Category — ADHD: Modafinil

Long-Term Safety Questioned of Ritalin

In research published in Pediatrics, [December 2007; vol 120: pp 1494-1501], lead author, Almut G. Winterstein, PhD, assistant professor of pharmacy health care administration, University of Florida College of Pharmacy, Jacksonville, found that common stimulants used to treat attention deficit hyperactivity disorder (ADHD) don’t often cause serious heart complications in children. However, she warns that their safety is undetermined for prolonged use.

Winterstein found that stimulants such as Ritalin, Adderall, and Concerta frequently raise blood pressure and heart rate. The researchers analyzed health records from 55,000 children and teens newly diagnosed with ADHD from 1994 to 2004 with two significant findings:

1. Children who used stimulant medication had a 20% increase in visits to hospital ERs or doctors’ offices for heart palpitations and racing heartbeat, compared with children who didn’t use stimulant medication.
2. Stimulant medications did not appear to be associated with an increase in hospitalizations or deaths due to cardiac causes.

Last year the FDA took a special interest in the matter of heart safety when it announced a special Black Box advisory to be placed on stimulant medication. This was in part due to reports of the sudden deaths of 12 children who used ADHD Drug, Adderall.

The Canadian government quickly suspended sales of Adderall XR in Canada, but later permitted sales after further investigation.

Winterstein, PhD, in an interview with WebMD, notes:

… that because serious cardiac events are so rare among children and teens, a much larger study is needed to confirm the safety of these drugs.

“We can’t really say that there is no increase in risk (for serious cardiac events) among children who take these drugs,” she says. “What we can say is that if there is an increase in risk, it will not affect a large number of children.”

ADHD Drugs and Heart Risk

The CDC estimates that 4.4 million children between the ages of 4 and 17 have been diagnosed with ADHD, and as of 2003, 2.5 million were taking medication for it.

Children are increasingly taking the drugs for longer and longer periods, but little is known about their long-term cardiovascular impact, Winterstein says.

“The average exposure in our study was two years, but we see children who are on these drugs for five years, 10 years, and even longer,” she says.

She adds that it is also not clear if the drugs are safe for children with existing heart problems or with risk factors for heart disease.

McNeil Consumer & Specialty Pharmaceuticals, a division of Johnson & Johnson (”J&J”), announced that an agreement with  Cephalon, Inc. to Co-Promote Modafinil for Attention-Deficit/Hyperactivity Disorder (Thursday September 1). McNeil currently manufactures and distributes Concerta for AD/HD.

Modafinil (coated tablet) is a form of Provigil which is used to alleviate excessive sleepiness  (narcolepsy) and other sleep disorders. Cephalaon and McNeil are awaiting U.S. Food and Drug Administration (FDA) approval for the treatment of attention- deficit/hyperactivity disorder (ADHD) in children and adolescents.

By combining sales forces totaling more than 700 sales reps between the two companies and by marketing heavily, the agreement may produce heightened sales figures for both companies in a competitive multi-billion dollar market. Cephalon will pay McNeil commission fees calculated as a percentage of annual net sales of Modafinil during the term of the agreement according to their press release.

Look for Shire Pharmaceuticals to market a new drug ostensibly in the same manner as J&J to compete.

In J&J’s press release they say that “Our company has extensive experience with ADHD and the pediatric medical community,” said Colin F. Watts, president, McNeil Consumer & Specialty Pharmaceuticals, a subsidiary of Johnson & Johnson. “We are excited about the prospect of collaborating with Cephalon on this new ADHD therapy.”

The most frequently reported adverse events in clinical trials with PROVIGIL were headache, nausea, nervousness, stuffy nose, diarrhea, back pain, anxiety, trouble sleeping, dizziness and upset stomach.

It has always been a concern of mine that ventures like these will reap a large profit without addressing cognitive, behavioral, and social needs of the end user. The public’s current perception is that using these medications will indeed ‘fix’ their broken child. Unfortunately, and according to the National Institutes of Health, more than medication is needed to address the full needs of AD/HD children. So, as long as pharmaceutical companies keep marketing in a manner which encourages the public’s ‘fix’ perception, we’ll continue to have kids who historically remove themselves from medication whenever they can (usually upon emancipation) and carry their AD/HD into adulthood with no compensatory skills.