Fda Has Released Severe Warnings In Using Topamax, A Migraine And Anti-epileptic Drug

Fda Has Released Severe Warnings In Using Topamax, A Migraine And Anti-epileptic Drug

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Every consumer is entitled to have a safe and effective market. The FDA, which stands for Food and Drug Administration, sees to it that people choose and use safe products, as well as promote advancements in public health. As per the FDAs website, they are responsible in making sure that the food and drugs for consumption of humans and animals are clean, effective, safe and with proper labels. They issue warnings and reviews so everyone will be informed of the regulated products and those that could pose a threat to the general public or a specific population, an example of which is their recent crackdown on Topamax as it pose great threats to pregnant women and their unborn children

Consumer Information by Audience

As mentioned, the agency addresses a particular group and that includes pregnant women. From their website, the FDA-assigned pregnancy categories as used in the Drug Formulary, are as follows:

FDA Pregnancy Category

Category A
There is no demonstration of a significant risk to the fetus in the first trimester as well as in the later trimesters of pregnancy according to studies.

Category B
Animal reproduction studies and tests didnt establish fetal harm and there are no well-controlled observations in pregnant women.

Category C
Studies in animal reproduction does reveal some adverse effects on the growing fetus; there has been no adequate studies in human but the benefits warrant the use of the drug in pregnant women despite its potentials risks.

Category D
Human fetal risk is positive based on the adverse reaction date from marketing experience and investigations or studies done in humans but the benefits may justify the use of medication in pregnant women though it has potential risks.

Category X
Adequate and well-observed studies in animals and/ or humans have demonstrated abnormalities in the fetus and/or there is positive evidence of human fetal risk basing on the adverse reaction data from investigational or marketing experience, and the dangers involved in the use of the drug in pregnant women greatly outweigh potential benefits.


FDAs Concerns on Topamax

The FDA has been encouraging doctors to think carefully when prescribing Topamax to pregnant women and those of childbearing age in light of the studies showing the connection between the development of cleft lip and palate to new-borns from mothers of Topamax users. The drug was also reclassified from Category C to Category D and prior to that was asked to put a black label warning, the most serious labelling requirement of the FDA, after the medication has been linked to commission of suicide. The FDA has issued serious warnings about Topamax which is not to be taken lightly.



About the Author:
Epilepsy drug, Topamax, receives scrutiny after studies show it causes serious side effects among pregnant women and their newborns. Read more updates and news here.



Article Originally Published On: http://www.articlesnatch.com


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