Topamax Blamed for Causing Birth Defects
Topamax Linked to Cleft Lip and Cleft Palate
Originally the product of Ortho-McNeil, Johnson & Johnson gained rights to the drug with its acquisition of Ortho-McNeil which now exists as a Johnson & Johnson subsidiary in combination with Janssen Pharmaceuticals.
According to Bloomberg, Johnson & Johnson is currently facing 63 cases in connection with Topamax alleging that the company failed to warn expectant mothers of potential adverse effects including cleft lip and cleft palate.
Attorneys representing April Czimmer, whose 6-year-old son has undergone 4 surgeries to due to birth defects, claim that Johnson & Johnson knew of the birth defect risks associated with Topamax as early as 2002, but did not address them until 2011 when the FDA ordered the drug carry a stronger label.
Criminal Cases and Off-Label Use
Ms. Czimmer has stated that she could have gone without Topamax for the months she was pregnant as she had been prescribed the drug for the treatment of migraines, and does not have a history of epileptic seizures.
Approved for the treatment of epileptic seizures in 1996, Bloomberg reports that the drug was also prescribed for a number of off label uses including:
- Sleep apnea
- Cluster headaches
- Anxiety disorders
- Weight loss
- Substance abuse
The article also alludes to a program called ‘Doctor for a Day’ in which doctors were hired by Johnson & Johnson to accompany sale representatives as they pushed the off-label use of the drug.
These and similar actions resulted in Johnson and Johnson facing a number of criminal and civil cases alleging the illegal promotion of Topamax. The company paid $81 million in April 2010 to resolve all criminal and civil complaints.
Ortho-McNeil admitted to illegally marketing Topamax a month later and was charged with the selling of a misbranded drug.
Other Adverse Events Linked to Topamax
DrugCite.com also lists reports of adverse effects tied to Topamax including:
- Trouple breathing
- Memory impairment
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