Chicago Injury Law Blog

Thousands of patients have already suffered the adverse effects of Avandia, a popular diabetes drug that poses a serious heart attack risk. Now the federal government is finally stepping in, with an announcement that it will pull Avandia from retail pharmacy store shelves beginning November 18. The drug will be available only through a special mail-order program to diabetic patients who cannot control their blood sugar levels with any other drugs.

Avandia was once the world’s best-selling diabetes pill, generating about $3 billion in revenue for London-based GlaxoSmithKline. Sales dropped in 2007 when the FDA found clear evidence that Avandia was linked to more than 83,000 heart attacks, but the risk was not enough to deter most patients, and the drug still remained in widespread use. A Bloomberg report shows that 235,000 patients filled an Avandia prescription in January. 

The FDA severely restricted use of the drug in September 2010, but the latest restriction is much closer to a complete recall. Only a very limited number of patients will be able to receive a prescription for Avandia via a mail order from specially-certified pharmacies. And those patients must also be enrolled in a special program to ensure that they are fully informed about the risks of Avandia before they decide to take the drug. 

The new restrictions are promising because they impose strong government oversight, require informed patient consent, and encourage patients to consider less dangerous alternatives. But it will take 6 months for the program to be fully implemented, and patients are still being exposed to serious health risks every day that they take their Avandia prescriptions. Avandia increases the risk of heart attack by nearly 40 percent in people with Type II diabetes, who are already much more prone to a heart attack than those without the disease.    For these patients, the restrictions may be too little, too late. Drug recall attorneys at Pintas & Mullins Law Firm will continue to advocate on behalf of all patients who have been harmed by Avandia and will continue to push for a complete recall of the dangerous drug. 

We recently reported that the U.K’s biggest drugmaker, GlaxoKlineSmith, agreed to settle for an undisclosed amount with the family of an Avandia user who suffered a fatal heart attack in 2006 after using the diabetes drug for 15 months. That agreement sparked a wave of settlement negotiations, with Glaxo agreeing to pay more than $250 million to resolve another 5,500 Avandia claims. 

The lawsuits share a common theme, alleging that Glaxo hid Avandia’s heart attack and stroke risks. The latest round of settlements will result in an average payment of $46,000 to each Avandia user that recently filed suit against the drugmaker. This is in addition to the $460 million that the company already agreed to pay to resolve allegations that it did not properly warn doctors and consumers about the medicine’s risks.

Glaxo agreed to stop promoting Avandia worldwide in September, after European regulators removed it from the market and sales in the U.S. were severely restricted in response to studies that linked the drug to increased risks of heart attacks and strokes. The drugmaker updated Avandia’s warning label to include additional safety restrictions and warn users that the drug is only intended for patients who do not respond to other diabetes drugs.

The link between heart attacks and the diabetes drug Avandia sparked thousands of lawsuits across the country, including a heart attack death suit that was scheduled to go to trial earlier this week. In the hopes of avoiding a large jury award, drugmaker GlaxoKlineSmith agreed to settle the case on the eve of trial for an undisclosed amount. 

The lawsuit involved James Burford, an Avandia user from North Carolina who died in 2006. His lawsuit was the first to go to federal court and would likely have resulted in a substantial jury award against Britain’s biggest drugmaker. Although Glaxo used legal tactics to avoid the risk in this case, it still faces another 2,000 lawsuits alleging that the company hid Avandia’s health risks.

Sales of the popular diabetes drug plummeted in 2007 when researchers exposed its connection to heart attacks. In response, European regulators pulled the drug from the market and American regulators significantly curbed its use. 

Expenses linked to investigations and suits over Avandia have already taken a financial toll on the company. The $6.4 billion that Glaxo set aside to cover legal costs and federal prosecutor probes is expected to wipe out yearly profits. 

Legal fees are wiping out profits for British drug maker GlaxoKlineSmith.   This week the company announced that it will set aside $3.4 billion to pay for U.S. government investigations and product liability cases relating to the diabetes drug Avandia. This one time charge is expected to exceed the company’s fourth-quarter earnings.

European regulators banned Avandia back in September 2010 and the U.S. Food and Drug Administration severely restricted its use because of evidence that the drug increased the risk of heart attacks. 

Avandia was once the world’s top-selling diabetes medicine, before it was revealed that tens of thousands of patients taking the medication suffered heart attacks. GlaxoSmithKline knew of the risks for years, but failed to warn physicians or patients.

The company previously set aside more than $2 billion to cover litigation costs. Although many of the cases closed out this year, new claims continue to come in

British drug maker GlaxoSmithKline recently reported that its controversial diabetes drug Avandia is under investigation by federal and state law enforcement officials.

The announcement comes less than a month after the Food and Drug Administration issued severe restrictions on the use of Avandia because it increased the risk of heart attacks. Regulators in Europe pulled the drug off the market altogether.

The Department of Justice subpoenaed the drug maker to gain access to clinical data and marketing information amid accusations that the company failed to warn patients and doctors of the heart risks associated with the drug. Attorney Generals in several states are also investigating.

Avandia was once Glaxo’s third best-selling product, bringing in over $3 billion in sales in 2006. Sales plummeted the following year when a study revealed that Avandia increased the risk of heart attacks by 43%.

The federal probe follows years of investigation by congressional staffers into the company’s handling of the drug. Earlier this year a Senate Finance Committee report concluded that Glaxo knew about the risks of Avandia years before they were made public, and withheld important data from the FDA.

On Thursday, September 23, 2010 the FDA announced that sales for the once popular diabetes drug, Avandia, will now only be prescribed to patients after they and their doctors attest that the patients tried every other diabetes medication and the patients are aware of the substantial heart risks of Avandia.   It is currently estimated that 600,000 people are currently on Avandia, so this new restriction will have an immediate impact.

