|
BAYER WAITS TOO LONG BEFORE TELLING PATIENTS
OF BAYCOL RISKS 
The German pharmaceutical company, Bayer, has been struggling
since their anti-cholesterol drug Baycol was pulled from the
shelves August 8, 2001. Part of the drug class called statins,
700,000 Americans were taking Baycol when it was removed from
the U.S. market due to the reports of death and serious injury.
Linked to rhabdomyolysis,
a rare muscle side effect, there have been over one hundred
deaths worldwide due to Baycol.
Bayer has claimed they tried to pull Baycol from the market
as early as possible, but despite their claims the health
minister of Germany criticized the company for waiting too
long before telling patients of the dangers of Baycol. Baycol
safety concerns had been present for months prior to the announcement
of the Baycol recall. Before the Baycol
recall, British regulators had banned a high dose of Baycol
and FDA officials had also considered this action. Fatal rhabdomyolysis
had been reported to occur more frequently when used at higher
doses.
If you would like more information regarding the Baycol recall
please contact us to speak
with a Baycol attorney.
NBC Nightly News reports on the Baycol recall
that was announced August 8, 2001
April
2003 News Updates
March 2003 News Updates
Baycol Exhibits Decreasing Focus on
Drug Safety
-Baycol was the 12th prescription drug taken off the
U.S. market for dangerous side effects since 1997.
In 1992, the Prescription Drug User Fee Act (PDUFA) was first
enacted and reauthorized in 1997. Under PDUFA, the FDA collects
user fees from the drug industry in exchange for meeting specified
timeframes for the review of new drugs. Baycol was one of
the nine drugs approved under the passage of PDUFA that was
later recalled for safety reasons. When PDUFA was reauthorized
in 1997 as part of the Food and Drug Administration Modernization
Act along with it came more stringent requirements that the
FDA meet tight review deadlines that had been pushed by the
pharmaceutical industry.
The FDA did continue to meet these tight time restraints
but this may have been at a cost. With the number of drug
recalls, including Baycol, signs show that PDUFA may be contributing
to the clouding lines between the FDA and the drug industry.
Since the drug companies are able to pay fees to the agency
to approve new drugs the FDA has shifted their view of the
drug companies as clients opposed to a regulated industry.
The FDA has become more increasingly under attack for their
speedy reviews of drugs and PDUFA may have made it more difficult
for the agency to deny approval due to safety standards.
Former FDA employees that had been interviewed by the Los
Angeles Times claimed they felt the pressure to approve new
drugs due to increasing governmental pressure despite safety
implications. Baycol had been associated to 31 U.S. deaths
that were due to severe rhabdomyolysis, a condition resulting
gin muscle cell breakdown and release of the contents of muscle
cells into the bloodstream.
If you have taken Baycol and would like to learn more about
your legal rights contact us
to speak with a Baycol lawyer.
Baycol
and Rhabdomyolysis
When the muscle is damaged from rhabdomyolysis, it releases
pigments from the muscle and blood into the bloodstream .
. . read more
Baycol Legal
News
Drug companies do agree that the FDA has become more stringent
recently and that the Baycol deaths probably influenced this
safety action . . . read more
|
