Risk of Topiramate

Topiramate is a white crystalline powder with a bitter taste. It is most soluble in alkaline solutions containing sodium hydroxide or sodium phosphate and having a pH of 9 to 10. It is freely soluble in acetone, chloroform, dimethylsulfoxide, and ethanol. The solubility in water is 9.8 mg/mL. Its saturated solution has a pH of 6.3.

Topiramate has the molecular formula C12H21NO8S and a molecular weight of 339.36, the CAS NO. is 97240-79-4. It is designated chemically as 2,3:4,5Di-O-isopropyliden-β-D-fructopyranose sulfamate.

Topiramate is an oral drug that is used to prevent the seizures of epilepsy. It is an anti-epileptic or anti-seizure drug. It is used primarily among patients who are not controlled by other anti-epileptic drugs. About 1 in 4 Americans diagnosed with epilepsy has seizures that resist treatment with other anti-epileptic drugs. It also prevents migraine headaches.

A GlaxoSmithKline-sponsored Phase IV study suggested that cognitive side effects may be more common with topiramate than with lamotrigine. In studies of healthy volunteers, therapeutic doses of topiramate for bipolar disorder produced greater cognitive deficits than lamotrigine, including short term memory loss and word-finding difficulty.

Side-effects reported by > 10% of subjects in at least one clinical study (listed by prevalence):

paresthesia (numbness & tingling) (23.7%)
upper respiratory tract infection (17.5%)
diarrhea (16.8%)
nausea (15.4%)
anorexia (loss of appetite) (13.3%)
memory problems (11.2%)

Side-effects most frequently leading to discontinuation of therapy with topiramate:

psychomotor slowing (4.1%)
memory problems (3.3%)
fatigue (3.3%)
confusion (3.2%)
somnolence (3.2%)

That same study also reported that in adult patients with Bipolar 1 disorder who were already receiving either lithium or valproate, the addition of topiramate did not produce a statistically significant improvement versus placebo, while adding the above adverse reactions.

Rarely, the inhibition of carbonic anhydrase may be strong enough to cause metabolic acidosis of clinical importance.

The U.S. Food and Drug Administration (FDA) has notified prescribers that topiramate can cause acute myopia and secondary angle closure glaucoma in a small subset of people who take this medicine regularly. The symptoms, which typically begin in the first month of use, include blurred vision and eye pain. Discontinuation of this medicine may halt the progression of the ocular damage, and may reverse the visual impairment.

Preliminary data suggests that, as with several other anti-epileptic drugs, topiramate carries an increased risk of congenital malformations. This might be particularly important for women who take this medicine to prevent migraine attacks. In March 2011 the FDA notified healthcare professionals and patients of an increased risk of development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with topiramate during pregnancy and placed it in Pregnancy Category D.

Topiramate has been associated with a statistically significant increase in suicidality, and "suicidal thoughts or actions" is now listed as one of the possible side effects of the drug "in a very small number of people, about 1 in 500."

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