Dexedrine to carry new warning

On Monday, the Food and Drug Administration announced that the labels of Dexedrine, a pep pill used to treat attention-deficit hyperactivity disorder and narcolepsy, be changed, and consumers be warned of the heart problems it may cause.

The drug is attached with a black box warning, the strongest alert possible, after it was reported that stimulant treatment in children and adolescents with serious heart problems, has caused deaths.

The new warning updated, includes the caution that the drug should not be misused, or it will lead to serious cardiovascular adverse events and even deaths.

In the beginning of the month, Dexedrine manufacturer GlaxoSmithKline, had advised the health professionals to change the labels of the drug as many reports of strokes, deaths and myocardial infarction in adults and children, who were taking stimulant drugs at usual doses for ADHD, have been reported.

As per the new label, the already existing psychotic disorders, such as bipolar illness, may be aggravated. Not only this, new symptoms like hallucinations or delusional thinking may also come forth.

Glaxo spokeswoman Holly Russell, said that in the month of May, the Food and Drug Administration asked the maker of these drugs to add warnings based on the recommendations from two advisory committees.

The president of the American College of Cardiology and chairman of cardiology at the Cleveland Clinic, Steven Nissen, said that the warning should be taken seriously. He further said that the warning is well phrased and lets the patients and physicians know that the drug may have adverse affects on the cardiovascular system.