http://news.yahoo.com/s/ap/20060209/ap_on_he_me/attention_deficit
WASHINGTON - A federal advisory committee voted Thursday to recommend that stimulants prescribed for attention deficit hyperactivity disorder be required to bear the most serious type of warning on their labels.
The 8-7 vote, with one abstention, by the Food and Drug Administration committee was to recommend the agency add so-called “black box” warnings to Ritalin and other ADHD drugs. Doctors prescribe the increasingly popular drugs to about 2 million children and 1 million adults a month.
The FDA isn’t required to follow the recommendations of its advisory committees but typically does.
The vote on warning labels followed an earlier 15-0 vote to recommend that the FDA require that the drugs include a medication guide for patients and parents.
There have been 51 deaths among children and adults taking drugs for ADHD (attention deficit hyperactivity disorder) in the US since 1999. Yesterday the UK licensing authority, the Medicines and Healthcare Products Regulatory Agency (MHRA), said nine children had died in this country among a smaller population on medication…
…The recommendation by an advisory panel of the Food and Drug Administration to put a “black box” warning - the most serious possible - on all ADHD drugs in the US is likely to be accepted. Pressure will mount now on the British authorities to warn publicly of the risk…
…There is growing concern about the rising numbers of children being put on drugs. This class of drugs, known as methylphenidates, are amphetamine-based and it is thought they could cause heart problems in some children and adults because they raise blood pressure. There is already a warning on the drug most widely used in the US, Adderall, which is not licensed in the UK…
…The FDA advisers said it was not certain the drugs contributed to the 51 deaths. “The data is only suggestive at this point, but because of the gravity of the side-effect, namely sudden death, physicians need to be made clearly aware of that concern,” said Dr Peter Gross, the panel chairman and head of internal medicine at Hackensack University Medical Centre in New Jersey. One member of the panel was clear that he hoped the warning might slow down the soaring rate of prescription of the drugs to children who are inattentive or badly behaved at school. “I want to get people’s hands to tremble a little bit before they write that [prescription],” said Steven Nissen, a panel member and cardiologist at the Cleveland Clinic.
more at: http://www.guardian.co.uk/medicine/story/0„1707536,00.html