Weight-loss Drugs and FDA Recalls
We hear too many stories about pharmaceuticals and medical devices that end up doing more harm than good to patients who are seeking treatment for a disease or illness. Serious injuries and deaths happen when companies place profits ahead of patients. Just last year the FDA approved two new drugs to fight obesity: Belviq and Qsymia. While we hope these drugs are able to produce good results for the patients who need them, we am skeptical about the performance of weight-loss drugs based on the number of FDA recalls in the past.
Recent news about these weight-loss drugs reports that sales of Qsymia have not performed as well as the manufacturer had hoped. Belviq is currently waiting for the U.S. Drug Enforcement Agency to classify it as a controlled substance. Once the classification is complete, Belviq will be in U.S. pharmacies.
A new FDA recall in the weight-loss industry caught my attention. Recently, the FDA recalled the weight-loss product– Maxiloss Weight Advanced softgels. This recall gave me that all too familiar concern about product liability and consumer safety.
This FDA recall is a little different than other drug recalls. First, Maxiloss Weight Advanced Softgel product is classified as a dietary supplement rather than a drug. This means that it is not subject to FDA approval. However, the FDA does have some regulatory function over supplements and does require that manufacturers of dietary supplements disclose all ingredients of the product on its label.
In February, the FDA discovered that the Maxiloss Weight Advanced product contained the ingredient Sibutramine, which was not on its label. This ingredient is considered a drug which is classified as a controlled substance. Sibutramine had previously been used to treat obesity until it was removed from the U.S. market in October 2010 for safety reasons. Sibutramine has been known to substantially increase blood pressure and may pose a serious risk to patients with a history of coronary heart disease, congestive heart failure, arrhythmias and stroke.
The Maxiloss Weight Advanced product has been on the market since January 2011 and has now been recalled due to a safety risk to consumers. It is my hope that the new weight-loss drugs, Belviq and Qsymia, do not follow a similar pattern of being found to cause more harm than good to a patient’s health.
Belviq is an entirely new weight-loss drug. It acts as an appetite suppressant by using serotonin receptors in the brain to allow users to feel full after smaller meals. The FDA approved this drug in conjunction with diet and exercise to treat obesity last summer. Once the U.S. Drug Enforcement Agency classifies Belviq as a controlled substance, the manufacturer will be ready to market this drug. This should happen in early 2013.
Qsymia is another weight loss drug that also earned FDA approval last year. Qsymia is a combination of two already approved drugs, phentermine and topimirate. Phentermine was part of the fen-phen diet combo that was found to cause heart problems in patients and taken off the market in the late 1990s.Phentermine is a stimulant that suppresses appetite, while topimirate is an anticonvulsant that is used to treat epilepsy.
The obesity epidemic in the U.S. poses a very serious concern for health care providers. Lifestyle changes involving diet and exercise can go a long way in curbing this problem. Drug manufacturers continue to scramble to find a “miracle pill” that will help patients lose weight in an effort to better their health. While a “miracle pill” sounds like a good idea, it’s important to remember that anytime you ingest a chemical into your body there is the potential for side effects to occur. Drug manufacturers need to be vigilant in conducting efficacy and safety tests to protect consumers and not put profits ahead of people.
People who have been injured by dangerous drugs or defective medical devices should contact a product liability/personal injury attorney to discuss their legal rights and options in obtaining compensation for their injuries.