Healthy Skepticism Library item: 915

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: news

Harris G.
Citizens' Group Wants Hyperactivity Drug Taken Off the Market
The New York Times 2005 Mar 25

Full text:

30-year-old drug to treat hyperactivity made by Abbott Laboratories should be banned immediately because of its toxic effects on the liver, a citizen’s group said yesterday in a petition to federal drug regulators.

At least 13 patients have died since 1975 taking the drug, known as Cylert or pemoline, according to the group. Reports given to the Food and Drug Administration show that at least 193 patients have suffered serious consequences from the drug, said Dr. Peter Lurie, deputy director of the group, Public Citizen.

Dr. Lurie said that several newer drugs worked as well as Cylert without its potentially lethal side effects.

“This is an outmoded drug,” he said, “and there is no reason for it to be still on the market.”

Melissa Brotz, a spokeswoman for Abbott, said the company planned to discontinue selling its version of the drug “in the next several months” because of declining sales.

A spokesman for the drug agency said the petition would be reviewed.

Copycat versions of the drug are also sold by generic-drug manufacturers. Sales of all versions have declined substantially since 1999, when the drug agency stiffened warnings on the drug’s label. Last year, doctors in the United States wrote about 117,000 prescriptions for Cylert and its generic equivalents, the petition said.

Britain and Canada removed the drug from the market, but the F.D.A. instead twice chose to stiffen warnings on the drug’s label, the petition said. In 1996, the agency sent a letter to Abbott saying that the drug’s marketing could continue “if and only if a good faith effort is made on your part to collect the data necessary” to measure the drug’s risks. The agency suggested that Abbott create a patient registry for this task, the letter stated.

But Abbott never created a registry, the petition stated. Ms. Brotz of Abbott said that she did not know about a registry but that all patients for whom the drug was prescribed must sign a consent form.

Cylert originally appealed to doctors because it was given once a day, the petition said. But other drugs for children with attention-deficit disorder now offer once-daily dosing,

An F.D.A. analysis concluded that Cylert increased the risk of liver failure almost 17 times, the petition stated. A 2002 agency report found that stiffer label warnings had failed to prompt doctors to increase testing of patients’ livers, the petition stated.

Most drugs withdrawn over the past 14 years were taken off the market because patients continued to die even after the drug agency stiffened warnings on labels. Doctors and patients often ignore or fail to heed such warnings, sometimes resulting in dire consequences.

Dr. Lurie said Public Citizen had wanted for some time to file a petition about Cylert but was only recently able to complete the task.

Many drugs linger on the market long after newer, safer drugs have been introduced that render the older drugs obsolete, Dr. Lurie said. The drug agency should undertake a comprehensive review of these medications and ban those with unacceptable risks, he said.

In 33 years, Public Citizen has filed more than two dozen petitions to ban drugs. It recently asked the agency to ban Crestor, a cholesterol-lowering drug made by AstraZeneca. The agency rejected the petition on Crestor, saying the drug’s risks were not substantially different from those of similar drugs.