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Ritalin, other stimulants to carry cardiac warnings
San Francisco Chronicle
August 22, 2006
08-22) 04:00 PDT Washington -- Federal drug regulators have ordered that strong warnings be put on the labels of stimulants like Dexedrine and Ritalin to caution against their use in adults or children with heart problems and to alert doctors that the drugs cause 1 child in 1,000 to experience hallucinations.
The new warnings are not as strong as those approved in February by an advisory committee for the Food and Drug Administration, but they significantly strengthen the risk information already on the drugs.
The warnings come after scattered reports of children dying suddenly while taking the drugs. In some cases, the children were later determined to have had structural defects of the heart.
The new warnings state in part, "Sudden deaths, strokes and myocardial infarction have been reported in adults taking stimulant drugs at usual doses."
Nearly 4 million people take stimulants to treat attention deficit disorder and hyperactivity. Ritalin has been marketed since 1955, and dozens of studies have shown it to be safe and effective. But no studies have been of sufficient duration or included enough participants to evaluate stimulants' long-term effects on the heart.
Temple said the FDA was exploring ways to study the problem.
Weitz & Luxenberg is no longer accepting Ritalin cases.
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