Thursday, May 5, 2011

Topamax Under Scrutiny By FDA

Topamax was first approved in 1998 by the FDA for the treatment of seizures due to epilepsy. The drug is also referred to by the generic name Topiramate. In 2004, it was also approved for treating migraine headaches. It has been increasingly reported that Topamax has been linked to serious birth defects such as cleft palate/cleft lip. On March 4 of this year, the FDA required the manufacturers of Topamax to significantly strengthen warnings for the drug because of increasing data linking the product to certain types of birth defects including cleft lip/cleft palate and genital malformations including Hypospadias.

It appears that the greatest risk to the unborn baby comes from exposure to the drug during the first trimester of the pregnancy. During this extremely important developmental period, the mother may or may not know that she is pregnant. Therefore, it is not just women who know they are pregnant that are risk, but any woman of childbearing age taking Topamax. One study shows that expecting mothers on Topamax are 21.3 times more likely to give birth to infants with oral birth defects compared to the risk in a background population of untreated women.

Topamax is manufactured by Ortho-McNeil Pharmaceutical LLC, a subsidiary of Johnson & Johnson. From January 2007 through December 2010, approximately 32.3 million Topamax prescriptions were filled for over 4 million people in the United States. 

Johnson and Johnson has had a staggering number of recalled products in the last year and a half, notably the DePuy ASR Hip device recalled in the fall of 2010. In fact in April of 2011, Johnson & Johnson  recalled close to 57,000 bottles of Topamax because of complaints of an odor. This odor is believed to be caused by trace amounts of a chemical used to preserve the wooden pallets used in storage -- that's the same cause that prompted massive recalls of Tylenol and other over-the-counter medications at McNeil Consumer Healthcare.
In March of 2010, Ortho-McNeil pled guilty and paid $6.14 million in criminal fines for the misbranding of Topamax. Ortho-McNeil also paid an additional $75.37 million to resolve civil allegations (mostly reimbursement for fraudulent Medicare claims). The U.S. government said that Ortho-McNeil promoted Topamax by hiring doctors to join sales representatives in promoting Topamax for unapproved uses in unapproved doses for medical indications not covered by those programs. Reports indicate they promoted the drug as a way to help with weight loss and pain. The federal share of the civil settlement is $50,688,483.52, and the state Medicaid share of the civil settlement is $24,681,516.48.

Our firm is currently investigating claims for those people who have been injured by Topamax. If you would like a free case evaluation, please contact Chris Hellums at toll free 1-866-515-8880 or at