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Injured by Cylert?

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.

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companies can still sell their versions even after Abbott pulls the medicine, unless the FDA determines the drug was withdrawn for safety reasons.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.

If you or a loved one took Cylert and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.
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ADHD drugmakers must tell of risks

Feb 23, 2007 | SOUTH FLORIDA SUN-SENTINEL
Federal officials told the makers of Ritalin, Adderall, Strattera and all other drugs for treatment of attention deficit hyperactivity disorder, or ADHD, on Wednesday to come up with new pamphlets to explain the potential risks of the drugs to patients and parents. The announcement came almost a year after panels of Food and Drug Administration advisers recommended that informational guides be provided to consumers. There are 15 drugs to treat ADHD, including extended-release, patch and...

Government wants further ADHD drug warnings

Feb 22, 2007 | Baltimore Sun
The makers of Ritalin, Adderall, Strattera and other drugs treating attention-deficit hyperactivity disorder were advised by the government Wednesday to give patients and their parents an additional warning that those medicines could cause serious psychiatric and heart problems, including sudden death. Patients would receive with their prescriptions two-page "medication guides" that warn about possible side effects and urge them to notify doctors immediately after any sign of heart...

ADHD drug makers to warn of side effects

Feb 21, 2007 | AP
Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death. The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems. ...

Drug makers to add warnings to ADHD pills

Feb 21, 2007 | AP
Drugs prescribed to treat attention deficit hyperactivity disorder will include guides to alert patients and parents of the risks of mental and heart problems, including sudden death. The Food and Drug Administration said Wednesday that it directed the manufacturers of Ritalin, Adderall, Strattera and all other ADHD drugs to develop the guides. In May 2006, the agency told manufacturers to revise the labels of the drugs to reflect concerns about the cardiovascular and psychiatric problems. ...

ADHD Drugs to Get New Warnings

Feb 21, 2007 | NewsInferno.com
The U.S. Food and Drug Administration (FDA) announced today that it is ordering all manufacturers of attention deficit hyperactivity disorder (ADHD) medication to develop Patient Medication Guides to warn patients of potentially serious side effects. The most significant warnings will be related to adverse psychiatric symptoms and to cardiovascular risks. “Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well,”...

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