FDA tightens restrictions on acne drug
14th August, 2005: U.S. officials said on
Friday that 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.
The restriction which will take effect on December
31 is part of a plan announced in November 2004 to
strengthen safeguards to restrict pregnant women
from taking Acutane. Use of this drug may lead to
birth disorders or miscarriages, if taken by
The Food and Drug Administration said that the
wholesalers and pharmacies should sign up with
manufacturers to get the drug from November 1 and
pledge to follow distribution rules.
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. The F.D.A said that about 1.2
million prescriptions are written per year for the
F.D.A changed the existing warnings on Acutane, so
that doctors and patients could better identify
depression, suicidal behavior and other
psychiatric problems that may occur as a result of
the use of the drug.
Accutane is also called by the generic name
isotretinoin. Mylan Laboratories Inc.
India's Ranbaxy Laboratories Ltd. and Barr
Pharmaceuticals Inc. sell generic versions.
All the drug manufacturers said in a statement
that they supported the new distribution limits.
They also said it was unknown if Accutane caused
"If this does not prevent pregnancy exposures, we
would consider calling for a withdrawal of the
drug from the market," March of Dimes Medical
Director Nancy Green said. The March of Dimes
works to prevent birth defects. They welcomed the
new rules and said that it would closely monitor
Several voluntary attempts have been made to keep
pregnant women from using the drug , but the
officials kept on getting reports of pregnancies.
The drug was introduced in 1982.
Under the new law, women of child-bearing
potential should register with the 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
The new plan insists that the doctors must pledge
to inform patients of possible side effects and
check for negative pregnancy tests. Male drug
users should sign a form saying that they have
been told of the potential risks in using the
The new restrictions follow the report of an
advisory panel set up in February 2004 for tighter
limits on Acutane.