August 9, 2001
Bayer Pharmaceutical announced today it is voluntarily withdrawing its cholesterol-lowering drug "Baycol" due to the risk of patients experiencing severe and sometimes fatal muscle reaction.
The withdrawal was announced by both the company and the Food and Drug Administration, which has reports of 31 deaths in the United States due to muscle cell breakdowns associated with the drug.
The drug is being pulled from pharmacy shelves at all doses and from all markets worldwide, except in Japan, the company said. "We have decided on this action in the interest of patient safety," said Dr. David Ebsworth, head of Bayer's Pharmaceuticals Business Group. "We will continue to conduct further assessments over the next few months to evaluate the benefit/risk ratio of the drug."
Baycol, sold international as Lipobay, is also known by its active ingredient "Cerivastatin." It was approved for use in the United States in 1997 and is a member of a class of cholesterol-lowering drugs commonly known as "statins."
Statins lower cholesterol by blocking a specific enzyme in the body that is involved in the synthesis of cholesterol. All statins have been associated with rare reports of the muscle breakdown condition, called "rhabdomyolysis," but fatal cases in association with use of Baycol have been reported significantly more frequently than with other statins.
Rhabdomyolysis is a condition that results in muscle cell breakdown and release of the contents of muscle cells into the bloodstream. Symptoms 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. The muscles most frequently affected are the calves and lower back, but some patients report no symptoms of muscle injury. In some cases, muscle injury is so severe that patients develop kidney failure and failure of other organs, which can lead to death.
Fatal rhabdomyolysis reports with Baycol, have been reported most frequently when the medicine is taken at higher doses, when used by elderly patients, and particularly when used in combination with other types of cholesterol-lowering drugs that also cause rhabdomyolysis or with drugs that increase the level of statins in the body.
August 21, 2001
STATIN DRUGS MAY HAVE KILLED MORE THAN ORIGINALLY REPORTED
A rare but deadly side effect of the popular cholesterol-lowering drugs known as statins has killed and injured more people than the government has acknowledged, the consumer watchdog group Public Citizen reported Monday.
The group's analysis of the Food and Drug Administration's side-effect registry, linked 72 fatal and 772 non-fatal cases of muscle breakdown, known as rhabdomyolysis, to all six of the statins sold between October 1997 and December 2000.
Two weeks ago, Bayer and the FDA revealed that 31 people had died after taking Bayer's own product but the FDA offered no total for any of the other statins.
Bayer promptly pulled its drug off the market in every country but Japan.
Many Baycol deaths occurred in people who had taken cerivastation, sold as Baycol, at the highest dose or with a cholesterol drug called Lopoid. Almost 90% of the cases involving other statins didn't involve the second drug, the Public Citizen study found.
The Washington-based group hasn't asked that statins be withdrawn from the market because research indicates that they sharply cut blood cholesterol levels and can reduce the number of deaths from heart disease and stroke by roughly 30%. Instead, the watchdog group petitioned the FDA to require a prominently displayed, strongly worded "black box" warning on the drugs' label and patient information sheets, listing such symptoms of muscle pain, tenderness, weakness, and tiredness. The condition is reversible if patients stop taking the drug when symptoms appear.
"Doctors and patients are grossly uninformed about this," says Sidney Wolfe, director of Public Citizen's Health Research Group.
The petition, delivered Monday to the FDA, also asks the agency to send registered letters to every US doctor. The agency is considering revising warnings for the drugs.
Statins were prescribed almost 100 million times in the USA last year, reports IMS Health.
By Steve Sternberg, Scripps News Service, USA Today, August 21, 2001.