Following the FDA's Oral Cleft Warning on Topamax, CJF Launched an Educational Resource for Mothers
Submitted by: Consumer Justice Foundation
The Consumer Justice Foundation (CJF) has launched an educational resource for mothers in response to the FDA's recent oral cleft warning regarding Topamax. Topamax is an anticonvulsant drug frequently prescribed to women suffering from epilepsy or migraine headaches. For more information about the pregnancy risks of Topamax, visit www.TopamaxBirthInjury.com, a free resource for American consumers provided by the CJF.
(OPENPRESS) July 28, 2011 -- Following the FDA's new safety announcement concerning the link between Topamax and oral cleft birth defects, the Consumer Justice Foundation has developed an educational resource to provide mothers with more information about Topamax birth defects. According to this recent FDA action, there is an increased risk of oral clefts like cleft lip and cleft palate among infants whose mothers take Topamax while pregnant (fda.gov). After reviewing new Topamax birth defect data, the FDA has also elevated the pregnancy category of Topamax from C to D, which means there is positive human evidence of the drug's potential to cause serious harm to a fetus when taken during pregnancy (fda.gov).
Topamax is a prescription anticonvulsant drug, currently manufactured by Ortho-McNeil Pharmaceutical, a division of pharmaceutical giant Johnson & Johnson. Although anticonvulsant drugs were originally designed to treat epilepsy specifically, many of these medications have been indicated for additional purposes in recent years. The FDA approved Topamax, for example, in 1996 for the treatment of epilepsy, and again in 2004 for the prevention of migraine headaches. Since its introduction to the U.S. market, Topamax has become one of the most commonly prescribed anticonvulsants available.
The March 2011 notice issued by the FDA was influenced largely by data collected by the North American Antiepileptic Drug (NAAED) Pregnancy Registry. According to this information, infants whose mothers took Topamax in early pregnancy were a shocking twenty times more likely to develop oral clefts like cleft lip and cleft palate than infants whose mothers received no anticonvulsant treatment (fda.gov). Another study published in the journal Neurology in 2008 indicated that infants exposed to Topamax in utero were eleven times more likely to be born with oral clefts, and fourteen times more likely to be born with genital defects like hypospadias, compared to the expected rate among the general population (Topiramate in pregnancy: Preliminary experience from the UK Epilepsy and Pregnancy Register).
Cleft lip and cleft palate occur when a child's oral structures fail to develop properly in utero. Cleft lip is characterized by a vertical fissure in the upper lip which may extend up through the nose. Cleft palate can vary in severity from a small opening at the back of the mouth to a nearly complete separation of the roof of the mouth. Children born with cleft lip or cleft palate may struggle with severe side effects like feeding difficulties, recurring ear infections, dental problems, hearing loss, and delays in speech and language development.
Due to the potential for Topamax side effects to cause serious fetal harm, the FDA has advised physicians to consider all benefits and risks of Topamax before prescribing the drug to women of childbearing age, especially for conditions not usually associated with permanent injury or death (fda.gov). Most birth defects occur during the first trimester of pregnancy, before many women are even aware they are pregnant. Because of this risk, the FDA suggests that alternative medications associated with a lower risk of birth defects be considered in treating women of childbearing age (fda.gov).
It is important for mothers to be aware of the pregnancy risks of pharmaceutical drugs like Topamax in order to protect themselves and their children from unnecessary harm. In order to adequately inform mothers of the birth defects potentially associated with Topamax, and to connect injured consumers to professionals who can help, the Consumer Justice Foundation has launched www.TopamaxBirthInjury.com, an educational resource consisting of critical information about the dangers of certain pharmaceutical drugs and Topamax lawsuits for those who have been injured.