Tuesday, July 22, 2008

More Bad News for Topamax Users

Small Study Shows Increase Risks in Birth Defects When Topamax Is Used During Pregnancy

July 21, 2008 -- A small study published in the latest issue of the journal Neurology, shows Topamax (topiramate) has been linked to an increase risk of birth defects in babies born to patients who took it during pregnancy.

"More research needs to be done to confirm these results, especially since it was a small study," researcher John Craig, MRCP, of the Royal Group of Hospitals in Belfast, Northern Ireland said in a news release.

He added that although the study included only epilepsy patients, the results may be of particular relevance for migraine patients "since [Topamax] is also used for preventing migraines, which is an even more common condition that also occurs frequently in women of childbearing age."

If the study findings are confirmed, they suggest that Topamax may not be an appropriate migraine treatment for women who are considering pregnancy, neurologist Shlomo Shinnar, MD, PhD, of New York's Montefiore Medical Center told WebMD. Shinnar is a spokesman for the American Academy of Neurology.

Information from the Official Topamax Web Site
In review of the information on the official Topamax site we found a report by Dr. Diamond associate director of the Diamond Headache Clinic of Chicago, from July 19, 2007 regarding Topamax During Pregnancy. She reported that although some prescription and over-the-counter drugs may pose a small degree of risk to the fetus, few pregnant migraine sufferers can go 9 months without treatment for migraine pain, and there are headache pain medications that are proven safer than others.

In this report, the only prescription medications she mentioned that should not be taken during pregnancy because of their known adverse effects, are phenytoin, valproic acid, and lithium carbonate.

Dr. Diamond went on to say pregnant women should be recommended nonpharmacological treatments for migraines during all trimesters, such as rest, biofeedback, ice/heat, massage, exercise, folate, and avoiding migraine triggers.

Dr. Merle Diamond has indicated that she has served as a speaker and/or consultant, or has conducted research for AstraZeneca, GlaxoSmithKline, Merck, Pfizer, and Ortho-McNeil the makers of Topamax.

Information from TOPAMAX full U.S. Prescribing Information


"
What Should I Do If I Get Pregnant While Taking TOPAMAX?"

"It is not clear if there is a risk to the fetus/baby if you are exposed to TOPAMAX and you are pregnant. Various abnormalities have been described in the offspring of animals exposed to TOPAMAX during pregnancy. If you use TOPAMAX while you are pregnant, ask your healthcare professional about reporting your experience to the North American Drug Pregnancy Registry at Massachusetts General Hospital (Boston, MA). This registry collects information about the babies born to women who are taking drugs to treat various conditions. Information about the North American Drug Pregnancy Registry can be found at http://www.massgeneral.org/aed/.You can also join the registry by calling 1-877-376-3872."

"In a rat embryo/fetal development study with a postnatal component (0.2, 2.5, 30, or 400 mg/kg during organogenesis; pups exhibited delayed physical development at 400 mg/kg (10 times the RHD on a mg/m2 basis) and persistent reductions in body weight gain at 30 mg/kg (1 times the RHD on a mg/m2 basis) and higher.

There are no studies using TOPAMAX® in pregnant women. TOPAMAX® should be used during pregnancy only if the potential benefit outweighs the potential risk to the fetus. In post-marketing experience, cases of hypospadias have been reported in male infants exposed in utero to topiramate, with or without other anticonvulsants; however, a causal relationship with topiramate has not been established."

Note from Lyle

I readily add that any women who is thinking about or becomes pregnant should meet with her doctor(s) to fully review each and every medication whether it be pharmaceutical, OTC, natural, or herbal to determine what is best for her and her baby.

Lyle