U.S. reports deaths of attention drug patients
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U.S. regulators were told of 24 deaths among patients who took Shire Pharmaceuticals Group Plc’s attention deficit drug Adderall through 2003, according to a report released on Wednesday.
Another 16 deaths were reported through 2003 in patients who took other attention deficit drugs known as methylphenidates, said the report prepared by Food and Drug Administration staff. Ten deaths were reported among other drugs in the amphetamine class, it said.
The report from April 2004, which disclosed all the deaths, did not say the drugs were responsible for the fatalities but urged close monitoring of possible cardiac problems in children who took them.
An FDA advisory panel will meet on Thursday to discuss how best to study the safety of the medicines, which are widely prescribed to children. FDA staff also will provide updated figures on health problems that have been reported in people who took the therapies, the report said.
Shire spokesman Matthew Cabrey said data has not shown any correlation between Adderall and the sudden deaths reported among children. He said the company supports the FDA’s review of the matter.
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