Topiramate Birth Defects

Topiramate (aka Topamax), manufactured by Mylan, is an anticonvulsive drug for the treatment of epileptic seizures. Topiramate/Topamax has a history of unfortunate actions against it, both medical and legal, some of which included charges of fraud (since Mylan did not acquaint consumers with Topiramate side effects).

In addition, it was discovered that Ortho-McNeil, the parent manufacturer of the drug, ran few if any safety tests before sending it out to the public for consumption, which resulted in a six million dollar settlement against the pharmaceutical company.

To return to the side effects: they are problematic mainly in their breadth and extent.   They include paresthesia (numbness and tingling sensations), diarrhea, nausea, a loss of appetite (to an extent that some patients reported near anorexic symptoms) and sleep disorders, among others.

It is, however, in the potential for Topiramate birth defects that the FDA exerted itself most powerfully, commissioning a study in June of 2010 that led to the drug’s being given a C rating for the category of pregnancy medications.   A C rating is not necessarily indicative of harmful birth defects to humans; however, the study found increases in the incidence of birth defects when the drug was given to experimental animals.

For example, pregnant rats, mice and monkeys, given the drug, experienced Topirimate-centered birth defects in their babies that included low natal weight, damaged or non-functional heart valves (ultimately resulting in fetal death), and miscarriages (particular in the simians).

What causes Topiramate Birth Defects?

In addition, the most unsettling fact about Topiramate birth defects is that the medication is “associated with metabolic acidosis . . . [which] may be associated with decreased fetal growth, decreased fetal oxygenation and fetal death” (FDA).   The drug has mandated warnings, and health professionals are strictly caused to practice full disclosure with potential users of the drug.

Topiramate’s potential birth defects do not prevent its use; many health care professionals continue to prescribe it, and the admittedly limited warnings are as yet the only strictures against its sale and distribution.  Recently Topiramate/Topamax has been “sold” to patients and doctors as a migraine medication, reducing the effects of the condition by up to 25%.  No scientific studies exist to prove this, however.

If you would like further information about Topamax/Topiramate’s potential for birth defects, or you are about to embark on a program include Topamax medication, consult your medical professional about your concerns.  If you have actually experienced damaging side effects from a prescription, you are urged not only to consult your health professional as soon as possible, but also to obtain a specialist lawyer at the American Bar Association, http://www.abalawinfo.org/

http://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/DevelopmentResources/UCM272684.pdf
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251556.htm
http://en.wikipedia.org/wiki/Topiramate
http://pediatrics.about.com/od/birthdefects/f/medicines
http://www.topamaxbirthdefectlaw.com/updates/ortho-mcneils-topamax-dosage-recommendations/
http://www.mylanpharms.com/professionals/product_list/product_details.aspx?pid=239&query=1
http://google2.fda.gov/search?q=cache:Eur7PdckcjAJ:www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/PediatricAdvisoryCommittee/UCM272371.pdf+zonegran+birth+defects&client=FDAgov&lr=&proxystylesheet=FDAgov&output=xml_no_dtd&ie=UTF-8&site=FDAgov&access=p&oe=UTF-8