Texas pharmaceutical injury lawyers note that the weight loss drug Qnexa is coming up before the FDA for a second round of scrutiny. WebMD reports that the drug’s manufacturer has conducted an additional year of clinical trials and collected further data that it wishes to present to support approval of the drug.
Qnexa manufacturer Vivus Inc. hopes that additional data will help sway an FDA panel to approve the weight loss drug Qnexa, which it previously rejected as unsafe. The FDA panel that considered Qnexa rejected the weight loss drug as unsafe in a 10 to 6 vote. The new FDA panel will consist of 22 members, 12 of whom were on the previous panel.
Our Texas pharmaceutical injury lawyers point out that Qnexa consists of a novel combination of two currently approved drugs. One of these drugs is phentermine, an appetite suppressant that formed part of the notoriously dangerous fen-phen diet drug. The second part of the Qnexa combo is topiramate, a seizure and migraine medication with some potentially dangerous side effects.
Phentermine was the safer part of the fen-phen combination. But topiramate has been linked with a host of troubling side effects which include: suicidal thoughts and behaviors, eye problems, decreased sweating coupled with increased body temperature, acidic body fluids, and fetal toxicity. Decreased sweating cupled with increased body temperature could lead to death from the body and its organs overheating. But the FDA is primarily concerned over the safety risks of birth defects and heart problems in obese people taking the drug.
The new data from Vivus, the manufacturer, suggests that neither of these safety risks presented issues in Vivus’ follow-up study. The follow-up study documented patients who took Qnexa for a second year after already completing a one-year clinical trial. The Vivus data showed that patient weight loss slightly exceeded FDA minimum efficacy requirements for a weight loss drug without producing serious complications in these patients. Accounts regarding the study indicate that an unusual number of the patients became pregnant during the study, despite being on birth control medication. Reportedly no birth defects were seen in the clinical trial.
The FDA has stated that only a long-term study can determine whether obese people already at high risk for heart problems experience increased risks to their safety from taking Qnexa. And since there was some evidence of increased heart rate and acidic body fluids in patients taking Qnexa during the clinical trial, these side effects remain a safety concern.
But Vivus remains hopeful that its new data can overcome lingering FDA concerns over the product’s safety. Vivus hopes to market its drug to the expanding host of obese Americans looking for the next magic pill to try as a weight loss aid. The FDA panel’s decision remains in the future. But our Texas pharmaceutical injury lawyers emphasize that as yet no drug has been shown to take the place of a sensible diet, regular exercise, and self-disciplined appetite control for causing weight loss.
If you’ve suffered injury from a pharmaceutical product and you’re concerned about your eligibility to pursue fair financial compensation from the product’s manufacturer, contact us for a free and confidential legal consultation. Our Texas pharmaceutical injury lawyers could evaluate your case with you and provide advice regarding your eligibility and potential for just monetary compensation. We could help you understand your legal options and useful strategies for your compensation claim. Call us today at 877-307-9500 or use our convenient web contact form to schedule your free consultation.