THURSDAY, Sept. 23 (HealthDay News) -- In response to major
concerns about heart risks, U.S. health officials on Thursday
severely restricted use of the diabetes drug rosiglitazone
(Avandia) to patients with type 2 diabetes who cannot control their
disease on other medications.
U.S. Food and Drug Administration officials also ordered the
drug's manufacturer, GlaxoSmithKline, to get an independent review
of a key company-run trial of the drug's heart effects. And they
pulled the plug on another company-run trial comparing Avandia to
its competitor, pioglitazone (Actos).
"Because of concerns about cardiovascular safety, FDA is announcing regulatory action on medications containing rosiglitazone," FDA Commissioner Dr. Margaret A. Hamburg said during a morning press conference. "FDA is significantly restricting the use of these products by requiring the manufacturer to submit a Risk Evaluation and Mitigation Strategy [REMS]."
The FDA is requiring GlaxoSmithKline to develop a program that
will restrict access to the drug to those patients for whom other
treatments have not worked.
In addition, doctors will have to state and document a patient's
eligibility to use Avandia. They will also have to tell patients
about the cardiovascular safety risks associated with Avandia, and
patients will have to acknowledge that they understand those
Those currently using Avandia will be allowed to continue taking
the drug, Hamburg said. However, once the REMS is in place these
patients will also have to have their doctors justify use of the
FDA officials believe this program will significantly reduce the
number of people taking Avandia.
According to the agency, there was not enough evidence of
Avandia's cardiovascular risks to pull the drug from the market,
which is why it opted to restrict its use instead.
But in Europe, the European Medicines Agency has suspended
marketing of the drug, forcing patients to find another drug to
control their blood sugar. The suspension will remain in place
unless there is new data showing that the benefits of the drug
outweigh its risks.
Avandia is also sold in combination with other diabetes drugs,
with metformin under the brand name Avandamet or with glimepiride
under the brand name Avandaryl, the FDA noted.
Avandia belongs to a class of drugs known as thiazolidinediones
and is intended to be used along with diet and exercise to control
blood sugar in patients with type 2 diabetes.
The FDA has also ordered GlaxoSmithKline to form an independent
group of scientists to review the company's clinical trial known as
RECORD, which studied the cardiovascular safety of Avandia compared
with standard diabetes drugs. During the agency's review of the
trial, questions came up about bias in identifying cardiovascular
"We believe this review will provide additional clarity about this trial and the safety of rosiglitazone," Hamburg said.
As published, the RECORD trial did not show any cardiovascular
risk from Avandia, Dr. Janet Woodock, director of the FDA's Center
for Drug Evaluation and Research, said during the press
However, "at this time we cannot rely on these results," Woodock
In addition, the FDA stopped the company's current trial, called
TIDE. This trial compares Avandia with Actos and with standard
diabetes drugs. "This study does not meet the criteria for safety
studies at this time," Hamburg said.
After the review of the RECORD trial is completed, the FDA may
choose to take additional action, officials said.
Dr. Ellen Strahlman, GlaxoSmithKline's chief medical officer,
said in a statement that "our primary concern continues to be
patients with type 2 diabetes and we are making every effort to
ensure that physicians in Europe and the U.S. have all the
information they need to help them understand how these regulatory
decisions affect them and their patients."
According to the company, worldwide sales of Avandia in the
first half of 2010 totaled $500 million. In the United States,
about 600,000 people are currently taking Avandia, Hamburg
Dr. Ronald Goldberg, a professor at the Diabetes Research
Institute of the University of Miami Miller School of Medicine,
said that "given all the evidence pointing to risk, even though
it's not conclusive by any stretch of the imagination, it rises to
a level to warrant restricting its [Avandia's] use."
Since there is a similar alternative, Actos, that hasn't been
shown to increase cardiovascular risk, "you would think there would
be very little place for Avandia," he said.
Goldberg said he will no longer prescribe Avandia, except to
patients who have been using it for many years. In addition, going
through the process to qualify patients for Avandia will deter many
doctors from even considering Avandia as a treatment for diabetes,
For more information on diabetes, visit the
U.S. National Library of Medicine.
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