FDA Panel Says Agency Should Reject New Diabetes Drug

A U.S. Food and Drug Administration’s (FDA) advisory panel voted yesterday against approving dapagliflozin, a diabetes medication linked to potential liver damage and cancer of the breast and bladder.

In a 9-to-6 vote, the FDA advisory panel voted against Bristol-Myers Squibb and AstraZeneca’s joint diabetes effort. The vote and panelist comments point to uncertainty with the drug, which is designed to remove sugar from the body and drop weight, explained WebMD. The agency will probably ask both drug makers to provide more information on side effects; however, said WebMD, it remains unknown if the request will come prior to or following approval of the controversial medication.

Dapagliflozin is the first drug in an emerging diabetes drug class to block glucose absorption into the bloodstream via the kidneys. Developed to minimize SGLT-2, a transporter molecule that moves sugar out of the body through the urine, not through the kidneys, means blood sugar, not insulin, is lowered, explained WebMD.

This process could be linked to increased cancer risks and does increase risks for urinary tract and genital infections because dapagliflozin leaves more sugar in the urine and could be acting as a bacterial and pathogenic nutrient, said Elisabeth Svanberg, vice president of development for dapagliflozin at Bristol-Myers, wrote Reuters previously. Dapagliflozin was also found to lead to dehydration, an intolerance to heat, and bone issues.

Patients also lose weight on this drug. In testing, patients diagnosed with Type 2 diabetes who took dapagliflozin for six months reportedly lost 1 to 5 pounds wrote WebMD. A special study specifically looking at diabetics and weight loss found that 30 percent of the participants taking dapagliflozin plus metformin lost 5 percent of their total body weight, added WebMD.

The FDA previously mentioned that dapagliflozin does not work as well in diabetics with impaired kidney function; WebMD noted that dapagliflozin can damage the kidney and even a small kidney function loss can render dapagliflozin much less effective. While dapagliflozin is only meant for patients with sufficient kidney function, some FDA panelists expressed concern about a potential test to determine kidney function for dapagliflozin treatment, reported WebMD.

According to clinical trials, more cases of breast and bladder cancers were seen in dapagliflozin patients than in those on a placebo, with 9 cases each of bladder cancer and breast cancer in dapagliflozin patients versus 1 each in the placebo, said Medical News Today, citing the clinical trials.

Diabetes drugs can be a troublesome class of medications, and several already on the martket have been associated with serious side efects. Actos, for instance, has also been linked increased risks for bladder cancer, prompting the Endocrine Society, the American Association of Clinical Endocrinologists, and the American Diabetes Association to urge diabetics to follow physician and FDA guidance. FDA guidance indicates that when taking Actos, there is the potential for increased risk of bladder cancer and patients should not take Actos if receiving bladder cancer treatment. Actos is being pulled from the French market because of this potential risk.

By November, the diabetes drug Avandia (rosiglitazone) will no longer be available in U.S. retail pharmacies. Patients prescribed Avandia will only be able to obtain the controversial medication from select certified pharmacies via mail order and only if they meet specific requirements. Heart risks prompted the FDA to impose the severe restrictions.

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