Drug Alert! FDA Pulls 'Statin' Cholesterol Drug After 31 Deaths

Source: www.nutracor.com

According to the Food and Drug Administration, Bayer Pharmaceuticals voluntarily withdrew the cholesterol blocking "statin" drug, Baycol. Known generically as cerivastatin, Baycol has been linked to 31 patient deaths over the last four years from severe muscle damaging side effect.

The FDA said it had received reports of Baycol patients experiencing severe rhabdomyolysis, a condition that results in muscle-cell breakdown and causes muscle pain, weakness, tenderness, malaise, fever, dark urine, nausea, vomiting and in some cases death. In some individuals, the muscle damage is so severe that patients develop kidney or other organ failure, which can be fatal.

In addition to Baycol, other statin drugs, including Pfizer Inc.'s Lipitor, Novartis AG's Lescol, Merck and Co.'s Mevacor and Zocor and Bristol-Myers Squibb Co.'s Pravachol are also known to cause the same side effects.

Public Citizen, the consumer "health watch-dog" has petitioned FDA regulators to mandate a "black box WARNING," the strongest warning for prescription drugs, to be placed on the label of all of the drugs, known as statins, to highlight the risk of rhabdomyolysis. FDA reports show that 385 people taking statins other than Baycol developed rhabdomyolysis from October 1997 to December 2000. Most patients required hospitalization and 52 of them died. An earlier FDA database showed another 29 deaths from statins prior to October 1997.

Statin drugs lower elevated cholesterol, a major risk factor for heart disease, by limiting cholesterol production in the liver. Statin sales were $14 billion last year and are expected to rise to $20 billion to $25 billion by 2005.

In addition to the black box warning and consumer guide, Public Citizen wants the FDA to require statin makers to send letters to doctors alerting them to the muscle side effect with tips on how to reduce risks.

Dr. Hansen's Note: Thank goodness Bayer pulled Baycol at 31 reported deaths. My question is, why did it take so long and who gave the FDA the authority to decide that 30 deaths were acceptable but 31 was too many?

Statin Drugs May Increase Risk Of Peripheral Neuropathy

Source: American Academy Of Neurology (http://www.aan.com)

St. Paul, MN - Statin drugs can increase the risk of developing peripheral neuropathy, according to a study published in the May 14 issue of Neurology, the scientific journal of the American Academy of Neurology.

Peripheral neuropathy results from damage to the peripheral nerves and causes weakness, numbness and pain in the hands and feet. Statin drugs are prescribed for millions of Americans to lower cholesterol.

People taking statins were 14 times more likely to develop peripheral neuropathy than people who were not taking statins, according to the Danish study. However, the overall risk of developing neuropathy is rare, said study author David Gaist, MD, PhD, of the University of Southern Denmark in Odense.

"The positive benefits of statins, particularly on reducing the risk of heart disease, far outweigh the potential risk of developing neuropathy," Gaist said. "These findings shouldn't affect doctor or patient decisions to start using statins. But if people who take statins develop neuropathy symptoms, they should talk with their doctor, who may reconsider the use of statins."

For the population-based study, the researchers used a patient registry to identify all of the first-time cases of peripheral neuropathy with no known cause (such as diabetes) in Funen County, Denmark, over a five-year period. Each case was matched to 25 people of the same age and sex with no neuropathy as a control group. The use of statins was then determined for each group.

They identified 166 cases of first-time neuropathy with no known cause. Of those, 35 had a definite diagnosis, 54 were probable cases and 77 were possible cases. Nine of the people with neuropathy had taken statins. They had taken statins for an average of 2.8 years.

For those with a definite diagnosis of neuropathy, the statin users' risk of developing neuropathy was 16 times higher than for the control group. When all cases of neuropathy were taken into account, the statin users' risk of developing neuropathy was four times higher than the control group's risk. Taking statins for longer periods of time and taking higher doses of them increased the risk of developing neuropathy.

Statins lower levels of low-density lipoprotein (LDL) cholesterol by blocking the production of a liver enzyme used by the body to make cholesterol. The American Academy of Neurology, an association of more than 17,000 neurologists and neuroscience professionals, is dedicated to improving patient care through education and research. For more information about the American Academy of Neurology, visit its web site at http://www.aan.com.

2002-09