Glaxo adds safety restrictions to Avandia label

Feb 07, 2011

(AP) -- GlaxoSmithKline says it has updated the labeling of its diabetes pill Avandia to include safety restrictions ordered by federal health authorities because of the drug's links to heart attack.

The announced the changes in September as the latest safety action against the former blockbuster drug, which has triggered thousands of lawsuits and a Department of Justice investigation. The pill is banned in Europe.

The new U.S. label indicates the drug is only intended for patients who cannot control their blood sugar with any of the other medications on the market.

The FDA first approved Avandia in 1999 and it became the top-selling diabetes pill in the world by 2006. But use has plummeted since a 2007 analysis linked the drug to .

Explore further: Acne pill benefits outweigh blood clot risk: EU agency

not rated yet
add to favorites email to friend print save as pdf

Related Stories

US restricts, EU bans controversial diabetes pill (Update)

Sep 23, 2010

(AP) -- European regulators ordered the diabetes drug Avandia off the market and the Food and Drug Administration placed stringent restrictions on its use in the United States, saying heart attack risks associated with the ...

FDA review spotlights heart risk of diabetes pill

Jul 09, 2010

(AP) -- A review by federal health scientists reinforces potential ties between the diabetes pill Avandia and heart attack and death, opening the door for government action, including a possible withdrawal of the once blockbuster ...

FDA issues hold on much-debated Avandia study

Jul 21, 2010

(AP) -- Federal health officials are barring new patients from enrolling in a safety study of GlaxoSmithKline's controversial diabetes pill Avandia, a week after a panel of experts ruled that the drug increases ...

FDA panel: Diabetes drug should stay on market

Jul 14, 2010

(AP) -- A majority of federal health experts voted Wednesday to keep the controversial diabetes pill Avandia on the market despite evidence that it increases the risk of heart attack.

Glaxo defends handling of Avandia heart risks

Feb 24, 2010

(AP) -- GlaxoSmithKline said Wednesday a Senate report criticizing its handling of heart risks with its diabetes drug Avandia "mischaracterizes and distorts" the company's record.

Senate report: Avandia maker knew of cardiac risks

Feb 22, 2010

(AP) -- A Senate report said Saturday that drug maker GlaxoSmithKline knew of possible heart attack risks tied to Avandia, its diabetes medication, years before such evidence became public.

Recommended for you

First influenza vaccine brought to clinical testing

May 17, 2013

Singapore's Agency for Science, Technology and Research (A*STAR) and Switzerland's Cytos Biotechnology AG today announced that the first healthy volunteer has been dosed in a Phase 1 clinical trial with their ...

Aspirin not always best treatment for many individuals

May 16, 2013

(Medical Xpress)—An aspirin a day may not always keep heart disease away, say two University of Florida cardiologists. But a new algorithm they have developed outlines factors physicians should weigh as ...

FDA: lower ambien's dose to prevent drowsy driving

May 15, 2013

(HealthDay)—The U.S. Food and Drug Administration has approved new, lower-dose labeling for the popular sleep drug Ambien (zolpidem) in an effort to cut down on daytime drowsiness that could be a hazard ...

Simponi approved for ulcerative colitis

May 15, 2013

(HealthDay)—Simponi (golimumab) injection has been approved by the U.S. Food and Drug Administration to treat adults with moderate-to-severe ulcerative colitis.

FDA approves genetic test for lung cancer drug

May 14, 2013

The Food and Drug Administration says it approved a genetic test from Roche to help doctors identify patients who can benefit from a lung cancer drug made by Genentech.

User comments : 0

More news stories

US psychiatry gets makeover in new manual

The latest makeover to a massive psychiatric tome honored by some, reviled by others and even called the "Bible" of mental disorders is being released Saturday with a host of new changes.

New case of SARS-like virus in Saudi: ministry

A new case of the deadly coronavirus has been detected in Saudi Arabia where 15 people have already died after contracting it, the health ministry announced on Saturday on its Internet website.

New colonoscope provides ground-breaking view of colon

A ground-breaking advance in colonoscopy technology signals the future of colorectal care, according to research presented today at Digestive Disease Week(DDW). Additional research focuses on optimizing the minimal withdrawal ...

Morocco to harness the wind in energy hunt

Morocco is ploughing ahead with a programme to boost wind energy production, particularly in the southern Tarfaya region, where Africa's largest wind farm is set to open in 2014.

Galaxy's Ring of Fire

Johnny Cash may have preferred this galaxy's burning ring of fire to the one he sang about falling into in his popular song. The "starburst ring" seen at center in red and yellow hues is not the product of ...