Product News and Recalls

Clinical trial sounds warning about Tredaptive

A clinical trial found that the cholesterol drug Tredaptive increased the rate of side effects such as bleeding and infections, while failing in its ostensible purpose of reducing stroke, heart attack, death or the need for surgery in patients with vascular disease.

According to a Bloomberg report, researchers presented the study of 25,673 patients at the American College of Cardiology meeting in San Francisco.

Tredaptive’s manufacturer, Merck, has suffered from other recent setbacks.

Another study has found that Merck’s diabetes drug, Januvia, may double the risk of a pancreas inflammation called pancreatitis. That study found a similar risk for a Bristol-Myers Squibb diabetes drug called Byetta. Previous studies have linked Januvia and Byetta to pancreatitis and pancreatic cancer, and Byetta to thyroid cancer.

In December, Merck announced that it wouldn’t seek U.S. approval for Tredaptive, which combines the vitamin niacin with the experimental medicine laropiprant. And in January, the company stopped selling it globally.

According to Reuters, the study found that 2.5 percent of patients suffered bleeding while they were taking Tredaptive, compared to 1.9 percent of study participants taking a placebo.

The rate of infections for patients taking Tredaptive was to 8 percent, compared to 6.6 percent for those taking a placebo.

Patients taking Tredaptive also reported higher rates of diabetes, complications from diabetes, gastrointestinal problems, and rashes or itching, the story says.

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/2013-03-09/merck-heart-drug-tredaptive-raises-side-effects-in-study.html