Despite warning dangerous ADHD drug still being sold

• Drug Abuse • Oct 25, 2005



	Tweet

According to the U.S. Food and Drug Administration, liver problems linked to the attention deficit drug Cylert and other generic versions of the drug make it too dangerous for the U.S. market.

FDA officials have stopped short of recalling the drug, which has been on the market since 1975, but are advising doctors who prescribe it, or its generic counterparts to seek alternative therapy for their patients.

In a warning posted on its web site the FDA says it has concluded that the overall risk of liver toxicity from Cylert and generic pemoline products outweighs the benefits of the drug.

The agency says Cylert will remain available until current supplies run out, which has angered consumer advocates who argue that the drug is too dangerous.

Earlier this year drug company Abbott said it would no longer make the 30-year-old drug due to declining sales, and generic makers also agreed to stop sales.

Laureen Cassidy, a spokeswoman for Abbott, says the decision to discontinue Cylert was based on commercial reasons as demand for pemoline products has declined significantly over the years.

Attention-deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder (a problem related to brain development) that causes hyperactivity (always on the move), impulsive behavior (doing things without any self control), and attention problems (not able to pay attention). ADHD is the most common problem encountered in outpatient child and adolescent mental health settings. It is estimated that ADHD affects between 4 percent and 12 percent of school-aged children, more often boys than girls. Studies suggest that the amount of ADHD seen in the population has risen significantly in recent years. This is partly because of an increased awareness and recognition of the disorder, and partly because the specific things needed to make the diagnosis of ADHD have been more clearly defined during the past 20 years.

Symptoms
Parents of a child who has ADHD may receive a note from school saying that their child “won’t listen to the teacher,” “is too active or hyper,” or “causes trouble in class and is disruptive.” Even though a child with ADHD often wants to be a good student, his or her impulsive behavior and inability to pay attention in class make it difficult. Teachers, parents and friends may see that the child is “misbehaving” or acting “different,” but they might not be able to tell exactly what is wrong.

The FDA says it received 13 reports of liver failure that led to patient death or an organ transplant, and the rate involving patients taking pemoline was 10 to 25 times higher.

The fact that there are “multiple other drug treatments” for Attention deficit hyperactivity disorder, or ADHD, apparently aided the agency’s decision.

However Public Citizen’s Health Research Group Director Sidney Wolfe, which filed a petition with the FDA in March calling for the drug’s withdrawal, said the new warning did not go far enough and urges a total recall.

He maintains the use of the drug is reckless and insensitive to the health and lives of children and adults.

Wolfe says a uniquely dangerous is basically being sold off until it runs out. He says about 10,000 Cylert prescriptions have been sold since it was discontinued, while around 50,000 generic prescriptions have been filled.

The FDA’s warning is posted online.

Provided by ArmMed Media
Revision date: June 18, 2011
Last revised: by Sebastian Scheller, MD, ScD



RELATED STORIES:
Glaxo warns of birth defect from antiepileptic drug New warnings added to agents used in MRI tests Germany tells some patients to stop using Celebrex UK cost watchdog backs limited Alzheimer drug use Internet tied to rise in drug abuse Fake drugs, including Tamiflu, thrive on Internet Vitamin E in high doses called unsafe Drug abuse effects linger China drug scams challenge pharmaceutical firms Experts raise questions about Vioxx decision Fake drugs threaten gains made in war on malaria Teens of epileptic moms display poor school performance

Comments

[ + Post Your Own ]

Now you're in the public comment zone. What follows is not Armenian Medical Network's stuff; it comes from other people and we don't vouch for it. A reminder: By using this Web site you agree to accept our Terms of Service. Click here to read the Rules of Engagement.

There are no comments for this entry yet. [ + Comment here + ]

Childhood cancer effects may linger in adults
- Full Story - - »»»

Child addicts at heart of Indonesia anti-smoking suit
- Full Story - - »»»

Miracle sweetener stevia may have a sour note
- Full Story - - »»»

Scientists turn skin cells into beating heart muscle
- Full Story - - »»»

Too many people get angioplasties, study suggests
- Full Story - - »»»

Viewers’ family background affects how they react to MTV shows ‘16 and Pregnant,’ ‘Teen Mom’
- Full Story - - »»»

Weight management in pregnancy with diet is beneficial and safe and can reduce complications
- Full Story - - »»»