In 2007, Dr. Steven Nissen, a Cleveland Clinic cardiologist, reported a study finding Avandia increased the risk of heart attacks, despite an advisory committee agreement, it still voted to keep it on the market.   After Thursday’s new, Dr. Steven Nissen said that the FDA decision brought an end to “one of the worst drug safety tragedies in our lifetime,” adding that it was “essential to fully investigate what went wrong with the regulatory process to prevent this type of tragedy from endangering patients in the future.”   

In a recent study, it was estimated over 47,000 people suffered heart attacks, stroke or death caused by Avandia in a ten year period.  

Also reported on Thursday, the sales for Avandia have been completely suspended in Europe.

As uncertainty surrounds the safety of the popular diabetes drug Avandia, federal health officials are prohibiting new patients from enrolling in a safety study of the prescription medication because of the associated risks. The TIDE study is designed to give a definite answer to whether or not Avandia holds more risk for heart problems than similar drugs. The Federal Food and Drug Administration (FDA) issued a “partial clinical hold” on the TIDE trial, which Avandia’s manufacturer GlaxoSmithKline agreed to conduct when the drug’s safety was first questioned in 2007. However, patients who are already participating are permitted to continue.

A panel of experts recently voted that although Avandia seems to increase the risk of heart problems, the majority voted to leave it on the market.  Some health professionals are  arguing that the TIDE trial is unethical since there is enough evidence to prove that the drug is more dangerous. Other health professionals have speculated that Avandia will be pulled off the market soon.

It was recently reported by the Wall Street Journal that one of the members of the government advisory panel who voted to back Avandia last week was on GlaxoSmithKline’s payroll. More specifically, endocrinologist David Capuzzi is a paid speaker for the drug manufacturer.

Avandia, a diabetes drug, has carried the Federal Food and Drug Administration’s (“FDA’s”) strongest warning, a black box warning, regarding its risk for heart problems since 2007.  Last week, a FDA advisory panel met to consider further restrictions on the drug in the wake of new information indicating it to be more harmful than previously thought.  During the meeting of 33 panel members, 12 voted Avandia should be withdrawn; 10 voted its sales should be restricted and warning labels enhanced; 7 voted solely for enhanced warning labels; and 3 voted to keep Avandia on the market with no changes to its warnings.  Because of the lack of unity, it is difficult to predict what the FDA will do with regard to the drug.

According to the Wall Street Journal, Dr. Capuzzi was one of the three panel members who voted to keep Avandia on the market with no changes to its warnings, and defended the drug during the two-day panel meeting.  Dr. Capuzzi has received almost $15,000 in speaking fees from GlaxoSmithKline, but has denied previously speaking about Avandia. The controversy surrounding Dr. Capuzzi and Avandia highlights a problem in the FDA’s regulations: the disclosure form for outside experts who advise the FDA on risky drugs only requires them to list fees from speaking or writing for a drug company for the previous 12 months or that are under negotiation. This is typically too short a period of time to catch most conflicts in the pharmaceuticals business. In Dr. Capuzzi’s case, the FDA’s current requirement would not have captured the majority of GlaxoSmithKline’s payments to him.  

As a follow-up to our previous blog on the current controversy surrounding the popular diabetes drug Avandia, it was recently reported that Avandia’s manufacturer GlaxoSmithCline hid a 1999 study that indicated the drug’s danger.

In the fall of 1999, the manufacturer secretly began a study to test if Avandia was better and safer in terms of heart problem risks than the competing drug Actos. The study showed that Avandia was not better than Actos, and was in fact riskier for the heart. The company did not share these results, but instead tried to cover them up, likely due to fear of lost profits. In most cases, the law requires posting the results in a public forum or submitting them to federal drug regulators. In fact, GlaxoSmithKline has not only hid valuable data regarding Avandia’s safety, it has also manipulated data to make the drug appear less risky.

Avandia went on to become one of the most popular drugs in the world, earning GlaxoSmithKline hundreds of millions in profits.  It was not until May 2007 when a cardiologist at the Cleveland Clinic  disclosed a study that showed an increase risk of heart attacks  associated with Avandia.  Currently, the FDA is debating whether or not to allow a further clinical trial to test the safety risks of the drug proceed.

Contact an Experienced Drug Litigation Attorney

The attorneys at the Pintas & Mullins Law Firm have extensive experience with drug litigation cases.  If you or a loved one has suffered heart problems as a result of taking Avandia, contact us for a free no-obligation consultation to find out about your legal rights.  You can also visit our website to learn more about Avandia.

On May 21, 2007 the FDA issued an alert warning people with underlying heart disease are at an increased risk of heart attack or stroke while taking Avandia. On July 30, 2007, the FDA’s advisory committee concluded that the use of Avandia for treatment of Type 2 diabetes was associated with a greater risk of cardiovascular problems compared to a placebo. The FDA is now requiring GlaxoSmithKline, the maker of Avandia, to conduct a cardiovascular outcome trial on Avandia to provide a definitive answer to whether Avandia poses an unacceptable risk of cardiovascular disease.

Avandia has also been associated with other health risks including a greater risk of fractures in women as well as a higher risk for macular edema (swelling in the retina). In addition, Public Citizen, a consumer advocacy organization, has identified 14 cases of liver failure induced by Avandia, including 12 deaths.  

The FDA has not recalled Avandia, but has required the drug to include a black box warning as of November 14, 2007. The warning states that people with underlying heart disease should be monitored closely while taking Avandia. If you believe you or a family member have  suffered heart problems or a stroke while taking  Avandia, please contact the Pintas Firm immediately. Consult your physician before discontinuing your medications.