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FDA To Finally Study Possible Increased Heart Risks Caused By Attention Deficit Medications

The Safety Profile Of Adderall, Concerta, Ritalin, Dexedrine And All Other ADHD / ADD Drugs Will Be Reviewed

(Posted by Tom Lamb at DrugInjuryWatch.com)

In a September 17, 2007 FDA News article titled "AHRQ and FDA to Collaborate in Largest Study Ever of Possible Heart Risks With ADHD Medications" we learned that the safety of Adderall, Concerta, Ritalin, and Dexedrine — as well as all other attention deficit hyperactivity disorder (ADHD) and attention deficit disorder (ADD) drugs — will finally be reviewed.

In more detail, the FDA will collaborate with the Agency for Healthcare Research and Quality (AHRQ) to examine clinical data regarding 500,000 children and adults who have used ADHD / ADD drugs in the past to determine these drugs cause an increased risk of heart attacks, strokes, or other serious cardiovascular problems.  The study is expected to take about two years to complete.

As stated in the September 17 FDA News item:

"Case reports have described adverse cardiovascular events in adult and pediatric patients with certain underlying risk factors who receive drug treatment for ADHD, but it is unknown whether or not these events are causally related to treatment," said Gerald Dal Pan, M.D., director of FDA’s Office of Surveillance and Epidemiology. "The goal of this study is to develop better information on this question."

We get the impressions of Steven Nissen, a prominent cardiologist who has been involved previously with the ADHD / ADD safety debate about this new FDA study announcement from the September 17, 2007 post "Feds Studying Risks of ADHD Drugs" by Jacob Goldstein at The Wall Street Journal (WSJ) Health Blog:

… told the Health Blog that the study could be “potentially very helpful,” because it will look at seven years’ worth of data, while earlier studies have looked at shorter periods of time….

Nissen… pointed out both that ADD and ADHD drugs tend to raise blood pressure (which raises cardiovascular risks) and that 10% of those treated for the disorders are over 55 years old — an age group where the risk of heart attack and stroke tends to be higher to begin with.

“We really don’t know what the long-term impact of the drugs is going to be on cardiovascular health,” said Nissen, who is not involved in the federal project. “This would obviously be unique data and potentially very helpful because it’s long-term.”

In August 2006 the FDA approved label changes they had requested from the drug companies that make ADHD / ADD medications — such as Novartis AG’s Ritalin and Shire Plc’s Adderall — to add information about the emerging heart-related issues.  Later, in February 2007, the FDA asked those same drug companies to develop patient guides that explained the possible cardiovascular risks associated with ADHD / ADD drugs.

We will monitor and report the results of this seemingly long overdue ADHD / ADD drug safety study by the FDA and AHRQ.

7 responses to “FDA To Finally Study Possible Increased Heart Risks Caused By Attention Deficit Medications”

  1. IV Avatar
    IV

    Hi,
    I’m glad to see the alarm being sounded online about the heart risks to ADD patients taking stimulants. Someone should now warn the parents of these children on Adderall and Dexedrine that these are both just amphetamine in new formulations. The risks of amphetamine have been known for decades (heart attack, stroke, Parkinson’s diseases, addiction). Amphetamine is a scheduled drug. Renaming it doesn’t make it safer for children.
    Thanks,
    IV

    Reply
  2. Tom Lamb Avatar
    Tom Lamb

    Your information is right on point and, unfortunately, probably unknown to most parents.
    Moreover, these parents would no doubt be shocked to learn that their child has been prescribed and is using what is essentially what used to be called “speed”.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  3. Mother 2-1 Avatar
    Mother 2-1

    Are there any safe alternatives out there to help our children instead of these dangerous drugs? The side effects seem to outweight the benefits…just personal opinion.

    Reply
  4. Tom Lamb Avatar
    Tom Lamb

    I appreciate your concern but this type of question is better directed to a doctor for their medical advice. As an attorney, I am not qualified to do that.
    Thanks for reading Drug Injury Watch.
    Tom Lamb

    Reply
  5. Debbie Avatar
    Debbie

    My son was on adderall for 8 years (6 – 14), at 16 he was diagnosed with hypertrophic cardiomyopathy after the family physician detected an irregular heartbeat when we were in the office for a sore throat. We were immediately referred to a interventiive cardiologist in Mesa, AZ, and after much testing the irregular/racing heartbeat was contributed to hypertrophic cardiomyopathy. His heartbeat was found to be 190 in resting state and we were told there was a possibility he would not live to see his 21st birthday. He was placed on coreg along with other minerals/vitamins for 10 months – he is now off coreg (stopped taking in November of 07 and we hope he is able to remain off, we have a follow-up in one week with cardiologist), however we’ve been told by the cardiologist that he will need to have heart monitoring (regular visits to the cardiologist) for the rest of his life.
    Although obviously an unpleasant discovery, we feel lucky that the condition was caught, son was an athlete – high school basketball team and club boxing – at the time of his diagnosis and as I’ve learned more about the condition and the number of deaths in student athletes from hypertrophic cardiomyopathy, I have to feel fortunate.
    I am however angry at the FDA, at the makers of adderall, our government and myself for giving my son this drug for 8 years. I think there are so many parents out there unknowingly giving their children ADHD drugs without understanding the longterm effects it may have on their childrens lives. These drugs would not be allowed on the market without the approval of the FDA and I feel like the intense lobbying on the part of the drug companies is endangering our children.
    I found your information on the internet and just wanted to share our story in the event you were involved in any litigation against the makers of adderall or the FDA and needed to hear from real-life stories.
    We live in Arizona, however my son was first placed on adderall by a school psychologist in Overland Park, KS.
    Thank you and I hope you are able to get this drug off the market.

    Reply
  6. Tom Lamb Avatar
    Tom Lamb

    Thank you for sharing your son’s experience — as you said, unpleasant but fortunate in the end.
    Perhaps someone who reads your information will take their child off Adderall before any permanent long-term damage can be done.
    As a precaution to any such person, however, please know that the FDA advises that a person should not stop taking any prescription medication before talking to their doctor.
    Thanks for reading Drug Injury Watch.

    Reply
  7. hill Avatar
    hill

    Hi Debbie, We live in overland park. My 13 yr old son died 3 years ago. He was taking concerta I found him on his bed. His heart just stopped. Autopsy report said a build up of concerta in his blood. But hedid not take an overdose, as we had all his pills. Metabolism problem.

    Reply

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