Most of us know that our country is in the grips of an obesity epidemic. Doctor recommended diet and exercise programs have not controlled the problem, so pharmaceutical companies are hard at work coming up with other solutions. Last month, the FDA approved Belviq (lorcaserin) as a weight-loss drug for those with a body mass index (BMI) of 30 or greater. More recently, the FDA approved Qsymia (phentermine and topiramate extended-release) for chronic weight management in addition to a reduced-calorie diet and exercise.
These drugs come with potentially serious side effects, and it seems like once again the public is taking part in a giant experiment. For example, federal officials are requiring post-marketing studies to look for evidence of increased heart disease or stroke risk in those who take Qsymia.
Concerns About Cardiovascular Risks
It was only about a year-and-a-half ago that the FDA rejected manufacturer Vivus’ first petition to approve Qsymia (pronounced kyoo sim EE uh). Among other things, the agency was concerned that the drug could increase the risk of heart attack and stroke. The FDA rejected Belviq in an earlier request for approval because of similar concerns.
Experts believe the agency has changed their position because of new data presented by the manufacturers, but also because of the ever-increasing health dangers associated with obesity. According to the Centers for Disease Control and Prevention, more than one-third of U.S. adults are obese, which can lead to heart disease, stroke, type 2 diabetes, and certain types of cancer.
In pre-approval studies, patients taking Qsymia who also made lifestyle changes lost an average of about 10 percent of their body weight after one year. Studies showed no evidence of increased cardiovascular risks. Critics note, however, that a similar drug, Fen-Phen, combined phentermine (an appetite suppressant) with fenfluramine, and was later taken off the market because of links to heart valve problems.
Concerns About Birth Defects
This time, the drug combines phentermine with topiramate, also known as Topamax, a drug currently prescribed to help control epileptic seizures and migraine headaches. In early 2011, the FDA warned that taking Topamax during pregnancy increases the risk of oral cleft birth defects such as cleft lip and palate. An analysis of the data shows that the risk is up to 16 times higher among women who take the drug than those who do not.
Many feel the warning came late, particularly women who took the drug in years past without the knowledge of the risks and gave birth to babies with birth defects. Hundreds of Topamax lawsuits were filed before awareness increased on the issue, but now the FDA has changed the classification from category C to category D risk, reflecting human data that confirms the fetal risk.
The FDA warns that women of childbearing age should have a negative pregnancy test before taking Qsymia, and then repeat the test every month while using the drug. They also suggest patients start on a middle dose, avoiding the high dose unless absolutely necessary, and have their heart rates regularly monitored.
National Public Experiment?
Anyone deciding to try these drugs may become part of a national experiment. The FDA states in their press release that Qsymia can increase heart rate, and that its effect on patients at high risk for heart attack or stroke is not known. Obesity, by its very nature, also increases the risk of cardiovascular disease making this a potentially dangerous experiment.
The FDA has required Vivus Inc. to conduct 10 post-marketing requirements, including a long-term cardiovascular trial to assess the effects of Qsymia on the risk for major cardiac events, such as heart attack and stroke. What this means is that the risks associated with Qsymia are unknown and the public is being used to find them out.
The FDA believes the fight against obesity requires drugs like these, despite the risks. The good news is that they are requiring manufacturers to provide warnings. Let us hope the doctors point them out very clearly to patients, or we are likely to see another wave of lawsuits in the next few years.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
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