A list of currently approved Medication Guides are available at
http://www.fda.gov/cder/Offices/ODS/medication_guides.htm.

See the MedWatch 2008 safety summary, including links to the Medication Guide and the current Prescribing Information for Avandia, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Avandia POSTED 2/28/2008

FDA MedWatch - Heparin Sodium Injection - Serious Adverse Events Reported In Patients Receiving Bolus Doses Of Medication
FDA informed healthcare professionals of important warnings and instructions for Heparin Sodium Injection use. There have been reports of serious adverse events including allergic or hypersensitivity-type reactions, with symptoms of oral swelling, nausea, vomiting, sweating, shortness of breath, and cases of severe hypotension.  Most events developed within minutes of heparin initiation although the possibility for a delayed response has not been excluded. The reports have largely involved use of multiple-dose vials. However, there have been several cases in which product from multiple, single-dose vials have been combined to administer a bolus dose. Heparin sodium is an anticoagulant (blood thinner) that is used in patients undergoing kidney dialysis, certain types of cardiac surgery, and treatment or prevention of other serious medical conditions, including deep venous thrombosis and pulmonary emboli. Heparin treatment is initiated using high doses (5000-50,000 units) given directly into the blood stream (intravenously) as a bolus. Serious adverse events have recently been reported in patients who received these higher bolus doses.
The manufacture of multiple-dose vials of heparin sodium has been suspended pending the completion of an extensive ongoing investigation to determine the root cause of the problem. Because heparin sodium is a medically necessary product and serious public health consequences would result if there were a sudden shortage of the drug, the multiple-dose vials of heparin sodium manufactured by Baxter that are currently in distribution will not be recalled. See the FDA Public Health Advisory for Agency recommendations to healthcare professionals on the use of heparin sodium for injection.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory, Q & A Document, and News Release regarding this issue at: 
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj2 POSTED 2/11/2008

 

FDA MedWatch - The February 2008 FDA Patient Safety News Is Now Available...
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.
Stories in the February 2008 edition include:
Helping Patients Avoid Counterfeit Drugs over the Internet (September 2007)
Be sure to use only U.S. sites licensed by a State board of pharmacy…
Safe Use of Pneumatic Tourniquet Cuffs (April 2007)
The effectiveness of the tourniquet cuff can become compromised if the cuff becomes crinkled, folded or bent…
Avoiding Accidental Overdoses when Methadone is Prescribed for Pain (February 2007)
Methadone can build up to toxic levels if it is taken too often, if the amount taken is too high, or if it is taken with certain other medicines or supplements…
Avoiding Burns from Electrodes and Cables during MRI Exams (February 2007)
Radiofrequency fields created during an MRI exam can heat ECG cables and electrodes, seriously burning the underlying skin…
Severe Tissue Injury with IV Promethazine (December 2006)
ISMP warns that administering promethazine parenterally may cause more severe tissue injuries than previously recognized…
For more FDA Patient Safety News, visit http://www.fda.gov/psn . Please send any comments, questions or suggestions about the program to PSNews@fda.gov. POSTED 2/6/2008

FDA MedWatch- FDA MedWatch- Medtronic Inc. SnychroMed EL Implantable Infusion Pump - Class I Recall
FDA issued a Class I Recall of Medtronic Inc, SynchroMed EL Implantable Infusion Pump Models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, and 8627L-18. The device administers drugs to a specific site in the body to treat pain, spasticity (continuous muscle contraction), and cancer. The pump is implanted in the patient, either with or without a side catheter access port, catheters, and catheter accessories. The models were recalled because there is a potential pump motor stall issue that affects SynchroMed EL infusion pumps with motors manufactured before September 1999. If a pump motor stalls, drug delivery will stop suddenly and without warning. This stoppage will result in loss of therapy, return of the patient's symptoms, and/or symptoms of drug under infusion or withdrawal. Healthcare professionals and patients with questions should contact the manufacturer.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Class I Recall Notice regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#SynchroMed POSTED 2/4/2008

