Product News and Recalls

FDA withholds approval of diabetes treatment

The U.S. Food and Drug Administration will hold off on approving Novo Nordisk’s diabetes medication Tresiba, a long-acting insulin, until the company conducts extra tests to address heart risks.

A Reuters story says over-eating and lack of exercise have created an “epidemic” of type 2 diabetes, creating a high demand for treatment.

But the FDA is wary of new diabetes treatments, in light of controversy over GlaxoSmithKline’s Avandia pill. According to Reuters, Avandia had been on the market for many years before researchers linked it to serious heart problems.

Other type 2 diabetes medications that studies have recently associated with health problems include Byetta and Januvia, both of which have been linked to pancreatitis and pancreatic cancer. Byetta has also been linked to an increased risk of thyroid cancer.

According to Reuters, the FDA had requested additional data from a trial focused on cardiovascular effects before it would consider approving Tresiba and related product Ryzodeg.

At a meeting last year, FDA advisers voiced concern about a trend toward higher incidence of adverse heart events with the new insulin than with older ones.

Following the announcement, shares in Novo dropped 12.5 percent. Meanwhile, shares in rival insulin producer Sanofi rose 4.5 percent.

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/2013/02/11/us-novonordisk-tresiba-idUSBRE9190DK20130211