Avandia Side Effects
The diabetes drug Avandia, also called rosiglitazone, has a long history of adverse side effects. The first report linking Avandia to side effects was in 2007, which stated that use of Avandia may increase risk of heart attack by as much as 43%. This report from the Cleveland clinic famously caused the FDA to issue a public safety warning and to request a black box warning. The Avandia label now includes a warning that use may lead to a heart attack or cardiac danger.
Avandia Side Effects Heart Attack
Heart Attack and congestive heart failure are the most severe of the Avandia Side Effects, but there are more that avandia patients need to be aware of.
Some of the most reported Avandia Side Effects are: stroke, heart attack, congestive heart failure, cardiovascular hear disease among other heart injuries and liver failure.
Other injuries or side effects related to the use of Avandia include osteoporosis, bone fractures, back pain and edema. Backpain, hypoglycemia, blurred vision, hyperflycemia, severe allergic reaction and myocardial ischemia are other Avandia Side Effects.
Other patients have reported Avandia side effects of severe allergic reactions which include syptoms like rash, hives, itching, difficulty breathing, tightness in chest, swelling of the mouth, face, lips or tongue
Avandia Side Effects Reported
The first report linking Avandia side effects to heart risk came out in 2007, which stated that use of Avandia may increase risk of heart attack by as much as 43%. The FDA initially issued an alert that the drug may cause increased harm. However, a few months later, additional meta-analysis led the FDA to conclude that Avandia caused no more increase in risk of heart attack than any other similar drug, but the FDA did issue a black-box warning for the label warning of the potential heart risks of Avandia. The FDA then launched the TIDE trials to compare the potential increase of heart risks between Avandia and other similar drugs.
Later in 2007, the FDA announced that a study has found that “Significantly more female patients who received rosiglitazone experienced fractures of the upper arm, hand, or foot, than did female patients who received either metformin or glyburide.” As a result, GlaxoSmithKline warned healthcare providers to consider the risks of Avandia before prescribing it.
In 2009, The Lancet ran an independent study called RECORD (Rosiglitazone evaluated for cardiovascular outcomes in oral agent combination therapy for type 2 diabetes) in which they concluded that Avandia side effects did increase the risk of heart attacks.
In July of 2010, FDA posted analysis of the RECORD study, which involved more than 4000 patients and compared Avandia with two other similar diabetes drugs. The analysis was conducted by Dr. Thomas Marciniak who said of the RECORD study that researches submitted sloppy data and failed to follow up on reports of problems in patients.
GSK’s vice president for Clinical Development, Dr. Murray Stewart, said, “Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.”
However, Dr. Marciniak said that design of the RECORD study, the largest study of the cardiological effects of Avandia and the one that GSK sites the most, was “inappropriate and biased.”
After re-evaluating the meta-analysis, the European Medicines Agency concluded that the increased risk with Avandia outweighed the potential benefits and the drug was removed from the European market. Shortly afterwards, New Zealand also removed the drug from the market and recommended that patients currently taking Avandia should consult their medical advisors for alternate treatment methods and be aware of Avandia side effects.
Then, the FDA announced that they were halting the TIDE trials. They also stated that, in response to the results from RECORD, that they were forcing GlaxoSmithKline to re-evaluate the drug. However, Avandia-related drugs will remain on the market until more conclusive evidence arises and the FDA is instead placing the burden of patient education on the medical advisors while the FDA continues to evaluate the benefits and risk potential of Avandia.
RECOMMENDATIONS
If you or someone you know is currently taking Avandia (or an Avandia related drug) in order to treat type-II diabetes, it is highly recommended to speak to a medical professional about alternative treatments.
If you have shown any of the Avandia side effects while taking Avandia, you should speak to an Avandia Lawyer to assess whether or not you have a viable Avandia Lawsuit. There is a statutory deadline for filing an Avandia claim, so you want to act as fast as possible if you are thinking of filing an Avandia Lawsuit or you may be barred from future legal action.
The statute of limitations on Avandia lawsuits is based on many factors surrounding your claim. These factors include the state you file your Avandia Lawsuit in, the injuries that were suffered and type of claim made. Every case is different and if you have any questions on the best practices when filing an Avandia Lawsuit, please contact our legal team. Complete the Free Case Evaluation form to the right to have your case reviewed. If you have suffered injury as a result of taking Avandia, you should consult an Avandia lawyer as soon as possible in order to protect your claim for an Avandia settlement. If you are experiencing any Avandia side effects contact your doctor.