FDA unveils tighter restrictions on acne drug
By Lisa Richwine
WASHINGTON (Reuters) – Patients and doctors must register
with manufacturers and promise to comply with tight
restrictions on Roche Holding AG’s acne drug Accutane and
generic versions, U.S. officials said on Friday.
The requirement starts December 31 and is part of a plan
announced in November 2004 to strengthen safeguards meant to
keep pregnant women from taking Accutane. The prescription drug
can cause severe birth defects or miscarriages.
Wholesalers and pharmacies also must sign up with makers to
obtain the drug starting November 1 and pledge to follow
distribution rules, the Food and Drug Administration said.
The program is an “unprecedented” effort to manage a
serious safety concern of a widely used drug, said Dr. Sandra
Kweder, deputy director of FDA’s Office of New Drugs. About 1.2
million prescriptions per year are written for the medicine,
the FDA said.
“This is a new way of doing business. We really have felt
if we truly are going to have a restricted distribution, we
need to involve everyone who’s part of the distribution,”
Kweder told reporters.
The FDA also said on Friday it changed existing warnings on
Accutane so doctors and patients could better identify
depression, suicidal behavior and other psychiatric problems
that could occur.
Accutane is known by the generic name isotretinoin. Mylan
Laboratories Inc., India’s Ranbaxy Laboratories Ltd. and Barr
Pharmaceuticals Inc. sell generic versions.
All makers said in a statement they supported the new
The March of Dimes, a group that works to prevent birth
defects, welcomed the effort but said it would closely monitor
whether it worked.
“If this does not prevent pregnancy exposures, we would
consider calling for a withdrawal of the drug from the market.
This is a major source of birth defects in this country,” March
of Dimes Medical Director Nancy Green said.
The risk of severe birth defects has been known since
Accutane won approval in 1982. Several mostly voluntary efforts
were made to keep pregnant women from taking it, but officials
continued to receive reports of pregnancies.
In a one-year period after safety measures were
strengthened in 2002, 120 pregnancies were reported in women
taking the drug, the FDA said.
Under the new plan, women of child-bearing potential must
register with manufacturers, sign consent forms and be
counseled about risks. They must have monthly pregnancy tests
to get refills and promise to use two forms of birth control.
Male patients need to sign a form saying they were told of
Accutane’s psychiatric and other risks. Doctors must pledge to
inform patients of potential side effects and check that
pregnancy tests are negative.
Accutane treats severe acne that causes inflamed,
cystic-like pimples and can prevent scarring, but some critics
say it is overprescribed for milder cases.
The measures follow recommendations from an FDA advisory
panel in February 2004 for tighter limits on Accutane. In
November 2004, veteran FDA scientist David Graham called for
closer scrutiny of five drugs, including Accutane.