FDA Investigates Serious Tylenol Recall
May 26, 2010
By Parija Kavilanz
The Food and Drug Administration is looking into reports of at least 775 serious side effects from drugs recalled by McNeil, a division of Johnson & Johnson, according to a source close to a Congressional investigation.
Included in the reports were 30 deaths, nearly all of which were found to not be tied to McNeil’s recall of Tylenol, Motrin and Benadryl drugs from Jan. 1, 2008 through April 30, 2010, according to another source close to the investigation.
The FDA is also investigating reports of several hundred serious side effects — or “adverse events” — and seven deaths since May 1, when McNeil recalled 50 children’s versions of these non-prescription medicines because of serious quality and safety concerns.
The FDA’s investigation into the recalls is ongoing and the agency would not comment on the matter.
Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the FDA. Adverse events could include death, hospitalization, disability and other health complications.
The House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall.
Following the most recent recall, Johnson & Johnson (JNJ, Fortune 500) has suspended production at McNeil’s facility in Fort Washington, Penn., that manufactured the children’s drugs.
McNeil’s latest recall is its fourth in the past seven months:
In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.
In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.
In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other over-the-counter drugs after complaints of consumers feeling sick from an odor.
McNeil has maintained that its recall of the children’s drugs was not “undertaken on the basis of adverse medical events” but as a precautionary measure.
“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,” McNeil said in a statement Tuesday.
The FDA, which earlier this month issued a scathing 17-page inspection report listing 20 violations at the Fort Washington plant, also maintains that the recalled drugs pose a “remote” potential for serious health problems.
The House panel invited Johnson & Johnson Chief Executive William Weldon to testify but he declined to be present due to health reasons. The Committee said Colleen Goggins, worldwide chairman of Johnson & Johnson’s consumer group will testify at the hearings.
The FDA said Dr. Joshua Sharfstein, principal deputy Commissioner, Deborah Autor, Director of the office of compliance and Michael Chappell, acting commissioner for regulatory affairs, will testify on behalf of the agency.