Avandia, marketed by GlaxoSmithKline, has been a popular drug prescribed to diabetics in the U.S. Because of their disease, diabetics are at high risk of heart attack and heart failure – in fact, two-thirds of people with diabetes die of heart problems. Diabetics have been prescribed Avandia largely to lessen their chance of heart attack and heart failure. However, Avandia has been found to increase the risk of heart disease in patients who use it for a long period of time. Avandia has been investigated by the Food and Drug Administration since 2007, but it is still available in the U.S. market. An estimated 13,000 Avandia law suits have been brought against the company since 2007.
To date, GlaxoSmithKline has settled in over 10,000 of the Avandia law suits, paying out an estimated $1 – $6 billion dollars in damages. Successful Avandia lawyers have represented individuals who can connect their experience of one of the following conditions to taking Avandia: congestive heart failure, heart attack, liver toxicity, severe allergic reaction and stroke. The drug maker, GlaxoSmithKline, has been accused of withholding information from the FDA and patients of potential side effects of the drug. Evidence suggests that the drug maker had documentation of these risks and withheld the information in order to continue to sell this popular product. In its investigation of Avandia, the Senate Finance Committee revealed that GlaxoSmithKline paid to have articles written lauding the value of Avandia in spite of GlaxoSmithKline’s awareness of opposing evidence as early as 2000.
Despite three years of investigations into the drug and the thousands of law suits GlaxoSmithKline that have been filed by Avandia lawyers, the drug is still used in some cases in the U.S. Conflicting studies have created disagreement at the FDA over the safety of Avandia. In 2007, the FDA voted to keep the drug on the market, but added a “black box” warning about the serious health risks of Avandia. The FDA voted again in July 0f 2010 that Avandia would still be available in the U.S.. The idea of attaching a new, stronger warning was discussed but rejected at that time. During September of 2010, the FDA finally voted to restrict the sale of Avandia to patients who had no other alternative. Sales of the drug dropped significantly following the release of FDA warnings in 2007 and some physicians reportedly have stopped prescribing the drug to their patients altogether. The FDA recommends that patients continue the drug until their physician prescribes an alternative.
Avandia passed initial safety testing and was approved for use in the U.S. by the Food and Drug Administration, and was also in wide use in Europe and other countries. However, testing for drugs, which occurs over a two- to three-year period, did not reveal the negative effects of taking the drug over the long-term. Two- to three-year testing is most effective for drugs used to treat acute symptoms in the short term, but the failure to detect the side effects of prolonged ingestion of Avandia suggests that another method for long-term drug testing needs to be established. It is interesting to note that the FDA’s Associate Director of Drug Safety pointed to alternative prescriptions withequal efficacy in treatment but without the deadly side effects much earlier. There have since been numerous news articles regarding the FDA’s use of advisory boards with members being on the drug manufacturer’s payroll. The US Senate Finance Committee has previously alleged GlaxoSmithKline knowingly withheld vital safety information about Avandia from the FDA and the public. Plus thousands of Avandia lawyers are proceeding with their own discovery process as part of the lawsuits over Avandia they are engaged in. While the questions about the FDA’s handling of Avandia are now numerous, the questions about Avandia have now largely been answered, and it has been proven to be a deadly diabetes drug, whereas others are not.