Approved by the U.S. Food and Drug Administration on July 17, 2012, the “chronic weight management” medication Qsymia was introduced with a medication guide partially intended to “educate prescribers and their patients about the increased risk of birth defects associated with first trimester exposure.” That warning traveled with one of the drug’s ingredients, topiramate.
The precaution was not necessarily the downer which, at first blush, it might have seemed.
Here was the reason. The FDA in March 2011 OKd revised prescribing information for Topamax, the topiramate brand-name antiepileptic that also has been used to treat migraines in adults. Unfortunately, the new information about the Topamax birth defects risk came out nearly 15 years after the administration approved Topamax tablets. At least women who wanted to take the weight-loss pill while they were pregnant or potentially could become pregnant knew about the increased gestational risks from the very beginning, not 15 years into the drug’s existence.
Patients today are informed, according to the September 2012 FDA-approved Topamax medication guide, “If you take Topamax during pregnancy, your baby has a higher risk for birth defects called cleft lip and cleft palate. These defects can begin early in pregnancy, even before you know you are pregnant.”
Another Topamax guide reads, in part, “When appropriate, prescribers should counsel pregnant women and women of childbearing potential about alternative therapeutic options.”
Millions of patients have taken Topamax, too many prior to the posting of warnings. Think of all the women who for nearly a generation did not know about Topamax side effects.
This sort of warning should not have slipped through the safety wicket, plaintiffs in Topamax lawsuits would argue through counsel. It took some years for women to learn about risks that perhaps more meticulous experimentation might have uncovered in the 1990s or right after the turn of the century, if not pre-market. Topamax lawsuits are based on, among other issues, the assertion that the manufacturer, Janssen, should have known and should have warned a lot sooner about the incompatibility of pregnancy and Topamax.
The compensation that Topamax victims deserve is not readily handed on a silver platter. Anyone who believes that his or her child’s birth defects may be traced to the use of Topamax should contact an attorney with specialized skill in pharmaceutical injury litigation, such as the personal injury attorneys at Reich & Binstock [www.reichandbinstock.com]. They represent plaintiffs in Topamax lawsuits who would have been able to avoid the increased risk of birth defects associated with Topamax had they been properly informed of the unreasonable risk.
It costs nothing to determine whether there is an entitlement to compensation. For a free consultation, someone in any state may contact one of the experienced Topamax attorneys at Reich & Binstock toll-free at 1-866-LAW-2400.