FDA Relaxes Stance on ADHD Drugs and Cardiovascular Risk

The Food and Drug Administration (FDA) says there are no plans to change current label requirements on attention deficit hyperactivity disorder (ADHD) medications. The stimulant drugs were suspected of increasing the risk of heart disease after 20 deaths and 12 strokes occurred in patients taking one of the drugs. After reviewing study results related to heart disease and the use of these particular drugs, the FDA does not feel additional warning labels are necessary.

Currently, the drug Adderall XR warns about the use of the pharmaceutical in those with heart conditions. Before the drug is prescribed, doctors will consider a patient’s medical history first. The British company, Shire, who manufactures Adderall XR, had been nervously awaiting the results of the study and were relieved to learn of the FDA’s findings. Shares of Shire rose 1.7 percent immediately following the announcement.

In 2006, shortly after Adderall XR was approved, the FDA recommended the stimulants be sold under the “black box label.” However, this label was only a recommendation and was not required. Drug companies were asked to include warnings about using stimulants in patients with heart problems or high blood pressure. Doctors were advised to perform complete cardiovascular workups before the drugs were prescribed.

The FDA will release a more in depth report about the study’s findings.

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