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ADHD drugs sent 2,500 to hospital

Overdose cases fill emergency rooms

WASHINGTON -- More than 2,500 children went to hospital emergency rooms in 2004 after taking a stimulant used to treat attention deficit hyperactivity disorder, most because of accidental overdoses, a US government report suggests.

About 1 in 4 children who took the drugs and went to emergency rooms had serious heart or blood pressure events including palpitations, chest pain, or fainting, said the report by the Atlanta-based Centers for Disease Control and Prevention. Many other cases involved children who accidentally took someone else's medication, the report found.

The researchers reviewed emergency room visits at 64 hospitals between August 2003 and 2005, finding 188 events related to attention deficit drugs. From that number, they projected that there were probably 3,075 visits nationally among both children and adults. The review is made as US regulators weigh whether to require a stronger warning on the drugs about a possible link to sudden death and heart risks.

``Clinicians should recognize that unintentional overdoses of stimulant medications are an important cause of injury to patients," said the CDC's Adam Cohen who, with colleagues, wrote a research letter on the report published today in The New England Journal of Medicine.

It was the first time the CDC collected such data, Cohen said, so he was unable to say whether such problems were new or how common they might have been.

The survey was prompted by reports of side effects among the estimated 3.3 million children and nearly 1.5 million adults who take the drugs. Twenty-five deaths linked to ADHD drugs, 19 involving children, were reported to the Food and Drug Administration from 1999 through 2003. Fifty-four other cases of serious heart problems, including heart attacks and strokes, were also reported. Some of the patients had prior heart problems.

In February, an advisory committee to the FDA narrowly recommended that ADHD drugs -- such as Adderall and Adderall XR, which are made by Shire Plc ; Strattera by Eli Lilly and Co. ; and Ritalin and Focalin by Novartis AG -- include a ``black box" warning about the heart risks .

But in March, a different panel of advisers concluded that such a strong warning was not necessary and might dissuade doctors and patients from prescribing or using the drugs. FDA spokeswoman Kimberly Rawlings said she could not say when the FDA would make a decision on the warning.

``This is what I was concerned about at the first advisory committee, that what we were seeing was the tip of the iceberg," Steven Nissen, interim chairman of the department of cardiovascular medicine at the Cleveland Clinic, said. Material from the Associated Press was used in this report.

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