In the past 1 1/2 years, there has been a lot of news about the safety of medications for ADHD/ADD. While this has led to many people being very concerned about using medication for ADHD, I hope that it is also reassuring - i.e. the fact that active ongoing monitoring of medication is going on should reassure people taking the medication.
The FDA, Health Canada, and other monitoring agencies in different countries have kept active watch on medications for ADHD.
Last week, the FDA announced new concerns and warnings for ADHD medications - including Dexedrine and Ritalin. I am preparing a summary of this issue - and it will be posted shortly.
With this post, I wanted to provide some background about the issues, taken from two previous reports I have done:
1) Adderall XR: its removal and reinstatement in Canada
2) The FDA concerns and suggestion of a black box warning in February 2006.
Adderall XR - The Canadian Story:
On February 9, 2005, Health Canada (the Canadian version of the FDA), suspended Adderall XR from the Canadian market due to safety concerns. There were concerns that Adderall may have been associated with an increased risk of sudden/cardiac death, and stroke in children and adults taking the medication. View the original statement by Health Canada here.
The FDA in the United States reviewed the Health Canada concerns about Adderall, and decided that there was not a need to change the labeling or availability of Adderall XR based on their review of the data. View their original statement here.
Health Canada established a ‘New Drug Committee’ (NDC) to review the data on safety and adverse events on Adderall XR. The committee included three members - a specialist in childhood behavioral disorders (doctor who is an expert in ADHD), a pediatric cardiologist (heart specialist for kids), and a pharmaco-epidemiologist (expert in research on medicines).
The New Drug Committee reviewed Adderall XR, the safety concerns, and found that there was no increased risk for Adderall compared to other ADHD Medications. So, Adderall was reinstated in Canada on August 26, 2005. The NDC did include the following quote at the end of their report:
That ALL stimulant drugs prescribed in the management of ADHD should be used with caution in patients who:
(a) are involved in strenuous exercise or activities
(b) use other stimulants or,
(c) have a family history of sudden/cardiac death.
You can see the full report of the New Drug Committee here.
Many patients were affected by Adderall XR being taken off the market in Canada. If you or someone you love were affected when Adderall XR was taken off the market, please post a comment and describe the impact on you or your loved one.
2) The FDA concerns about ADHD medications and the suggestion of a ‘Black Box’ Warning in February 2006
On February 9th, 2006, an advisory committee of the FDA met to review safety in ADHD medication. This subcommittee shocked the ADHD world by coming out with the recommendation of a Black Box warning for ADHD Medications - which is a the strongest warning possible by the FDA.
On that day, I prepared a detailed, audio ’special report’ to summarize the issues. You can hear or download this report here:
FDA concerns about ADHD Medication
This article is just the start of a series of articles which will help to review the evolving issues about safety of ADHD medications.I want to keep you up to date and informed!
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