Product News and Recalls

FDA advisers recommend approval of diabetes medication

A panel of advisers to the U.S. Food and Drug Administration voted 10-5 that Johnson & Johnson’s diabetes drug should be approved, although they also voted 8-7 that it also raises concerns about heart risks.

According to Bloomberg, the once-a-day pill that the company has proposed calling Invokana is part of a group of medications known as SGLT2 inhibitors, which are intended to minimize side effects such as low blood sugar and weight gain compared to current diabetes drugs.

Johnson & Johnson is trying to get it to market before similar drugs in development from competitors.

The company’s studies showed the drug worked as well Merck & Co.’s second best-seller Januvia. That could give Johnson & Johnson an advantage because Januvia and diabetes drug Byetta have both been linked to pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

Invokana raises LDL, or bad cholesterol, which may lead to the heart risk, despite favorable changes in HDL, or good, cholesterol, blood pressure and body weight. An earlier report indicated the drug may carry heart risk, although FDA staff said the agency isn’t yet ready to declare a definite link.

According to Bloomberg, Johnson & Johnson representatives said the company plans to complete its review of heart risks in 2015.

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.bloomberg.com/news/2013-01-10/j-j-clears-u-s-advisers-in-bid-for-new-diabetes-drugs.html