About the Baycol Recall

In August 2001, the anti-cholesterol drug Baycol was recalled. Part of the class of drugs
called statins all statins have been associated to the rare and deadly condition involving
muscle complication called rhabdomyolysis. Statins were considered a revolutionary
treatment to lower cholesterol, but Baycol was found to have an increased likelihood of
causing rhabdomyolysis than other statin drugs, resulting in around 100 Baycol patient
deaths worldwide.
Expected to hit the $875 million mark in 2001, the Baycol recall caused many cholesterollowering patients to discontinue the use of other statin drugs as well. Statins are the most
widely prescribed class of cholesterol-lowering drugs, and was one of the fastest growing
segments of the drug industry. Following the Baycol recall, Public Citizen consumer
advocacy group petitioned the FDA to add a black box warning to the remaining five
statins available on the market, warning patients of the serious and deadly risks found to
occur with the drug class. The petition noted there had been an additional 50 deaths as
the result of other statin drugs than Baycol.
Rhabdomyolysis, a rare side effect of prescription drugs that causes muscle cells to break
down and allows cell contents to enter the bloodstream, was found linked to Baycol. After
the Baycol recall was announced, the health minister of Germany attacked the
Leverkusen based manufacturer of Baycol saying the company left doctors and patients
in the dark about Baycol and should have acted sooner to release the information. The
highest risk patients for Baycol side effects were elderly patients and those combining
Baycol with gemfibrozil.

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Baycol and Rhabdomyolysis

Baycol is part of the class of drugs called statins. All statins have been linked to the very
rare condition called rhabdomyolysis, but Baycol was recalled because of the significantly
more fatal cases resulting from its use. At the time of the Baycol recall, 32 FDA reports of
Baycol deaths attributed to severe rhabdomyolysis in the U.S. Over one hundred deaths
have been due to rhabdomyolysis and the use of Baycol, in addition to the belief that
hundreds of other Baycol patients have suffered from rhabdomyolysis attacks.
Rhabdomyolysis is a life-threatening condition that destroys muscle cells and releases
them into the bloodstream. The result of the condition is severe muscle pain that is most
often felt in the calves and lower back, though it can occur in other body parts as well.
Due to the similarity of rhabdomyolysis symptoms to common occurrences like the flu,
symptoms were often not taken seriously until the condition progressed into later stages.
This did not allow Baycol patients to be properly treated.
Symptoms often present with cases of severe rhabdomyolysis as the result of Baycol use
may include muscle pain, weakness, malaise, fever, dark urine, nausea, and vomiting. At
the time of the Baycol recall, Bayer executives refused to report how many
rhabdomyolysis victims they had encountered worldwide. Blood tests can determine if an
individual is suffering from rhabdomyolysis by measuring if an elevated level of creatine
kinase is present.

Baycol Recall
On August 8, 2001, the FDA announced that Baycol cholesterol-lowering drug was being
recalled. The decision was based on the significantly higher number of deadly side effects
associated to the use of statin drug Baycol.

