Hot Topics
Avandia Under Fire
Released on February 20th, the results of a two-year Senate Finance Committee investigation into the popular diabetes drug Avandia have focused a brighter spotlight on a product which has been under scrutiny for a number of years. Avandia has been the subject of particular concern since 2007, when an FDA investigation into possible cardiac side effects nearly led to a recall. Instead, a “black box” warning was added to the drug’s labeling that August. The Senate Committee report included recommendations by two FDA reviewers that Avandia be taken off the market due to the increased risk of cardiac side effects, including heart attack. On February 22nd, FDA advised patients to continue taking the drug unless otherwise directed by their doctor, but did schedule a July 2010 advisory panel to discuss the issue (which will be the second such panel since 2007). The Senate report is also making headlines because of suggestions that Avandia’s maker, GlaxoSmithKline, knew of the cardiac risks associated with the product years before investigations began but worked to minimize concern over them instead of warning physicians and the public. Make sure you have all the background as this topic continues to make headlines.
Extensive Device Recalls
Japanese manufacturer Nipro Corp. is involved in two extensive recalls announced in January. Nipro Medical Corp., a Miami-based subsidiary of the firm, has issued a recall of all its GlucoPro insulin syringes with expiration dates prior to November 2011. There is concern over a defect which may cause the needles to detach during use.
In an even more extensive move, Nipro has voluntarily recalled over 2 million of the Exel/Exelint Huber needles and infusion sets it makes for Exelint International Corp. During an October 2009 inspection of Nipro’s manufacturing facilities in Japan, FDA found that over 60% of the needles tested cut slivers of silicone when in use. This “coring” defect poses a high risk of introducing silicone into the veins or surrounding tissues of patients. The recall is being classified as a Class I recall, indicating a “reasonable probability” that use of the product could cause “serious adverse health consequences or death”.
Here you’ll find documents on GlucoPro and Huber syringes, as well as warning letters regarding previous concerns over Nipro products.