Qnexa was originally rejected in 2010 due to concerns that it caused “suicidal thoughts, heart palpitations, memory lapses and birth defects. Now, Vivus has re-submitted the very same drug again for approval.”
Red Bank, New Jersey (PRWEB) March 06, 2012
According to Public Citizen, “Qnexa (a combination of phentermine, an amphetamine, and topiramate, an anti-seizure medication), causes increased heart rate and may lead to severe cardiovascular problems, such as heart attacks and arrhythmias, as well as birth defects, kidney stones, decreased bone mineral density and memory impairment.”
The FDA rejected Qnexa, manufactured by Vivus, when it was first up for approval in 2010 because of concerns about the risk of birth defects, including cleft palate (due to the topiramate component) and about cardiovascular risks from phentermine.
Rayna E. Kessler, associate attorney at the law firm of Cohen, Placitella & Roth, posted a response to this on the Cohen, Placitella & Roth blog stating, “In recent years, The Food and Drug Administration already rejected three weight loss drugs, including Vivus' pill, Qnexa, and Arena's Lorcaserin. Qnexa is a combination of two older drugs one of which is the same drug that was in Wyeth's dangerous fen-phen. Qnexa was originally rejected in 2010 due to concerns that it caused “suicidal thoughts, heart palpitations, memory lapses and birth defects. Now, Vivus has re-submitted the very same drug again for approval.”
“Some believe the FDA may be reacting to pressure from Congress to support new weight loss drug treatments. If this is true, the FDA should be reminded that the risks to public health with releasing a drug that affects the cardiovascular system of potentially millions of users should weigh equally in the drug approval process. The health of consumers depends on an impartial and effective pharmaceutical regulatory system.”
About Rayna E. Kessler
Rayna E. Kessler is an associate with the law firm of Cohen, Placitella & Roth PC, and focuses her practice on product liability, catastrophic personal injury, medical device litigation, and pharmaceutical litigation.
About Cohen, Placitella & Roth, PC
Cohen, Placitella & Roth, P.C., is a nationally recognized law firm concentrating on representing injured parties in a wide array of complex litigation matters such as product liability, personal injury/wrongful death, defective products, securities fraud, unfair and deceptive business acts. The firm's achievements include obtaining record high settlements and verdicts on behalf of clients. To learn more, please visit http://www.cprlaw.com or call 1-888-375-7600.