Product News and Recalls

FDA: Diabetes drug has heart risks

U.S. Food and Drug Administration staffers said a diabetes drug called canagliflozin, which Johnson & Johnson submitted for review, may carry heart risks.

The development could jeopardize Johnson & Johnson’s ambitions in the profitable diabetes medication market, Bloomberg reports.

The pill, which Johnson & Johnson proposed marketing under the name Invokana, is part of a new class of diabetes treatments aimed at cutting side effects from current drugs. Variations are being developed by Eli Lilly & Co., Boehringer Ingelheim GmbH, Bristol-Myers Squibb Co. and AstraZeneca Plc.

But some of the previously approved drugs have proven problematic. Merck’s Januvia and Eli Lilly’s Byetta have been linked to pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

FDA staffers said canagliflozin worked as well as Januvia in clinical trials. But they also found that canagliflozin showed a potentially higher risk for heart events in the first 30 days compared with a placebo.

Bloomberg says an FDA advisory panel, which will make recommendations on the drug, is set to meet Jan. 10. Regulators are expected to make a recommendation on the drug’s approval by the end of March.

You should consult with a doctor if you have any ongoing symptoms or health concerns, and before making any changes in medication. You should also consult with a Lopez McHugh attorney if you or a loved one was diagnosed with pancreatic cancer after taking Januvia or Byetta.

See the story here:

http://www.businessweek.com/news/2013-01-08/j-and-j-diabetes-pill-may-have-heart-risks-fda-staff-says