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US
FDA to add details of psychiatric side effects to ADHD drug labels |
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The
FDA will investigate other ADHD medicines for similar problems. In
a document posted yesterday on its website, the FDA said it has received
reports of patients experiencing psychiatric events such as
hallucinations, suicidal thoughts and psychotic behaviour as well as
aggression and violent actions while using forms of methylphenidate, which
is the generic name for Ritalin. Concerta
is a long-acting form of methylphenidate. Ritalin is widely prescribed as
a generic, the report said. The
FDA said it "intends to make labeling changes describing these
events," and asked its pediatric advisory committee for comments. However,
the agency's approach likely signals that it doesn't see the label change
as an urgent safety issue, the report said. The
statement doesn't say the FDA has confirmed any causal link between such
reports and the drugs, or that the descriptions will necessarily go in the
warnings section of the drugs' labels. An
FDA spokeswoman said the FDA doesn't plan to change the labeling on the
methylphenidate drugs until it has evaluated competing products such as
amphetamines -- a group that includes Shire Pharmaceuticals Group PLC's
Adderall. The
FDA statement said it hopes to bring to the committee a review of events
associated with these products in early 2006, which would seem to indicate
that the label change won't be until then. Shire
Pharmaceuticals didn't respond to calls requesting comment on Adderall. A
Novartis spokeswoman said the company hadn't yet reviewed the FDA
information and declined to comment. |
