Johnson & Johnson OTC med probe widens

Courtesy of Reuters

U.S. health regulators are investigating hundreds of reported complications with dozens of recalled children's medications made by Johnson & Johnson (JNJ.N), including 30 deaths, but so far no direct link has been found, according to a congressional report. The Food and Drug Administration does not consider the 775 reported adverse events a "spike" and there is no "clear pattern" indicating the problems were caused by the recalled products,

Since the April 30 recall, several hundred more cases of complications, including seven deaths, have been reported to the FDA, the report said. When the recall was announced, FDA officials said the chance of getting sick from the products was "remote." On Thursday, the committee will hold a hearing with officials from both the FDA and J&J over manufacturing lapses that led to contamination and a nationwide recall of liquid children's versions of Tylenol pain reliever and other medications. Infant and children's versions of pain medicine Motrin and allergy drugs Benadryl and Zyrtec were also recalled. In total, about "70 percent of the market for over-the-counter pediatric liquid medicines were involved," the staff said. "It is the largest recall of children's medicine in the history of the FDA," they wrote in the memo to committee lawmakers.