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Pregnancy and Medications: FAQs
Q. Are over the counter(OTC) drugs dangerous during pregnancy? A. According to the New England Journal of Medicine, an estimated 10 to 45 percent of pregnant women in the first trimester, unaware of their condition, reach for the most common OTC drug, aspirin. Aspirin and other drugs containing salicylate are not recommended throughout pregnancy, especially during the last three months, except under a doctor's supervision. Acetylsalicylate, a common ingredient in many OTC painkillers, may prolong pregnancy and cause excessive bleeding before and after delivery. Overall, according to Debbie Limkins of FDA's division of OTC drug evaluation, most other OTC drugs can be used during pregnancy with the supervision of a physician. Although scientists do not know the effects on the fetus of all OTC and prescriptions drugs, some are known to cause birth defects and should be avoided. (See "Drugs and Pregnancy: Often the Two Don't Mix" in the June 1989 FDA Consumer.) Since 1984, all OTC drug products have carried the following warning: "As with any other drug, if you are pregnant or nursing, seek the advice of a health professional before using this product." In July 1990, FDA issued a regulation requiring all oral and rectal nonprescription aspirin and drugs that contain aspirin to include the additional warning "It is especially important not to use aspirin during the last three months of pregnancy unless specifically directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery." One drug that can cause severe birth defects is Accutane, or isotretinoin. Accutane, a derivative of vitamin A, is a powerful prescription drug that can clear severe cystic acne, but can cause birth defects (such as heart defects, small jaw, cleft palate, and skull and facial disfigurements) in about 1 out of every 4 exposed fetuses. Accutane can also cause miscarriages. Since its approval, Accutane has been labeled as being in pregnancy category X, meaning it should not be used during pregnancy. However, due to persistent reports of birth defects associated with the use of the drug in 1988, the manufacturer, Hoffman-La Roche, began including additional patient information in the packaging, including a drawing of a baby with birth defects associated with the drug. Before being permitted to take Accutane, a woman of childbearing age must sign a consent form stating that she has been fully informed of the drug's side effects. (See "Acne: Taming That Age-Old Adolescent Affliction" in the October 1990 FDA Consumer.) Another derivative of vitamin A, etretinate (or Tegison), was approved in the mid-1980's to treat psoriasis. This drug is also forbidden for use by women who are pregnant or who are likely to become pregnant either while taking it or for a certain period after they have stopped taking it. Q. I have heard that some women who were pregnant between 1938 and 1971 were given a drug to prevent miscarriages (DES) that is now known to cause cancers. How do I know if was exposed to the drug? A. Many people do not know that they were exposed to DES. Mothers may not have known they were taking DES or remember the kinds of medication they were given when they were pregnant. Some prescription vitamins included DES. WHAT TO DO Women Who might Have Taken DES If you remember taking any medicine during pregnancy, try to get your medical records. Daughters and Sons
Q. What are the names of the products I (or my mother) may have taken during pregnancy that contained DES or DES-like compounds? A. Following are some names under which DES and other Nonsteroidal Estrogens have been sold in the United States:
Q. What kind of health problems can women and children exposure to DES have? A. WOMEN WHO TOOK DES Women who took DES are advised to pay particular attention to their breast care because they may have a small increase in their risk of breast cancer. Mothers are advised to tell their DES-exposed sons and daughters about their exposure, even if these children have not had health problems. They need to know about DES so they can get the health care they need. DES CHILDREN DES Sons Men exposed to DES before birth DES sons are at increased risk for non-cancerous cysts on the back of the testicles (on the epididymis) and for underdeveloped testicles. DES sons should practice testicular self-examination regularly. There has been little research on the effects of DES exposure in DES sons, but new studies are in progress. To protect your health, find out if you were exposed, and stay informed of new research findings. DES DAUGHTER Women exposed to DES before birth All DES daughters need regular screening exams for a rare form of vaginal cancer (early detection saves lives). This exam is somewhat different from the one for non-exposed women (see page 17). It should begin at puberty and continue throughout their lives. All DES daughters need special care beginning in the first weeks of pregnancy, even if they have already had children. You can learn about the pregnancy care you need in this booklet. With proper care most DES daughter can have successful pregnancies. Q. Where can I obtain more information on DES? A. DES: The Basic Booklet National Institutes of Health, National Cancer Institute, National Institute of Child and Human Development, January 1995. National Cancer Institute, Cancer Facts: Questions and Answers about DES This information was taken from "DES: The Basic Booklet", National Institutes of Health, National Cancer Institute, National Institute of Child and Human Development, January 1995. For more information..... You can find out more about pregnancy and medication by contacting the following organizations: Food and Drug Administration |
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