Avandia is an oral antidiabetic agent used to increase insulin sensitivity. The goal of this medication is to improve overall glycemic control while reducing the insulin levels moving through the body. Avandia was first introduced in 1999, and the drug has been under scrutiny and involved in scandals since the first year of release. People who have been taking this medication should be aware of the risks, and they should also understand what is currently happening with allegations and class action lawsuits that are being filed against GlaxoSmithKline, the manufacturer of this drug.
The Uses of Avandia
This oral medication is used for type 2 diabetes, but it has not been proven useful for type 1 diabetes. It is not designed to be used along with insulin as this can increase the risk of serious heart problems. The medication is available only for certain people who have type 2 diabetes and have not been able to control this medical condition with other treatment options.
The medication can be taken with or without food, and its use should be monitored by a doctor. The doses taken should be in line with doctor’s recommendations based on individual results. The medication should be used on a regular basis to get the most benefits. It is often used as part of a larger treatment program that includes dietary changes, regular exercise, weight control, special medical care, and regular blood sugar testing. Missed doses should be taken as soon as they are remembered, or they can be skipped if it is nearly time for the next doses. Patients should never take a double dose to make up for one that was missed.
Potential Side Effects
Avandia is not recommended for anyone with blood pressure or heart problems as it can make these conditions worse. The drug also has a host of side effects that can affect people who use this mediation. The most common side effects include headache and coughing.
The mildest side effects of Avandia include stuffy nose, sneezing, sore throat, and back pain. However, more side effects can include swelling, rapid weight gain, shortness of breath, nausea, blurred vision, pale skin and chest pain. Some people are allergic to Avandia. Signs of a dangerous allergic reaction include hives, difficulty breathing and swelling in the face, tongue, lips or throat.
Life-Threatening Side Effects
There are also some life-threatening side effects associated with Avandia. While the medication was initially approved for use in 1999, it has taken more than a decade for the most serious problems and allegations to surface. Avandia is part of the thiazolidinediones family, or TZDs. Another member of the TZD family, Rezulin, was withdrawn from the market after is causes liver failure in a significant but small number of patients. Avandia was released with the claim that it would help with diabetes care without causing liver failure. However, there have been reports of liver failure among Avandia users along with allegations that the drug is responsible.
At least one study, the DREAM study, has shown that patients who take Avandia have a higher risk of heart attacks, stroke and death from cardiovascular-related health problems. FDA drug reviewers also published a report showing that patients taking Avandia are more likely to die from heart problems than those taking other medications. The manufacturer has disputed these studies. The most serious potential complication comes when Avandia is combined with insulin. In these cases, it appears that the incidence of heart failure is increased.
Timeline of Avandia
Avandia was released in May, 1999. Shortly after the release, allegations surfaces that the manufacturer had buried the results of a study showing that the drug was potentially dangerous and could have a negative impact on heart health. In April of 2001, the manufacturer began a study into the drug at the request of the FDA. While manufacturer GSK claimed that the study showed the drug posed no risk to heart health, critics claim that the RECORD study was inadequately designed and conducted.
After a lawsuit was concluded in June, 2004, GSK was forced to make all clinical trials available online. This came in response to allegations that GSK was hiding results showing Paxil caused increased suicidal behavior in juveniles.
In May, 2007, the chief cardiologist at the Cleveland Clinic, Dr. Steven Nissen, analyzed 42 clinical trials of Avandia posted on the GSK wesite. He wrote an article for the New England Journal of medicine claiming that Avandia increased heart attack risks by 43 percent. GSK responded to the claim by saying that the numbers “can be explained.” In June, Dr. Nissen went on to publish his findings even while the manufacturer attempted to stop him from going public with the information. In November of that year, the FDA required GSK to start putting stronger warnings on Avandia. The drug was required to use the strictest “Black-box” warning and to disclose that it could pose an increased risk for congestive heart failure.
The findings that Avandia is dangerous for heart health were supported in a Harvard study in November, 2008. This study looked at nearly 30,000 patients and found that Avandia users were 15 percent more likely to die than people taking Actos. Over the next two years, the Senate Finance Committee conducted hearings on the drug. In February of 2010 they concluded that GSK was aware of the heart attack risks and had made efforts to suppress this information and continue promoting sales of the drug.
June of 2010 saw the release of more studies on Avandia. Both the Journal of the American Medical Association and the Archives of Internal Medicine published studies that Avania should be pulled from the market. In July of 2010, FDA researchers claimed that the RECORD study sponsored by GSK in 2001 had omitted crucial data and was flawed. GSK responded with a statement expressing confidence in the drug, and the New England Journal of Medicine published an editorial accusing the manufacturer of tampering with trials and hiring biased experts. The FDA considered pulling Avandia from shelves, but they did not follow through with this step. Instead, they allowed it to remain on the market with more warnings. Around the same time, the European Medicines Agency started to assess the safety of the drug to determine if it should stay on the market in Europe.
Legal Action Regarding Avandia
A scientist for the FDA reports that Avandia has been linked to an incredible number of heart attacks. Currently, it’s believed that Avandia played a role in nearly 100,000 heart attacks. There are currently more than 50,000 Avandia lawsuits around the country. They are being heard in both state and federal courts. The claimants are suing because GSK failed to inform patients about all of the risks, specifically the impact on cardiovascular health.
The manufacturer has settled many cases out of court. In May, 2010 it settled about 700 cases with a payment of roughly $60 million. Later that same year, they settled approximately 10,000 cases with a payment of $460 million.
While many cases have been settled outside of the courtroom, the criticism of GSK and Avandia have increased in recent years. The company has plead guilty to charges that it failed to report clinical data regarding this mediation. They have agreed to pay the Department of Justice $3 billion as part of a settlement regarding their marketing campaign of Paxil and Wellbutrin. It is reported that they have set aside funds to handle the growing number of Avandia lawsuits. While some cases will be resolved through settlements, it is expected that others will go to court.
http://www.drugs.com/avandia.html – the uses of Avandia
http://www.rxlist.com/avandia-side-effects-drug-center.htm – Potential Side Effects
http://www.phlaunt.com/diabetes/18554346.php – Life threatening side effects
http://www.pbs.org/wnet/need-to-know/health/timeline-history-of-avandia/2314/#1 – Timeline of Avandia
http://www.drugwatch.com/avandia/lawsuit.php – Legal action regarding Avandia