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FDA and Medical News
FDA NEWS
FDA Recalls Anemia Drug Omontys
On February 24, 2013, the FDA issued a voluntary nationwide recall of all lots of Omontys Injection, a drug manufactured by Affymax and Takeda Pharmaceuticals to treat anemia in adults receiving dialysis. The FDA issued the recall after 19 reports of anaphylaxis from dialysis centers throughout the United States were brought to its attention. Of these cases, there were three deaths, and the remaining patients required prompt medical intervention or hospitalization, with some being resuscitated. All anaphylactic reactions took place within 30 minutes of the patient receiving his or her first dose of Omontys. There have been no reports of reactions after subsequent dosing, or in patients who have completed their dialysis session.
“Due to the severity of the public health risk, we want to be certain that healthcare providers stop using Omontys,” said Howard Sklamberg, director, Office of Compliance, Center for Drug Evaluation and Research, in an FDA press release. “Americans deserve medications that are safe, effective, and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more,” he noted.
Until further information becomes available, healthcare providers should stop using Omontys and return the product to Takeda Pharmaceuticals. The FDA also asks that healthcare professionals and consumers report any adverse reactions to the FDA’s MedWatch program at www.fda.gov/medwatch/report.htm. For additional information, healthcare providers can call the Omontys reimbursement support line at (855) 466-6689.
FDA Approves Over-the-Counter Oxytrol for Women
On January 25, 2013, the FDA approved Oxytrol for Women, which is the first and only over-the-counter treatment for overactive bladder (OAB) in women, a condition that affects more than 20 million American women annually, most of who develop the condition between 45 and 60 years of age. While OAB is treatable, more than 80% of patients do not seek treatment because they think it is a normal part of aging, and they subsequently develop strategies to manage their condition, including wearing pads and mapping out the location of toilets.
Oxytrol for Women is a transdermal patch that releases oxybutynin 3.9 mg per day. Each patch works continuously for 4 days and nights. The approval for the switch from prescription to an over-the-counter form of oxytrol was based on nine studies that included more than 5000 patients. Studies determined that consumers could recognize OAB symptoms, understand labeling information, properly determine if the product was right for them, and use the drug appropriately in an unsupervised setting.
Adverse effects for Oxytrol for Women were mild and included skin irritation at the application site, dry mouth, and constipation. Oxytrol is also available for men, but only with a prescription. Oxytrol for Women will be available in stores beginning in September 2013. For more
information, visit www.oxytrolforwomen.com.
Angina Does Not Impact Adverse Cardiovascular Outcomes in Persons With Diabetes and Stable Coronary Artery Disease
According to the American Heart Association, at least 65% of adults with type 2 diabetes will die from a stroke, myocardial infarction, or another cardiovascular complication, making assessment of mortality risk essential for this population. Because angina is common in persons with type 2 diabetes and coronary artery disease (CAD), Gilles Dagenais, MD, Quebec Heart and Lung University Institute, Quebec City, and colleagues performed a post-hoc analysis of the BARI 2D (Bypass Angioplasty Revascularization Investigation 2 Diabetes) trial to assess the prognostic significance of the presence or absence of angina on mortality and cardiovascular outcomes in persons with these conditions.
Dagenais and colleagues’ study included a total of 2364 patients with type 2 diabetes and stable CAD, of whom 1434 had angina, 506 had angina equivalents (eg, dyspnea, diaphoresis, extreme fatigue, or pain at a site other than the chest), and 424 had neither at baseline. The authors compared the occurrence of death, myocardial infraction, stroke symptoms, and composite of death at 5-year follow-up between groups. There were a total of 316 deaths, with a cumulative death rate of 12% for those with angina, 14% for those with an angina equivalent, and 10% for those with neither (P=.3). The cumulative cardiovascular composite rates were 24% for those with angina, 24% in those with an angina equivalent, and 21% for those with neither (P=.5).
Because the risk of death and cardiovascular events was found to be similar between patients with and without angina or its equivalents, the authors concluded that patients with type 2 diabetes and stable CAD could be treated similarly with regard to risk stratification and preventive therapies, regardless of whether they have angina. For more information about this study, visit https://1.usa.gov/WDN1Wf.
