Drugs/Therapy

Merck Drug Side Effects Revealed in Study, Already Retailing in Europe

By Jennifer Broderick | Update Date: Mar 09, 2013 11:03 PM EST

Dangerous and unexpected drug side effects were found in a study of a Merck & Co niacin drug caused increased bleeding and/or infections, according to a report released Saturday.

Niacin, a B vitamin that's been a staple of heart treatment for years, is commonly used to try to lower "bad" LDL cholesterol and raise "good" HDL cholesterol. Niacin - in doses about 100 times higher than the recommended amount from food - was thought to be helpful.

The Merck drug Tredaptive used in the study, which is a combination of niacin with laropiprant - is already approved in 70 countries, though not the US, according to Agence France-Presse. The study of 25,673 patients found the drug failed to reduce the risk of stroke, death, heart attack or the need for surgery in people with vascular diseases. .

The study also revealed that patients taking niacin had more incidents of bleeding and/or infections than those who were taking an inactive placebo. The patients taking the drug also had a more than fourfold increased risk of muscle pain or weakness compared to the placebo group, the team noted.

"We are disappointed that these results did not show benefits for our patients," study lead author Jane Armitage, a professor at the University of Oxford in England, said in a meeting news release. "Niacin has been used for many years in the belief that it would help patients and prevent heart attacks and stroke, but we now know that its adverse side effects outweigh the benefits when used with current treatments."

Meanwhile, a European medical journal last week said the drug caused concerning muscle weakness, especially in Asian patients. The results were revealed at annual meeting of the American College of Cardiology on Saturday in San Francisco.

"The main reason for patients stopping the treatment was because of adverse side effects, such as itching, rashes, flushing, indigestion, diarrhea, diabetes and muscle problems," Armitage said at the time in a journal news release. "We found that patients allocated to the experimental treatment were four times more likely to stop for skin-related reasons, and twice as likely to stop because of gastrointestinal problems or diabetes-related problems."

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