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FDA Remains Ambiguous On Adderall
The federal Food and Drug Administration (FDA) just can't seem to make up its mind about one of the most controversial drugs on the market: Adderall, a powerful stimulant used for the treatment of attention-deficit disorder with hyperactivity (ADHD). Though the drug, which is distributed by Shire Pharmaceuticals, Inc., was briefly banned in Canada after allegations of adverse cardiac side effects, the FDA has yet to issue any kind of public warning on the drug, despite an 8 to 7 vote on the part of FDA safety officials who felt a "black box" warning was necessary.
What is Adderall?
Adderall is the brand name for amphetamine mixed salts, a stimulant drug used to treat ADHD in children and adults. The drug stimulates the brain's production of hormones dopamine and norepinephrine, improving concentration and focus in hyperactive patients. It was originally prescribed in the 1970s as Obetrol, an anorectic (appetite-suppressant) drug. Adderall is recognized as being highly habit-forming and enjoys a large illegal following among students, who use the drug as a study aid.
Canadian Side Effect Claims
While Adderall has a number of documented side effects, including gastrointestinal disorders, vertigo, sweating, irritability, sexual dysfunction, loss of appetite, and insomnia, among others, it was the drug's link to sudden death in 12 American children that led to Canada's temporary ban on the drug. Between 1999 and 2003, 12 children took Adderall and died of cardiac symptoms. Though officials in the United States pointed out that preexisting conditions had likely lead to the children's deaths (five of the children had preexisting cardiac disorders and two died after possible overdoses), Health Canada suspended all sales of the drug in February 2005. The FDA did not follow suit, citing over 35 million successful prescriptions over five years.
After an independent report of three independent physicians was released in August 2005, Health Canada lifted the Adderall ban, though the organization still warns against the use of Adderall in patients with pre-existing mental or cardiac illness (a warning shared by the FDA). However, the FDA chose not to ban the drug and has not passed any warnings aside from standard warnings about the addictive potential of amphetamine usage and a warning that Adderall is not suitable for patients with a history of drug abuse. In March 2006, the FDA's pediatric advisory committee voted not to give the drug its severest "black box" warning, despite an 8 to 7 vote on the part of FDA safety advisors to warn consumers about the fatal side effects of Adderall use.
If You've Been Affected
If your child has suffered from Adderall side effects including sudden death, you may be able to recover settlement monies to cover medical care and pain and suffering caused to your family. After obtaining the proper medical care, contact a lawyer experienced in unsafe drugs litigation. Your Adderall attorney can tell you whether you have a claim and help you file suit. An Adderall lawyer may also help you obtain compensation for your child's death or other Adderall side effects, which may include cash payments for pain and suffering, medications and current and future medical costs.