FDA MedWatch- Chantix (varenicline)-Associated With Reports Of Changes In Behavior, Agitation, Depressed Mood, Suicidal Ideation, and Attempted/Completed Suicide
FDA informed healthcare professionals and consumers of important revisions to the WARNINGS and PRECAUTIONS sections of the prescribing information for Chantix regarding serious neuropsychiatric symptoms experienced in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy. See the FDA Information for Healthcare Professionals Sheet for recommendations and considerations for healthcare professionals on using Chantix therapy for patients. 
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory, Healthcare Professional Information Sheet and the prescribing information for Chantix regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Varenicline POSTED 2/4/2008

FDA MedWatch- Antiepileptic Drugs- FDA Analysis Showed Patients Receiving Antiepileptic Drugs Had Approximately Twice The Risk of Suicidal Behavior Or Ideation
FDA informed healthcare professionals that the Agency has analyzed reports of suicidality (suicidal behavior or ideation) from placebo-controlled clinical studies of eleven drugs used to treat epilepsy as well as psychiatric disorders, and other conditions. In the FDA's analysis, patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation (0.43%) compared to patients receiving placebo (0.22%). The increased risk of suicidal behavior and suicidal ideation was observed as early as one week after starting the antiepileptic drug and continued through 24 weeks. The results were generally consistent among the eleven drugs. The relative risk for suicidality was higher in patients with epilepsy compared to patients who were given one of the drugs in the class for psychiatric or other conditions.
Healthcare professionals should closely monitor all patients currently taking or starting any antiepileptic drug for notable changes in behavior that could indicate the emergence or worsening of suicidal thoughts or behavior or depression.
The drugs included in the analyses include (some of these drugs are also available in generic form):
Carbamazepine (marketed as Carbatrol, Equetro, Tegretol, Tegretol XR)
Felbamate (marketed as Felbatol)
Gabapentin (marketed as Neurontin)
Lamotrigine (marketed as Lamictal)
Levetiracetam (marketed as Keppra)
Oxcarbazepine (marketed as Trileptal)
Pregabalin (marketed as Lyrica)
Tiagabine (marketed as Gabitril)
Topiramate (marketed as Topamax)
Valproate (marketed as Depakote, Depakote ER, Depakene, Depacon)
Zonisamide (marketed as Zonegran)
Although the 11 drugs listed above were the ones included in the analysis, FDA expects that the increased risk of suicidality is shared by all antiepileptic drugs and anticipates that the class labeling changes will be applied broadly.
Read the complete 2008 MedWatch Safety Summary including a link to the Healthcare Professional Sheet regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Antiepileptic POSTED 1/31/2008

