Sudden Cardiac Death and Stroke Case Reports Had Caused Health Canada to Recall Adderall in February 2005

Health Canada announced on August 24, 2005 that Adderall XR, an attention deficit hyperactivity disorder ("ADHD") drug, can be reintroduced to the Canadian market.  Health Canada had recalled Adderall XR, a once-a-day treatment for ADHD, from the Canadian market on February 9, 2005 after learning about 20 cases of sudden death and 12 cases of stroke in people using the ADHD drug.  These case reports came from Shire Pharmaceuticals Group Plc, the company responsible for Adderall XR in Canada.

Health Canada’s recall of Adderall XR was unusual in the fact that none of the 20 cases of sudden death and 12 cases of stroke occurred in Canada.  Moreover, the FDA had reviewed the underlying data for this set of case reports in the summer of 2004 and concluded that the rate of sudden deaths and strokes in Adderall XR users was not significantly higher than the so-called "background rate" — the incidence rate of such events expected to occur in people who had not been taking the subject drug.

Health Canada’s reversal of its Adderall recall decision comes after a panel of drug-safety experts — called a New Drug Committee ("NDC") — reviewed the safety data provided by Shire regarding Adderall XR.  Shire triggered this review by appealing Health Canada’s decision to recall Adderall from the market earlier this year.

Health Canada spokesperson Jirina Vlk had these comments:

The NDC came to the conclusion that there was not enough evidence of an increased harm from Adderall compared to other therapies available….  The benefits of treating ADHD has to be balanced with the known harms of this class of drugs.

According to an August 24, 2005 News Release from Health Canada regarding Adderall, there are a number of steps that Shire must take in connection with Adderall XR being returned to pharmacies in Canada, among them:

• Revise the prescribing and patient information to reinforce the safe use of Adderall XR, as well as to reflect safety concerns, including the risk of sudden cardiac death; and,
• Distribute a letter to healthcare providers, i.e., "Dear Doctor" letter, to inform them about the risks of use of Adderall XR.

It is estimated by Health Canada and Shire that it could take two to three weeks before Adderall XR actually becomes available in Canadian pharmacies due to logistical matters.

(Posted by: Tom Lamb)