Thursday, August 30, 2001

drug recall concerns
Hawaii patients

The recall of Baycol has people
questioning medicine from a family
of drugs called statins

By Leila Fujimori

Since the cholesterol-lowering drug Baycol was recalled three weeks ago, Honolulu cardiologist Denny Bales said he has received dozens of calls from concerned patients, who are now taking substitute drugs.

"This has spooked people who really need to be on these drugs, who think they're poisoned and afraid to tell their doctors they aren't taking the drug," Bales said.

"It's very important that people who need these drugs stay on them and not get panicked," he said.

Patients across the country have become nervous about taking any of the medications in the family of drugs called statins, which have been shown to dramatically lower cholesterol and reduce the risk of heart attack.

Bayer Pharmaceutical recalled the drug Aug. 8 after it was linked to 31 U.S. deaths and at least nine more abroad. About 700,000 Americans were taking the drug.

Baycol was tied to rhabdomyolysis, a life-threatening condition in which muscle cells are destroyed and released into the bloodstream. The condition, which can cause extreme muscle pain, is occasionally so severe that patients develop potentially fatal kidney failure.

Doctors across the country have been busy reassuring their patients that the other popular statins -- Lipitor, Zocor, Mevacor, Pravachol and Lescol -- are safe.

"Baycol stood out as having more risk than any of the others. It was the black sheep of the statin family," Bales said.

He stresses to his patients that the benefits are still much higher than the risk of a heart attack.

The vast majority of Bales' patients on cholesterol-lowering drugs take statins.

It was the combination of Baycol and another drug, Gemfibrozil, that caused rhabdomyolysis.

Drug companies are now trying to get former Baycol users to switch to their statins.

Bristol-Myers Squibb took out full-page ads in the New York Times, USA Today and the Philadelphia Inquirer, offering a free one-month supply of Pravachol. Merck took out a full-page ad in the Wall Street Journal with a headline alerting Baycol users to its drug Zocor.

Pfizer, which makes Lipitor, the market leader, said it will highlight Lipitor's safety record and offer free cholesterol screenings around the country.

But many are still nervous about taking any of the other statin drugs.

"I heard the rumor that the same kinds of problems may be related to that statin class of drugs," said a Honolulu man with high cholesterol who measures 300 if unmedicated.

The 35-year-old man, who asked not to be named since he is trying to get life insurance, said he has not stopped taking his usual high dose of Lipitor, a statin drug.

He has talked to a person in the medical field and intends to talk to his doctor soon to get an opinion on the dangers and risks.

"Risk balancing is an important thing," he said. "I certainly don't want a heart attack, I'll tell you that. Heart attack or muscle failure, that's not much of a choice."

Marc Matsumoto, a pharmacist at Daiei-Holiday Mart Kaheka Pharmacy, said he was surprised only a handful expressed concern over the recall, but said more may be talking to their doctors.

He said he has not seen a drop-off in the number of cholesterol-lowering drugs being dispensed.

"All (statin drugs) showed a history of these kinds of problems -- muscle wasting or muscle problems and pain," but Baycol showed a significantly higher amount of kidney failure and death, he said.

Pali Longs Drug Store pharmacist Rod Yee said, "I think everybody's pretty much decided, until they hear any more, they're going to take it because they feel the benefits outweigh the risks."

Jan Kagehiro, spokeswoman for Kaiser Permanente, said, "People were reacting more to the headlines, so we got a slew of calls from our members who were on cholesterol-lowering drugs."

Kaiser Permanente pharmacists reassured members they had not been stocking Baycol.

"We have not seen any kind of trend toward people not picking up prescriptions or not taking the drugs," a Kaiser pharmacist who works with a lot of patients reported, according to Kagehiro.

Others on cholesterol-lowering drugs are not worried.

Donna Toyofuku, who just switched to Lipitor, said she is not too concerned.

"I'm under doctor's care," the Pearl City woman said. "I feel pretty confident he knows what he's doing."

The Associated Press contributed to this report.

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