http://ca.news.yahoo.com/s/23032006/2/xhealth-narcolepsy-drug-needs-study-possible-adhd-treatment-fda-advisers.html

Narcolepsy drug needs more study as possible ADHD treatment: FDA advisers

Thu Mar 23, 06:47 PM EST


WASHINGTON (AP) - The narcolepsy drug modafinil should not be approved as a treatment for attention deficit hyperactivity disorder in children until more is learned about a possible link to a serious skin disease, U.S. government advisers said Thursday.<SCRIPT language=javascript>if(window.yzq_d==null)window.yzq_d=new Object();window.yzq_d['iGVqmdhtfFk-']='&U=139kpava4%2fN%3diGVqmdhtfFk-%2fC%3d398395.7980153.8834572.1559897%2fD%3dLREC%2 fB%3d3306082';</SCRIPT> <NOSCRIPT>http://row.bc.yahoo.com/b?P=29y009htdXNR5A5bQ_pb9eDhGOIi7kQlVZ0ABCpy&T=13vgdt1ck%2fX%3d1143297437%2fE%3d96571803%2fR%3d ca_news%2fK%3d5%2fV%3d2.1%2fW%3dHR%2fY%3dCA%2fF%3d 4101159640%2fQ%3d-1%2fS%3d1%2fJ%3d76756DD8&U=139kpava4%2fN%3diGVqmdhtfFk-%2fC%3d398395.7980153.8834572.1559897%2fD%3dLREC%2 fB%3d3306082</NOSCRIPT>

A U.S. Food and Drug Administration advisory committee voted 12-1 against recommending modafinil as safe for children with ADHD. Earlier Thursday, the psychopharmacologic drugs panel agreed unanimously modafinil works in treating ADHD.

The FDA is not required to follow the recommendations of its advisory committees but usually does.

The committee recommended Cephalon Inc. undertake a 3,000-patient trial to determine what risk modafinil may pose for Stevens-Johnson Syndrome. Drug reactions cause nearly all cases of the sometimes fatal skin disease, which can produce widespread blistering and rashes, the Merck Manual states.

The FDA's drug chief, Dr. Robert Temple, said one out of roughly 900 children involved in earlier studies of the drug developed the disease.

Temple and Cephalon spokeswoman Jenifer Antonacci said the agency and company would discuss the committee's recommendation. The Frazer, Pa.-based company does not see a "clear link" between its drug and the skin disease, Antonacci said.

In December 1998, the FDA originally approved modafinil, under the brand name Provigil, to treat adults with sleepiness associated with narcolepsy. The company has proposed calling a higher-dose version of the pill Sparlon when used to treat ADHD.

A different advisory committee recommended Wednesday that the FDA add warnings to the labels of those and other ADHD drugs on the market alerting doctors and parents to the possible risk of hallucinations in the more than three million children receiving the popular medications.

Stevens-Johnson's syndrome?

Ugh. . . Watch out for any blistering rash and fever, and STOP taking the drug in question.

Lamictal can cause this, but so can a simple antibiotic. Dangerous, life threatening, but exceedingly rare. I'm wondering why they're only seeing it now, when modafinil has been used successfully in the treatment of narcolepsy? Is it the higher dose, or just that children are more susceptible?

Don't be fooled by Stevens-Johnson Syndrome being called a "skin disease". It's not the heartbreak of psoriasis, at it's worst it's more like third degree burns and skin shedding. We are not pythons, we're not set up to shed our skin! Wikipedia:

Stevens-Johnson syndrome (SJS) is a life-threatening condition affecting the skin, in which due to cell death the epidermis separates from the dermis. The syndrome is thought to be a hypersensitivity complex affecting the skin and the mucous membranes. Although the majority of cases are idiopathic, the main class of known causes is medications, followed by infections and (rarely) cancers.

A gal at work almost lost her husband to this. The separation of the skin happened both externally and on the internal organs. Eek.

Ducky

I've had SJS. I was lucky in that it stopped relatively early. I was very sick for about 10 days and my skin eventually came off as things started to heal. ...and I mean ALL of my skin came off.

What SJS is, is a form of toxic shock. Your body thinks it is allergic to itself and starts taking itself apart. It starts as a sore throat, and maybe a fever. It escalates into sores in the mouth , swolen tounge and mouth, skin rash, edema, swelling and redness. In general terms it resembles scarlet fever or hand foot and mouth disease rather closely. The doctors treated mine with a antibiotics to prevent infection and steroids to promote healing.

If you ever get this get to a doctor really fast. It hits you fast, in just a few hours and it is extremely life threatening.

ME :D