Thursday, February 02, 2006

FDA Studies ADD Drugs

Due to sudden deaths, strokes, hypertension and heart attacks in children and adults that take medicine to treat their ADHD, a new government study on the safety of these medications has begun.
In recent years, sales of ADHD drugs have increased sharply, with adult use growing at a faster rate. This is according to a recent study done by Medco Health Solutions, which is a prescription benefit manager. Spending for these ADHD drugs has gone from 759 million in 2000 to 3.1 billion in 2004, according to IMS Health, which is a pharmaceutical information and consulting firm.
Although no additional details were immediately available, the FDA said it had received reports of serious adverse events, including death, associated with the therapeutic use of the drugs.
Health Canada pulled the drug Adderall XR off the shelves for six months last year after reports of 20 sudden deaths and 12 strokes in adults and children while using the drug. A number of these incidents involved children with structural heart defects. Health Canada concluded that there was inadequate evidence of any increased harm from Adderall XR compared to other ADHD medications. This is the same conclusion reached by the FDA based on the given data.
The U.S. regulatory agency is asking the Drug Safety and Risk Management advisory committee to study the potential cardiovascular risks of the medications. The FDA says that the few studies that have looked at long term use of ADHD drugs has provided little information on the risks. Some feel that this is comparable to the cox-2 inhibitor incident where painkillers like Bextra and Vioxx were pulled from the shelves do to evidence that they can raise the risk of heart attack or stroke.
The FDA committee will meet February 9th and 10th in Gaithersburg, MD. Some feel that the issue of treatment for ADHD has been a controversial one already. And now it will add the issue of cardiovascular risk too.
The FDA website does not identify any of the drugs by name. However, the most common ADHD drugs include Adderall XR, which is made by Shire Pharmaceuticals, and Ritalin, that is produced by Novartis Pharmaceutical Corp. The makers of Adderall had not been told about the meeting, but they still may send representatives.
The February 10th meeting will have updates on FDA actions on cox-2 medicines and a new patient, doctor and pharmacist registry program for an anti-acne drug called Accutane and it’s competitors. There are now numerous lawsuits pending in regards to the side effects of these drugs. Some of these side effects include inflammatory bowel disease and rectal bleeding, Crohns Disease, ulcerative colitis, cirrhoses, birth defects and depression-related side effects just to name a few.
The committee will also discuss the FDA’s Drug Safety Oversight Board. This is an internal government panel created almost a year ago that is supposed to monitor the FDA approved medicines once on the market. They’re also supposed to keep physicians and patients updated with important new information on risks and benefits. Some say there are concerns regarding the boards impartiality and independence, along with its relationship to the committee and the similar work it provides.

No comments: