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Avandia Lawsuits, Recall, and Update

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Avandia-logo-02-24-10.jpgIf my Google Reader subscriptions are any indication, about 50% of the new blog posts across the web in the past couple of days have been about Avandia. This post is intended as a hub for basic information on Avandia and the status of the proposed Avandia recall.

Indications:
Avandia is used to treat type 2 diabetes mellitus. That type of diabetes, commonly called adult-onset diabetes or non-insulin-dependent diabetes mellitus, is reflected by high blood glucose and insulin deficiency/resistance. Avandia (rosiglitazone), as well as Avandamet and Avandaryl (two drugs combining rosiglitazone with either metformin or glimepiride), is intended to help the body use its natural insulin for better glucose control.


Contraindications:
Avandia should not be used by patients with certain types of heart failure. In May 2007, the FDA required a black box warning recounting Avandia’s association with myocardial ischemia (angina). The manufacturer’s website posts the following warning:

AVANDIA can cause or worsen heart failure. If you have severe heart failure (very poor pumping ability of the heart) you cannot be started on AVANDIA. AVANDIA is also not recommended if you have heart failure with symptoms (such as shortness of breath or swelling) even if these symptoms are not severe.
AVANDIA may increase your risk of other heart problems that occur when there is reduced blood flow to the heart, such as chest pain (angina) or heart attack (myocardial infarction). This risk appeared higher in patients taking medicines called nitrates or insulin.

Furthermore, it may be contraindicated in patients with a history of other forms of diabetes or liver problems.

Injuries:
There are two major types of injuries that are being associated with Avandia. The first is heart attacks—in July 2007, FDA scientists determined that Avandia caused more than 80,000 heart attacks. Some FDA officials recommended that the drug be recalled at that time; however, the FDA took the step of requiring a black box warning, instead.
The second is liver injuries—as reported by the Drug Injury Watch, an article in Pharmacoepidemiology and Drug Safety, published in July 2009, links Avandia to liver failure.

Timeline:

  • May 25, 1999: Avandia released to the market by GlaxoSmithKline (GSK).
  • May 2007: Cleveland Clinic analysis of 42 clinical trials, showing that Avandia patients had a 43% higher risk of a heart attack.
  • July 2007: FDA estimates that Avandia responsible for over 80,000 heart attacks.
  • October 2008: two FDA scientists recommend Avandia recall.
  • November 2007: FDA requires Avandia black box warning.
  • August 2009: FDA receives GlaxoSmithKline’s RECORD study results. RECORD was a large (2,220 patients), long-term (5.5 years) clinical study designed to evaluate risks of Avandia.
  • July 2010: FDA will hold a joint public meeting of Endocrinologic and Metabolic Drugs and Drug Safety and Risk Management Advisory Committees to consider an updated assessment of risks and benefits of Avandia.

Public Furor:
The reason this is all coming to a head now is because of a February 20 Senate Finance Committee report on Avandia. The report took two years to write and involved a review of documents from GlaxoSmithKline, the FDA, and several research institutes. In particular, the report criticizes the FDA’s internal structure and its alliance with drug companies, all of which seem to preclude, rather than protect, patients. The FDA is being pressured to move up the timeline to review the RECORD and other studies, but it appears that they are steadfastly holding to their July 2010 timetable.

Patient Reaction:
What’s a patient to do? Per the FDA:

There are a lot of moving parts with this drug right now. The FDA’s July meeting will be interesting and may give support to the thousands of people who have filed Avandia lawsuits.