FDA MedWatch - October 2007 Monthly Safety Labeling Changes Posted on MedWatch Website
The October 2007 posting includes 49 drug products with safety labeling changes to the following sections:  BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, and PATIENT PACKAGE INSERTS, and MEDICATION GUIDES.
The Summary Page provides a listing of drug names and safety labeling sections revised:
ttp://www.fda.gov/medwatch/safety/2007/oct07_quickview.htm
The Detailed View Page identifies safety labeling sections and subsections revised along with a brief summary of new or modified safety information to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
http://www.fda.gov/medwatch/SAFETY/2007/oct07.htm
In October 2007, the following drugs had modifications to the BOXED WARNING, CONTRAINDICATIONS, and/or WARNINGS sections:
Definity Vial for (perflutren lipid microsphere) Injectable Suspension For Intravenous Use
Elaprase (idursulfase) Solution For Intravenous Infusion
Erbitux (cetuximab) Solution for Intravenous Use
Soriatane (acitretin) Capsules
Aptivus (tipranavir) Capsules
Azithromycin for Injection For I.V. Infusion Only
DDAVP Injection (desmopressin acetate) 4 mcg/mL
DDAVP Nasal Spray (desmopressin acetate)
DDAVP Rhinal Tube (desmopressin acetate)
DDAVP Tablets (desmopressin acetate)
Inderal LA (propranolol hydrochloride) Long-Acting Capsules
Januvia (sitagliptin) Tablets
Lodine (etodolac capsules and tablets)
Prevpac (lansoprazole 30-mg capsules, amoxicillin 500-mg capsules, USP, and clarithromycin 500-mg tablets, USP)
ProQuad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live] [Frozen Formulation]
ProQuad [Measles, Mumps, Rubella and Varicella (Oka/Merck) Virus Vaccine Live][Refrigerator-Stable Formulation]
Zithromax (azithromycin tablets and azithromycin for oral suspension)
Zmax (azithromycin extended release) for Oral Suspension
Cubicin (daptomycin for injection)
Dalmane (flurazepam hydrochloride) Capsules
Doral (quazepam tablets, USP)
Lexxel (enalapril maleate-felodipine ER) Tablets
Lymphazurin 1% (isosulfan blue) Aqueous Solution
NuvaRing (etonogestrel/ethinyl estradiol vaginal ring) For Vaginal Use Only
Rapamune (sirolimus) Oral Solution and Tablets
Renagel (sevelamer hydrochloride) Tablets For Oral Use
Vaseretic (enalapril maleate - hydrochlorothiazide) Tablets
Vasotec (enalapril maleate) Tablets
Visken (pindolol) Tablets, USP
Zestoretic (lisinopril and hydrochlorothiazide) Tablets
Zestril (lisinopril) Tablets POSTED 1/31/2008

FDA - MedWatch - Cordis Dura Star RX, Fire Star RX PTCA Balloon Catheters recall due to deflation problems
Cordis Corporation and FDA informed healthcare professionals of a Class I recall of All Fire Star and Dura Star balloon catheters, lots 13173912 through 13315455, plus 52 additional lots above 13315455. Balloon catheters are used in a medical procedure (known as percutaneous transluminal coronary angioplasty or PTCA) to open narrowed or blocked blood vessels or arteries of the heart. The product has a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels. This may potentially result in a total blockage of the artery or blood vessels, resulting in a change in the heart rate or heart rhythm, injury to the heart artery, a heart attack, need for a surgical procedure, or death.
Read the complete MedWatch 2008 safety summary, including a link to the recall notice, at
http://www.fda.gov/medwatch/safety/2008/safety08.htm#DuraStar POSTED 1/25/2008

FDA - MedWatch - Vytorin, Zetia, Zocor: Early Communication about an Ongoing Data Review
FDA provided healthcare professionals with an early communication about an ongoing data review for Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor). This early communication is in keeping with FDA’s commitment to inform the public about ongoing postmarketing drug issues.
Merck/Schering Plough Pharmaceuticals reported preliminary results from the Effect of Combination Ezetimibe and High-Dose Simvastatin vs. Simvastatin Alone on the Atherosclerotic Process in Patients with Heterozygous Familial Hypercholesterolemia (ENHANCE) trial. This trial was designed to evaluate the amount of atherosclerotic plaque in blood vessels located in the neck based on images obtained through ultrasound in patients treated with Vytorin (ezetimibe plus simvastatin) or simvastatin alone.  Merck/Schering Plough stated that there was no significant difference between Vytorin and simvastatin in the amount of atherosclerotic plaque in the inner walls of the carotid (neck) arteries despite greater lowering of LDL-cholesterol (bad cholesterol) with Vytorin compared to simvastatin. Once Merck/Schering Plough completes the analysis of the unblinded data from ENHANCE, it will submit a final study report to FDA. Once FDA receives the final study report, FDA estimates it will take approximately 6 months to fully evaluate the data. After reviewing the data from the ENHANCE study, and considering all other available information about the link between LDL lowering and reduction of cardiovascular events, FDA will determine whether any further regulatory action is warranted with regard to Zetia and Vytorin and also whether any changes to FDA’s current approach to drugs that lower LDL cholesterol are warranted.
Patients should talk to their doctors if they have any questions about the information from the ENHANCE trial.
Read the complete MedWatch 2008 safety summary, including a link to the early communication, at: http://www.fda.gov/medwatch/safety/2008/safety08.htm#Ezetimibe POSTED 1/25/2008

