Drug Safety Developments

Risk of death no greater with ADHD drugs: study

Quoted from http://www.reuters.com/article/2011/05/16/us-adhd-drugs-idUSTRE74F0TH20110516

Risk of death no greater with ADHD drugs: study

By Frederik Joelving

NEW YORK | Mon May 16, 2011 1:19am EDT

NEW YORK (Reuters Health) - Drugs to treat attention deficit hyperactivity disorder, or ADHD, don't appear to put kids at higher risk of heart problems or death, scientists said Monday.

Scattered reports of sudden deaths among children on the medications have caused concern among parents and doctors in recent years, and several of the drugs now carry warnings about heart complications and behavioral side effects.

While the new study has limitations, researchers called the findings reassuring.

"The risk of death is certainly no higher in children who take ADHD medications than in children who don't," said Sean Hennessy, a pharmacist at Philadelphia's University of Pennsylvania, who led the work.

Some 2.7 million children and teens in the U.S. use the drugs, which are stimulants that can raise blood pressure and heart rate. The drugs include Novartis' Ritalin and Shire's Adderall.

The new study, funded by Shire, is based on claims data from Medicaid and a commercial insurer. It includes more than 240,000 kids ages three to 17, who received ADHD drugs and were followed for 135 days on average.

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FDA eases ADHD drugs heart-disease concerns

Quoted from http://www.reuters.com/article/2011/04/08/us-fda-adhd-idUSTRE7371WO20110408?feedType=nl&feedName=ushealth1100

FDA eases ADHD drugs heart-disease concerns

LONDON | Fri Apr 8, 2011 6:39am EDT

LONDON (Reuters) - The U.S. drugs regulator said it was not recommending changes in the use of stimulants such as Adderall XR and Ritalin to treat hyperactivity, after a review of a study into potential heart disease risks from the drugs.

"At this time, FDA is not recommending any changes to the drug labels and or use of these medications," the U.S. Food and Drug Administration said on its website.

The FDA said it would give a full update after the final analyses on the potential impact of stimulant ADHD drugs on the risk of heart disease and strokes were evaluated.

Shares in British group Shire, which makes the stimulant Vyvanse as well as Adderall XR, rose 1.7 percent after analysts said the update clearly suggested the FDA had seen no obvious safety signals in the study.

"While not absolutely definitive, this is positive for the stimulant class and for Shire," Beinstein analyst Jack Scannell said. "Concerns over the possibility of a bad outcome have curbed our enthusiasm for Shire."

Justin Smith at MF Global said the news was unsurprising, as rigorous monitoring for any potential change in cardiovascular risk had been in place since the study started in 2007, but was still positive for sentiment.

Adderall XR carries a warning about cardiovascular risks for patient with serious heart problems, and doctors generally assess a patient's cardiovascular history before starting treatment.

US FDA questions heart risk findings on ADHD drugs

Quoted from http://www.reuters.com/article/marketsNews/idINN1520804220090615?rpc=44

US FDA questions heart risk findings on ADHD drugs

Mon Jun 15, 2009 4:01pm EDT

By Lisa Richwine

WASHINGTON, June 15 (Reuters) - A study that found possible heart risks for healthy children who took attention deficit drugs had limitations and should not prompt parents to stop giving the medications, U.S. health officials said on Monday.

The study, published on Monday in the American Journal of Psychiatry, found use of stimulant medications that treat attention deficit hyperactivity disorder (ADHD) may be associated with rare cases of sudden death in children.

"Because of the study's limitations, parents should not stop a child's stimulant medication based on the study," the Food and Drug Administration, which partly funded the research, said in a statement.

 

Millions of people take ADHD drugs including Novartis AG's Ritalin and Shire PLC's  Adderall and Vyvanse. Annual U.S. sales totaled about $4.8 billion in 2008, according to data from IMS Health.

 

Because the drugs can increase heart rate and blood pressure, there have been concerns for years that the medications may raise the risk of heart attacks, strokes or other cardiovascular problems.

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