Adderall XR Recall

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The information in this article is intended as a helpful guide only. It is not intended to be used as a substitute for professional advice. If you have any questions about your medications and what is right for you see your doctor, pharmacist or other health care professional.

On February 9, 2005 Health Canada instructed Shire BioChem Inc. to pull Adderall XR off the market. Adderall XR contains mixed salts of amphetamine in a long acting format and is used to treat Attention Deficit Hyperactivity Disorder (ADHD). There is concern that the drug is linked to sudden deaths, heart-related deaths, and strokes in children and adults taking usual doses of Adderall XR (long acting) and Adderall (short acting). The short acting Adderall was never available in Canada.

The concern is that 20 people worldwide have died while taking usual doses of Adderall and Adderall XR. Fourteen of the deaths occurred in children, and six of the deaths occurred in adults. There were 12 reports of strokes, two of which were in children. None of the reported deaths or strokes occurred in Canada.

Health Canada’s decision is not without its opponents. The manufacturer, Shire, points out that approximately 30 million prescriptions of Adderall products were written between 1999 and 2003 (the period of time that the deaths occurred), and that, although unfortunate, the reported number of deaths and strokes in a population that size is to be expected whether they were taking Adderall or not. They state that at least 5 of the cases were in patients with pre-existing heart defects like abnormal arteries, valves or heart walls. This is why in the US the regulating body there, the Food and Drug Administration (FDA) did not pull Adderall off the market. Instead the FDA changed the labeling for Adderall XR to emphasize to doctors not to prescribe Adderall XR to patients with pre-existing heart problems.

So what should you do if you or your child is taking Adderall XR? Contact your doctor about whether to continue the drug in the short term and about getting an alternative medication. After you have got an alternative medication, do not flush the rest of your Adderall XR down the sink or toilet. Return any unused portion of the medication to your pharmacy. The company, Shire, says it will reimburse your money if you return it to the pharmacy on or before March 4, 2005.

So what should you do if you or your child is on a medication in the same class as Adderall XR? Nothing different, yet. Health Canada is reviewing the other ADHD medications and will release information as it becomes available. Until we know different, we will assume the other ADHD medications are safe if used appropriately.

As always if you have any questions or concerns about these or other products, ask your pharmacist.