Originally published August 21 2005
Accutane users, doctors must sign national registry
by Mike Adams, the Health Ranger, NaturalNews Editor
Americans who take the prescription acne medication accutane and also the doctors who prescribe the drug must now enroll in a National Registry established by the FDA, and patients must sign documents showing they understand the drug may cause suicidal thoughts and can cause severe heart and brain birth defects if taken during pregnancy.
The thousands of Americans who take the acne drug Accutane -- and people who prescribe and dispense it -- must enroll in a national registry, part of a major government program to tighten access to the medicine that causes birth defects.
The Food and Drug Administration enacted unprecedented curbs Friday in trying to keep Accutane and its generic competitors on the market while ensuring that women who use the risky pills don't get pregnant.
Under the program, every patient -- men and women -- must enroll in the iPLEDGE computerized registry starting Dec. 31 to receive Accutane or generic versions of the drug isotretinoin.
All patients seeking a prescription must sign a document informing them of Accutane's risks, including the possibility that it contributes to depression or suicidal thoughts -- a warning on the drug's label that FDA also strengthened Friday.
Patients must agree to monthly doctor visits for refills and not to share the pills with anyone.
Then the doctor registers each patient into the iPLEDGE database, giving him or her a special identifying code number, and writes the prescription.
Accutane manufacturer Hoffman-La Roche and generic manufacturers will monitor drugstores and wholesalers, and are supposed to cut off violators' sales supplies.
"We are very happy that this has happened and wish it had been done years ago," said Dr. Nancy Green, medical director of the March of Dimes.
But the organization, which fights birth defects, will be watching closely to see if the program stops fetal exposure to the risky pill -- something tough to do considering the acne drug's chief market is young people, and that half of all U.S. pregnancies are unplanned.
Critics note there likely were many more pregnancies because doctors haven't been required to report Accutane-linked pregnancies.
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