Product News and Recalls

European regulators approve diabetes drug

The European Commission has approved a diabetes medicine that U.S. regulators have rejected, Reuters reports.

The medication, by Bristol-Myers Squibb Co and AstraZeneca Plc, is called Forxiga. It’s part of a new class of diabetes drugs that work independently of insulin to control blood sugar.

Its manufacturers are touting Forxiga’s capacity for lowering blood pressure and inducing weight loss. But when regulators with the U.S. Food and Drug Administration rejected it in January, they cited concerns about the risk of cancer and liver injury and asked for more clinical data on the once-daily tablets.

Some diabetes drugs already approved in the United States have raised concerns as well. Studies have linked the diabetes medications Byetta and Januvia to pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

According to Reuters, Forxiga works by blocking a protein called SGLT2, or sodium-glucose cotransporter 2. It’s supposed to be used in combination with other treatments for type 2 diabetes, including insulin. It can also be used as a standalone treatment for patients who can’t use the oral medication metformin.

According to the story, Bristol-Myers officials intend to resubmit the company’s U.S. marketing application for Forxiga by mid-2013. Johnson & Johnson is also awaiting approval of canagliflozin, its own drug in the same class as Forxiga.

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.reuters.com/article/2012/11/14/us-bristolmyers-astrazeneca-diabetes-idUSBRE8AD1JR20121114