Patients in the Dark About
Cholesterol Drug Recall

Oct. 31, 2002

FDA Needs Statutory Authority to Order and Enforce Recalls; Drug Industry Should Pay for Patient Notification, Consumer Advocate Says

WASHINGTON, D.C. – A study showing that only a fraction of patients at a Chicago hospital clinic who had been prescribed a cholesterol-lowering drug were aware of its subsequent recall underscores the need for more effective recall systems, Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group, wrote in an editorial accompanying the study. The study, available online Oct. 31, will be published in the December issue of Pharmacoepidemiology and Drug Safety.

Researchers at Cook County Hospital surveyed patients who were taking cerivastatin, popularly called Baycol, after the drug’s maker voluntarily recalled the drug in the United States. The drug was recalled in August 2001 after 416 cases of severe muscle damage, including 31 deaths, were associated with it.

Patients taking cerivastatin along with gemfibrozil, prescribed to control triglyceride levels, were at an increased risk for muscle damage. Sixty-seven Cook County patients had been prescribed the drugs together. Of the patients taking the drugs together whom the researchers could reach, only a fifth had heard of the recall and more than half continued to take cerivastatin. Forty percent of the surveyed patients had physical symptoms of muscle damage, almost half of them severe.

Because virtually all recalls are voluntary, the U.S. Food and Drug Administration (FDA) has a limited ability to ensure that patients are aware of a drug’s withdrawal. The responsibility then falls to pharmacists, who maintain computerized databases of prescriptions and can effectively notify patients but often don’t. Wolfe’s editorial suggests that the funding for such notification should come from the recalled drug’s manufacturer.

"When they look at their bottom lines, pharmaceutical companies apparently conclude that they’ll save more money by paying a few settlements to patients who have been injured or to families of those who have been killed by a dangerous drug than by funding a patient notification program," Wolfe said.

Not only should drug makers bear the cost of notifying patients, but the FDA should be given authority to impose mandatory drug recalls and regulate the level and speed of a recall and patient notification, Wolfe said. It is also essential that the FDA obtain the legal authority to impose civil monetary penalties if pharmaceutical companies were to violate FDA’s new authority, Wolfe wrote.

The finding that so many patients were unaware of the early symptoms of rhabdomyolysis, the severe muscle damage, highlights the need for FDA oversight and approval of MedGuides – patient information leaflets handed out at the time a prescription is filled – to alert patients to such symptoms.

"Because cerivastatin was causing severe muscle damage to hundreds of patients and killed dozens of people, there should have been a major effort to ensure that all patients were aware of the dangers and stopped taking the drug," Wolfe said. "Drug makers are not doing enough to protect consumers, and the FDA needs the authority to hold them accountable."

Wolfe also noted that about 10 months before the August 2001 withdrawal of cerivastatin, Bayer underbid drug companies that had been previously supplying statins for the Cook County clinic. In November of 2000, cerivastatin, for which the clinical benefits are unproven, replaced three previous statins used by the clinic, all of which have been found in clinical trials to lower cholesterol and reduce the risks of major coronary events and mortality.