FDA – Patient Safety News

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Tylenol Arthritis Pain Caplet 100 count: Recall of all lots

Audience: Consumers, Pharmacists
McNeil Consumer Healthcare and FDA notified consumers that it is expanding a voluntary recall to include all available product lots of TYLENOL Arthritis Pain Caplet 100 count bottles, with the distinctive red EZ-OPEN CAP (Full list of lot numbers provided in press release at link below). In November 2009, 5 lots of this product were recalled due to consumer reports of an unusual moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. The odor is caused by the presence of a chemical 2,4,6-tribromoanisole, believed to be the breakdown of a chemical used to treat wooden pallets that transport and store packaging materials. The health effects of this compound have not been well studied, and to date all of the observed events reported to McNeil were temporary and non-serious. Consumers who purchased TYLENOL Arthritis Pain Caplet 100 count bottles with the distinctive red EZ-OPEN CAP from the lots included in this recall should stop using the product and contact McNeil for instructions on a refund or replacement.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm195704.htm
Posted 12/29/2009


FDA MedWatch – Sitagliptin (marketed as Januvia and Janumet) – acute pancreatitis

Audience: Diabetes healthcare professionals, patients
FDA notified healthcare professionals and patients of revisions to the prescribing information for Januvia (sitagliptin) and Janumet (sitagliptin/metformin) to include information on reported cases of acute pancreatitis in patients using these products. Eighty-eight post-marketing cases of acute pancreatitis, including two cases of hemorrhagic or necrotizing pancreatitis in patients using sitagliptin, were reported to the Agency between October 2006 and February 2009. It is recommended that healthcare professionals monitor patients carefully for the development of pancreatitis after initiation or dose increases of sitagliptin or sitagliptin/metformin. Sitagliptin has not been studied in patients with a history of pancreatitis. Therefore, it is not known whether these patients are at an increased risk for developing pancreatitis and the medication should be used with caution and with appropriate monitoring in patients with a history of pancreatitis. Considerations for healthcare professionals, information for patients, and a Data Summary are provided.
Read the complete MedWatch 2009 Safety summary including a link to the Information for Healthcare Professionals sheet, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm183800.htm
Posted 09/28/2009


FDA MedWatch – Accusure Insulin Syringes [31G, 1/2 cc and 1 cc]

Audience: Patients with diabetes mellitus, pharmacists and diabetes healthcare professionals
Qualitest Pharmaceuticals and FDA notified patients and healthcare professionals of a voluntary nationwide recall of two lots of Accusure Insulin Syringes. The syringes in these lots have been found to have needles which can detach from the syringe. When the needle becomes detached from the syringe during use, it can become stuck in the insulin vial, push back into the syringe, or remain in the skin after an injection. Consumers who have any recalled Accusure Insulin Syringes (31 G –Short Needle-either 1/2 cc or 1 cc, lot number 6JCB1 or lot number 7CPT1) should stop using them and contact Qualitest at 1-800-444-4011 for product replacement instructions. The lot number can be found on the white paper backing of each individual syringe. These recalled products were distributed from January 2007 through June 2008 to wholesalers and retail pharmacies nationwide (including Puerto Rico).
Read the complete MedWatch 2009 Safety summmary including a link to the firm press release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179955.htm

Posted 08/24/2009


Ibuprofen (Unapproved) topical drug products

Audience: Consumers, pharmacists
FDA informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen. The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Topical ibuprofen is often promoted as a “safer” alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.
The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

Read the complete MedWatch 2009 Safety summary including a link to the FDA press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm179925.htm
Posted 08/21/2009


Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump

Audience: Diabetes healthcare professionals, patients
Disetronic Medical Systems Inc. and FDA notified healthcare professionals about a defect in the “up” and/or “down” buttons of some ACCU-CHEK Spirit insulin pumps. This failure may present as an intermittent or complete loss of function of the “up” and/or “down” buttons. If the buttons do not function, users may not be able to change any programmed setting on the pump. If this failure occurs, the pump may not respond with a vibration or acoustic confirmation signal to a button press and the display will remain unchanged. Users may contact ACCU-CHEK Spirit hotline noted in the Press Release for a replacement pump or for any other questions regarding this potential defect.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Spirit

Posted 05/01/2009


MedWatch: Libimax-Recall of dietary supplement due to undeclared drug tadalafil, which may interact with nitrates found in prescription drugs and lower blood pressure to dangerous levels

