Advisers Reject "Black Box" Warning For ADHD Drugs

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Main Category: ADHD
Also Included In: Psychology / Psychiatry;  Pediatrics / Children's Health
Article Date: 23 Mar 2006 - 15:00 PDT

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A Food and Drug Administration Pediatric Advisory Committee has rejected having "black box" warnings regarding psychiatric and cardiovascular risks associated with ADHD drugs. This advice goes against a recommendation issued one month ago by the Drug Safety And Risk Management Advisory Committee, which supported the idea of a black box warning.

The Pediatric Advisory Committee said drug labels should have warnings that people can understand.

It is most likely the FDA will follow the decision not include a black box warning.

It could be several years before pharmaceutical companies start using a recently adopted format, which may then have updated information on drugs.

The USA is the world's highest consumer of ADHD drugs for children and people under the age of 19 (in total numbers and percentage of population terms), over 3 million people last year consumed these drugs.

Many in the medical profession, especially psychiatrists, have been expressing their concerns about the disadvantages of including stronger warnings, saying warnings could do more harm than good. The dangers of leaving many patients untreated may be much greater than the present risks these drugs present.

The FDA asked the committee to examine the issue of incidents of mania and psychosis among children who take normal doses of ADHD medications.

Written by: Christian Nordqvist
Editor: Medical News Today
Copyright: Medical News Today
Not to be reproduced without permission of Medical News Today

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