Baycol
Recall
Baycol
was approved in 1997 as a newer statin cholesterol drug
but was quickly linked to fatal Baycol side effects
that led Bayer to announce a Baycol recall in August
2001. Responding to the sometimes fatal instances of
rhabdomyolysis that continued to be reported, the Baycol
recall ended up occurring much later than it should
have, according to many critics. When the Baycol recall
was announced, reports of 416 cases of rhabdomyolysis,
the rare, severe muscle disease, including 31 deaths
had already been made.
As
it later turned out, over 100 deaths were linked to
Baycol use, leading consumers to become upset at why
so many serious adverse effects were reported before
Bayer decided to issue a Baycol recall. Over one year
after the Baycol recall, Public Citizen consumer group
questioned who is the responsible party for adequately
notifying Baycol patients that a Baycol recall had occurred
since a study had showed many Baycol patients were still
unaware the Baycol recall had taken place.
According
to the consumer group, in instances that a drug recall,
such as the Baycol recall, is issued as a “voluntary”
action by the pharmaceutical company, the FDA’s
involvement is merely a passive oversight of a product
withdrawal. The FDA will post on its’ web site
the Baycol recall, however most patients and physicians
will fail to regularly use the FDA site. A study indicated
over a year after the Baycol recall, physicians and
patients were still unaware of the Baycol recall and
were still prescribing and using the statin drug.
The
federal government and the pharmaceutical companies
have a responsibility to consumers and patients to alert
them of safety changes such as a Baycol recall and the
absence of federal authority to mandate a drug recall
is unacceptable. The Baycol recall has resulted in Bayer
already paying $477 million to settle out of court 1,342
U.S. Baycol lawsuits, and the company still faces over
11,000 Baycol lawsuits in response to the Baycol recall.
For
more information on the Baycol recall contact
us to confer with a Baycol recall lawyer.
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