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  FOR ALL YOU ACCUTANE USERS

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Author Topic:   FOR ALL YOU ACCUTANE USERS
GAAV KOSH

Amateur Bodybuilder

Posts: 178
From:USA
Registered: Jul 2000

posted January 27, 2001 02:56 AM

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This was printed in USA TODAY:

By Rita Rubin
USA TODAY


Under pressure from the Food and Drug Administration, the maker of the popular acne medication Accutane is sending information about the drug's link to mental problems to every dermatologist, family physician, psychiatrist and pharmacist in the country.

This week, Hoffmann-La Roche began mailing copies of a plain-English ''medication guide'' and a patient consent form detailing the link, spokeswoman Melissa Ziriakus said Thursday. Both documents are posted on the FDA's Web site.

The FDA requires medication guides for products it believes pose serious risks that can be reduced by informing patients. Only a handful of other drugs, including Mifeprex, or RU486, the so-called abortion pill, have such guides. Pharmacists are to dispense the Accutane medication guide with the pills.

Accutane, sold since 1982 for the treatment of severe acne, was Roche's second-best-selling U.S. drug in 1999; sales totaled nearly $500 million. Rocephin, an antibiotic, was first.

Accutane's package insert has noted links to depression since 1986 and to suicide since May. As of early December, the FDA had received reports of 66 suicides and 1,373 cases of psychiatric problems among users.

But patients often don't read the fine print. In recent months, parents of many Accutane users who attempted or committed suicide have come forward to say their doctors never told them the drug might cause mental problems. They include Rep. Bart Stupak, D-Mich., whose son, 17, killed himself in May. If the consent form and guide are distributed as required, Stupak says, ''I think you'll never find a situation like my wife and I experienced.''

Besides the link to mental problems, the medication guide details the well-documented risk of birth defects in babies of mothers who took Accutane while pregnant.

The new consent form, devoted mainly to psychiatric problems, is to be completed by the patient or a parent or guardian and signed by the prescriber. In addition, a consent form outlining the risk of birth defects will continue to be given to female patients. Without completed consent forms, Accutane prescribers could be liable if a patient develops problems.

Accutane's maker still does not believe it can cause mental problems, Ziriakus says


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BigJay81

Guru

Posts: 4866
From:LIFT UNTIL YOU DIE!!!!!!!!!!!!!!!!!!!!!!!!!!!
Registered: Jan 2000

posted January 27, 2001 02:57 AM

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THEIR GIVING IT TO MOSTLY KIDS THEY HAVE MENTAL PROBLEMS ANYWAY ITS CALLED PUBERTY

SO ALL THIS SAYS IT THEY THEY ARE GOING TO PASS A BROCHURE OUT WITH THE MED.

THANKS FOR THE INFO THOUGH


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lawnsaver

Elite Bodybuilder

Posts: 1289
From:FL
Registered: Sep 2000

posted January 27, 2001 02:59 AM

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Vit A is no joke I guess????

------------------

" That which does not kill me, will make me stronger"

"Catch a man a fish, he eats for a day. Teach a man to fish, and he eats for a lifetime."


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d1734

Elite Bodybuilder

Posts: 1129
From:
Registered: Feb 2000

posted January 27, 2001 07:23 AM

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i hate assholes like Rep. Bart Stupak who make decisions based on emotion instead of logic. His kid killed himself so how he has a vendetta on accutane.

Typical democrat.


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