FDA Evaluating 775 Side Effect Reports from Children’s OTC Drugs
The U.S. Food & Drug Administration (FDA) is currently evaluating reports of at least 775 side effects from over-the-counter (OTC) children’s medicines from McNeil Consumer Healthcare, a division of Johnson & Johnson, according to CNN Money.
The investigation allegedly includes 30 deaths originally not connected to previous Tylenol recalls from January 2008 to April 30, 2010, and several hundred “adverse effects” and seven deaths reported after May 1, 2010. The CNN Money report stated a hearing would be held on May 27 to examine the recall.
When a pharmaceutical company scrutinizes adverse effects, this means there have been complaints of serious drug side effects from death, disability, hospitalization, to other critical health concerns.
Stemming from an April 30 recall of dozens of children’s OTC drugs, in May, the FDA released a 17 page unfavorable report that detailed quality control issues and other problems at a Fort Washington, PA., manufacturing plant. Soon after, the facility closed.
On May 18, 2010 CNN Money wrote the FDA was expanding their McNeil investigation and May 25, Reuters said that Iowa Senator Tom Harkin recently had sent a letter to the FDA requesting more information.
The first McNeil recall in November 2009, was for Tylenol Arthritis Pain caplets (100 count) with the red EZ open cap. Five lots were pulled for unusual odor or taste. Soon after, all lots of the product were included.
In December, another recall involved an unidentified number of Tylenol, Motrin and other OTC drugs after the firm received additional complaints of consumers becoming ill from an odor. Next was the April 30 children’s drug recall.
McNeil has adamently maintained these recalls were voluntary and done as a precautionary measure–not due to adverse health effects. The pharmaceutical giant released a statement that said “We track all adverse events and thoroughly investigate all serious adverse cases that are reported and, in turn, report these to the FDA, whether or not the event may be caused by our products”.
For additional recall details and information on how to report problems consumers can visit McNeil’s recall web page.
Posted on Wednesday, May 26th, 2010 at 5:04 pm under 