Nature & Health Co. and FDA notified healthcare professionals of a recall of a supplement product, Libimax. FDA analysis found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction. This product poses a threat to health because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have Libimax in their possession should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product.
Read the complete MedWatch 2009 Safety summary, including a link to the firm’s press release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Libimax

Posted 05/01/2009


MedWatch – Zencore Plus recalled due to product containing undeclared drug

Bodee LLC and FDA notified consumers and healthcare professionals of a nationwide recall of all the company’s supplement product sold under the name Zencore Plus. FDA lab analysis of Zencore Plus samples found the product contains benzamidenafil, an undeclared drug product and a PDE5 inhibitor. The use of Zencore Plus by an unsuspecting user of organic nitrates may pose a life-threatening risk of sudden and profound drop of blood pressure due to potential interaction between benzamidenafil and organic nitrates. Zencore Plus is sold in health food stores and by mail order on internet nationwide. Consumers who have this product in their possession should stop using it immediately.
Read the MedWatch safety summary, including a link to the company’s Press Release, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Zencore

Posted 03/20/2009


Transdermal Drug Patches with Metallic Backings: risk of burns during MRI scans

FDA notified healthcare professionals and patients that certain transdermal patches (medicated patches applied to the skin), containing aluminum or other metals in the backing of the patches, can overheat during an MRI scan and cause skin burns in the immediate area of the patch. FDA is in the process of reviewing the labeling and composition of all medicated patches to ensure that those made with materials containing metal provide a warning about the risk of burns to patients who wear the patches during an MRI scan. Until this review is complete, FDA recommends that healthcare professionals referring patients to have an MRI scan identify those patients who are wearing a patch before the patients have the MRI scan. The healthcare professional should advise these patients about the procedures for removing and disposing of the patch before the MRI scan, and replacing the patch after the MRI scan. MRI facilities should follow published safe practice recommendations concerning patients who are wearing patches.
Read the MedWatch safety summary, including a link to the FDA Public Health Advisory, at:
http://www.fda.gov/medwatch/safety/2009/safety09.htm#Transdermal

Posted 03/05/2009


Updated FDA Information on Peanut Products

http://www.fda.gov/oc/opacom/hottopics/salmonellatyph.html

Posted 01/29/2009


FDA MedWatch – Recalls, Market Withdrawals and Safety Alerts

Information on peanut butter paste can be found at:
http://www.fda.gov/opacom/7alerts.HTML

Posted 01/22/2009


FDA MedWatch – January/February 2009 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 e-list. 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 January/February 2009 edition include:

Serious Infections and Neurological Events with Raptiva (efalizumab)
New boxed warning to highlight the risk of bacterial sepsis, viral meningitis, PML and other opportunistic infections…

Recall of ReliOn Syringes
In the one recalled lot sold by Wal-Mart and Sam’s Club, some U-40 insulin syringes mistakenly labeled as U-100 insulin syringes…

Ethex Corp. Recalls Several Generic Drugs
Oversized tablets may contain up to twice the labeled amount of active ingredient…

Serious Complications with Surgical Mesh for Gynecologic Surgery
Healthcare professionals should be vigilant for adverse events such as erosion and infection…

More Mix-ups between Propylthiouracil and Purinethol (mercaptopurine)
ISMP’s recommendations to help prevent dangerous mix-ups with between the two drugs…

Drug Name Confusion between Kuric (ketoconazole) and Carac (fluorouracil)
Helping to prevent mix-ups between these two topical creams with “sound-alike” names…

New Labels for Non-prescription Cough and Cold Medications
Most makers of these products are changing the labels to say “do not use” for children under 4…

Posted 01/12/2009


FDA MedWatch-Terumo Cardiovascular Systems Tenderflow Pediatric Arterial Cannulae- Recalled due to reports of difficulty retracting the introducer from the cannula

Terumo Cardiovascular Systems notified healthcare professionals of a worldwide recall of its Tenderflow Pediatric Arterial Cannulae involving 21 lot codes (see Terumo press release for complete list). Terumo received five reports of difficulty retracting the introducer from the cannula. When the introducer cannot be retracted from the cannula, the cannula must be removed and replaced, a process that may lead to aortic damage, blood loss and/or death. Healthcare professionals are advised to not use the product unless medically necessary. In those cases, the cannula should be used without the introducer.
Read the MedWatch 2008 safety summary, including a link to the firm press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Tenderflow

