oral-facial deformities such as cleft lip and cleft palate may be linked to the use of Topamax during pregnancy
(Vocus/PRWEB) April 12, 2011
On March 29, 2011 the Wall Street Journal covered the growing concern surrounding birth defects related to prescription medications taken by women during pregnancy. The article, entitiled “Can Mom’s Medicine Hurt The Baby?” examines the history of drug approval in the United States, as well as the lack of appropriate measures to determine dangers to pregnant women and unborn children (Can Mom's Medicine Hurt the Baby, March 29, 2011, Wall Street Journal).
The article was spurred by the fact that in March of 2011, the FDA released a new MedAlert Safety Update regarding the pregnancy category classification of the popular migraine drug Topamax (also known as Topiragen or topiramate). (Topamax (topiramate): Label Change - Risk For Development of Cleft Lip and/or Cleft Palate in Newborns, March 4, 2011, fda.gov). This alert followed a troubling February 2011 annoucement that certain antipsychotic drugs including Haldol, Zyprexa, Seroquel and Abilify, could cause significant withdrawal symptoms after birth if a child is exposed en uteri. (Antipsychotic Drugs Used During Pregnancy Could Harm Newborn, February 2011, fda.gov).
A drug classification change for Topamax means that the drug is now placed in a drug category that indicates “there is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans”. (Chart of FDA Pregnancy Categories, fda.gov) The FDA strongly advises that all other options be explored before a woman uses a category D drug during pregnancy and that the drug only be used if the risk to the mother outweighs the potential risk to the fetus.
The specific Topamax re-classification was encouraged by evidence presented by the North American Antiepileptic Drug (NAAED) Pregnancy Registry suggesting that oral-facial deformities such as cleft lip and cleft palate may be linked to the use of Topamax during pregnancy. Specifically, the NAAED cites that the existence of major malformations was 3.8% in the topiramate-exposed group of infants versus 1.3% in the unexposed reference group. The prevalence of cleft lip was 0.69% versus the expected rate of .07% in the normal population. (Source: Herndandez-Diaz, S., Mittendorf, R., Holmes L.B. Comparative Safety of Topiramate During Pregnancy. Birth Defects Research (Part A); 88:408 (2010).)
Topamax is part of a class of drugs known as “anticonvulsants” or “anti-epileptics”, a class of drugs at the center of the birth defect debate. Numerous other anticonvulsant drugs, including the epileptic and seizure medication Depakote, have been linked to potential birth defects. Depakote, specifically, has been linked to serious neural tube malformations that cause the debilitating condition of spina bifida (Source: The Teratogenicity of Anticonvulsant Drugs, Lewis B. Holmes, M.D., N Engl J Med 2001; 344:1132-1138, April 12, 2001).
Currently, no comprehensive testing of potential drug risks for pregnant or breastfeeding women or unborn children exists. The ethical issues surrounding testing on these demographic groups prevents organized studies for this population. As a result, many of the birth defects that may be related to prescription drugs are not discovered until after the drug is released to the public and physicians or drug registry programs begin reporting a pattern of birth injuries.
RXBirthDefects.com is part of the family of resource websites created by the Consumer Justice Foundation, an online consumer watchdog agency. Following the Wall Street Journal article and the FDA classification change for Topamax, RXBirthDefects.com added a resource section dedicated to providing information about potential birth defects related to Topamax use during pregnancy.
The Topamax birth defect information covered on RXBirthDefects.com includes detailed information about the oral-facial malformations and genital malformations that may be related to the drug use. This includes facial clefts such as cleft lip, cleft palate and the male genital deformation of hypospadias (Source: Herndandez-Diaz, S., Mittendorf, R., Holmes L.B. Comparative Safety of Topiramate During Pregnancy. Birth Defects Research (Part A); 88:408 (2010)).
Families seeking legal recourse for birth injuries related to Topamax taken during pregnancy can find more information about how to file a Topamax lawsuit and updated news on the status of ongoing Topamax litigation in the United States. Families can connect immediately with reputable Topamax attorneys and legal representation via the free case evaluation form available online at RXBirthDefects.com.
RXBirthDefects.com provides comprehensive information and resources regarding the use of prescription medication during pregnancy. The information on RXBirthDefects.com currently covers the prescription anticonvulsants Topamax, Dilantin, Depakote and Tegretol as well as the common antidepressants Celexa, Lexapro, Paxil, Pristiq, Prozac and Zoloft. The website provides an online resource center and free claim review form for women and families seeking more information about the specific birth defects that may be related to these drugs when used during pregnancy.
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