Generic: Amphetamine Mixed Salts
Manufacturer: Catalytica Pharmaceuticals, Inc.
Date approved: 2002
Status: Prescription only
Approved uses: Treatment of Attention Deficit Disorder with Hyperactivity (ADHD)
Off-Label uses: Depression; illegal use to improve concentration, especially among students
• Increased heart rate
Related topics: Paxil, Strattera
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.
Off-Label Use of Adderall Poses Increasing Threat
Initially prescribed to adults and children for the treatment of attention-deficit disorder with hyperactivity (ADHD), Adderall is coming under increasing scrutiny for another use: off-label, illegal abuse of the drug, especially among college students. The off-label use of Adderall is on the rise, and is causing rising Adderall side effects in a population that is for the most part uninformed about Adderall side effects and indications.
Intended Use of Adderall
Adderall is the brand name for the amphetamine mixed salts marketed by Shire Pharmaceuticals, Inc. and sold in the United States and Canada for the treatment of ADHD in adults and children over age six. The drug was approved for the treatment of children in 1996 and for adult treatment in 2004. Adderall stimulates the brain’s production of the hormones dopamine and norepinephrine, causing users to experience increased attention levels and longer concentration times. This focusing effect helps patients who suffer from ADHD, which is estimated to affect between three and seven percent of school-aged children and continue into adulthood for over 60 percent of these patients.
Growing Off-Label Use
Though Adderall is used under-the-counter by illegal users, some of Adderall’s off-label use is due to doctors who prescribe the drug to aid with depression in patients. The drug is also used for narcoleptic patients, which is an approved but less common use. However, Adderall is growing in popularity as a “study drug” and as an appetite suppressant in users who wish to lose weight.
Prescription stimulant abuse is a growing concern in the United States, where the competitive atmosphere of colleges makes students more likely to pursue stimulant abuse as an option to help them succeed in school through increased concentration and energy levels. Adderall is sold illegally as a street drug and referred to as “zing”, “study buddies”, “diet coke”, and “smart pills” by aficionados, who purchase the pills for between $2 and $10 per pill, depending on dosage. Some users crush and snort Adderall in order to receive the drug’s amphetamine boost more quickly.
Dependency is a primary concern in off-label Adderall abuse. The drug is highly habit-forming (as attested to by strong FDA labeling to that effect), and users who begin using Adderall as a study drug often find that they are unable to feel confident in their study habits and learning skills without the drug, leading to long-term use and long-term Adderall side effects, such as gastrointestinal complaints, insomnia, and sexual dysfunction. In addition, users of off-label Adderall have been found to be more likely to engage in other risky behavior such as cocaine abuse, cigarette smoking, alcohol abuse and drunk driving.
Notwithstanding the drug’s obvious habit-forming properties, Adderall can present additional risk to off-label users who do not adequately inform themselves about Adderall’s potential interactions and side effects. Users with histories of past mental illness, drug abuse or cardiac conditions can experience life-threatening Adderall side effects such as high blood pressure, hallucinations and Tourette’s syndrome. Those without pre-existing conditions may still be at risk for Adderall side effects such as nervous tics, gastrointestinal distress, loss of appetite and inability to sleep.
If You’ve Experienced Adderall Side Effects
Unfortunately, off-label use of Adderall may disqualify you for compensation and settlements in relation to severe Adderall side effects. If you are dependent on Adderall, you may wish to seek rehabilitation or other medical help. If you are suffering from on-label Adderall side effects like the ones mentioned above, you may wish to contact an Adderall attorney and see if you have a valid Adderall claim. Your Adderall law suit may help you collect damages for costs such as medical expenses, future medical care, lost wages, and pain and suffering. An attorney experienced in Adderall litigation and unsafe drugs can help you assess your claim and potential settlement.