Johnson & Johnson ‘s Ortho-McNeil Nuerologics and Noramco divisions manufacture a class of drugs knows as “anticonvulsants” which have come under recent scrutiny. Recent evidence suggests Johnson & Johnson’s anti-seizure medication Topomax may increase the risk of birth defects for pregnant women. This particular drug is also sold to the public under the generic name of “Topiramate”.
Side Effects and Uses of Topomax
Topomax was approved by the FDA to treat epilepsy in 1996, and subsequently approved in 2004 for the additional use as a preventative migraine headache treatment. In addition, Topomax, or topiramate, is often prescribed for various psychiatric conditions including:
- nicotine addiction
- eating disorders
- borderline personality disorder
- Seizure in adults
The most reported and common side effects of the topiramate chemical included:
- birth defects
- weight loss
- upper respiratory infections
- tingling in arms and legs
- loss of appetite
- taste change
- kidney stones or kidney disease
- decreased concentration
The above side effects are the most commonly reported and are not a comprehensive list of all known side effects. If you have recently taken Topomax, it is extremely important to contact your physician to determine if the recall applies to you.
Topomax Linked to Birth Defects
In March of 2011, the FDA warned the public through a Drug Safety Alert which advised taking Topomax during pregnancies increased the risk of birth defects know as “cleft palate” and “oral clefts” in infants. Through the research of North American Antiepileptic Drug Pregnancy Registry and the UK Epilepsy and Pregnancy Register, the FDA placed topiramate in the FDA’s Pregnancy Category D. The FDA’s Pregnancy Category D warns the public that there is “positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite risk”.
In April of 2011, FDA mandated Ortho-McNeil to recall approximately 57,000 bottles of Topomax. The recall came after numerous consumer complaints of unusual odors coming out of the Topomax bottles. According to the manufactures, the odors were thought to be caused by a chemical byproduct known as TBA. According to Ortho-McNeil, TBA is thought to be associated with the wood pallets on which the Topomax is transported. Johnson & Johnson again is seeking to escape responsibility for their harmful products.
This is another classic example of the large pharmaceutical companies placing monetary interests ahead of their consumers. Instead of spending the appropriate time researching and developing these drugs, Johnson & Johnson has again shown that they are more concerned with corporate profits than the public safety. (See Johnson & Johnson’s Depuy hip replacement recall) If you or a loved one has been injured as a result of Topomax, or other generic forms of topiramate, contact a pharmaceutical litigation attorney today. You have the right to seek reimbursement for all of your harms and losses caused by the negligent introduction of harmful drugs.
Call Topomax lawyer Chris Dixon today to discuss your rights at 314.409.7060, or toll-free at 855.402.7274.