FDA MedWatch: Leukine (sargramostim) liquid formulation of drug withdrawn from the market due to an upward trend in spontaneous reports of adverse reactions
Bayer and FDA informed healthcare professionals of the market withdrawal of the current liquid formulation of Leukine, a growth factor that helps fight infection and disease in appropriate patients by enhancing immune cell function. The product was withdrawn because of an upward trend in spontaneous reports of adverse reactions, including syncope (fainting), which are temporally correlated with a change in the formulation of liquid Leukine to include edetate disodium (EDTA). The upward trend in adverse reaction reporting rates has not been observed with the use of lyophilized Leukine. Healthcare professionals should immediately stop using liquid Leukine and return unused vials to the manufacturer.
Read the complete MedWatch 2008 Safety Summary including a link to the manufacturer's Dear Healthcare Professional Letter at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Leukine POSTED 1/24/2008

FDA MedWatch - Heparin and Normal Saline Pre-Filled Flushes- Nationwide Recall Because One Lot Was Contaminated With Bacteria
AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Saline pre-filled  flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Sierratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor.
Read the complete 2008 MedWatch Safety Summary including a link to the Manufacturer's Recall Notice regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Heparin POSTED 1/22/2008

 

FDA MedWatch - Heparin Sodium Injection 1000 units/mL recalled due to multiple adverse reactions reported
Baxter Healthcare and FDA notified healthcare professionals of a voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots. Baxter is in the process of an in-depth investigation to determine the root cause of the reported reactions.
Reported adverse events include abdominal pain, decreased blood pressure, burning sensation, chest pain, diarrhea, dizziness, drug ineffectiveness, dyspepsia, dyspnea, erythema, flushing, headache, hyperhidrosis, hypoesthesia, hypotension, increased lacrimation, loss of consciousness, malaise, nausea, pallor, palpitations, paresthesia, pharyngeal edema, restlessness, vomiting/retching, stomach discomfort, tachycardia, thirst, trismus, and unresponsiveness to stimuli. There have been no reports involving fatality. See the recall notice for a list of affected lots.
Read the complete 2008 MedWatch Safety Summary including a link to the firm's recall notice, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#HeparinInj POSTED 1/21/2008

FDA MedWatch - Heparin and Normal Saline Pre-Filled Flushes- Nationwide Recall Because One Lot Was Contaminated With Bacteria
AM2 PAT, Inc., notified healthcare professionals and patients of a nationwide recall of all lots of both Heparin and Saline pre-filled  flushes. These products are distributed under two brand names, Sierra Pre-Filled Inc and B. Braun. The products are sold in 3ml and 5ml sizes for Heparin and 3ml, 5ml, and 10ml sizes for Normal Saline. One lot of Heparin IV flush syringes (1003-02, Lot 070926H) was contaminated with Sierratia marcescens which has resulted in patient infections. This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death. User facilities and consumers should stop using the product immediately, quarantine remaining inventory, and return the product to their respective distributor.
Read the complete 2008 MedWatch Safety Summary including a link to the Manufacturer's Recall Notice regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Heparin POSTED 1/18/2008

 

FDA MedWatch - Nonprescription Cough And Cold Medicine Should Not Be Used For Children Under 2 Years Of Age
FDA informed consumers and healthcare professionals that the Agency has completed its review of information regarding the safety of over-the-counter (OTC) cough and cold medicines in children under 2 years of age and recommends that these drugs not be used to treat children in this age group because serious and potentially life-threatening side effects can occur. FDA's recommendation is based on both the review of the information the Agency received about serious side effects in children in the referenced age group and the discussion and recommendations made at the October 18 -19, 2007, public advisory committee meeting at which this issue was discussed. FDA has not completed its review of information about the safety of OTC cough and cold medicines in children 2 through 11 years of age. See the FDA Public Health Advisory for Agency recommendations regarding this issue.  
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory and a previous MedWatch alert dated January 12, 2007, regarding this issue.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#cough POSTED 1/17/2008

