FDA on Topamax Side Effects
Topiramate or Topamax is an anticonvulsant antiepilepsy drug. It treats seizures of epilepsy and is usually taken orally. Topamax is considered ultimate cure for epilepsy. It also treats or prevents migraine headaches and is given to adults and children above ten years of age. Its exact mechanism of action is unknown but studies show that it works on brain nerves. It is beneficial for bipolar disorder.
However it has severe side effects. It is also a cause of developing suicidal tendencies. Some effects like psychomotor slowing, memory problems, fatigue, confusion, somnolence lead to the discontinuity of the drug.
A manufacturing company, Ortho-McNeil Pharmaceutical, Inc. issued a letter on September 26, 2001. It states that 23 cases are reported to develop an ocular syndrome, acute myopia, and secondary angle closure glaucoma after using Topamax. Initially, in the first month of use, vision blurs, anterior chamber shallows, redness, increased intraocular pressure, pupils dilate unusually even myopia develops. Those patients who, while on Topamax, developed blurred vision or eye pain should immediately consult a specialist. If the pressure keeps on elevating and you leave it without any treatment, then the consequence could be a permanent loss of vision.
Over the last four years500,000 physicians prescribed this drug to 825,000 patients which caused so much side effects that The Food & Drug Administration had to issue warnings.
Usage of Topamax during pregnancy especially in first trimester the use of topiramate or Topamax comes with a note of caution by the FDA. FDA followed surveillance reports and found that the drug is a cause of increase in frequency of cleft lip and/or cleft palate (oral clefts). Avoid pregnancy or at least inform your doctor about your planning to get pregnant if you are on this drug. It is advisable to take birth control as Topamax is mainly given for epilepsy, bipolar disorder and various other nerve pains. Most of antiepileptic drugs, if used during pregnancy, cause different birth defects. Your doctor will decide the rest according to your health condition. The FDA has addressed such concerns in :
Further, while prescribing this drug to the expecting mothers, the pros and cons should be kept in mind. Better option would be to consider alternative options for patients suffering from seizures of epilepsy. FDA approved its usage, not to ease the pain of migraine headaches but, to prevent migraine headaches. Topamax is used off-label for other conditions. It is continuously used as a treatment of bipolar disorder and many doctors also prescribe it off-label for such usage but it has never been approved by FDA for such a use.
The patent for putting topiramate for pediatric usage expired on February 28, 2009. Ortho-McNeil projected Topamax as the cure for psychiatric disorders which they had no right to. All of this was done without the approval of FDA. Therefore Ortho-McNeil was fined US$6.14 million by the FDA for this misleading.
Approximately 32.3 million prescriptions of using topiramate are given to approximately 4.3 million patients. Patients get it from retail pharmacies.