Topamax (topiramate) is an anticonvulsant drug. It has received approval from the U.S. Food and Drug Administration (FDA) to treat epilepsy and migraine headaches. The manufacturer is Janssen Pharmaceuticals, a subsidiary of manufacturing giant Johnson & Johnson. Topiramate is a widely used anticonvulsant drug. It dominates more than 20 percent of the epilepsy drug market.
Topamax grew to become a blockbuster drug. In 2008, Topamax sales peaked at $2.7 billion for Johnson & Johnson. When the generic version of topiramate was released in 2009, sales plummeted to $148 million. In 2010, Topamax manufacturers paid more than $80 million in fines and penalties for illegally marketing the drug. Recently, a number of Topamax lawsuits have surfaced from women who claim that Topamax treatment caused their children to be born with debilitating birth defects.
Topamax Lawsuit – Birth Defects
In 2011, the FDA issued a warning for Topamax users. Research was published that compared pregnant women who took Topamax during their first trimester and those who did not. The results indicated that comparatively, pregnant Topamax users experienced a 21-fold increase in oral cleft defects in their children. The FDA assigns a pregnancy category to illustrate pregnancy safety of certain prescription drugs. Topamax has received a D classification. This means that sufficient evidence exists to prove that the drug can cause harm to developing human embryos.
A similar study was conducted on pregnant women who took Topamax versus other seizure medications. The results showed that the risk of oral defects was three times higher for women who took Topamax. In addition to oral defects, Topamax may also cause birth defects such as malformations of the lungs, heart, and limbs. Some users have reported incidences of neural tube defects such as spina bifida, a condition during which the embryonic neural tube does not completely close.
Illegal Topamax Marketing
In April 2010, Topamax manufacturers agreed to pay more than $81 million for illegal marketing of Topamax. Manufacturers admitted to marketing the drug for unapproved psychiatric uses under a program called Doctor-for-a-Day. Doctor-for-a-Day hired third party doctors to join the company’s sales representatives. Together, the doctors and representatives visited healthcare providers and spoke publicly about prescribing the drug for unapproved uses.
Topamax Lawsuit Claims
Topamax lawsuit plaintiffs allege that Janssen Pharmaceuticals failed to provide consumers with an adequate warning of the drug’s dangers. By failing to do so, the company breached its legal duty and acted negligently in protecting its consumers. Topamax lawsuit plaintiffs also allege that they were deprived of the ability to protect themselves from Topamax side effects when the company failed to give warning. If Topamax patients had been warned of the dangers to their children, they would have been able to consider opting for other, safer epilepsy and migraine treatment.
Filing a Topamax Lawsuit
A number of Topamax lawsuits were filed in a Philadelphia state court in late 2011. The plaintiffs of these Topamax lawsuits allege that taking the drug during their pregnancy directly contributed to birth defects in their children. More Topamax lawsuits are expected to follow, as it is believed that many more people suffered unnecessary harm from Topamax treatment. In many cases, Topamax birth defects can prove costly in financial, physical, and emotional terms.
Women who believe that their child’s birth defects were caused by Topamax treatment may be eligible to file a Topamax lawsuit against Janssen Pharmaceuticals and Johnson & Johnson. Those who wish to pursue a Topamax lawsuit should speak with an experienced attorney immediately to have their Topamax lawsuit questions answered. An attorney can help discuss the specifics of each plaintiff’s case and advise legal options for pursuing a Topamax lawsuit.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.