FDA MedWatch - Edetate Disodium (marketed as Endrate and generic products) - Important Safety Considerations For Healthcare Professionals
FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an emergency treatment for certain patients with hypercalcemia (very high levels of calcium in the blood) or certain patients with heart rhythm problems as a result of very high amounts of digitalis in the blood. Edetate Calcium Disodium was approved to reduce dangerously high blood lead levels (severe lead poisoning).
The two drugs have very similar names and are commonly referred to only as EDTA. As a result, the two products are easily mistaken for each other when prescribing, dispensing, and administering them. Edetate Disodium and Edetate Calcium Disodium works by binding with heavy metals or minerals in the body allowing them to be passed out of the body through the urine. Read the FDA Public Health Advisory and Questions and Answers for recommended and important safety considerations for healthcare professionals until the FDA's ongoing evaluation of the risks and benefits of Edetate Disodium is complete.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Advisory and Questions and Answers at: 
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Edetate POSTED 1/17/2008

 

FDA MedWatch - Unretrieved Device Fragments (UDFs)- Adverse Events Associated With UDFs
FDA advised healthcare professionals of serious adverse events associated with unretrieved device fragments (UDFs). A UDF is a fragment of a medical device that has separated unintentionally and remains in the patient after a procedure. Patients may not be aware that this has occurred. The FDA Center for Devices and Radiological Health receives nearly 1000 adverse event reports each year related to UDFs. The adverse events reported included local tissue reaction, infection, perforation and obstruction of blood vessels, and death. Contributing factors may include biocompatibility of the device materials, location of the fragment, potential migration of the fragment, and patient anatomy. During MRI procedures, magnetic fields may cause metallic fragments to migrate, and radiofrequency fields may cause them to heat, causing internal tissue damage and/or burns. See the FDA Public Health Notification for the Agency's recommendations regarding this issue.
Read the complete 2008 MedWatch Safety Summary including a link to the FDA Public Health Notification regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Fragments POSTED 1/15/2008

FDA MedWatch - Bisphosphonates- Possible Cause Of Severe And Sometimes Incapacitating Bone, Joint, and/or Muscle Pain
FDA informed healthcare professionals and patients of the possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain in patients taking bisphosphonates. Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics. The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonates. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution. The risk factors for and incidence of severe musculoskeletal pain associated with bisphosphonates are unknown.
Healthcare professionals should consider whether bisphosphonate use might be responsible for severe musculoskeletal pain in patients who present with these symptoms and consider temporary or permanent discontinuation of the drug.
Read the complete 2007 and 2008 MedWatch Safety Summary including a link to the FDA Drug Information Page regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Bisphosphonates POSTED 1/9/2008

FDA MedWatch - The January 2008 FDA Patient Safety News Is Now Available
FDA Patient Safety News (PSN) is a monthly video news show for healthcare professionals. It covers significant safety alerts, recalls, new product approvals, and offers important tips on protecting patients. Read the complete stories and watch or download the video program at http://www.fda.gov/psn. You may have already received notification of some of these safety issues through the MedWatch list serve. However, many of these PSN stories contain video footage and demonstrations that may be especially useful to educators in healthcare facilities and academic institutions.

Used to reduce excessive sleepiness in adults with narcolepsy and other sleep disorders, Provigil can cause life-threatening skin and hypersensitivity reactions…

Sudden Hearing Loss from Erectile Dysfunction Drugs

Sudden hearing loss reported with PDE5 inhibitors Viagra, Levitra and Cialis…

Certain Welch Allyn Defibrillators Recalled