January 27, 2012
/24-7PressRelease/ -- An Ingredient in Medication Taken by Women is Causing Birth Defects
It is such an exciting time -- preparing for the birth of a child. An expecting mother carefully monitors what she eats and drinks in order to maximize the health of the child growing inside of her. She prepares the nursery, engages in a safe level of exercise and sees her doctor on a regular basis, all with the hopes of delivering a healthy, bouncing baby. Unfortunately, a medication she took prior to her pregnancy or during the first trimester of her pregnancy could produce devastating side effects on her unborn child.
Topiramate -- brand name Topamax -- is an ingredient in a number of drugs used to treat the following conditions:
-Seizures
-Epilepsy
-Migraine headaches
-Weight loss
-Bipolar disorder
-Post-traumatic stress syndrome (clinical trials only)
In the 1990s, the FDA approved Topamax as an anticonvulsant (anti-seizure) medication and for treatment of migraine headaches. However, in 2008, a medical study came out showing that women who took the drug before or during pregnancy had a greatly increased risk of having children with birth defects. In 2011, the FDA issued a medication guide stating that Topamax can harm an unborn baby, creating a high risk for the following defects:
-Cleft palette
-Cleft lip
-Metabolic acidosis -- producing too much acid in the body
-Other oral deformities, malformations and craniofacial defects
Despite the warnings, Topamax continues to be used as an ingredient in a number of drugs. Most recently, experimental weight-loss pill Qnexa has been developed with Topamax as a main ingredient. The FDA required Vivus Inc., the maker of the drug, to analyze existing database information to determine the risk of oral cleft in children whose mothers took Topamax during or prior to their pregnancies. The analysis revealed that the risk is higher, especially for those women who take the drug during the initial stages of pregnancy, including those who do not yet know they are pregnant.
Despite the increased risk, should the FDA approve the drug early this year, the maker of the drug will not be required to include warnings for all women capable of becoming pregnant but only warn those who already are.
If you have taken Topamax and are concerned about its side effects, or if you have a child with an oral deformity or malformation, consult with a lawyer knowledgeable about birth defects and dangerous drugs.
Article provided by Miller Weisbrod, L.L.P.
Visit us at http://www.badpharmalawyer.com/
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