J & J Exec To Appear At Hearing Thursday
The news keeps getting worse for Johnson & Johnson (J & J), maker of children‘s Tylenol.
Health regulators are now expanding their look at complications from infant and child medications made by J & J, including 30 deaths.
So far no direct link has been established between an April 30th recall of 40 types of children’s pain and allergy medications made by J & J subsidiary, McNeil Healthcare, and 775 reported adverse events, according to a congressional report released Tuesday.
The House Oversight and Government Reform Committee has been investigating J & J ever since its Fort Washington, Pennsylvania manufacturing facility was closed following an FDA inspection.
The FDA, in its April inspection report, found holes in the ceiling, filthy equipment, bacterial contamination (B. cepacia) and inconsistencies in the active ingredient in children’s cold medicines that could result in "super potent" formulations.
The report led to the recall of more than 40 child and infant medications on April 30.
The report says ever since the recall, several hundred more adverse reports have come into the FDA, including seven deaths.
“At this time, FDA is not aware of any child being harmed by taking one of the recalled products," said the staff report, dated May 24.
"FDA is still investigating some of these adverse events to determine if the events were related to a child taking one of the recalled medicines” reports Reuters.
The FDA still says the chance of being sickened from the more potent active formulations is “remote,” although the agency did go out on a limb by publicly suggesting parents choose generics over the J & J / McNeil brands.
On Thursday at 10 a.m., the committee will convene a live hearing gathering FDA officials and J & J over the manufacturing lapses.
The head of J & J, William Weldon, is expected to be the first witness.
On April 30, McNeil Consumer Healthcare, a subsidiary of Johnson and Johnson recalled infant and children’s versions of Motrin, Benadryl and Zyrtec, along with children’s Tylenol pain reliever and other mediations, in all about 70% of the children’s over-the-market liquid medications.
It was the largest recall of children’s medicine in the history of the FDA the congressional staff reports and the third recall of McNeil product over the last eight months. #