Glaxo failed to provide FDA with complete data on Avandia side effects
GlaxoSmithKline Plc, maker of the diabetes drug Avandia, received a harsh warning letter from the FDA this week as a result of their failure to report safety results as required by federal regulations. Over the past year, a lot of attention has been focused on Avandia side effects, since studies suggested that the medication increases the risk of heart attacks. The FDA letter states that Glaxo neglected to provide them with certain data between 2001 and 2007.
>>INFORMATION: Avandia Side Effects
The FDA labeled the omissions “serious” and indicated that the drug makers actions “may be symptomatic of underlying post-market reporting failures.” The FDA discovered the violations during an inspection of company records, and they have ordered Glaxo to take prompt action to prevent future failures.
The timing of the warning letter is interesting, given recent attempts by drug makers to escape liability for dangerous and defective drugs on the basis that the FDA approved the medications and their label. However, time and time again, drug makers demonstrate that they can not be trusted to police themselves, and the FDA largely relies on the pharmaceutical companies to provide them with information about adverse events and clinical studies.
The FDA’s oversight of prescription medications has been loudly criticized recently by groups who point out that it took years for the agency to identify the life threatening side effects of Avandia and Vioxx, a painkiller manufactured by Merck, which was withdrawn in 2004.
AVANDIA HEART SIDE EFFECTS
Information about Avandia side effects which could increase the risk of a heart attack, first surfaced in May 2007. An independent meta analysis of data from clinical studies conducted by Glaxo found that the diabetes drug increased the risk of heart attacks 43%. Some data has suggested that as many as 100,000 Avandia heart attacks may have been caused since the drug was approved.
Following internal debate within the FDA, a black box warning about the possible increased risk of heart attacks was added to Avandia’s label last year. Although an Avandia recall was not issued, the American Diabetes Association and European Association for the Study of Diabetes have issued consensus statements that Avandia side effects increase the risk of heart attacks, and many doctors have switched their patients to other drugs. In addition, the Department of Veteran Affairs has dropped Avandia from its drug formulary of available medications for members.
Following pressure from the FDA, Glaxo has agreed to conduct a long-term study reviewing Avandia heart side effects in comparison to other type 2 diabetes drugs. However, because Glaxo did not acknowledge the heart problems earlier and begin the study sooner, data is not expected until at least 2014.
AVANDIA LAWSUITS
The lawyers at Saiontz & Kirk, P.A. represent individuals who are pursuing an Avandia lawsuit after suffering a heart attack, stroke, heart failure or death caused by the diabetes drug. If you, a friend or family member have experienced Avandia heart problems, request a free consultation and claim evaluation.
No Comments • Add Your Comments