Millions of Americans use prescription drugs to manage all sorts of medical conditions and diseases. For the most part, these drugs help patients lead normal, active lives. Sometimes, however, these medications cause serious and unexpected health hazards. The prescription drug Avandia is a good example.
In cases like this, it's up to the federal government and patients to take action to make sure the public is safe.
What Is Avandia?
Avandia (rosiglitazone maleate) is an oral anti-diabetic drug made by GlaxoSmithKline. It helps lower blood sugar levels to manage type 2 diabetes (or non-insulin dependent diabetes) by increasing insulin sensitivity. The Federal Drug Administration (FDA) approved Avandia on May 25, 1999.
Since then, millions of Americans have used the drug.
Problems with the Drug Discovered
The FDA's Center for Drug Evaluation and Research (CDER) ensures that drugs are safe and effective. While the CDER doesn't test drugs, it does conduct limited research in the areas of drug quality, safety and effectiveness.
On May 21, 2007, the FDA issued a safety alert after data from controlled clinical trials indicated that there was a potentially significant increase in the risk of heart attack and heart-related deaths in patients taking Avandia.
Alert Wasn't Good Enough
Four years after it first learned the drug increased heart attack risk, the FDA limited access to Avandia. Starting November, 2011, health care providers and patients must enroll in a special program in order to prescribe and receive Avandia, Avandamet and Avandaryl. The drugs are limited to use for patients:
- Who are already being treated with these drugs, or
- Whose blood sugar can't be controlled with other anti-diabetic medicines and who, after consulting with their health care professional, don't want to use pioglitazone-containing medicines (Actos, Actoplus Met, Actoplus Met XR, or Duetact)
The FDA was criticized for taking so long to limit its use.
Risks Associated with Taking Avandia
The most serious risk associated with taking Avandia is heart failure. Avandia can cause your body to keep extra fluid (fluid retention), which leads to swelling and weight gain. Extra body fluid can make some heart problems worse or lead to heart failure.
Other side effects associated with taking Avandia include:
- Swelling (edema) from fluid retention
- Low blood sugar (hypoglycemia)
- Weight gain
- Low red blood cell count (anemia)
- Ovulation leading to pregnancy
- Liver problems
- Cold-like symptoms
Who Can File an Avandia Lawsuit?
Anyone who has taken Avandia and suffered an Avandia-related injury, or anyone with a close family member who died as a result of an Avandia-related injury, may be able to file an-Avandia lawsuit.
Filing an Avandia Claim
First, see your doctor if you're using Avandia now or have used it in the past. Your health is your number one priority.
Once you have reason to believe you have an Avandia-related claim, it's best to contact an attorney who specializes in Avandia litigation or medication-related lawsuits in general.
Numerous class action lawsuits have been filed over Avandia, and you may be able to join one. These types of suits improve court efficiency by allowing a large group of people with similar claims to join together in one lawsuit.
Report a Serious Side Effect With Avandia to the FDA
Don't hesitate to report any serious adverse reaction to Avandia to the FDA by visiting MedWatch report or calling 1-800-FDA 1088.
You didn't do anything wrong! All you wanted to do was control your diabetes and feel better, and Avandia promised you those things. Stand up for your rights and your health, and help make sure drug manufacturers make safe, effective medicines for you and the rest of us.
Questions for Your Attorney
- How long do I have to file a lawsuit or join a class action lawsuit for my Avandia-related injury?
- How can I prove my spouse's death last year was connected to Avandia?
- If I continue using Avandia following the FDA's new limitations, does that mean I waive any legal rights if I later suffer an Avandia-related injury?