The FDA is investigating hundreds of complaints involving problems with Children’s Tylenol, Benadryl and Motrin, including at least seven deaths, which may be connected to the recently recalled children’s medications sold by Johnson & Johnson.
According to staff members of the House Oversight and Government Reform Committee, the FDA has received 775 reports from consumers regarding recalled Johnson & Johnson drugs between January 2008 and April 2010. The committee staffers say that the recall, which affected 40 J&J drugs, is the largest child medicine recall in the FDA’s history.
The FDA has not confirmed the number of reports or the seven deaths, and says that it is investigating reports. The agency has not yet determined that any children were harmed by any of the drugs involved in the recall.
The information was released before a congressional hearing which will put Johnson & Johnson executives before U.S. lawmakers today to answer questions about quality control at the company’s manufacturing plants that have been cited as lacking by FDA investigators.
On April 30, a recall was announced for nearly 40 liquid children’s medications by Johnson & Johnson subsidiary, McNeil Consumer Healthcare, including infant Tylenol, Benadryl, and Motrin. The products were recalled due to particulate contamination and irregularities in potency and resulted in a warning letter from FDA regarding quality control issues at a Johnson & Johnson manufacturing plant in Ft. Washington, Pennsylvania.
Although parents have been told that the risk of serious medical problems from the recalled Children’s Tylenol, Motrin and Benadryl is low, federal regulators have indicated that the medications should no longer be used. In addition to the possibility of contamination by organisms, some of the products may have higher concentrations of active ingredients than are specified, others may contain inactive ingredients that do not meet internal testing requirements and some may contain tiny particles, according to the FDA.
Johnson and Johnson pledged this week to overhaul manufacturing operations and to make administrative and management changes in order to restore public confidence and prevent a repeat of the manufacturing failings in the future.