Posted 12/10/2008


FDA MedWatch – The December 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 e-list. 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 December 2008 edition include:

Statin Use and the Risk of ALS
Recent FDA analysis indicates that using statins does not increase the risk of amyotrophic lateral sclerosis (ALS)…

Leukemia Risk with Intra-Articular Use of Phosphocol P 32
Phosphocol P 32 is not approved for intra-articular injection and safety and effectiveness in children has not been established…

Problems with Medtronic Intrathecal Catheters
Incomplete connection between the sutureless pump connector and the catheter port may lead to severe medication underdosing…

Hepatic Failure and Hepatorenal Syndrome with Tarceva (erlotinib)
Patients with hepatic impairment and who are treated with Tarceva should be monitored closely…

Filter Ammonul to Remove Particulates
Since particulates may not be visible, the filter included in future shipments of Ammonul should be used…

Drug Name Confusion: Ephedrine and Epinephrine
ISMP’s recommendations to help prevent mix-ups between ephedrine and epinephrine…

Removing Insulin from Cartons
Once opened, insulin vials stored in cardboard cartons may lead to potentially serious insulin mix-ups…

Recognizing Warfarin Brand Names
When dispensing branded generics, such as Jantoven (warfarin), use both brand and generic names to help prevent errors…

More Heparin Dosing Errors with Neonates
ISMP’s recommendations on preventing dangerous overdoses in neonates…

Posted 12/1/2008


MedWatch – WalMart “ReliOn” insulin syringe recall due to potential for serious overdose

ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare – Covidien)
Audience: Patients with insulin-dependent diabetes; pharmacists
Covidien and FDA notified patients and healthcare professionals of a recall of ReliOn sterile, single-use, disposable, hypodermic syringes with permanently affixed hypodermic needles. The mislabeled syringe may result in patients receiving an overdose of as much as 2.5 times the intended dose, with serious health consequences, low blood sugar, and even death. These syringes are sold only by Wal-Mart or Sam’s Club pharmacies under the ReliOn name. The recall applies only to lot number 813900. The product was distributed from Aug. 1, 2008 until Oct. 8, 2008, and includes 471,000 individual syringes in 4,710 boxes. FDA urges patients and health care professionals to check syringe packaging carefully for products with this lot number, not to use the product, and return the product to the pharmacy for replacement. The lot number can be found on the back panel of the 100 count syringe carton, or on the white paper backing of each individual syringe “peel-pack”.
Read the complete MedWatch 2008 Safety summary, including a link to the FDA press release, at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#ReliOn

Posted 11/6/2008


FDA MedWatch – The September 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. This special edition repeats some of the most important safety issues that continue to pose a public health problem. 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 September 2008 edition include:

Mixups between Insulin U-100 and U-500 (April 2008)
ISMP describes medication errors could result in dangerous hyperglycemia or hypoglycemia…

Severe Pain with Osteoporosis Drugs (March 2008)
Incapacitating musculoskeletal pain can occur in patients taking certain bisphosphonate drugs such as Fosamax, Actonel, Reclast and Boniva…

Preventing Meningitis in Children with Cochlear Implants (December 2007)
FDA reminds healthcare professionals and parents about the importance of following immunization recommendations for children with cochlear implants…

More Patient Deaths from Luer Misconnections (October 2007)
Design of luer connectors makes it easy for unrelated delivery systems to be connected to each other, sometimes with disastrous results…

Preventing Patient Deaths from Fentanyl Patches (September 2007)
Patches should only be prescribed for patients who are opioid-tolerant, not those with post-operative or acute pain…

What to Do about Unretrieved Device Fragments (January 2008)
The fragments may have been left in the body because they could not be retrieved or because the risk of removing them was greater than the risk of leaving them in place…
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 8/30/2008


FDA MedWatch -The August 2008 FDA Patient Safety News Video 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 August 2008 edition include:
Warning Added to Regranex (becaplermin) Label
Use caution when treating diabetic foot and leg ulcers with Regranex in patients who have known malignancies…

Cellcept and Myfortic Linked to Birth Defects and Fetal Loss
Before prescribing these drugs, healthcare professionals should ensure that women are not pregnant and are using two effective forms of birth control…

Possible Association between TNF Blockers and Cancer
Ongoing safety reviews of Remicade, Enbrel, Humira, and Cimzia…

