Category: Drug Recalls

FDA May Take Action Against Johnson & Johnson

The New York Times (5/28, B1, Singer) reports that McNeil Consumer Healthcare, the division of Johnson & Johnson that recalled millions of bottles of liquid children’s Tylenol, “may face criminal penalties, product seizures, or other sanctions, an official from the Food and Drug Administration said Thursday.” At a Congressional hearing yesterday, the principal deputy commissioner at the FDA, Joshua Sharfstein, said that the agency found “a pattern of violations in manufacturing and quality control practices” that “led to a number of recent recalls.”

Following revelations at the hearing that McNeil hired contractors to buy the products under orders not to mention the word ‘recall,’ the chairwomen of Johnson & Johnson’s consumer division, Colleen Goggins, apologized “to the mothers and fathers and caregivers for the concern and inconvenience” caused by the recall. Los Angeles Times (5/28, Zajac)

Senate Committee Links Diabetes Drug Avandia to Heart Attacks, Death

On February 20, 2010 the New York Times carried a front-page story reporting that hundreds of patients taking the controversial diabetes medicine, Avandia (rosiglitazone), needlessly suffered heart attacks and heart failure each month, according to confidential governmental reports.  The Wall Street Journal (Monday, 2/22), reported that a Senate Finance Committee concluded that Glaxo was aware of the risks, but minimized the issue and tried to suppress concerned physicians.  FDA documents indicate that in 2008, agency scientists recommended that the drug be pulled from the market, but FDA chiefs rejected the recommendation.  It is estimated that the drug caused 83,000.00 heart attacks between 1999 and 2007.