Featured Research

from universities, journals, and other organizations

Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment

Date:
July 9, 2014
Source:
Boston Children's Hospital
Summary:
Over the last 60 years, the US Food and Drug Administration approved 20 medications for attention deficit/hyperactivity disorder based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers report. The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process.

Over the last 60 years, the U.S. Food and Drug Administration (FDA) approved 20 medications for attention deficit/hyperactivity disorder (ADHD) based on clinical trials that were not designed to study their long-term efficacy and safety or to detect rare adverse events, researchers at Boston Children's Hospital report today in PLOS ONE. The study highlights gaps in how the long-term safety of drugs intended for chronic use in children is assessed as part of the FDA approval process.

Related Articles


"This study doesn't address whether ADHD drugs are safe, though their safety has since been established through years of clinical experience," says study senior author Kenneth Mandl, MD, MPH, Boston Children's chair in biomedical informatics and population health and director of the Intelligent Health Laboratory in Boston Children's Informatics Program. "Instead, we point to the need for an agenda emphasizing improved assessment of rare adverse events and long-term safety through post-marketing trials, comparative effectiveness trials and more active FDA enforcement."

According to the U.S. Centers for Disease Control and Prevention, 11 percent of children in the U.S. between the ages of four and 17 -- or about 6.4 million children -- have been diagnosed with ADHD. On average, children prescribed ADHD medications take them for several years.

To understand how extensively the long-term safety of common ADHD medications had been studied before going on the market, the researchers reviewed the clinical trial data included in the FDA drug approval packages for 20 drugs, reaching as far back as the original FDA approval for methylphenidate (Ritalinฎ) in 1955.

The team identified 32 clinical trials on the 20 drugs. Only five trials were focused specifically on drug safety. The team calculated that each drug was tested in a median of 75 patients prior to FDA approval, with a median trial duration of four weeks. Eleven of the 20 drugs were approved after having been tested in fewer than 100 patients, and 14 in fewer than 300. Seven drugs that the FDA had previously approved for other conditions (e.g., obesity) were approved for ADHD without any condition-specific trials or trials in children.

For context, the authors note that the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) -- a forum for best practices in drug development -- recommends that drugs intended for chronic use in non-life-threatening conditions (such as ADHD) should be tested in a minimum of 300 to 600 patients for at least six months, in a minimum of 100 patients for at least one year, and in about 1,500 patients total before regulatory approval.

"ADHD drugs are so effective at producing a behavioral effect quickly that one can measure a statistically significant treatment effect rapidly and with relatively few patients," Mandl says. "However, in the real world, these drugs are prescribed often for years, not for a few weeks, and long-term cognitive effects were never measured during the approval process."

Of note, six of the drugs received FDA approval with the caveat that the manufacturers conduct post-marketing surveillance studies of long-term safety. However, based on the records the researchers reviewed, only two of those requested studies were ever conducted.

"One approach used by the FDA to increase our knowledge around rare adverse drug events and the long-term safety of drugs is to require pharmaceutical companies to conduct post-marketing trials after a drug is approved," says study first author Florence Bourgeois, MD, MPH, of Boston Children's Department of Emergency Medicine. "However, historically there has been little enforcement of this requirement and sponsors have not been conducting the requested post-marketing trials."

Mandl and Bourgeois see the results as a call for increased regulatory emphasis on drugs' long-term safety and efficacy, particularly ones prescribed on a chronic basis.


Story Source:

The above story is based on materials provided by Boston Children's Hospital. Note: Materials may be edited for content and length.


Journal Reference:

  1. Florence T. Bourgeois, Jeong Min Kim, Kenneth D. Mandl. Premarket Safety and Efficacy Studies for ADHD Medications in Children. PLoS ONE, 2014; 9 (7): e102249 DOI: 10.1371/journal.pone.0102249

Cite This Page:

Boston Children's Hospital. "Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment." ScienceDaily. ScienceDaily, 9 July 2014. <www.sciencedaily.com/releases/2014/07/140709151626.htm>.
Boston Children's Hospital. (2014, July 9). Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment. ScienceDaily. Retrieved December 20, 2014 from www.sciencedaily.com/releases/2014/07/140709151626.htm
Boston Children's Hospital. "Review of ADHD drug approvals highlights gaps between approval process, long-term safety assessment." ScienceDaily. www.sciencedaily.com/releases/2014/07/140709151626.htm (accessed December 20, 2014).

Share This


More From ScienceDaily



More Health & Medicine News

Saturday, December 20, 2014

Featured Research

from universities, journals, and other organizations


Featured Videos

from AP, Reuters, AFP, and other news services

The Best Tips to Curb Holiday Carbs

The Best Tips to Curb Holiday Carbs

Buzz60 (Dec. 19, 2014) — It's hard to resist those delicious but fattening carbs we all crave during the winter months, but there are some ways to stay satisfied without consuming the extra calories. Vanessa Freeman (@VanessaFreeTV) has the details. Video provided by Buzz60
Powered by NewsLook.com
Sierra Leone Bikers Spread the Message to Fight Ebola

Sierra Leone Bikers Spread the Message to Fight Ebola

AFP (Dec. 19, 2014) — More than 100 motorcyclists hit the road to spread awareness messages about Ebola. Nearly 7,000 people have now died from the virus, almost all of them in west Africa, according to the World Health Organization. Video provided by AFP
Powered by NewsLook.com
Researchers Test Colombian Village With High Alzheimer's Rates

Researchers Test Colombian Village With High Alzheimer's Rates

AFP (Dec. 19, 2014) — In Yarumal, a village in N. Colombia, Alzheimer's has ravaged a disproportionately large number of families. A genetic "curse" that may pave the way for research on how to treat the disease that claims a new victim every four seconds. Duration: 02:42 Video provided by AFP
Powered by NewsLook.com
The Best Protein-Filled Foods to Energize You for the New Year

The Best Protein-Filled Foods to Energize You for the New Year

Buzz60 (Dec. 19, 2014) — The new year is coming and nothing will energize you more for 2015 than protein-filled foods. Fitness and nutrition expert John Basedow (@JohnBasedow) gives his favorite high protein foods that will help you build muscle, lose fat and have endless energy. Video provided by Buzz60
Powered by NewsLook.com

Search ScienceDaily

Number of stories in archives: 140,361

Find with keyword(s):
 
Enter a keyword or phrase to search ScienceDaily for related topics and research stories.

Save/Print:
Share:  

Breaking News:

Strange & Offbeat Stories

 

Health & Medicine

Mind & Brain

Living & Well

In Other News

... from NewsDaily.com

Science News

Health News

Environment News

Technology News



Save/Print:
Share:  

Free Subscriptions


Get the latest science news with ScienceDaily's free email newsletters, updated daily and weekly. Or view hourly updated newsfeeds in your RSS reader:

Get Social & Mobile


Keep up to date with the latest news from ScienceDaily via social networks and mobile apps:

Have Feedback?


Tell us what you think of ScienceDaily -- we welcome both positive and negative comments. Have any problems using the site? Questions?
Mobile iPhone Android Web
Follow Facebook Twitter Google+
Subscribe RSS Feeds Email Newsletters
Latest Headlines Health & Medicine Mind & Brain Space & Time Matter & Energy Computers & Math Plants & Animals Earth & Climate Fossils & Ruins