Tuesday, October 10, 2006

US FDA's quiet move on ADHD drugs draws complaints

US FDA's quiet move on ADHD drugs draws complaints
Thu Aug 24, 2006 5:22 PM ET

By Susan Heavey

WASHINGTON, Aug 24 (Reuters) - The U.S. Food and Drug Administration's quiet decision to require heart and psychiatric warnings on attention deficit drugs has sparked new criticism from a top Republican senator and others over the agency's handling of safety issues.

The agency's new caution for stimulants like Novartis AG's <NOVN.VX> <NVS.N> Ritalin, which came to light this week, follows a wave of recent concerns over safety problems linked with antidepressants and painkillers.

Meanwhile, some analysts and doctors say the warnings, over possible heart risks and psychiatric problems, are unlikely to affect the millions of ADHD prescriptions written each month.

Senate Finance Committee Chairman Charles Grassley said the FDA should have been more forthcoming and questioned why the agency and drugmakers did not announce the changes for attention deficit hyperactivity disorder, or ADHD, drugs.

"Doctors, parents and patients deserved to hear about the changes. They shouldn't have to search high and low for information," Grassley, an Iowa Republican, told Reuters on Thursday.

"It's of great concern if the FDA took a keep-it-quiet approach in order to protect the drug companies," he added.

Months after two FDA advisory panels offered conflicting opinions over the warnings, the FDA in May asked most ADHD drug manufacturers to add the warnings.

Its decision was made public Monday when the FDA released a letter GlaxoSmithKline Plc <GSK.L><GSK.N> sent to doctors.

Other ADHD stimulants include Shire Plc's <SHP.L> Adderall, Glaxo's Dexedrine, Novartis's Focalin and Johnson & Johnson's <JNJ.N> Concerta, among others. Eli Lilly and Co.'s <LLY.N> Strattera, a non-stimulant ADHD drug, does not carry the new warning.

The FDA can take a range of actions when changing drug labels, but in many cases it issues a public health advisory.

"I do wish it had been done in a more public way," said Dr. Steven Nissen, a member of the FDA panel who pushed for strong boxed warnings on the drugs when it met in February.

In March, another panel said warnings were needed but a boxed version, the strongest available, could scare patients.

Nissen, head of cardiovascular medicine at the Cleveland Clinic in Ohio, added he was satisfied some action was taken.

Dr. Robert Temple, head of FDA's medical policy office, said earlier this week the agency "probably should have" announced its decision. "We did after the March advisory committee pretty much say what we were going to do," he said.

Companies weren't required to send doctors a letter, Temple said, but the agency was developing a brochure to be given to patients with each prescription.

In response to the criticism, FDA spokeswoman Susan Bro said the "FDA remains as committed as ever to ensuring prescribers and patients have the benefit of accurate, timely information so they can make educated health care choices."


Drugs to treat ADHD have come under fire in recent years from critics who say they are too often used as a quick-fix treat people who don't need them.

In the first half of this year, such stimulants have raked in $1.7 billion in U.S. sales, according to data from IMS Health. For all of 2005, sales reached nearly $3 billion.

Paul Diggle, an analyst for Nomura Code Securities analyst in London, said the ADHD drug market had already felt the impact from the risks made public earlier this year.

"Most companies have put that down in part to people being a bit more nervous about these drugs," he said.

Ira Loss, a health care analyst for Washington Analysis Corp., said doctors are likely to look at the warnings but not change their prescribing habits.

"I don't thing there any kind of tidal wave that going to result from these changes," he said.

Dr. Adelaide Robb, a child psychiatrist at Children's National Medical Center in Washington, said there was a big difference between ADHD drugs and antidepressants, which have warranted new warnings about possible suicidal behavior.

"The efficacy in medications for ADHD have a much longer and stronger record," she said. (Additional reporting by Lisa Richwine in Washington and Ben Hirschler in London)  


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