Help may be coming to some families that were affected by birth defects after taking a commonly prescribed medication known as Topamax. And, I am certain it can not come soon enough for some!
In recent news, all Topamax lawsuits filed in Pennsylvania state court are now centralized in Philadelphia for pretrial proceedings. The Pennsylvania state court litigation was centralized in the Philadelphia Court of Common Pleas on September 16. The lawsuits have been by families who claim that use of the epilepsy and migraine medication during pregnancy caused their children to be born with severe birth defects.
The complaints all involve similar allegations that Ortho-McNeil Neurologics, a subsidiary of Johnson & Johnson, failed to properly research the pregnancy risks associated with their medication or adequately warn about the risk of birth defects from Topamax, such as cleft lip, cleft palate, genital malformations and other problems.
Topamax, known generically as topiramate, was first introduced in 1979 by McNeil Pharmaceutical, a division of Johnson & Johnson. It was approved by the FDA in 2004 for the treatment of epilepsy and later was also approved to treat migraines. It became available as a generic in September 2006. It is also often prescribed off-label to treat bipolar disorder.
Research has linked side effects of Topamax to a risk of cleft lip and cleft palate, a class of birth defects known as oral cleft defects. Use of the medication during the first trimester, before many women even know they are pregnant, may cause these serious and potentially debilitating malformations and birth defects from Topamax.
Therefore in March 2011, the FDA issued a warning concerning these defects. The FDA also urged doctors to avoid giving Topamax to pregnant women or women who are of child-bearing age and at a high risk of pregnancy.
Cleft palate and cleft lip occur when parts of the lip or palate fail to completely fuse together. The defect results in the child being born with defects as small as a notched lip to extreme as an open groove that goes from the roof of the mouth to the nose. Cleft palate and cleft lip can cause problems eating and talking and can increase the risk of ear infections, resulting in the need for corrective surgery.
In 2008, a study published in the medical journal Neurology found that a higher-than-expected number of pregnant women treated with Topamax gave birth to babies with cleft lips, cleft palates, genital defects or other birth malformations. Although the study identifying a potential risk was small, only involving 178 babies, the rate of birth defects was 11 times higher than would be expected in the general population.
Topamax lawyers say that manufacturers of the medication knew or should have known about the potential risk of Topamax problems for unborn children, yet failed to adequately research the side effects of topiramate or warn about the risk of a cleft lip or cleft palate from Topamax.
If proper warnings had been provided, women who were planning to become pregnant or those not practicing birth control may have been able to take a different medication during pregnancy, as not all epilepsy drugs have the same risk of birth defects as Topamax.
Although only a small number of cases have been filed so far, several Topamax birth defect lawyers are investigating and reviewing potential claims for children born with birth malformations or defects after the mother was given the medication during pregnancy.
The FDA estimates that approximately 32.3 million prescriptions for Topamax or a generic equivalent were issued from January 2007 through December 2010. In many cases the drug is prescribed for off-label uses.