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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

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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 - 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#Charantea Posted 10/15/2007

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