Avandia Restrictions Lifted but Should You Trust This Diabetes Drug?
I was raised to believe in giving people a second chance, but I am not so sure that same philosophy should apply to things such as Avandia. Yet that is what the recent lifting of restrictions from Avandia by the Food and Drug Administration (FDA) is asking people with type 2 diabetes to do.
More specifically, that is what the drug maker, GlaxoSmithKline, is hoping doctors and their patients will do. But should you put aside all the past difficulties and doubts, including the questionable studies regarding heart attack risk, reluctance of GSK to reveal study results, lawsuits initiated by patients, reports of GSK intimidating doctors, and other negative circumstances revolving around this drug and take this drug just because the restrictions have been removed?
History of Avandia
Avandia (rosiglitazone) is a drug in the thiazolidinedione class that was first approved for treatment of type 2 diabetes in May 1999. At that time, the drug was made by Smith Kline Beecham (the merger between this company and Glaxo Wellcome to form GSK did not occur until the end of 2000).
The safety and integrity of the drug soon came under scrutiny. After a GSK study in 2001 reported no significant heart problems associated with the drug, some experts called foul and said the study was flawed. This ultimately led to a legal battle that forced GSK to publish (in 2004) the details of all of its clinical trials.
Then a fire storm erupted. A study by Dr. Steven Nissen that appeared in the New England Journal of Medicine in June 2007 reported that use of Avandia increased a person’s risk of heart attack by 43 percent.
By November of that same year, the FDA ordered black box warnings on Avandia that stressed its link to congestive heart disease. A surge of lawsuits ensued by patients who used the drug and who reported side effects.
Between late 2007 and September 2010, several more studies pointed out the health dangers of Avandia, and GSK settled about 10,700 lawsuits. In addition, the US Senate Finance Committee accused GSK of pressuring doctors, hiding negative information regarding their studies, and keeping their critics quiet while still pushing sales of Avandia.
Then in September 2010, the FDA placed severe limitations on use of Avandia because of heart health risks. Those limitations meant anyone whose doctor recommended the drug had to get it through a special registry and then only from special pharmacies.
These restrictions also meant GSK suddenly lost a significant amount of money from sales in the United States. Nearly overnight, the drug that once had been the best-selling drug for type 2 diabetes on the market in the world suffered declining sales.
GSK fought long and hard to get Avandia back on the market without the strangling restrictions. That struggle cost the company billions of dollars (in July 2012, GSK admitted guilt concerning its failure to report clinical data as part of a $3 billion federal settlement) and a noticeable black eye. Also during that struggle, GSK’s patent on Avandia expired in March 2012.
The battle appears to have ended with the new FDA ruling. Now the FDA experts say a recent review of an important study of Avandia has shown that the drug presents no greater risk to the heart than do other drugs for diabetes.
Dr. Nissen does not agree. In a recent statement, he noted that “A single reanalysis of a trial does not exonerate a drug where all the other data point to increased cardiovascular risks.”
What do you think?
The side effects of Avandia are considerable. Although the FDA lifted the severe restrictions, use of the drug is still associated with a risk of heart attack and cardiovascular death as well as back pain, hyperglycemia, fatigue, upper respiratory tract infection, headache, and sinusitis.
Let’s not forget the other two drugs in the thiazolidinedione class, Rezulin (recalled in 2000 because it caused liver damage) and Actos (glitazone). The latter drug is still on the market, but it has been linked to an increased risk of developing bladder cancer and heart failure.
Avandia is one of only numerous drugs on the market for type 2 diabetes, so patients have many alternatives. In addition, anyone with the disease should seriously consider non-drug options, including dietary plans that have been shown to significantly help in the management of glucose levels and even reverse the disease in some people.
Natural remedies that can complement drug and non-drug management programs for type 2 diabetes are also options. Such remedies include but are not limited to cinnamon, bitter melon, turmeric, seaweed, baobob, and marijuana.
Now that Avandia has finally had its severe limitations removed, does it really matter to you? With so many other choices for type 2 diabetes management, does this drug even deserve a second chance?
Drug Discovery Development Nov 26, 2013
Nissen SE, Wolski K. Effect of rosiglitazone on the risk of myocaridla infarction and death from cardiovascular causes. New England Journal of Medicine 2007 Jun 14; 356(24): 2457-71