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About Health Canada

Statement regarding ADHD drugs

September 27, 2012

Health Canada understands how important it is to parents to know that the drugs being taken by their children are rigourously assessed for safety and effectiveness before they are allowed on the market and are closely monitored for safety after they are approved. Health Canada takes this responsibility very seriously.

A recent media story on the safety of drugs to treat attention deficit hyperactivity disorder (ADHD) fundamentally misrepresented the extensive work Health Canada does to help protect Canadians from unsafe drugs.

The use of any drug carries risks and benefits. Health Canada works to make sure any risks are widely understood by health care professionals and Canadians. Contrary to this inaccurate report, the department has been vigilant in looking at ADHD drug safety and has repeatedly taken action when necessary to strengthen the protection of patients taking these medications. The potential risks, including rare psychiatric and cardiac risks, are well-known and clearly labeled. The risks and labeling changes have all been communicated to health professionals and the public by Health Canada and the manufacturers. These public communications included a reminder to health care providers to work with patients, family members and caregivers to monitor moods, behaviours, thoughts and feelings of children when ADHD medications are used. One product, ADDERALL XR, was even taken off the market for a period while new safety information was assessed.

The article ignores the benefits these drugs have for the majority of users. Health Canada's job is to weigh those benefits against the potential risks, which it has done in a scientifically accepted manner. Only products where the benefits outweigh the risks when used as directed are authorized for sale in Canada.

All health products have risks. Decisions about taking ADHD drugs are made in consultation with a licensed medical doctor, who plays a key role in informing patients about the benefits and risks. Doctors have access to a number of sources of information (including Health Canada) when making decisions on the best treatment for individual patients. How doctors prescribe the health products authorized for sale by Health Canada is considered the "practice of medicine" and is regulated by the provinces and territories. Proper use is an important part of drug safety.

Health Canada has highly trained specialists who use Canadian adverse reaction data as well as other sources of information to thoroughly monitor, analyze and act on safety issues related to health products. Sources of data include post-market studies, company data including sales figures, published data, international safety data and collaboration with international counterparts.

All domestic adverse reaction reports are assessed for seriousness and outcome. This information is monitored to identify rare, new or unexpected adverse reactions. Reports are analyzed to confirm or rule out a cause-and-effect relationship and to discover potential safety concerns.

The pharmaceutical industry does not "police itself," as this article claims. The safe use of drugs is a responsibility shared among a number of parties, including Health Canada as the regulator that reviews and monitors the safety and efficacy of drugs, the manufacturers that make drugs, health professionals who prescribe and dispense drugs, and informed consumers. Health Canada takes action to revise the labeling of products or remove them from the market when necessary.

The media also has a responsibility to report accurately and completely on drug safety so that the fears of patients who rely on drugs are not needlessly provoked. In this case the reporter was provided ample and accurate information that was simply not incorporated into the story.

Health Canada will continue to monitor the safety of these drugs and will inform health care practitioners and the public should new risks emerge or labeling changes occur.