Topamax Birth Defects

Taking Topamax, a drug used as an anti seizure medication and to prevent migraines, has been found unsafe during pregnancy.  Although it has been prescribed to patients for years, the Food and Drug Administration recently increased the danger level from a C rating to a D rating.  For women who have taken the drug while pregnant – it is too late.  Many pregnancies have resulted in birth defects for the baby.

Since Topamax has been one of the leading medications prescribed for patients with epilepsy – the number of birth defect cases is on the increase.  In a recent article in the journal Neurology, the report stated that taking Topamax along with other anti seizure drugs made birth defects more likely.  Topamax is also used to prevent migraines which affect more than 30 million Americans.  Women in their childbearing years are more likely to suffer from migraines which results in a large number of pregnancies affected by this drug.

Neurologist Shlomo Shinnar, MD, PhD, of New York confirmed studies that suggested Topamax or Topiramate should not be used to prevent migraines for women who are considering pregnancy.  In the small study several babies were born with cleft lips or cleft palates and several male babies were born with genital birth defects.  These studies have shown that Topamax birth defects are more common than previously thought.

Although seizures are also dangerous for a woman during pregnancy the studies provide information that if medication needs to be taken it should be in the smallest dosage possible.  Many of the birth defects associated with Topamax occur before a woman even realizes she is pregnant.  Since the new upgraded status of the drug more and more women are planning to file Topamax lawsuits.

The FDA pregnancy category definitions used to rate potentially dangerous drugs is one reason more attention is being called to the drug Topamax.

An “A’” rating shows results in a well controlled and adequate study of women during pregnancy has failed to demonstrate a risk to an unborn baby in the 1st trimester and no evidence of risk in later trimesters.

A “B” rating shows results in animal reproduction studies have failed to show a risk to unborn babies and the benefits from using the drug may outweigh potential risks.

A “C” rating shows animal reproduction studies have shown adverse effects on a unborn baby and there are no well controlled studies in humans.  The benefits of the drug outweigh the risks.

A “D” rating shows there is positive evidence in human’s based on adverse reaction data from marketing experience and investigational studies in humans.  The potential benefits for pregnant women outweigh the risks in the case of a life threatening situation.

A “X” rating shows there are studies in animals that have shown fetal abnormalities or there is positive evidence of risk based on reports and experience.  The risk of the using drug must clearly outweigh possible benefits.(language summarized from the Code of Federal Regulations 21- 201.57)

Unfortunately the information is being made available too late to help prevent Topamax birth defects for many children.  One of the major defects is a cleft lip or cleft palate which can interfere with eating and even cause hearing problems.  Although there is surgery that can be performed to correct these deformities it does not ease the pain and suffering caused by both the parents and the baby itself.  Topamax will need to take responsibility for affecting the lives of women and their babies all over the country.