FDA Forces Vivus to Update Qnexa Labels to Include Birth Defects Risks Linked to Topamirate

In light of the information that one of weight loss drug Qnexa’s primary ingredients causes birth defects in babies whose mothers take the drug while pregnant, the FDA has ordered Vivus, the maker of the drug, to update its warnings labels.

The new warning labels are to reflect Qnexa’s links to birth defects which are caused by one of the drug’s primary ingredients, topiramate. Topiramate (also called Topamax) is an epileptic medication that is also used to treat migraines. One of the drug’s side effects is weight loss, which is what Qnexa is used for. Once studies revealed that Topamax side effects are shared by Qnexa patients, the FDA decided to intervene. For its part, the FDA told Vivus to “remove a contraindication stating the drug’s risks outweighed possible benefits for women of childbearing potential.” The FDA is planning on convening an advisory panel to review Qnexa on Feb. 22, with a decision about the fate of the drug to be revealed by April 17.

This label change could cause Qnexa to be removed from the shelves after the advisory panel meets. Steve Yoo, an analyst with Leerink Swann & Co., said “They’re changing things in mid-process. Anytime you change things in mid-process, the timelines can be pushed out.”

While topiramate (Topamax) is known to cause birth defects like oral clefts, the preliminary earlier testing conducted by Vivus states that it “found five oral clefts in the group of 1,740 children whose mothers had taken topiramate alone in the first trimester of pregnancy, for a prevalence rate of 0.29 percent. That compared with a rate of 0.16 percent in the group whose mothers had taken anti-seizure drugs, including topiramate, before pregnancy.”

The final results of this study are not expected until later on this year, says Yoo. The fact that Qnexa patients will experience the same adverse side effects as Topamax patients is not surprising; however, Topamax birth defects has caused numerous lawsuits to be filed on behalf of the victims. Some of the birth defects linked to Topamax use by mothers during gestation include oral clefts, PPHN and heart, brain and lung defects.

If your baby was born with a birth defect after the mother used Topamax during pregnancy, contact attorney 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 injuries.

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