Drug Warnings: Adderall Side Effects and Risks
Adderall, distributed by Shire Pharmaceuticals, is a stimulant marketed to treat restlessness and an inability to focus in both children and adults. These symptoms are called Attention Deficit Hyperactivity Disorder (ADHD), though the diagnosis is controversial and has been the subject of both litigation and public debate. ADHD drugs, including Adderall have been linked to serious side effects and death, primarily in children.
In a March 3, 2006 staff memo, the FDA (Food and Drug Administration) expressed concerns about occurrences of psychotic symptoms, such as hallucinations, in patients with no identifiable risk factors for psychosis and who are taking Adderall and other ADHD drugs. These psychotic symptoms can occur after the patient has stopped taking the drug. Current labeling doesn’t say that the drug should be stopped if these symptoms occur. The FDA recommended improved label warnings for these adverse reactions.
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An FDA advisory committee recommended an even stronger action in February 2006. The Drug Safety Risk Management Advisory Committee voted 8-7 on February 9th to recommend that the FDA require the highest level of warning, a black box warning, for the dangers of high blood pressure, heart attack, stroke, and sudden death from ADHD medication. The FDA doesn’t have to follow the recommendations of its committees for this Adderall warning, but it often does follow committee recommendations.
Adderall was banned from sale in Canada in February 2005 after reports of 24 deaths and 54 cases of severe cardiovascular problems were reported in the U.S. The Canadian regulatory agency found that the Adderall risk was too high to allow sale of the product. The FDA issued a MedWatch alert announcing the ban. In August, Canada allowed sales of Adderall to resume, but continues monitoring the Adderall risks and Adderall side effects.
Check out the following articles for more information about Adderall, filing an Adderall lawsuit and finding an Adderall attorney.
Suffered harm from Adderall? You may have a lawsuit. Click here, for a top rated law firm to evaluate your legal rights.