Drug Abuse Deaths
Pregnancy Changes Related To Antiepileptic Drug, Topamax
One of the things that women look forward to in life is to be pregnant. When a woman will be expecting a child, there are several changes that may take place and she is expected to take on a different experience. It brings both physical and psychological changes to the woman and her partner. In terms of the physical, her body and its physiology will remarkably be different as when she wasn’t pregnant. In terms of the psychological, she will be dealing with her body changes and the future responsibilities of being a parent to her child. She has to adapt to her new situation and she has to be careful in things that can affect her and her baby’s health including nutrition, medication and exercise. She is expected to be careful in taking and using the products that can be bought over the counter as some may cause harm to the fetus. An example of a medication that is linked with congenital defects is rated Pregnancy Category D by FDA, Topamax.
Normally, when the woman and her partner are expecting a baby, they have the tendency to ask questions to their doctors and sometimes find answers through their own research. Often times, they come across lifestyle changes (e.g. diet, daily activities, exercise and etc.) and medications. In their personal inquiries, they may have read something on prohibited products and medications according to the pregnancy categories. With that being said, the U.S. FDA or Food and Drug Administration has assigned pregnancy categories that are used in drug formulary for pregnant women, so they’ll know what’s safe for them and for the fetus. This is also used by doctors in prescribing drugs to patients.
The FDA Pregnancy Category has five categories; A, B, C, D and X. Studies have shown that Category A medications and products are generally safe for the fetus and has no significant risk in all trimesters. Category B products and medications weren’t tested in humans but tests in animal reproductions didn’t show any risk for the baby. Products and medications belonging to Category C have been tested in animal reproduction and have shown adverse effects, they’re not tested in humans but the potentials benefits warrant the use in pregnant women despite the risks. For those under Category D, it showed that human fetal risk is positive based on the adverse reaction data from investigational or marketing experience or studies in human, but the potential drug benefits may warrant its use in pregnant women despite the potential risks. Lastly, Category X indicates that well-observed and adequate studies in humans and/or animals as evidenced by abnormalities in the fetus and human fetal risk is positive based on the adverse reaction data from the investigational or marketing experience and the perils involved outweighs the potential benefits.
Some medications, such as Topamax belong to Pregnancy Category D. Topamax is a medication used in the treatment of epilepsy and prevention of migraine but has been associated with congenital anomalies such as cleft lip and palate, and hypospadias. It has also been connected to the commission of suicide. With all the complications being said, the FDA had serious warnings on Topamax and encouraged physicians to greatly consider other alternatives before prescribing Topamax to pregnant women and those of the childbearing age. In our fast-paced world, we normally look up the internet for answers to our questions, but it is strongly encouraged that you ask your doctors with concerns regarding medications and health care for they can give you the best answers.
