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. Psychologically, she has to deal with the physical changes as well as the future responsibilities of having a child. 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. An example of a medication that is linked with congenital defects is Topamax and is rated Category D by FDA.
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. They mostly chance upon lifestyle changes(e.g. diet, daily activities, exercise and etc.) and medications to take. They might have read some articles on what products and medications to avoid in relation to the pregnancy categories. On that note, the U.S. Food and Drugs Administration (FDA) has assigned pregnancy categories used in drug formulary for special consumers like pregnant women and their families, to know what’s safe for the mother and the baby. This guide is also being used by physicians when they prescribe medications to their patients.
The U.S. FDA Pregnancy Category consists of the following:A, B, C, D and X. Adequate and well-controlled studies for Category A showed that it has no significant risk to the fetus in all trimesters of pregnancy and it is generally safe. Products and medications in Category B have no adequate studies in pregnant women but tests in animal reproductions failed to show a marked risk for the growing fetus. 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. 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 of the medications belong to Pregnancy Category D, such as Topamax. Topamax is an anti-epileptic and migraine drug but it has been linked to birth defects such as the formation of clefts and hypospadias. Topamax has also been linked with suicide. With all the side effects presented, the U.S. FDA encouraged doctors to carefully think if giving the drug as a prescription to pregnant patients and those of 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.
Tags: Womens World