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Concerta and Ritalin warnings
All ADHD drugs being investigated for side effects
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Concerta (OROS methylphenidate), a drug commonly used for for treatment of attention deficit hyperactivity disorder (ADHD) in patients aged 6 to 17 years, may be headed for a recall, but for the timing only a label change is being recommended. A similar drug,
Adderall XR was recalled in Canada but continues to be on the market
in the US despite serious concerns about its safety. The
FDA has refused to act on the matter (and has merely changed the label) and the drugmaker
Shire
pushed for a reversal of the decision in
Canada and succeeded, though trouble is not
over for all ADHD drugs. Dexedrine, another
drug in this category, now includes a warning
about the possible risk of sudden death and
serious heart problems. (Related article: Health
Canada bans Adderall) |
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Kathleen M. Phelan, who works as a
Safety Evaluator at the Division of Drug Safety Evaluation at the FDA, found that areas of possibly insufficient labeling are psychiatric adverse events, which are presented in labeling as exacerbations of pre-existing conditions or as being reported with methylphenidate products other than Concerta, and cardiovascular adverse events. She is recommending that the context in which this information is provided on the label be updated. Cindy Kortepeter, the
Safety Evaluator Team Leader, concurs with Phelan in a memo made public by the FDA.
The FDA says that it has received reports of what it called "serious adverse events" — including deaths — in association with the therapeutic use of
these drugs. The agency considers the reports "rare though
serious.." A Food and Drug Administration advisory
panel has urged that the strongest possible safety warning
(black box) be issued for these drugs, because of emerging
concern that they may increase the risks of heart attacks,
strokes and sudden death. |
Phelan's research retrieved three reports of death during the 1-year period following the granting of pediatric exclusivity. Two deaths occurred in adults and one death was confounded by cocaine. This death by cardiac arrest occurred 1 week after
Conerta was discontinued and cocaine was found on the 16-year-old male’s clothing.
Concerta is manufactured by McNeil Consumer & Specialty Pharmaceuticals (a division of Johnson & Johnson) and Concerta is a registered trademark of Alza Corporation. Other ADHD drugs like Ritalin, (Related article: Ritalin
may damage DNA and cause cancer) and amphetamines are also being investigated for their side effects.
Cylert was recalled in March 2005 after lot of
foot-dragging by Abbott Laboratories.
However, another drug Prozac
that has been mired in controversy for the longest
time, is still going strong. After receiving
data about Strattera, the FDA and Eli Lilly have
already agreed to add a black box warning on the
drug. |
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