Product News and Recalls

Company pleads guilty to drug safety violations

Ranbaxy, a subsidiary of Japanese pharmaceutical company Daiichi Sankyo, has pleaded guilty to drug safety violations. According to a story in the New York Times, the company will pay $500 million in fines over allegations that it sold subpar drugs.

Company officials also allegedly made false statements to the U.S. Food and Drug Administration about manufacturing practices at two factories in India.

Daiichi Sankyo has faced other allegations recently concerning its medications.

Two clinical drug trials have prompted a U.S. Food and Drug Administration investigation into whether a blood pressure drug called Benicar increases the risk of heart-related deaths.

Benicar, the brand name for the drug known chemically as olmesartan, was given to some patients with Type 2 diabetes in both of the clinical trials to see whether it would slow the progression of kidney disease or diabetes. Other patients took a placebo. And in both of the clinical trials, diabetes patients who took the drug had a higher rate of death from heart-related causes than patients taking a placebo.

A recent Mayo Clinic report has also linked Benicar to stomach problems including chronic diarrhea, vomiting, intestinal inflammation and weight loss.

According to the New York Times, Ranbaxy pleaded guilty to three felony counts of violating the federal drug safety law and four of making false statements to the F.D.A. The company acknowledged that it failed to perform proper safety and quality tests on several drugs manufactured at its Indian plants.

The company also admitted that it knew certain batches of an epilepsy drug had tested positive for “unknown impurities” and had unreliable shelf lives. But it waited months to alert the F.D.A. and announce a recall, which ultimately involved more than 73 million pills.

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 lawyer if you have injuries connected with Benicar.

See the story here:

http://www.nytimes.com/2013/05/14/business/global/ranbaxy-in-500-million-settlement-of-generic-drug-case.html