For two days, an FDA panel considered the diabetes drug Avandia (rosiglitazone) and debated whether or not it should stay on the market. It is a drug for Type 2 diabetes, also called adult onset diabetes, made by Britain’s largest pharmaceutical company, GlaxoSmithKline. The panel has now decided to keep Avandia on the market but with new warnings and restricted use.
Glaxo is facing about 13,000 lawsuits over the tendency of Avandia to cause heart problems. Although Avandia has been one of the best-selling drugs worldwide, it has been linked to many cases of cardiac arrest.
While this has been given a great deal of negative publicity, many medical professionals regard the risk of heart attack as insignificant. The risk has risen, according to many studies, but only from 0.3 percent to 0.4 percent – that is, from three people per hundred who take the drug to four. Further, few of the cardiac arrest cases have been fatal and studies show that the death rate has not risen with the risk rate.
The FDA Panel Proceedings
There were 33 panel members and they listened to many presentations. They were asked a series of questions that called for a decision and to vote on each question, members pressed one of several buttons. This is a new voting system for the FDA and it caused some confusion, with some panelists changing their votes after pushing a wrong button.
The vote to keep Avandia on the market was a split vote, as 12 panel members voted to withdraw it and three voted to make no changes in warnings or use. There was vigorous debate over which type of doctor should be able to prescribe Avandia, with perhaps only endocrinologists having that authority. The panel debated having Avandia available only as a back-up medication after another drug, such as Actos, failed in a given case.
On several questions, panel members voted that the data presented to them was insufficient to make a decision:
•They voted 20 to 1 that the data was insufficient to justify significant safety concerns over death and 12 members abstained – in the FDA’s current terminology, they “could not make a finding” on that issue.
•The panel voted 12 to 7 that data was insufficient to determine that Avandia was safer than Actos and 14 abstained.
The General Outcome
Avandia will stay on the U.S. market but will be used after another medication has failed to be effective. There will be no restriction on which type of doctor can prescribe it. Overall, this is not a big change. There is always the possibility that one drug will be ineffective for a given patient and another will work well. A doctor needs to have leeway to make individual decisions and if there is more choice in available drugs, rather than less, that is helpful in giving good patient care.
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