NEWS - FDA Tightens Restrictions on Accutane

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FDA Tightens Restrictions on Accutane

TUESDAY, Nov. 23 (HealthDayNews) -- The U.S. Food and Drug

Administration announced Tuesday that it has set up a national registry

to follow women of childbearing age who are prescribed the acne drug

Accutane, which has been shown to cause serious birth defects.

The agency followed the suggestions of an expert advisory panel, which

in February said the agency should track women who could become pregnant

while taking the drug. Accutane, generically known as isotretinoin, is

known to cause brain and heart damage in the fetuses of women who use

the drug, even in small amounts.

The move comes amid allegations by some critics that the agency hasn't

worked hard enough to protect the public against the harms caused by

some drugs, including Accutane, after they have been approved.

Under changes to the drug's tougher risk minimization plan, women must

document a negative pregnancy test before they are able to obtain the

drug. The national registry will track each woman's name, prescribing

doctor, and pharmacy that dispensed the medication, the FDA said in a

statement.

The registration system will incorporate patient and physician codes

that will protect the privacy of both, the agency said.

Last week, Accutane was singled out by FDA safety reviewer Dr.

Graham as one of five drugs still on the market that posed health

dangers like Vioxx, the now-withdrawn arthritis medication. Graham was

an early critic of Vioxx, which was withdrawn by Merck & Co in September

after the company's own research cited an increased risk of heart attack

and stroke.

In testimony on Nov. 18 before the Senate Finance Committee, Graham said

Accutane was similarly dangerous and should be " seriously looked at. "

The FDA's new Accutane rules include provisions for providing ongoing

patient education about the drug's potential risks. Accutane has been

shown to cause mental retardation and physical birth defects, including

cleft lip and palate. The risks continue for about a month after a

patient discontinues the drug.

Since 1982, when the drug was first introduced, the FDA has had more

than 2,000 reports of women becoming pregnant while taking the drug.

Most had an abortion, some gave birth to healthy babies, but more than

160 babies were born with Accutane-related defects.

The FDA instituted a voluntary testing and contraceptive education

program in 2001 for patients considering the drug.FDA Tightens

Restrictions on Accutane

http://www.forbes.com/lifestyle/health/feeds/hscout/2004/11/23/hscout522515.html

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Mayo Clinic in Rochester

http://www.mayoclinic.org/rochester

s Hopkins Medicine

http://www.hopkinsmedicine.org