http://www.yourlawyer.com/topics/overview/dexedrine Sat, 21 Nov 2009 13:27:58 -0800 pixel-app en http://www.yourlawyer.com/articles/read/16643 Tue, 16 Jun 2009 00:00:00 -0700 http://www.yourlawyer.com/articles/read/16643
Labeling for drugs like Ritalin, Adderall, Dexedrine, and Concerta already include  warnings about the risk of sudden cardiac death in patients with heart problems, but they have been considered safe for children who don't have pre-existing heart conditions.   There have been worries, however, that such stimulants could be risky in children with undiagnosed heart problems.  It is not known how often cardiac events  occur in children taking these drugs.

According to a report on WebMD, concerns about the drugs' heart risks were raised in 2006, when an FDA panel reported that between 1992 and 2005, 11 sudden cardiac deaths occurred in children taking Ritalin and Concerta, and 13 sudden cardiac deaths occurred among children taking Adderall and Dexedrine.  Last year, the American Heart Association recommended screening all children and teens taking ADHD drugs for hidden heart problems, as well electrocardiogram  screening of all patients being placed on the stimulants for the first time, WebMD said.

This latest study on ADHD stimulant drugs, which was published in the American Journal of Psychiatry, did find a slight increase in the risk of sudden cardiac death among children and teens taking the medications.  The study was funded by the FDA and the National Institute of Mental Health.

According to the FDA, the study compared the use of stimulant medications in 564 healthy children from across the United States who died suddenly, most likely due to sudden cardiac disturbance, to the use of stimulant medications in 564 children who died as passengers in a motor vehicle accident. According to the study report, out of the children who died suddenly, 10 were reported to be taking a stimulant medication at the time of death. Out of those who died in a motor vehicle accident, two were reported to be taking a stimulant medication at the time of death. Researchers  concluded that the odds of using stimulant medication were six to seven times greater among the children who died suddenly of unexplained causes than among those who died in car crashes.

However, the FDA maintains that the study had several limitations, including the significant time lag between when the deaths occurred  and when the information was collected.  Given such limitations, the FDA said it is unable to conclude that the data presented in the study affect the overall risk-and-benefit profile of stimulant medications used to treat ADHD in children.  The agency said that parents should not stop a child’s stimulant medication based on the study. Instead, parents  should discuss concerns about the use of these medications with the prescribing health care professional, FDA said.

According to report in the Los Angeles Times, for more conclusive answers, parents of ADHD children are going to have to wait for the results of two more studies due to be released next fall and winter. Those studies will look at rates of heart attack and stroke in children and adults who take stimulant medication for ADHD and compare them to cardiovascular events in populations not on ADHD medication, the Times said.

]]> http://www.yourlawyer.com/articles/read/12594 Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/articles/read/12594
"Medicines approved for the treatment of ADHD have real benefits for many patients but they may have serious risks as well," said Steven Galson, M.D., Director, Center for Drug Evaluation and Research (CDER). "In our ongoing commitment to strengthen drug safety, FDA is working closely with manufacturers of all ADHD medicines to include important information in the product labeling and in developing new Patient Medication Guides to better inform doctors and patients about these concerns."

Patient Medication Guides are handouts given to patients, families and caregivers when a medicine is dispensed. The guides contain FDA-approved patient information that could help prevent serious adverse events. Patients being treated with ADHD products should read the information before taking the medication and talk to their doctors if they have any questions or concerns.

ADHD is a condition that affects approximately 3 percent to 7 percent of school-aged children and approximately 4 percent of adults. The three main symptoms are inattention, hyperactivity, and impulsivity. People with ADHD may have difficulty in school, troubled relationships with family and peers, and low self-esteem.

An FDA review of reports of serious cardiovascular adverse events in patients taking usual doses of ADHD products revealed reports of sudden death in patients with underlying serious heart problems or defects, and reports of stroke and heart attack in adults with certain risk factors.

Another FDA review of ADHD medicines revealed a slight increased risk (about 1 per 1,000) for drug-related psychiatric adverse events, such as hearing voices, becoming suspicious for no reason, or becoming manic, even in patients who did not have previous psychiatric problems.

FDA recommends that children, adolescents, or adults who are being considered for treatment with ADHD drug products work with their physician or other health care professional to develop a treatment plan that includes a careful health history and evaluation of current status, particularly for cardiovascular and psychiatric problems (including assessment for a family history of such problems).

As part of the Agency’s ongoing regulatory activity, in May 2006 the FDA directed manufacturers of these products to revise product labeling for doctors to reflect concerns about adverse cardiovascular and psychiatric events. These changes were based on recommendations from the FDA Pediatric Advisory Committee and the Drug Safety and Risk Management Advisory Committee. To help patients understand these risks, an additional part of this revised labeling process is the creation of a Patient Medication Guide for each individual product.

The medicines that are the focus of the revised labeling and new Patient Medication Guides include the following 15 products:

• Adderall (mixed salts of a single entity amphetamine product) Tablets
• Adderall XR (mixed salts of a single entity amphetamine product) Extended-Release Capsules
• Concerta (methylphenidate hydrochloride) Extended-Release Tablets
• Daytrana (methylphenidate) Transdermal System
• Desoxyn (methamphetamine HCl) Tablets
• Dexedrine (dextroamphetamine sulfate) Spansule Capsules and Tablets
• Focalin (dexmethylphenidate hydrochloride) Tablets
• Focalin XR (dexmethylphenidate hydrochloride) Extended-Release Capsules
• Metadate CD (methylphenidate hydrochloride) Extended-Release Capsules
• Methylin (methylphenidate hydrochloride) Oral Solution
• Methylin (methylphenidate hydrochloride) Chewable Tablets
• Ritalin (methylphenidate hydrochloride) Tablets
• Ritalin SR (methylphenidate hydrochloride) Sustained-Release Tablets
• Ritalin LA (methylphenidate hydrochloride) Extended-Release Capsules
• Strattera (atomoxetine HCl) Capsules

]]> http://www.yourlawyer.com/topics/overview/dexedrine Wed, 21 Feb 2007 00:00:00 -0800 http://www.yourlawyer.com/topics/overview/dexedrine Injured by Dexedrine? On August 21, 2006, GlaxoSmithKline announced it would add a strong warning about possible heart risk to its attention deficit hyperactivity drug (ADHD) Dexedrine. Dexedrine (Generic: Dextroamphetamine sulfate) gained FDA approval on July 9, 1997.

In March 2006, an FDA panel stated new information about heart risks should be added to the labels for attention deficit drugs. The outside experts stopped short of supporting a "black box" warning, the strongest warning possible saying they did not want to scare off patients or their parents. Additionally, in February 2006, a different FDA panel recommended black box warnings for all ADHD drugs.

Packaging for the drug will also contain additional information about possible psychiatric adverse events, like hallucinations and mania, linked to ADHD drugs, according to the letter dated Aug. 4, 2006.

If you or a loved one has taken Dexedrine and suffered a heart attack or any other serious side effects you may be entitled to compensation. Please fill out the form to the right, for a free case evaluation.]]>