Advocates, Parents Urge Restrictions on Accutane

Advocates, Parents Urge Restrictions on Acne Drug

Fri Dec 13, 1:58 PM ET

http://story.news.yahoo.com/news?tmpl=story&u=/nm/20021213/hl_nm/ac...


By Ori Twersky

WASHINGTON (Reuters Health)

A student well-liked by his teachers, Matthew Turney of Watertown, New York, took his own life at age 16 shortly after starting to take the Acne drug Accutane (isotretinoin). His parents blame his death on the controversial drug.



James Bencz, a certified firefighter, rescue diver, athlete, licensed appraiser and homeowner, was found dead on March 4, 2002 at the bottom of a lake with a 44-pound barbell strapped to him shortly after beginning a course of the drug to treat pimples on his neck and back.


His parents too were convinced that Accutane was responsible.


According to US Food and Drug Administration (news - web sites) (FDA), 173 suicides have been reported and credited worldwide to the drug, made by Hoffmann-La Roche, since it was first approved in 1982 to treat severe Acne that does not respond to conventional therapy, such as Antibiotics .


As a result, some consumer activists and family members want the US regulatory agency to further restrict use of the drug in response to these deaths as well as its documented ability to cause birth defects.


In testimony before a congressional committee on Wednesday, these individuals argued that anything less would mean sanctioning such events, given the FDA's authority to take action to prevent future problems.


"You will hear from families and people who say this drug saved their complexion and gave them a better outlook on life," said Michael Bencz, father of James Bencz. "James could not have had a better outlook on life, and he killed himself without warning. How many more suicides and deaths have to occur before someone says enough is enough?"


Still, the drugmaker says that sufficient steps have been taken and further restrictions would just serve to prevent the drug from reaching desperate patients.


"Over 6 million US patients have benefited from Accutane since it was first approved," Hoffmann-La Roche CEO George Abercombie testified on behalf of the drug. "We believe such prescribing is generally appropriate and intended to alleviate the suffering of patients with severe recalcitrant nodular acne rather than less severe conditions."


The company and FDA officials further noted that a number of steps have been taken recently to ensure the drug's appropriate use and that these steps have led to a decline in the number of reported events.


"Overall, the steps we have taken to address the psychiatric events in the Accutane population are highly precautionary and unprecedented in scope," Abercombie said.

Among these steps was the development of a "Medication Guide" to emphasize key safety issues in lay language and a risk-management program to address concerns regarding the drug's potential to cause birth defects, said Dr. Janet Woodcock, director of the FDA's prescription drug division.

"FDA has worked diligently with the manufacturers and the medical and scientific communities to assure that patients have access to Accutane under conditions that make its use as safe as possible," she said.

But Dr. Nancy Green, medical director of the March of Dimes Birth Defects Foundation, said she believed further steps could still be taken if only to address the drug's ability to cause birth defects.

"No pregnant women should take isotretinoin, and no women taking isotretinoin should get pregnant," Green said, while noting that many pregnant women continue to take this drug and that the number is likely to grow now that the FDA is approving generic equivalents.

In November, the FDA approved the first generic version of the drug, which will be marketed by Bertek Pharmaceuticals of Research Triangle Park, North Carolina, the branded arm of generic drugmaker Mylan Laboratories.

Nonetheless, other healthcare professionals said they agreed with Roche that the risks were exaggerated and that the steps taken so far were adequate to protect patients.

"In the last 15 years I have prescribed Accutane to hundreds of patients without incident," said Dr. Diane S. Berson of Cornell Medical College in New York City. "I implore you to allow dermatologists to continue to prescribe Accutane to the patients for whom it is the only effective therapy. Please do not deny access to this 'life changing' medication."