takes action to halt marketing of unapproved ergotamine
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ordered to cease manufacturing and distribution of illegal drugs to
treat migraine headaches
[March 06, 2007]
The Food and Drug Administration (FDA)
on March 1 told 20 companies to cease marketing unapproved drug
products containing ergotamine tartrate. Ergotamine tartrate
products are used to treat vascular headaches, including migraines.
As part of the FDA's continued efforts to combat the marketing of
unapproved drugs, the agency sent warning letters to eight
manufacturers and 12 distributors warning them that they are subject
to further enforcement action if they do not stop manufacturing and
distributing these products.
The agency urges consumers who are
using ergotamine products and have questions or concerns to contact
their health care provider. This action does not affect FDA-approved
products containing ergotamine, which will remain on the market.
"Unapproved drugs pose real risks to the American public," said
Steven Galson, M.D., director of the FDA's Center for Drug
Evaluation and Research (CDER). "Because they have not been subject
to FDA review, the safety, effectiveness, and quality of such
products are unknown. We remain dedicated to tackling this problem
through education and outreach, as well as enforcement actions like
these. It is central to our mission to ensure a safe and effective
drug supply for the American public."
In addition to marketing these products without FDA approval,
most of the companies receiving warning letters have omitted from
their drugs' labeling critical warnings regarding the potential for
serious, possibly fatal, interactions with certain other drugs.
Based on recent scientific information, the five marketed, approved
versions of ergotamine-containing products have updated their
labeling to include a box warning (the strongest agency warning)
against using such products when also taking potent CYP 3A4
inhibitors, including some antifungal agents, protease inhibitors,
and certain antibiotics. CYP 3A4 is a metabolic enzyme that helps
the body eliminate drugs or other chemicals. Serious and
life-threatening ischemia (a restriction in blood supply), including
death and gangrene, have resulted when such products are used
together. Most unapproved versions of the drug do not carry these
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"The warning letters we issued are
another example of our commitment to the Unapproved Drugs
Initiative. We are taking a sensible, risk-based approach to the
problem, and remain dedicated to the goal of getting unapproved
drugs off the market," said CDER's Director of Compliance, Deborah
M. Autor. "Doctors and patients often do not realize that not all
drugs that are available on the market are backed by FDA approval.
We estimate that less than 2% of prescribed drugs are unapproved.
This lack of approval undermines FDA's drug safety efforts. Drugs
that skirt the approval process may be unsafe, may not work, and in
our experience, often have inadequate labeling."
Companies have 15 days to respond to the FDA with a
discontinuation plan for their products. Manufacturers have 60 days
to cease manufacturing of new product, and distributors have 180
days to cease further shipment of existing products. Previously
manufactured unapproved ergotamine products may still be found on
pharmacy shelves for a short period of time.
FDA's actions against unapproved drugs are part of the agency's
broader initiative, announced in June 2006, to ensure that consumers
and the health care community are provided with established and
emerging drug safety information so that they can make the best
possible medical decisions about the safe and effective use of
For additional information, including copies of the Warning
Letters (which identify the firms involved and the names of their
products), see FDA's Unapproved Drugs Web page, located at
from U.S. Food and Drug Administration