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Monday, July 18, 2011

Changes Brought By Topamax When Used By Pregnant Women

Aside from puberty, most women view pregnancy as one of the things to look forward to. When one is pregnant, several changes can happen and a whole new kind of experience is expected. 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. Psychologically speaking, she has to deal with all the physical changes she’s going through as well the as the responsibilities that she’ll be facing in the future. She has to adjust to the new experience and has to be cautious in a lot of things that may have an effect on her and her baby’s health which might include but not limited to nutrition, medication and exercise. She has to cope up with the experiences of being pregnant and has to exercise caution in a lot of things that may affect her and her baby’s wellness like nutrition, medication and exercise. She is to be cautious in taking and using over-the-counter (OTC’s) products as some can be harmful to the growing fetus. She is to be careful in using and taking OTC’s or over-the-counter products as some of those could pose a threat to the baby. A medication Topamax and is rated Category D by FDA, is an example as it has been connected with the formation of birth defects.

In most cases, when a woman and her partner are faced with the situation, they are usually very curious and seek answers from their physicians or through their personal inquiries. Often times, they come across lifestyle changes (e.g. diet, daily activities, exercise and etc.) and medications. They might have read some articles on what products and medications to avoid in relation to the pregnancy categories. With that mentioned, U.S.Food and Drug Administration has established a category for pregnancy used in drug formulary for pregnant women and their families to know the products and medications that they can take without negative effects on them and their babies. This is also used by doctors in prescribing drugs to patients.

Under the FDA Pregnancy Category are the following: 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 indicates that tests in animal reproductions failed to establish marked risk for the fetus and no adequate studies in humans were made. Category C revealed adverse effects to the fetus on studies in animal reproduction; there are no studies in humans but the potential benefits justify the use of the medication in pregnant women in spite of the potential risks. In Category D, human fetal risk yielded positive results as based on the adverse reaction data from investigational or marketing studies done in humans, but the benefits may be enough to warrant its use in spite of the potential risks. The last category, X, is prohibited for pregnant women as adequate and well-observed studies in humans and/or animals demonstrated deformities in the fetus and there is positive evidence of human fetal risk as per the adverse reaction data from the investigational or marketing experience, and the dangers involved greatly outweigh potential benefits.

Some drugs, like the previously mentioned Topamax, has a Category D classification. Topamax is used to prevent migraine attacks and epilepsy but has been connected with birth defects such as craniofacial anomalies and development of hypospadias. The medication has also been associated with 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.



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