The FDA has given its approval to the weight loss drug Qsymia, which was once known as Qnexa, a drug that was famously deemed unsafe because of one of the drug’s active ingredients — Topamax. The decision to approve this new drug was made by an advisory panel that voted 20 to 2 for approval. As for the drug’s name change, the FDA required Vivus, the makers of Qsymia, to change the drug’s name so that the drug couldn’t be confused with other drugs.
Qsymia is made with both phentermine (once part of the now-banned drug Fen-Phen weight loss drug) and the epilepsy drug Topamax, which lists weight loss as one of its side effects. There were some initial concerns about Qsymia’s safety which included the fear that it could cause heart problems (due to the phentermine) and birth defects in babies because of the Topamax. Topamax is known to cause birth defects including PPHN, cleft palate and spina bifida among others for babies whose mothers took the pill while pregnant. Because of those side effects, the most recent panel voted to approve Qsymia only if Vivus agreed to post the warnings of these side effects on their labels and properly warn doctors how to prescribe them. These side effects initially led a different panel refuse to approve the drug.
With the risk-to-benefit ratio being so iffy with Topamax and phentermine, Qsymia may prove to be too dangerous to take in the long run. This fact could result in the drug makers being sued. The drug may also find itself in the same position as previous weight loss drugs like Fen-Phen in that it may be banned from use altogether.
If your baby was born with any of these birth defects after being exposed to Topamax during gestation, contact Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your baby’s injuries.