ADHD DRUGS Panel: No 'black box' warning

The recommendations must still be accepted or rejected by the FDA.
KNIGHT RIDDER NEWSPAPERS
PHILADELPHIA -- Drug-safety experts have rejected slapping a stern "black box" warning about psychiatric side effects on attention deficit/hyperactivity disorder drugs.
Still, the advisers to the Food and Drug Administration called Wednesday on doctors and parents to be far more vigilant about the psychiatric side effects, citing rare but serious cases of horrific hallucinations, aggression and suicides by children.
The recommendation by the FDA's Pediatric Advisory Committee came nearly two months after another FDA advisory committee narrowly approved the idea of an black box on ADHD drug cardiovascular risks.
The split decision on "black boxes" -- a bold-faced label that often leads to fewer prescriptions and sales -- could provide some breathing room to makers of ADHD drugs and may deflect harsher FDA action.
The drugs include Adderall XR, made by Shire P.L.C., and Concerta, made by McNeil Consumer & amp; Specialty Pharmaceuticals.
Under review
Provigil, made by Cephalon Inc., is under review for ADHD treatment under the name Sparlon. The ADHD skin patch Daytrana, made by Noven Pharmaceuticals Inc. and marketed by Shire, is also under review.
Others drugs affected were Ritalin, made by Novartis AG and several generic firms; Strattera, made by Eli Lilly & amp; Co.; and Focalin XR, also made by Novartis.
An estimated 2.5 million children and 1.5 million adults take ADHD drugs. The top treatments generated about $3.5 billion in sales last year.
FDA officials still must accept or reject the recommendations. Officials already indicated they think a stern heart-attack warning is excessive but have not yet made a final decision.
Data on psychiatric risks were more solid. "We recommend that these issues be addressed," Kate Gelperin, a drug-safety expert at the Food and Drug Administration, told the committee during a daylong meeting Wednesday.
She said regulators were struck by the number of cases of "hallucinations, both visual and tactile, involving insects, snakes and worms," characterizing the tales as "particularly traumatic and undesirable."
Members of the committee agreed, by consensus, to recommend that the FDA order drug-makers to draft and distribute a detailed "medication guide" outlining the side effects.
The committee also called on the FDA to promote more voluntary reporting to the agency's MedWatch adverse event reporting system, to generate more data about problems.
One warning label
Only one of the drugs, Strattera, carries a warning label discussing risk of suicide. Adderall XR carries warnings about psychosis and sudden death in people with heart abnormalities. It also carries a warning about heart attacks from "misuse or abuse."
But proper use in otherwise psychologically healthy children is exactly where the FDA researchers said they found problems. One FDA review of real-world data failed to find any tell-tale psychological risk factors that physicians should look out for before prescribing the drugs.
"No risk factors were identified which could account for the majority of reports of psychosis-related events," the report said. "Also of note, in the overwhelming majority of cases, the patient had no prior history of a similar condition."
Gelperin said preliminary estimates indicate that as many as 6 percent of children using ADHD medications properly may experience a negative psychiatric side effect.
At least 10 deaths -- six from suicide -- were reported from real-world data on children using Concerta between 2000 and 2005, although not all were directly blamed on the drug. At least four suicide deaths were found in real-world data on children on Adderall or Adderall XR.