November 13, 2007

FDA To Study Adderall And Concerta For Heart Risks

The FDA announced yesterday that it would undertake a study of data from 500,000 patients who took ADHD drugs between 1998 and 2005. About 5 million children and adults take drugs such as Adderall, Concerta, Strattera, Ritalin, clonidine and the like each year in the US. Total US sales are about $4 billion a year. There have been reports of heart problems connected with the use of these drugs for years, and that's what the agency is looking into.

One hopes they look really hard.

"While case reports have described the heart complications, 'it is unknown whether or not these events are causally related to treatment,' said Gerald Dal Pan, director of FDA's office of surveillance and epidemiology, in a statement posted on the FDA's Web site. 'The goal of this study is to develop better information on this question.'"

What else would they be related to, especially in youngsters?

Fortunately, the FDA did slap a black box warning on ADHD drugs in May 2006 due to the drugs' potential--and let me stress it: potential--to cause heart problems and, in some cases, produce psychosis in patients taking the drugs. So I find it difficult to believe the FDA wouldn't find some sort of causal relationship in this new study.

But, perhaps, it will be like the lengthy battles over SSRIs and suicides, where the FDA over the last few years has fundamentally tried to have it both ways--claiming that there is suicidality in SSRI use in persons less than 25 years old, but not enough suicidality to merit warning in patients 25 and older.

A CDC report earlier this year stated that 2,500 children went to ERs after taking ADHD drugs. One in 4 of the kids had heart problems, blood pressure problems or fainted. Some of these adverse events were related to overdoses of the drug--but then ADHD drugs are very tricky and very easy to overdose on. I was unable to quickly find this report on the CDC's website. I'll try to update this later.

We shall see where this study winds up.

Posted by Philip Dawdy at November 13, 2007 12:03 AM
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Comments

Remember what Alice Cooper said, speed kills.

Posted by: Sally at November 13, 2007 12:24 AM

What really pisses me off about these studies is that they are always long into the use of the products. Even more alarming, is the push by Shire and Lilly for example, addressing the adults who have not been dx ADHD. This is the DTC literature piled up in my psych's office--for adult ADHD. Lilly has a CD, etc. adults having an added risk of heart problems, who may already have high blood pressure, etc. The CD from Lilly is promoting Strattera, for adult ADHD, and if anyone here remembers, years ago it was being promoted in childhood bipolar kids. It's just a re-packaging promotion effort.

Posted by: Stephany at November 13, 2007 09:00 AM

Strattera is a SNRI similar to Effexor and Cymbalta but not approved for depression strangely enough. Didn't stop my doctor from trying it out on me though for "bipolar" depression. (really I was just on a ton of sedating drugs---he was trying me on all the stimulants at that time too---I was a zombie)

Posted by: Gianna at November 13, 2007 10:26 AM

I was just prescribed Adderall and Sorequel. Anyone taking both of these? Or has anyone heard of doctors prescribing them at the same time?

Posted by: cc at November 14, 2007 04:28 PM

Personal opinion, but Adderall and Seroquel together don't make sense. I suspect the Seroquel was added for sleep issues?

Posted by: Stephany at November 16, 2007 02:12 AM

From my reading of Rock and Roll biographies, this is reminiscent of the combination of amphetamine and heroin, known as a speed ball. Speed (adderall)all day, major tranquilizer (seroquel) at night, causes severe heart damage. Did your doctor prescribe for Elvis too?

Posted by: Sally at November 16, 2007 04:05 AM

My ten year old boy has been on addreall for about two years.It was wonderful until this week. He went from failing school because he could not stay in his seat to making A-B student.He also made friends witch was very hard for him before because he was kind of all over the place. When I went to get his meds. this month I had to fill out a form for heart related problems. My doctor sent my son for an EKG an it came back abnormal. We have to go for more tests.I just keep thinking what have I done? Why did I let them give my son this drug?What is going to happen when he is coming off the meds.? Is anyone having this same problem? I'm scared!!!!

Posted by: christie at August 7, 2008 04:35 PM

I am also very upset at what is happening to my son's health. He has had high blood pressure for several years and the DR. kept beating around the bush about white collar fear meaning he was just high on his bp cause he was fearful of the DR office. I kept saying no no no its not that. FINALLY after a good 5-6 years they are taking me seriously not that his HEART IS DAMAGED it is enlarged left ventricular hypertophy, his heart murmer has become more pronounced and now his kidneys are not working right. his blood pressure is running 150 on 2 bp lowering medications. he is being seen at Riley hypertension clinic he has high amounts of protiene in his urine called protieneuria, and high Iron levels all from heart damage to vessels. we had seen an improvment in school but at what cost. He has been on concerta, strattera, adderall and focalin, and seroquel to help him sleep at night, due to stimulants. he is on clonidine and norvas to help with blood pressure. now he also is having small seizures and an abnormal ecg which can be due to hypertension and kidneys I am told. hopefully I have not screwed him up just trying to help him sueceed in his school work to get good grades and learn skills. they all told me this was safe I asked if it could cause him to shoot blanks in the long run and I was told NO if he is on this medication it helps him function I have read that it may also kill him very small percentage of heart damage guess we are that small % with the sudden deaths and heart attacks he can not function well if he is dead now can he??

Posted by: Melissa at November 6, 2008 12:32 PM

My husband was 33 when he began taking adderall. Through looking over the med records after the fact (ofcourse)in the 5 years of treatment he had hypertension.We were not told this,nor was the condition treated.As a result, at 38 he was diagnosed with cardiomyopathy and C.H.F. His E.F. or ejection fraction was 15%. A heart transplant was immeadiatly discussed.we opted to try the treatment meds avail,and 5 years later his E.F. is 50%. Research all you can &Keep the faith.

Posted by: kbbrochon at February 10, 2009 07:19 PM
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