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Celgene sees no impact yet on ADHD drug sales

Thu Feb 23, 2006 3:27pm EST

Reporter's Notebook

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BOSTON (Reuters) - A U.S. advisory panel's recent call for strong safety warnings on attention deficit drugs has not affected sales of Ritalin or a related drug, Focalin, a top Celgene Corp. (CELG.O: Quote, Profile, Research, Stock Buzz) executive said on Thursday.

Celgene receives royalties on the two drugs, which are sold by Swiss drug maker Novartis AG (NOVN.VX: Quote, Profile, Research, Stock Buzz) (NVS.N: Quote, Profile, Research, Stock Buzz).

An advisory panel to the U.S. Food and Drug Administration voted 8-7 on February 9 to urge "black box" warnings -- the most serious possible -- about potential cardiovascular risks from prescription drugs used to treat attention deficit hyperactivity disorder, or ADHD.

Some panel members said they hoped to reduce excessive prescribing of the medicines, which are taken by millions of adults and children.

"We haven't seen any impact so far in (prescriptions)," Celgene President and Chief Operating Officer Sol Barer said at the Reuters Biotechnology Summit in Boston.

Barer said he did not expect the FDA to take any "extreme measures" that would dampen use. He pointed to the close vote and statements from FDA officials that they did not want to unnecessarily alarm patients or parents.

"I would be surprised if there was a black-box warning regarding this," Barer said. "The potential overreaction by parents ... might be contrary to public health."

Members of the advisory panel and FDA officials agreed it is still unclear if ADHD drugs increase cardiovascular risks. The FDA became concerned after receiving reports of sudden deaths, heart attacks and other complications and is planning further study to tell if the drugs were responsible.

Other ADHD drugs include Shire Pharmaceuticals Group Plc's (SHP.L: Quote, Profile, Research, Stock Buzz) Adderall and Johnson & Johnson's (JNJ.N: Quote, Profile, Research, Stock Buzz) Concerta. Most ADHD drugs are stimulants, which can raise blood pressure.

"Any stimulant, if you have a heart condition, you have to be careful with ... Parents should be aware that these drugs are not 100 percent benign and they should be on the lookout for things," he said.

 
 
 
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