Danger Giving Topical Thrombin Intravascularly
ISMP recommends ways to reduce the risk of errors that can lead to extensive intravascular clotting and death…

Potential Problems with Insulin Pens in Hospitals
Insulin pen design and usage issues can present safety concerns…

Nonoxynol 9 (N9) Contraceptives: No Protection against HIV and Other STDs
Labeling warns that using nonoxynol 9 may increase the risk of contracting HIV/AIDS from an infected partner…
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 8/4/2008


FDA MedWatch -Electronic Medical Devices- Possible Malfunction Caused By Computed Tomography (CT) Scanning

FDA informed healthcare professionals of the possibility that x-rays used during CT examinations may cause some implanted and external electronic medical devices to malfunction. Most patients with electronic medical devices undergo CT scans without any adverse consequences. However, the Agency has received a small number of reports of adverse events in which CT scans may have interfered with electronic medical devices, including pacemakers, defibrillators, neurostimulators, and implanted or externally worn drug infusion pumps. FDA is continuing to investigate the issue and is working with the manufacturer to raise awareness in the healthcare community. See the FDA Public Health Notification for a description of adverse event reports and recommendations regarding reducing the potential risk to patients.
Read the entire 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#ElectronicMedical

Posted 7/17/2008


FDA MedWatch – The June 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 June 2008 edition include:
Inflammatory Masses with Synchromed EL, Sychomed II and IsoMed Implantable Infusion Pumps
Medtronic updates patient management and treatment recommendations for patients receiving intrathecal drugs…

FDA Studying Potential Safety Issues with Several Drugs
Ongoing safety reviews of CellCept (mycophenolate mofetil), Myfortic (mycophenolic acid), Singulair (montelukast), and the Spiriva Handihaler (tiotropium)

Neupro (rotigotine) Patches Recalled
Rotigotine may crystallize, which may affect absorption of the drug through the skin…

Avoid Using ReadyMED Infusion Pumps with Cubicin
Impurity isolated from reconstituted Cubicin that was stored in ReadyMED pumps…

Getting the Most Out of Blood Glucose Meters
Tips to help people with diabetes get accurate results from their glucose meters…
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 6/2/2008


FDA MedWatch- Xiadafil VIP Tablets- Product Contains Potentially Harmful, Undeclared Ingredient That May Cause Life-Threatening Side Effects

FDA alerted consumers and healthcare professionals not to buy or use Xiadafil VIP Tablets sold in bottles of 8 tablets (Lot #6K029) or blister cards of 2 tablets (Lot# 6K029-SEI). The product is marketed as a dietary supplement and is promoted and sold over the internet for sexual enhancement and to treat erectile dysfunction (ED). The product contains a potentially harmful, undeclared ingredient that may dangerously affect a person’s blood pressure and can cause other life-threatening side effects. Xiadafil VIP Tablets contain hydroxyhomosildenafil, an analog of sildenafil, the active ingredient in Viagra, an FDA approved prescription drug for ED. The undeclared ingredient may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Consumers who have used the product should discontinue use immediately and consult their healthcare professional if they have experienced any adverse events that they believe may be related to the use of this product.
Read the entire 2008 MedWatch Safety Summary, including a link to the Agency’s News Release regarding this issue at:
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Xiadafil

Posted 5/27/2008


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 – 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


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 – 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 – The FDA Safety Information and Adverse Event Reporting Program
U.S. Marshals seized approximately $71,000 of goods from FulLife Natural Options, Inc., which marketed and distributed Charantea Ampalaya Capsules and Charantea Ampalaya Tea. Although these products are labeled as dietary supplements, they are being promoted by FulLife for use in treating serious conditions, such as diabetes, anemia, and hypertension.
These claims are evident in the products’ labeling, including promotional literature and FulLife’s Internet Web site.
FDA considers these products to be unapproved new drugs because they make claims related to the prevention or treatment of diseases in the products’ labeling. Before a new drug product may be legally marketed, it must be shown to be safe and effective, and approved by FDA. This action protects consumers who may rely on unapproved products and unsubstantiated claims associated with these products when making important decisions about their health.
Read the complete MedWatch 2007 Safety Summary including a link to the FDA Press Release, at:
http://www.fda.gov/medwatch/safety/2007/safety07.htm#CharanteaPosted 10/15/2007

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