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Thursday, August 24, 2006

The Food and Drug Administration is proposing a new system for tracking what drugs are on the market after a study found that more than 9,000 products were missing from its master listing.

Companies would have to give electronic updates every six months on where their prescription and nonprescription medications are made and whether they are on the market. Currently, the FDA has 15 workers who manually enter paper registrations that companies file when they start or stop selling a drug.

A report Aug. 14 from the Department of Health and Human Services inspector general said the government's ability to enforce drug safety laws was hampered by a lack of information. The FDA's current list of 120,000 medications is missing 9,187 products and includes 34,257 that are no longer available, the report says.

Aneurysm-Causing Condition Often Missed

A genetic disorder first described just over a year ago is more widespread than doctors realize, and misdiagnosing it may be deadly, researchers said.

Loeys-Dietz syndrome is a connective-tissue disease marked by convoluted blood vessels and a weakened aorta that can fatally rupture, researchers said after studying patients from 52 families, adding that treatment should be more aggressive for Loeys-Dietz than for similar disorders for which it is often mistaken.

Patients with Loeys-Dietz are often misdiagnosed as having Marfan syndrome, suspected of causing Abraham Lincoln's lankiness, and the vascular disorder Ehlers-Danlos syndrome, the researchers said. Loeys-Dietz is the only one of the three in which the aorta may rupture even when it doesn't seem dangerously enlarged, said Harry C. Dietz of the Johns Hopkins University School of Medicine. Dietz and Bart L. Loeys of the Center for Medical Genetics at Ghent University Hospital in Belgium identified the disorder.

Nearly all Loeys-Dietz patients survive surgery to repair the vessel, Dietz said.

At the time, they knew of only 10 patients with the condition. The latest study, published in today's New England Journal of Medicine, involved 90 patients.

The disease leads to death at an average age of 26, and pregnancy complications in about half of women who have the condition, they found.

Stimulants for ADHD Carry New Warnings

All stimulant drugs to treat attention-deficit hyperactivity disorder must carry new warnings about the risk of sudden death and heart problems as well as possible psychiatric issues, said a top Food and Drug Administration official.

The drugs, such as Adderall, Dexedrine, Ritalin and Concerta, include the cautions on the product labels but not in a black box that highlights the most important risks, said Robert Temple, head of the FDA's medical policy office.

The FDA did not make a public announcement about its decision, but Monday it posted a letter on its Web site that GlaxoSmithKline PLC, which makes Dexedrine, sent to doctors about the new information.

Temple, acknowledging that the FDA "probably should have" made the label changes public, said makers of the stimulant ADHD drugs were asked in a May letter to add the warnings. Cautions on seizures, vision problems and stunted growth also were ordered for all the drugs.

-- From News Services

Stimulants for ADHD Carry New Warnings

All stimulant drugs to treat attention-deficit hyperactivity disorder must carry new warnings about the risk of sudden death and heart problems as well as possible psychiatric issues, said a top Food and Drug Administration official.

The drugs, such as Adderall, Dexedrine, Ritalin and Concerta, include the cautions on the product labels but not in a black box that highlights the most important risks, said Robert Temple, head of the FDA's medical policy office.

The FDA did not make a public announcement about its decision, but Monday it posted a letter on its Web site that GlaxoSmithKline PLC, which makes Dexedrine, sent to doctors about the new information.

Temple, acknowledging that the FDA "probably should have" made the label changes public, said makers of the stimulant ADHD drugs were asked in a May letter to add the warnings. Cautions on seizures, vision problems and stunted growth also were ordered for all the drugs.

-- From News Services


© 2006 The Washington Post Company

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