Don't look for GlaxoSmithKline's Avandia at your local pharmacy in six months. The controversial diabetes drug, now withdrawn in Europe, will be pulled from pharmacies November 18, the FDA said. After that, Avandia will only be available in the U.S. through a special access program.
The change is part of a risk management program required by the FDA after a long debate over Avandia's cardiovascular safety. Since 2007, experts have argued about Avandia's potential link to heart attacks and other serious heart problems. The FDA reviewed study data more than once, and last year, it decided to sharply restrict the drug in the U.S. On the same day, European regulators decided to ban it.
As Bloomberg notes, Avandia was once the world's best-selling diabetes pill. It boasted $3 billion in annual revenue. But by last year, that figure had dropped to $680 million, and in the future, GSK expects much less. As part of the new U.S. restrictions, GSK agreed not to market the drug at all, and with the risk-management program coming into play, even those patients who already know about the drug will have a tough time getting it.
After November, only patients who are already taking Avandia--or those who failed to get enough benefit from other diabetes drugs, or specifically refuse to take Avandia's closest rival, Actos--will be able to get it. These patients and their doctors will also have to enroll in an access program. As Forbes notes, these restrictions will drive Avandia sales down to little or none. Doctors will try eveything else first.
- see the announcement from the FDA
- read the Forbes coverage
- get more from the Los Angeles Times
- check out the Bloomberg article