Adderall Safety Is Not Proven By Health Canada's Decision To Reverse Ban On ADHD Drug

A Closer Look At How (Or Why) Adderall Got Back On The Market In Canada

In the October 7, 2005 edition of Psychiatric News there was an article by Jim Rosack entitled "Canada Reverses Ban On ADHD Medication" that examined how Adderall XR got back on the market six months after Health Canada had suspended sales of the popular attention-deficit/hyperactivity disorder (ADHD) drug.

As background, Health Canada announced on August 24, 2005 that Adderall XR could be reintroduced to the Canadian market.  Health Canada had recalled Adderall XR from the Canadian market in February 2005 after learning from Shire Pharmaceuticals Group Plc -- the company responsible for Adderall XR in Canada -- about 20 cases of sudden death and 12 cases of stroke in people using the ADHD drug.

An article published in the October 11, 2005 edition of the Canadian Medical Association Journal pointed out that Health Canada decided to allow Adderall back on the market in August 2005 not because the agency found Adderall to be safe but, rather, because "an independent panel found it impossible to accurately ascertain whether the drug increases the risk of cardiac death."

Given the February 2006 recommendation by an FDA advisory panel committee that a "black-box" warning be put Adderall and the other ADHD drugs, the "how-and-why" of Adderall getting back on pharmacy shelves in Canada is worth a second look. 

Health Canada rescinded its suspension order and allowed Adderall to return to the market after its committee of outside medical experts, called the Adderall XR New Drug Committee, had concluded that "an increased risk of sudden cardiac death and/or stroke with Adderall XR compared to alternate active treatments has not been proven."

It is important to know that the Health Canada committee concluded, also, that "such an increase [in risk of sudden cardiac death associated specifically with Adderall XR use] has not been ruled out due to limitations in the data currently available for analysis"  (emphasis added).

Faced with this predicament, the committee recommended several steps be taken by Health Canada and Shire before Adderall was put back on pharmacy shelves.  The full set of recommendations can be found in the report prepared by this Adderall XR New Drug Committee.  In his October 2005 Psychiatric News article, Rosack provides some of the highlights:

• recommended that Health Canada seek expert consultation "on the appropriateness of potential additional cautions (e.g., strenuous exercise, use of other stimulants, family history of sudden cardiac death) in patients treated with any ADHD drug (stimulant or non-stimulant) that might be considered in the assessment of benefit versus risk for an individual patient."
• recommended that Health Canada approve revised product labeling submitted by Shire in November 2004. That proposed labeling (virtually identical to the approved labeling in the United States) includes warnings regarding reports of sudden death in patients taking therapeutic doses of amphetamines, particularly children with structural cardiac abnormalities. The new Canadian labeling will also add myocardial infarction, sudden death, and stroke to the list of potential adverse events.
• recommended that Health Canada "enhance postmarketing surveillance for all stimulant drugs used in the management of ADHD," but did not list specific steps they thought should be taken. The committee also noted that while an increased risk of adverse cardiac events associated with stimulant medications "is lacking, even in the absence of this information, it may still be prudent for a baseline EKG be obtained prior to implementing drug therapy" for patients who are involved in strenuous exercise, use more than one stimulant medication, or have a family history of sudden cardiac death.

In the end, despite the fact that Health Canada let Adderall XR back on the market, it seems that there are some serious and yet unresolved safety issues for this ADHD drug.  As such, the FDA should give more consideration to the findings of its own advisory panel committee and, in particular, the recommendation that a black-box warning be added to Adderall and the other ADHD drugs.

(Posted by: Tom Lamb)