FDA Declines Diabetes Drug

Diabetes drug dapagliflozin not approved by FDA advisory committee

/ Author:  / Reviewed by: Joseph V. Madia, MD

(RxWiki News) Even if sceintist believe a drug is a breakthrough in the treatment of a disease, it is not a shoe-in for FDA approval. Dangerous side effects can keep a drug off the market.

That is exactly what happened recently with a new diabetes drug called dapagliflozin.

An advisory committee to the FDA voted 9 to 6 that dapagliflozin should not be approved because the drug may raise the risk of breast and bladder cancers.

"New diabetes drug requires more testing."

Even though the FDA does not have to listen to its advisory committees, it is unlikely that it would decide to send the drug to market after getting a vote saying not to do so.

Dapagliflozin - which is being developed by Bristol-Myers Squibb and AstraZeneca - is the first in a new class of drugs called sodium-glucose co-transporter 2 (SGLT2) inhibitors. With the addition of diet and exercise, these drugs are made to help diabetes patients control their blood sugar levels. SGLT2s are different than other diabetes drugs because they cause blood sugar to be expelled from the body through urine.

David M. Capuzzi, M.D., from Thomas Jefferson University and one of the committee members that voted no, told the New York Times that even though there are many aspects of the drug that committee members liked, there is not yet enough information on how to use it and to make sure that it is safe and effective.

Studies on dapagliflozin showed that while the drug helps patients lower their blood sugar levels by as much as 84 percent, it may also lead to genital infections, liver damage, and possibly even breast and bladder cancers.

Although the number of patients who got cancer was small, the risk possible risk should not be taken lightly. As Dr. Doris B. Strader from the University of Vermont told the New York Times, "The breast and bladder cancers, I can't dismiss as being irrelevant or minor."

The no-vote from this advisory committee does not mean that the FDA will not approve the drug in the coming years.

The committee members told the New York Times that more research should be done on the potential cancer risk as well as the other side effects before the FDA decides to approve the drug.

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Review Date: 
July 20, 2011
Last Updated:
July 22, 2011