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Avandia News
GlaxoSmithKline Avandia To Stay But Damage Is Done
An FDA advisory committee has recommended that GlaxoSmithKline's diabetes treatment Avandia should remain available on the US market, albeit with stronger health warnings. Although the company has avoided the more negative impact of a market withdrawal, the future competitiveness of the franchise has been put into doubt.
Glaxo's Avandia Can Stay
Shares of GlaxoSmithKline, Europe’s largest drugmaker, had their biggest gain in two years after a panel of US doctors voted to keep the diabetes pill Avandia on the market.
New Study Questions Avandia's Heart Risk
The debate over the heart-attack risks posed by the type 2 diabetes drug Avandia has taken another twist, with a new study questioning the results of the research that kick-started the controversy.
Sales Stay Healthy For Takeda Actos Diabetes Pill
About one month after a Food and Drug Administration advisory panel said the diabetes pill Avandia should remain on the market but with strict warnings about heart attack risk, a similar pill sold by a Deerfield-based drugmaker is holding its own in the market, according to a new analysis.
Service Alerts Doctors with Patients Affected by Avandia and Actos Drug Warnings
On August 14, 2007, the FDA issued a "black-box" cardiac risk warning label warning for the entire class of anti-diabetic drugs, known as thiazolidinediones (TZDs). The class includes Avandia (rosiglitazone), Actos (pioglitazone), and all combo-drugs containing these medications, such as Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin) and Duetact (pioglitazone and glimepride).
Safety Review On Diabetes Drug Avandia
The EMEA at the time pointed out that when Avandia was first introduced in EU countries in 2000, it was contraindicated in patients with a history of heart failure, and since then, the EMEA says it has kept the drug under close surveillance for adverse heart effects, including heart failure and other disorders including heart attack.
Diabetes Drugs Manufacturers to Strengthen Heart Failure Risk Warnings
After a review of postmarketing adverse event reports, FDA determined that an updated label with a boxed warning on the risks of heart failure was needed for the entire thiazolidinedione class of antidiabetic drugs. This class includes Avandia (rosiglitazone), Actos (pioglitazone) Avandaryl (rosiglitazone and glimepiride), Avandamet (rosiglitazone and metformin), and Duetact (pioglitazone and glimepride).
Drug Safety Surveillance Program
The University of Miami Miller School of Medicine and Humana Inc. (NYSE: HUM) today announced the launch of a new Pharmacovigilance Initiative at the University’s medical campus in Miami. The new program will focus on prescription drug safety -- in particular, the science of detecting and understanding adverse drug events.
Writing Off Avandia Rosiglitazone May Be Premature
A re-analysis of the data used in the Nissen and Wolski analysis - using different statistical models - suggests that the earlier methodology may have resulted in inflated risk estimates. The new analysis, conducted by researchers at Cedars-Sinai Medical Center, concludes "that only prospective clinical trials designed for the specific purpose of establishing the cardiovascular benefit or risk of rosiglitazone will resolve the controversy about its safety."
Cardiac Safety Of Rosiglitazone (Avandia, Avandamet, Avaglim)
An article published in the New England Journal of Medicine (NEJM) has raised concern about a small increased risk of myocardial infarction and cardiovascular death in patients with type 2 diabetes treated with rosiglitazone.
Diabetes May Not Need to be Managed with Avandia
The shocking news this week in the New England Journal of Medicine that the diabetes medication Avandia may raise the risk of heart attacks by 43 % and cardiovascular death by 64 % draws attention to the fact that in many instances, preventing and naturally treating type 2 diabetes by reducing sugar and exercising are much safer than pharmaceuticals.
Doctors Warn Diabetes Drug Avandia Still Has Heart Risks
A medical study intended to demonstrate the heart safety of a well-known diabetes treatment seems, instead, to have added to the controversy over the drug. Its manufacturer, GlaxoSmithKline, says preliminary results of the clinical trial provide reassurance that the drug, Avandia, an oral medication for Type 2 diabetes that has been used by an estimated seven million people worldwide, does not raise the risk of a heart attack or death from cardiovascular disease.
Warning on Avandia Is Old
News In Europe
GSK strongly disagrees with conclusions reached in NEJM article
on Avandia, but Europe's main medical regulator reiterated
that it had strengthened warnings about Avandia's cardiovascular
risks last fall based on company data available to regulators
on both sides of the Atlantic.
Major Heart, Diabetes Groups
Urge Caution in Wake of Avandia Warning
"The risk of heart attack and death for type
2 diabetes patients taking the drug Avandia appears to be
small, but must be considered carefully” says a statement
issued by the American College of Cardiology, American Diabetes
Association, and American Heart Association. They advise patients
using this drug should talk to their health care provider
to determine the most appropriate course of action.
Avandia Risks Prompt Doctors
to Switch Drugs
Boston doctor Annaswamy Raji says she was so alarmed by a
study linking GlaxoSmithKline Plc's drug Avandia to heart
disease that she immediately advised a diabetes patient to
stop taking the medicine.
FDA Issues Safety Alert
on Avandia
The U.S. Food and Drug Administration (FDA) is aware of a
potential safety issue related to Avandia (rosiglitazone),
a drug approved to treat type 2 diabetes. Safety data from
controlled clinical trials have shown that there is a potentially
significant increase in the risk of heart attack and heart-related
deaths in patients taking Avandia.
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