Top warning urged on drugs for ADD

FDA advisers say heart risks call for strongest label

February 10, 2006|By RICARDO ALONSO-ZALDIVAR | RICARDO ALONSO-ZALDIVAR,LOS ANGELES TIMES

WASHINGTON -- A Food and Drug Administration advisory panel urged yesterday that the strongest possible safety warning be issued for drugs used by millions of children and adults to treat attention deficit disorder, because of emerging concern that they might increase the risks of heart attacks, strokes and sudden death.

The FDA had called together the drug safety experts to help design further research on the risks. But in an unexpected twist, a majority of the panel members concluded the evidence of serious risks was so great that a strong new warning - not just more research - was needed.

"This is out-of-control use of drugs that have profound cardiovascular consequences," said Dr. Steven Nissen, a Cleveland Clinic cardiologist and member of the panel. "We have got a potential public health crisis. I think patients and families need to be made aware of these concerns."

The panel voted, 8-7, to call for a "black box" warning on literature distributed with the drugs - which include well-known brands such as Ritalin, Adderall and Concerta.

As many as 4 million Americans take the medications. Government figures show that almost 10 percent of 10-year-old boys in the United States get them; about 4 percent of girls that age use them.

"No one is saying that there aren't children who are desperately dysfunctional and need these drugs," Nissen said. "But it isn't 10 percent of 10-year-olds."

The safety experts also voted - unanimously - to recommend that a special brochure be provided to patients and families to inform them in greater detail about the risks and benefits. And it urged the FDA to expedite studies to develop a better understanding of the problem.

Senior FDA officials said they will study the panel's recommendations carefully and said they plan to refer the issue to another advisory panel dealing with psychological problems in children. FDA has been criticized in the past for being slow to respond to evidence of health risks with drugs, including painkillers and antidepressants.

"You don't want to over-scare people and make them not use an important drug," said Dr. Robert Temple, a top policy official at the FDA. "But you don't want people using drugs if they don't have to."

Drug makers said the attention deficit medications are safe when taken as directed. They pointed out that some have been in use for more than 50 years.

Shire, the maker of Adderall, said it would work with the FDA to make sure patients have all the information they need but that stronger warnings are not needed. Novartis, which makes Ritalin, said it has reviewed its own data and has not seen any increase in heart risks for patients.

The companies suggested there are probably other explanations for deaths and serious health problems reported to the FDA - for example, undetected heart problems.

The FDA has received reports of several dozen deaths linked to the drugs and a larger number of serious health consequences, such as heart attacks.

Most of the attention deficit drugs are derived from powerful stimulants, including amphetamines. They are believed to help patients concentrate. But they also raise blood pressure, a major risk factor for heart disease and stroke.

Attention deficit-hyperactivity disorder, known as ADHD, can prevent children from applying themselves to schoolwork; adult patients can have trouble with the multitasking demands of the modern workplace. In the United States, an estimated 2.5 million children and 1.5 million adults are taking medication for the condition.

While the drugs have been widely used by children since the 1990s, their use to treat adults is new. Prescriptions written for adults increased by 90 percent from 2002 to 2005.

And the risks for adults can be greater because high blood pressure and heart conditions are more prevalent among adults.

Ricardo Alonso-Zaldivar writes for the Los Angeles Times.

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