Cylert Side Effects Injury Lawsuits. On April 24, 2005, Abbott Laboratories Inc. halted sales and removed Cylert, an attention deficit drug from the market after a consumer group complained Cylert was too dangerous. Consumer group Public Citizen charges that Cylert has caused 21 cases of liver failure, including 13 that were fatal or required transplants.
Cylert is a stimulant that was approved to treat attention deficit hyperactivity disorder, or ADHD, in 1975. In 2004 about 117,000 prescriptions for the drug were filled in the United States, according to Public Citizen.
Reports given to the FDA show that at least 193 patients have suffered serious consequences from the drug, said Dr. Peter Lurie, deputy director of the group, Public Citizen. This is an outmoded drug, he said, and there is no reason for it to be still on the market. Generic companies sell copycat versions of the drug under the name Pemoline.
FDA Ban Cylert
Public Citizen asked the U.S. Food and Drug Administration to ban Cylert and its generic competitors immediately. Generic companies can still sell their versions even after Abbott pulls the medicine, unless the FDA determines the drug was withdrawn for safety reasons. 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. 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.
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.
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