On May 21, 2010, officials from Ortho-McNeil Pharmaceuticals, a subsidiary of Johnson & Johnson, pled guilty to criminal charges related to the illegal promotion of the epilepsy drug, Topamax. Ortho-McNeil was also ordered to pay over $81 million as part of a settlement with the Federal Government. While Topamax had been approved by the Food and Drug Administration for epileptic treatment, Ortho-McNeil overstepped their bounds, and promoted the drug for a whole host of over uses ranging from the treatment of bipolar disorder to its use as a weight loss supplement. This “off-label” promotion, strictly forbidden by the FDA, resulted in widespread use of Topamax by many individuals, including women of childbearing age.
Please read on to learn more about the Topamax Drug Safety Communication and how to protect your rights:
The Topamax Warning: What is it all about?
On March 04, 2011, the Food and Drug Administration issued a “Drug Safety Communication” notifying the public of new evidence demonstrating an increased risk for the development of oral birth defects in infants born to women who took Topamax (Topiramate) during pregnancy.
FDA Drug Safety Communication: Risk of oral clefts in children born to mothers taking Topamax (topiramate)
Additional Information for Patients
Additional Information for Healthcare Professionals
Data Summary More...
The Dangers of Topamax:
The FDA warns that recently released data has shown that women who took Topamax while pregnant were 21 times more likely to give birth to an infant with oral birth defects, specifically cleft lips or cleft palates. More...
How We Can Help:
As a qualified products liability law firm, Sullo & Sullo is able to help you in several very important ways: More...