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Wednesday, July 21, 2010

FDA Panel Keeps Avandia on the Market

Last week, a 33-member FDA panel met for two days to hear presentations about Avandia and its side effects and benefits. Their job was to decide whether Avandia should be withdrawn from the market or not.

Avandia (rosiglitazone) is a medication for Type 2 Diabetes, also called adult onset diabetes. It is made by GlaxoSmithKline, Britain’s largest pharmaceutical company and has been a big seller for many years, helping to control blood sugar levels, but never curing diabetes. It has been found to cause cardiac problems and lead to cardiac arrest.

One reason Avandia is a controversial drug is that many medical professionals support its continued use. According to many studies, the risk of heart problems from Avandia has been 0.3 percent and though it has recently risen, the rise is only to 0.4 percent. In other words, four out of every hundred people taking Avandia may experience a heart problem, not necessarily severe. To many, this is an insignificant risk, far outweighed by Avandia’s benefits for diabetes.

The FDA Panel Divided

Panel members were asked a series of questions and they voted on each one to register their decision about it. They were using a new voting system that caused some confusion, since some panel members pushed the wrong button and wanted to change their votes.

In a split vote, members voted to keep Avandia on the market. Twelve of the 33 members voted to withdraw it and three voted to keep everything as it is. Some wanted to restrict the type of doctor who can prescribe it – perhaps endocrinologists only. Many wanted to keep Avandia only as a second choice if another diabetes drug such as Actos failed in any given case.

For several of the questions, many felt that the data presented was inadequate for making any decision:

  • Twenty panelists voted that data was insufficient for judging safety concerns on death from Avandia; one thought it was sufficient; 12 abstained.
  • On the question of whether Avandia is safer than Actos, 12 voted the data was inadequate; seven that it was adequate; and 14 abstained.

Avandia will Stay

The panel did decide that Avandia will remain on the market, but as a back-up drug after another drug has been ineffective. It is a common situation in medicine that a given drug does not work well for a given patient and therefore a second drug is prescribed. So this panel decision does not seem to change the status quo much, except to delay Avandia for patients for whom it could have been an immediately effective treatment.

FDA-approved drugs are quite often determined later to cause pharmaceutical injury. Although the FDA trials are extensive, time-consuming, and expensive for the drug manufacturer, they cannot possibly predict how every individual person will react to every specific dose of each specific drug. There will always be a need for doctors to make a judgment call, perhaps use a drug off-label, and when necessary, prescribe a second drug.

If you have been harmed by a defective drug, or if you have lost a loved one in a wrongful death arising from a defective drug, please contact us for a free case review. We have offices throughout the nation.

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posted by Benjamin A. Irwin at 1:17 PM

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