Baycol Recall FDA Announcement

-From the FDA Talk Paper
August 8, 2001
FDA today announced that Bayer Pharmaceutical Division is voluntarily withdrawing
Baycol (cerivastatin) from the U.S. market because of reports of sometimes fatal
rhabdomyolysis, a severe muscle adverse reaction from this cholesterol-lowering (lipidlowering) product. The FDA agrees with and supports this decision.
Baycol (cerivastatin), which was initially approved in the U.S. in 1997, is a member of a
class of cholesterol lowering drugs that are commonly referred to as "statins." Statins
lower cholesterol levels by blocking a specific enzyme in the body that is involved in the
synthesis of cholesterol. While all statins have been associated with very rare reports of
rhabdomyolysis, cases of fatal rhabdomyolysis in association with the use of Baycol have
been reported significantly more frequently than for other approved statins.
Fatal rhabdomyolysis reports with Baycol have been reported most frequently when used
at higher doses, when used in elderly patients, and particularly, when used in combination
with gemfibrozil (LOPID and generics), another lipid lowering drug. FDA has received
reports of 31 U.S. deaths due to severe rhabdomyolysis associated with use of Baycol,
12 of which involved concomitant gemfibrozil use.
Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the
contents of muscle cells into the bloodstream. Symptoms of rhabdomyolysis include
muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, and vomiting.
The pain may involve specific groups of muscles or may be generalized throughout the
body.
Most frequently the involved muscle groups are the calves and lower back; however,
some patients report no symptoms of muscle injury. In rare cases the muscle injury is so
severe that patients develop renal failure and other organ failure, which can be fatal.
Bayer Pharmaceutical Division has announced plans to withdraw Baycol to the pharmacy
level. Pharmacies will be instructed to return the product to the manufacturer for a refund.
Patients who are taking Baycol should consult with their physicians about switching to
alternate medications to control their cholesterol levels. Patients taking Baycol who are
experiencing muscle pain or are also taking gemfibrozil should discontinue Baycol
immediately and consult their physician.
There are five other statins available in the U.S. that may be considered as alternatives to
Baycol. They are:

Lovastatin (Mevacor)

Pravastatin (Pravachol)

Simvastatin (Zocor)

Fluvastatin (Lescol)

Atorvastatin (Lipitor).

For further information regarding the withdrawal of Baycol, patients and physicians can
contact Bayer Customer Service at 1-800-758-9794 or the FDA's Drug Information Office
at 301-827-4573 or 1-888-INFO-FDA, or go to "Baycol Information" on FDA's Website.

Baycol FAQ
Why was Baycol recalled?
Baycol is part of a class of drugs called statins. While all statins have been linked to the
rare and life-threatening condition rhabdomyolysis, Baycol showed a significantly higher
amount of rhabdomyolysis occurrence. Over one hundred deaths have been due to
rhabdomyolysis and the use of Baycol, in addition to the belief that hundreds of other
Baycol patients have suffered from rhabdomyolysis attacks.
Are other statins safe to use?
After the FDA Baycol recall on August 8, 2001, Public Citizen petitioned the FDA to add a
black box warning on the remaining statins still available, the strongest warning issued.
The Baycol recall prompted other statin users to also discontinue their use of the
cholesterol-lowering drug.
What is rhabdomyolysis?
Rhabdomyolysis is a very rare condition where serious muscle damage results in release
of muscle cell contents into the bloodstream. Rhabdomyolysis may result in kidney
damage and other organ damage which may be fatal. All statins have been associated to
the risk of rhabdomyolysis but Baycol was found to have a much higher occurrence. At
the time of the Baycol recall there had been around 100 reported deaths due to
rhabdomyolysis.
How do I know if I am having this serious reaction (rhabdomyolysis) to Baycol or
other statins?
Patients who develop rhabdomyolysis often have muscle aches involving their calves,
back, or their entire body. The pain may be accompanied by weakness, fever, nausea,
vomiting, and passing of dark urine.
What should I do if I think I'm suffering from the life-threatening condition
rhabdomyolysis?
Immediately discontinue the use of the drug and call your physician.
What is Baycol used for?
Baycol is a cholesterol-lowering drug belonging to a class of drugs known as statins. It is
prescribed to reduce your cholesterol and to reduce your risk of heart disease. At the time
of the Baycol recall there were 700,000 Americans using the drug.

Will I have any problems if I immediately discontinue the use of Baycol or other
statins?
If you were prescribed Baycol to lower your cholesterol, these levels may go back to
where they were before you received the drug. These changes will not occur immediately
but will most likely occur over a couple of days to weeks. When stopping a prescription
medication it is advised to consult with your physician to discuss alternative therapies.
Are there any alternatives to Baycol?
There are five (5) other drugs in the same class (statins) available in the U.S. market.
They are atorvastatin (Lipitor), fluvastatin (Lescol), lovastatin (Mevacor), pravastatin
(Pravachol), and simvastatin (Zocor). There are also other drugs approved for lowering
cholesterol that are not statin drugs. You should consult you physician to determine which
treatment is right for you.

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recent Baycol recall.

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