Larry Gornick chosen to lead Attorneys Toyota Action Consortium in California:  Larry Gornick will be the point man in California for the upcoming class action lawsuits against Toyota  ------  NHTSA considers imposing civil penalty over Toyota recalls:  U.S. Transportation Secretary Ray LaHood today sharply criticized Toyota Motor Corp.'s handling of two major recalls. NHTSA is considering imposing civil penalties on Toyota for its conduct.  ------  Toyota owners file class action lawsuit:  Toyota car owners in Cincinnati asked a judge Tuesday to force the auto maker to pay their lease and car loan payments until the company fixes a problem with sticking accelerator pedals.  ------  Toyota accused of concealing safety issues from public:  A ruling expected soon in the suit could make public thousands of internal Toyota documents that show the company conspired to hide evidence in court.  ------  First NSF/Gadolinium case goes to trial in San Francisco:  Early signs of how each side could fare at trial in hundreds of lawsuits over contrasting agents that allegedly cause nephrogenic systemic fibrosis are expected to come out of a San Francisco courtroom.  ------  FDA Panel Suggests Bayer, GE MRI Drugs Be Restricted:  A panel of medical experts on Tuesday suggested drugs made by General Electric Co. and Bayer AG be restricted to people without severe kidney problems amid reports they may cause a fatal thickening and hardening of the skin.

Avandia Side Effects Prompt Black Box Warnings

GlaxoSmithKline’s Avandia has come under increased scrutiny following reports linking the type 2 diabetes drug with serious adverse effects. Patients taking Avandia are at increased risk of heart attack, cardiovascular death, primary pulmonary hypertension (PPH), heart valve disease and heart valve defects. In addition, studies have found a link between Avandia and increased risk of bone fracture in women.

An anti-diabetic drug, Avandia was developed to lower blood sugar when taken in conjunction with a balanced diet and exercise. Although proven effective as a treatment for type 2 (“adult onset”) diabetes, experts are now questioning whether or not the rewards outweigh the risks.

FDA Issues Black Box Warnings for Avandia

In May of 2007, the results of an extensive Avandia study were published in the New England Journal of Medicine. These results suggested a direct link between Avandia and an increased risk of serious cardiovascular problems. The wide-ranging study involved 42 groups and more than 27,000 patients. Researchers concluded that patients taking Avandia were 43 percent more likely to suffer a heart attack and 64 percent more likely to suffer cardiovascular disease than patients taking an alternative medication.

On May 21, 2007, the FDA issued a black box warning – the most severe warning issued by the FDA – for Avandia, advising patients and physicians about the potential increased risk of heart attack. The FDA also issued a safety alert for Avandia which stated in part:

“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… Recently, the manufacturer of Avandia provided FDA with a pooled analysis (meta analysis) of 42 randomized, controlled clinical trials in which Avandia was compared to either placebo or other anti-diabetic therapies in patients with type 2 diabetes. The pooled analysis suggested that patients receiving short-term (most studies were 6-months duration) treatment with Avandia may have a 30-40 percent greater risk of heart attack and other heart-related adverse events than patients treated with placebo or other anti-diabetic therapy.”

Link to using FDA Issues Avandia Safety Alert

On August 14, 2007, Avandia received another black box warning, this time to emphasize that Avandia causes or exacerbates heart failure. The second black box warning followed the analysis of some 42 studies (comprised of more than 14,000 patients) evaluating the anti-diabetic drug.

Avandia Lawsuits

Drug manufacturers are responsible for evaluating the safety of their products before marketing them. If you or someone you know has experienced any of the aforementioned Avandia side effects as a result of using the anti-diabetic drug, you may be eligible to receive personal injury compensation to help defray medical bills, loss of work or legal fees. The lawyers of Levin, Simes, Kaiser & Gornick are experienced professionals focused on defending the rights of personal injury victims. Rachel Abrams of Levin Simes Kaiser & Gornick has been appointed to the national Avandia litigation plaintiff's steering committee. Contact the law offices of Levin, Simes, Kaiser & Gornick today at (877) LSKG-LAW to find out if you are eligible to file an Avandia lawsuit.

About Avandia

Approved in 1999, Avandia (rosiglitazone maleate) is a drug manufactured and sold by GlaxoSmithKline for people suffering from type 2 diabetes mellitus. Type 2 diabetes is caused when a person’s body does not make enough insulin, or when their body cannot respond appropriately to its insulin production.

Avandia is taken in tablet form in a starting dose of 4mg (once a day) or 2mg (twice a day). There were more than 13 million prescriptions of Avandia written in the United States in 2006, generating in excess of $2 billion dollars for GlaxoSmithKline.

 

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