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GlaxoSmithKline Agrees to Record Settlement Over Avandia, Paxil Drug Marketing Charges

Drug maker GlaxoSmithKline just agreed to a record settlement over Avandia and Paxil drug marketing charges. According to the Justice Department, GlaxoSmithKline agreed to pay a massive $3 billion to settle the matter. The financial settlement is the largest of its kind to the government over illegal drug marketing, to date.

The drug maker also agreed to plead guilty to both criminal and civil charges concerning its off-label marketing of several medications that included the diabetes medication and anti-depressant, said Philly.com. (more…)

Avandia Lawsuit by 93 Claims Drug Caused Heart Injuries

More than 90 consumers who took Avandia are suing GlaxoSmithKline, claiming the company failed to warn them of the serious side effects associated with the diabetes drug. On May 19, the lead plaintiff, Barbara Meier, along with 93 others, filed a lawsuit against GSK and McKesson Corporation, alleging Avandia caused them to suffer from cardiovascular injuries and severe pain, reported the Madison Record.

The plaintiffs used Avandia to treat their Type 2 diabetes, but instead suffered from heart attacks and congestive heart failure, the complaint says. (more…)

Study Says Two Diabetes Drug Increase Risk of Eye Disease

Diabetes drugs Actos and Avandia may increase the risk of developing an eye disease that can lead to blindness, reported Bloomberg. A study to be presented Sunday at the American Diabetes Association’s annual meeting, reveals that patients taking either drug have a three to six times increased risk of developing diabetic macular edema (DME).

Actos and Avandia are known to increase the risk of fluid in the lungs and swelling in the legs; therefore, the study authors concluded “patients at high risk of sight-threatening DME should avoid” drugs such as Actos and Avandia. Those at high-risk include patients with issues controlling their blood sugar and those with a previous history of macular edema. (more…)

Avandia Restrictions Announced by FDA

The U.S. Food & Drug Administration (FDA) has restricted the sale of diabetes drug Avandia in retail pharmacies. The agency reported Wednesday that after November 18, the use of Avandia, generically known as rosigiltazone, will only be available to patients via mail order.

In 1999, GlaxoSmithKline introduced the drug to control Type 2 diabetes. By 2006, at least 1 million Americans were taking Avandia, says the Lost Angeles Times, and sales generated more than $3 billion. According to the FDA, from January 2010 through October 2010, about 460,500 patients filled a prescription for Avandia, Avandamet or Avandaryl. (more…)

FDA Finally Takes Action on Avandia

Finally, the US Food & Drug Administration (FDA) has made its long-awaited decision on Avandia. It’s not yanking Avandia from the market, but the agency is making the controversial diabetes drug more difficult to get.

Under new restrictions announced today, patients in the US will only have access to Avandia if they and their doctors attest that they have tried every other diabetes medicine and that patients have been made aware of Avandia’s cardiac side effects. The restrictions also apply to Avandamet and Avandaryl. (more…)

Enrollment Halted in Avandia TIDE Trial

Enrollment in a controversial Avandia study has been halted by the Food & Drug Administration (FDA) over safety concerns. The trial, called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), was designed to compare the long-term effects of Avandia with another diabetes drug called Actos.

For some time now, scientists inside and outside the FDA have opposed TIDE, saying it is unethical to compare Avandia, with its known cardiac risks, with a seemingly safer alternative. Actos has not raised as many safety concerns as Avandia. (more…)

Avandia Panel Member is a Paid Speaker for Glaxo

A member of a Food & Drug Advisory (FDA) panel that voted last week to keep Avandia on the market has been a paid speaker for GlaxoSmithKline, maker of the controversial diabetes drug. Apparently this wasn’t disclosed to other members of the panel prior to the vote being taken.

According to the Journal, the FDA is looking into whether there was disclosure to the agency and, if so, why it wasn’t conveyed to the committee. (more…)

FDA Panel Recommends More Avandia Restrictions

Avandia may be allowed to stay on the market after all, following recommendations made yesterday by a Food & Drug Administration (FDA) advisory panel. The panel voted that while sales of the controversial diabetes drug should be restricted, Avandia should be allowed to stay on the market.

Avandia was the biggest selling diabetes drug in the world, until 2007 when a Cleveland Clinic study raised questions about its heart risks. The study, conducted by Dr. Stephen Nissan, showed patients taking Avandia had a 43-percent higher risk of having a heart attack. The drug’s label has borne a black box warning – the FDA’s most serious safety alert – regarding its heart attack risk since November of that year. (more…)

Congresswoman Calls for Avandia Recall

Calls for an Avandia recall are increasing. The latest has come from Rep. Rosa DeLauro (D., Conn.), the chairwoman of the House appropriations panel that controls the FDA’s budget, is the latest to call on the agency to do so.

According to The Wall Street Journal, DeLauro said yesterday that it is “reprehensible that many people might have suffered heart attacks or heart failure as a result of taking this drug, especially if a safer alternative exists.”
(more…)

Avandia Faces More Scrutiny

Could Avandia’s days on the market be numbered? According to a New York Times report, some officials at the Food & Drug Administration (FDA) think the controversial diabetes drug should be pulled from the market because of its link to heart attacks. Meanwhile, a Senate Finance Committee report released over the weekend claims GlaxoSmithKline knew for years about Avandia’s heart attack risks, but took steps to keep the public in the dark.

According to The New York Times, Dr. Janet Woodcock, director of the FDA’s drug center, ordered that another FDA panel be convened to reconsider whether Avandia should stay on the market, after writing in a December 2009 memo that “there are multiple conflicting opinions” about Avandia within the agency. The advisory panel meeting is expected to take place this summer. (more…)

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