side effects unveiled: Hundreds injured, possible deaths
The FDA has announced
that it is investigating reports of at least 775 serious side effects, including
30 deaths, associated with Tylenol and other over-the-counter drugs recalled
by Johnson & Johnson subsidiary McNeil.
The side effects
were reported by consumers who experienced them after taking products involved
in one of four McNeil recalls in recent months. The FDA will determine whether
the drugs were directly responsible for any of the incidents. Thus far,
researchers have determined that most of the deaths were not caused by the
drugs, a source close to a Congressional investigation said.
The first word
of side effects came in November 2009, when McNeil recalled five lots of
Tylenol Arthritis Pain 100 count with EZ-open cap, after consumers reported
an unusual odor that caused nausea, stomach pain, diarrhea and vomiting.
One month later, the company expanded the recall to include all lots of
The next month,
after reports emerged of consumers experiencing feelings of sickness associated
with a strange odor from other McNeil drugs, the company recalled an unspecified
number of Tylenol, Motrin, Benadryl and other over-the-counter products.
The recall concerned drugs produced between January 1, 2008 and April 30,
In May 2010, McNeil
issued a separate recall for 50 children's versions of its over-the-counter
pain, allergy, cold and cough drugs due to severe concerns over their safety
and quality. According to the company, the recall was a precautionary measure,
not an action taken "on the basis of adverse medical events."
been suspended at the factory responsible for producing the drugs, and the
FDA has released a 17-page report detailing more than 20 violations that
took place there. The FDA is also investigating hundreds of serious side
effect reports associated with the recalled children's drugs, including
The House Committee
on Oversight and Government Reform launched its own investigation into the
for this story include: