Hyperactivity

...ba href=/hyperactivity/a/b disorder, was linked to serious skin rashes and psychiatric problems in children and should not be approved, a Food and Drug Administration staff reviewer said in documents released yesterday.

Cephalon's shares fell in morning trading, but closed up $1.45, or 2.02 percent, at $73.31.

The FDA staff comments were released in advance of an advisory panel meeting today to discuss approval of the drug, which is already sold as Provigil to treat sleep disorders.

In October, the FDA told Cephalon that Sparlon could be approved pending certain conditions.

However, a month earlier, a staff reviewer said the drug had "unacceptable risks" to children and adolescents and should not be approved.

In a 174-page report, FDA staff member and physician Glenn B.

Mannheim said rare but "worrisome" side effects were observed in eight clinical trials of 933 pediatric patients.

Among the safety concerns were skin rashes, including one case of Stevens Johnson syndrome, which causes blisters; a possible case of Reye's syndrome; psychiatric disorders including suicidal tendencies, depression, agitation and phobias; insomnia; headache; and anorexia.

"The risks associated with the use of Provigil are greater than the benefits and preclude the safe use of this drug" in children and adolescents with attention deficit ba href=/hyperactivity/a/b disorder, "a non-life-threatening disease," the reviewer wrote.

Mannheim's conclusion in a memo Sept.

26 was a month before the FDA on Oct.

20 issued an "approvabl...

...ba href=/hyperactivity/a/b disorder should not carry strong “black box” warnings about potential cardiovascular and psychiatric risks.

Rather, the Food and Drug Administration advisory committee recommended the drug labels be written so people can understand them.

“I wouldn’t use the word ‘tougher,’ panel chair Dr.

Robert Nelson said.

“‘Clearer.’” By rejecting the black-box warnings in a consensus decision, the advisory panel broke with another committee that voted last month to include them on some ADHD drugs.

The FDA is not required to follow the advice of its advisory committees, but usually does.

The FDA has struggled since last year with the question of how to communicate the potential risks associated with ADHD drugs.

Psychiatrists and mental health advocates said leaving the disease untreated could rival the risks the drugs might pose.

Nearly 3.3 million Americans 19 and younger used an ADHD drug last year, according to Medco Health Solutions Inc., a prescription drug benefit program manager.

• Fewer physicians providing charity care WASHINGTON — The percentage of physicians who provide free care to the poor has dropped in the past decade, signaling a growing problem for the uninsured, a survey suggests.

About three-quarters of physicians provided charity care in the mid-1990s, compared with about two-thirds now, according to a study being released today by the Center for Studying Health System Change.

The numb...

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