Topamax News
Depakote maker enters into settlement negotiations with prosecutors
The manufacturer of the epilepsy drug Depakote have entered into talks with the U.S. Justice Department to settle claims that it illegally promoted the medication for off-label prescription. Federal prosecutors have asked a judge in Virginia to postpone a July trial deadline in the case to allow for time to negotiate a settlement deal with Abbott Laboratories regarding Depakote. More »
Topamax recall issued over possible contamination
The manufacturers of Topamax have issued a recall for two lots of the drug due to a risk of possible contamination. About 57,000 bottles of Topamax that were manufactured between October and December 2010 were recalled after the company received multiple reports of an offensive odor that may be caused by contamination with the chemical TBA. More »
Analysis of FDA data reveals further evidence of Topamax related birth defects
Approximately 47% of Topamax related adverse event reports involving toddlers indicate serious birth defects which may be linked to use of the drug, according to data provided by the FDA’s Adverse Event Report database. The FDA has warned that using Topamax during pregnancy increases the risk of certain birth defects by as much as 21 fold. More »
Topamax Birth Defects Victims May be Eligible to File a Lawsuit, Says Hissey Kientz, LLP
The families of children whose mothers took the drug Topamax or Topiragen during pregnancy and gave birth to a child with cleft palate, cleft lip, spina bifida or other limb and facial birth defects may be eligible to file a lawsuit, according to the law firm of Hissey Kientz, LLP. Topamax is prescribed for the treatment of seizure in patients with epilepsy or for migraines. More »
FDA issues Topamax warning over new birth defects data
The Food and Drug Administration has warned that women who use the migraine and epilepsy drug Topamax while pregnant may be more likely to give birth to a child with a cleft lip, cleft palate or other birth defects. Based on new data about the risk of Topamax birth defects, the FDA upgraded the drug to Pregnancy Category D, meaning that the drug has a proven risk of birth defects. More »
J&J subsidiaries agree to $81M settlement in Topamax lawsuits
Two subsidiaries of Johnson & Johnson have agreed to pay more than $81 million to settle lawsuits that they promoted the migraine and epilepsy drug Topamax for off-label uses. The companies of marketing Topamax to treat conditions such as alcohol dependency and weight loss—neither of which it was approved to treat by the Food and Drug Administration—and for paying doctors to promote the drug to their colleagues. More »