Lawsuit Against Topamax
Topiramate, having a brand name Topamax, is an anticonvulsant drug discovered by Bruce E Marynoff and Joseph F Gardocki in 1979. It is used to treat seizures in adults and children of ten and above years of age. Small children of 2 years of age can be given this treatment in combination with other drugs. Topamax can prevent the attack of migraine headaches. Meals are not an issue for taking Topamax but the tablets should not be broken as it is bitter in taste.
For prophylaxis of migraine headache, as treatment for adults, total daily dose of Topamax is100 mg per day. It is recommended to divide it into two doses. Also open sprinkle capsules carefully and spray the contents on soft food, haste in swallowing this mixture you have made. Don’t chew it and never store it to use it in future. To minimize the damage of side effects, the intake of this drug is increased slowly.
But the patients using Topamax develop certain severe side effects. There is increase in the risk of oral clefts in new born whose mothers used to take Topamax during pregnancy. According to the statistics given by North American Antiepileptic Drug (NAAED), women on Topamax during the first trimester of pregnancy having children with oral clefts is 1.4% compared to a prevalence of 0.38% – 0.55% in infants exposed to other antiepileptic drugs (AEDs).
In the Pregnancy Registry of North American Antiepileptic Drug (NAAED), the relative risk of oral clefts in pregnancies exposed to topiramate was 21.3 as compared to the risk in a population of untreated women. Similarly the reports of The UK Epilepsy and Pregnancy Register shows a 16-fold increase in risk compared to the background population, in the prevalence of oral clefts among infants having mothers taking topiramate. It also causes eye pain and myopia. According to the reports, symptoms start showing within one month of the drug therapy.
Initially Topiramate was approves as no genuine case was seen at that time though some studies suggested fetal risks in animals. . Therefore Topiramate was considered as a Pregnancy Category C drug.
But new studies on humans suggest a dramatic increase in oral clefts. Also, solid evidences were produced which revealed that there are human fetal risk. Hence topiramate was put in Pregnancy Category D. There are some cases where it becomes necessary for pregnant women to take it despite all risks as the benefit weigh more at that time.
Health care professionals should see if any alternative method works, if nothing goes well, then topiramate may be used but the benefits should outdo harms. Also, explain all the side effects of topiramate to expecting mothers. They should encourage pregnant women to enroll by calling 1-888-233-2334. FDA MedWatch should be informed in case any adverse event occurs involving topiramate.
Lastly you should inform FDA about the side effects you faced after taking Topiramate. After seeing Topiramate in your prescription, you should go through the Medication Guide to know about potential side effects, pros and cons of taking this medication.