FDA Report: ADHD drugs linked to 51 US Deaths

February 8 , 2006

A report released by the Food and Drug Administration (FDA) stated that regulators were prompted in 2004 to start monitoring cases of heart attacks, high blood pressure and other cardiovascular problems in patients taking widely prescribed drugs, Adderall and Ritalin. According to the FDA report, these potentially dangerous ADHA drugs may be responsible for the deaths of 51 Americans.

At this point, states the FDA, there is not conclusive information linking the prescription drugs to these fatalities.

“These reports themselves do not establish a causal relationship between these medications and cardiovascular adverse events,” wrote Dr. Gerald Dal Pan, director of the FDA’s Office of Drug Safety, in a notice on the agency website.

Controversy has long surrounded the use of ADHD drugs. Many doctors and parents argue that Ritalin and Adderall are widely over prescribed, particularly to children. Widespread abuse of these habit-forming medications is also a tremendous source of concern in the United States.

The FDA will hold an advisory panel meeting to discuss how to evaluate the possible drug side effects caused by ADHD medications. Scientists and experts will supply updated information at the meeting and their concerns regarding the serious health problems the ADHD drugs pose.

The FDA report revealed 24 deaths from 1999 through 2003 among U.S. Adderall users. Sixteen more deaths were reported through 2003 in U.S. patients who took Ritalin or other ADHD drugs. Another 11 deaths among users of drugs other than Adderall in the amphetamine class were also reported.

At least 30 additional deaths have been recorded in connection to ADHD drugs, but involved cases outside the U.S. or ones that occurred after the review period.

Numerous death and injury reports prompted Health Canada to yank the ADHD drug Adderall from the market temporarily last year. However, the drug was available after six months after the agency was not able to prove that Adderall was more risky than other drugs.

“Conclusions about the relative safety of these two stimulant therapies cannot be made on the basis of this analysis,” the FDA said.

Adderall’s manufacturer, Shire Pharmaceuticals Group PIc, also claim they have no data linking Adderall and the sudden deaths reported among children. Spokesman Matthew Cabrey said the company supports the FDA’s current conclusions of the issue.

Novartis AG, makers of Ritalin, also found no correlation between the use of ADHD drugs and the increased risk of cardiovascular problems.

The FDA will continue to evaluate the risks that may be associated with these drugs as well as study if ADHD drugs may be related to psychiatric problems.

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