Antiseizure MedicationsNeurontin (gabapentin) was approved by the FDA in 1994 as an adjuvant medication (effective when used in combination with other drugs) to control partial seizures. In 2002, the FDA also approved Neurontin to treat the neuropathic pain following shingles. Like other antiepileptic drugs, Neurontin may cause suicidal thoughts or actions in a small number of people (about 1 in 500).
A number of individual lawsuits have been filed in federal and state courts alleging suicide, attempted suicide and other personal injuries as a result of use of Neurontin. Some of the federal actions have been transferred for consolidated pretrial proceedings to the multidistrict litigation (MDL) in the U.S. District Court for the District of Massachusetts (In re Neurontin Marketing, Sales Practice and Product Liability Litigation, MDL-1629). [1] FDA Medication Guide, Neurontin (05/01/2013). Topamax (topiramate) was approved by the FDA in 1997 for the treatment of epilepsy and to prevent migraines in adults and adolescents. Topamax is sold by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson (J&J).
In April 2010, J&J paid $81 million to resolve criminal and civil cases over the illegal promotion of Topamax. A month later, one of J&J's units admitted that it illegally marketed Topamax and pled guilty to a misdemeanor charge of selling a misbranded drug. According to court documents, J&J illegally promoted Topamax for off-label uses including bipolar disorder and drug and alcohol dependence. US v. Ortho-McNeil Pharmaceutical LLC, 10 CR-10147, U.S. District Court, District of Massachusetts (Boston). The company hired physicians through its "Doctor-for-a-Day" program to join sales representatives in speaking to other doctors about the unapproved uses and doses. With mounting evidence of birth defects, in 2011, the FDA issued a warning that topiramate (Topamax and generic products) increases the risk for the development of cleft lip and/or cleft palate in infants born to women treated with topiramate during pregnancy. The FDA also reclassified Topamax as a Pregnancy Category D, which means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations. Since then, more lawsuits have been filed against Janssen, many of which are consolidated in a Pennsylvania state proceeding, In Re Topamax Litigation, 110602131, Court of Common Pleas, Philadelphia County. In these cases plaintiffs allege that Topamax caused birth defects including cleft palettes in children born to pregnant women taking the epilepsy drug. The defects can lead to ear infections, problems with eating and talking, and often require surgery to correct. Janssen has defended against the state lawsuits by claiming that the FDA-approved prescribing information adequately set forth warnings and precautions associated with its use. However, over the last two years, three bellwether (test) trials in Pennsylvania have resulted in multi-million dollar awards of $4 million in October 2013, $11 million in November 2013, and $3 million in March 2014. Following these awards, in April 2014, Janssen reached an agreement to settle 76 lawsuits. About 60 lawsuits remain pending in the Pennsylvania state court. [1] Voreacos, D. J&J to Pay $81 Million, End U.S. Cases on Unauthorized Use of Topamax," Bloomberg News, Apr. 29, 2010. [2] FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate), March 4, 2011. [3] Pearson, S. "Janssen's Topamax Users Blame Drug for Birth Defects," Bloomberg News, Oct. 15, 2013. Alerts |
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