U.S. Food and Drug Administration Updates for Health Professionals
As part of our ongoing efforts to keep you informed about FDA issues, we want to make you aware of recent safety alerts, product approvals, announcements, upcoming meetings and resources. We have included a list of the issues, a brief summary of each issue, and links to detailed information on the FDA Web site.
PRODUCT SAFETY:
Serious Side Effects from Swallowing Topical Benadryl Product (May 12)
FDA is warning consumers about potentially serious side effects from mistakenly swallowing Benadryl Extra Strength Itch Stopping Gel, an over-the-counter (OTC) product that should only be used on the skin. FDA has received reports of serious side effects in people who have mistakenly swallowed the product. Some OTC Benadryl products are intended to be swallowed. However, Benadryl Extra Strength Itch Stopping Gel is only safe and effective when used, as directed, on the skin. People swallowing the gel can ingest a dangerous amount of the active ingredient, diphenhydramine. Large doses of diphenhydramine can result in serious side effects such as unconsciousness, hallucinations, and confusion.
Teleflex Medical Announces Worldwide Voluntary Recall of Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570) (May 6)
Teleflex Medical has announced a worldwide voluntary recall initiated on March 19, 2010, affecting certain lot numbers of the Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (HCH) (catalog number 1570), a passive humidifier indicated for use to effectively warm and humidify inspired gas during mechanical ventilation. The company received product complaints that the 22cm connector on the flex tube may not fit securely within the endotracheal tube (ET) connector. This may result in the product becoming disconnected from the patient ET tube. Device failure is recognizable by the user as an alarm from the ventilator, oxygen sensor or other compatible device to which the AQUA+FLEX tubing is connected. No injuries have been reported to date. However, a disconnected tube in ventilator dependent patients without prompt response to the alarm could lead to serious injury or death.
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients (May 4)
Alkermes and FDA notified healthcare professionals and patients of an update to the Warnings, Information for Patients, and Dosage and Administration sections of the Prescribing Information to strengthen language regarding the risk of injection site reactions based on postmarketing reports that had been received prior to June 2009.
Baxter Colleague Infusion Pumps: FDA Ordering Recall (May 4)
FDA notified healthcare professionals and consumers that it has ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps (Colleague pumps) currently in use. This action is based on a longstanding failure to correct many serious problems with the pumps.
GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer (May 3)
FDA notified healthcare professionals and patients of FDA's preliminary and ongoing review which suggests an increase in the risk of diabetes and certain cardiovascular diseases in men treated with GnRH agonists, drugs that suppress the production of testosterone, a hormone that is involved in the growth of prostate cancer.
Vita Breath Dietary Supplement (May 3)
FDA notified healthcare professionals, their patients, and consumers not to consume Vita Breath, a dietary supplement manufactured by American Herbal Lab and marketed at health fairs and on the Internet, because the product may contain hazardous levels of lead. The New York City Department of Health and Mental Hygiene analyzed a sample of Vita Breath and reported it contained 1,100 parts per million of lead. This level is more than 10,000 times higher than FDA’s maximum recommended level for lead in candy.
McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall (April 30)
McNeil Consumer Healthcare and FDA notified healthcare professionals of a voluntary recall of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States, including Tylenol, Motrin, Zyrtec, and Benadryl products. Some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events.
For more product safety information please visit our MedWatch website.
PRODUCT APPROVALS:
Combination Product Oral Contraceptive (May 6)
FDA approved Natazia, a combination hormonal tablet for use as an oral contraceptive. Natazia contains two female hormones, an estrogen (estradiol valerate) and a progestin (dienogest), and is the first four-phasic oral contraceptive marketed in the United States. Four-phasic refers to the doses of progestin and estrogen varying at four times throughout each 28-day treatment cycle.
Cellular Immunotherapy for Men with Advanced Prostate Cancer (April 29)
FDA approved Provenge (sipuleucel-T), a new therapy for certain men with advanced prostate cancer that uses their own immune system to fight the disease. Provenge is indicated for the treatment of asymptomatic or minimally symptomatic prostate cancer that has spread to other parts of the body and is resistant to standard hormone treatment.
For more information on drug approvals, please visit Drugs@FDA.
ANNOUNCEMENTS:
‘Bad Ad Program’ to Help Health Care Providers Detect, Report Misleading Drug Ads (May 11)
FDA launched a program designed to educate health care providers about their role in ensuring that prescription drug advertising and promotion is truthful, and not misleading. The Bad Ad Program is an FDA-sponsored educational outreach effort administered by the agency’s Division of Drug Marketing, Advertising, and Communications (DDMAC), in the FDA’s Center for Drug Evaluation and Research. “The Bad Ad Program will help health care providers recognize misleading prescription drug promotion and provide them with an easy way to report this activity to the agency,” said Thomas Abrams, director of DDMAC.