1/6. Accutane-exposed pregnancies--california, 1999.Accutane (Roche laboratories, Nutley, new jersey), known by the generic name "isotretinoin," is a prescription oral medication approved by the food and Drug Administration (FDA) to treat severe, recalcitrant nodular acne. It is also a known human teratogen that can cause multiple major malformations. Embryopathy associated with the mother's exposure to isotretinoin during the first trimester of pregnancy includes craniofacial, cardiac, thymic, and central nervous system malformations . In response to FDA recommendations, the manufacturer began a pregnancy-prevention program (PPP) in 1988 that included educational materials for physicians and patients and offered women reimbursement for contraceptive counseling by a physician. The PPP coordinators asked reproductive-aged women being treated with isotretinoin to enroll voluntarily in the boston University Accutane Survey (BUAS). The total number of reproductive-aged women taking isotretinoin in the united states is unknown; however, 454,273 women enrolled in the BUAS from 1989 to October 1999. BUAS has estimated that 38%-40% of reproductive-aged women taking isotretinoin chose to enroll in the survey (BUAS, unpublished data, 1999). Although isotretinoin is contraindicated in pregnancy and has a package label warning users to avoid pregnancy while taking it, exposed pregnancies occur. Approximately 900 pregnancies occurred among BUAS enrollees during 1989-1998 (BUAS, unpublished data, 1999). Roche laboratories began direct-to-consumer print advertisements in 1996, added television and radio advertisements to selected cities in 1997, and expanded the campaign to the entire united states in 1998.- - - - - - - - - - ranking = 1keywords = physician (Clic here for more details about this article) |
2/6. The neurodevelopmental consequences of prenatal alcohol exposure.During pregnancy, ingestion of alcohol, a known teratogen, can cause harm to the fetus. Prenatal alcohol exposure is one of the leading causes of birth defects, developmental disorders, and mental retardation in children. The fetal central nervous system is particularly vulnerable to alcohol; this vulnerability contributes to many of the long-term disabilities and disorders seen in individuals with prenatal alcohol exposure. Diagnoses associated with prenatal alcohol exposure include fetal alcohol syndrome (FAS), partial fetal alcohol syndrome, fetal alcohol effects, alcohol-related neurodevelopmental disorder, and alcohol-related birth defects. Once diagnosed, early intervention improves the long-term outcome of affected children. Without documentation of maternal alcohol use, a diagnosis, and consequently treatment, is often difficult to attain. It is imperative that nurses, physicians, and other healthcare providers become comfortable with obtaining a history of, and providing anticipatory guidance and counseling about, alcohol use.- - - - - - - - - - ranking = 0.5keywords = physician (Clic here for more details about this article) |
3/6. isotretinoin embryopathy--a continuing problem.First trimester exposure to isotretinoin is associated with an estimated 20% risk of major fetal malformations. product labeling in force up to August 1988 included a statement that the drug is contraindicated in pregnancy and suggested procedures for prescribing physicians to follow to prevent inadvertent first trimester exposure to the product. This limited educational intervention did not prevent the continued occurrence of isotretinoin-related birth defects. The effectiveness of recent changes in the package labeling in preventing such birth defects remains to be demonstrated. Two infants with major birth defects associated with first trimester exposure to isotretinoin (Accutane, Roche laboratories) were reported to the new jersey Birth Defects Registry within 6 months. Stimulated by these reports, we sought additional cases in new jersey and found three. We here describe these five cases of isotretinoin embryopathy, including available information on the circumstances which led to maternal use of isotretinoin during the first trimester of pregnancy. In response to a preliminary report of these cases and to investigations by epidemiologists at the U.S. food and Drug Administration (FDA), the manufacturer altered the package labeling. The revised product information includes a more prominent "contraindication and warning" section and a new "patient information/consent" section. The effectiveness of this educational intervention should be evaluated.- - - - - - - - - - ranking = 0.5keywords = physician (Clic here for more details about this article) |
4/6. Successful pregnancy following continuous treatment with combination chemotherapy before conception and throughout pregnancy.A 21-year-old woman with diffuse histiocytic lymphoma received combination chemotherapy continuously for 16 months before conception and throughout pregnancy. procarbazine and BCNU were given for 5 months before conception and throughout the first and second trimesters, and streptozotocin was given throughout the third trimester. A male infant who was phenotypically and genotypically normal was delivered. The authors reviewed the literature regarding chemotherapeutic agents given during the first trimester of pregnancy. Although most chemotherapeutic agents are teratogenic in the animal model, the incidence of teratogenicity of chemotherapeutic agents given to humans in the first trimester of pregnancy is 12.7%. This represents a fivefold increase in teratogenicity. As yet the administration of chemotherapeutic agents in the second and third trimesters has not resulted in teratogenicity. This information may help the physician when deciding whether to treat pregnant patients with chemotherapeutic agents during the first trimester or whether to continue treatment when the patient has become pregnant while receiving these agents.- - - - - - - - - - ranking = 0.5keywords = physician (Clic here for more details about this article) |
5/6. Legal issues in neurology and pregnancy. The physician's duty of care.physicians face some unique legal issues when they treat women who have neurologic conditions in their childbearing years. These issues stem from the physician's responsibility to foresee and inform the woman of the impact of her neurologic condition and its treatment on her reproductive choices, as well as on her fetus. The physician's legal responsibility may extend to third parties, including not only the woman's spouse and child, but also to the general public. Legal liability may be imposed on a doctor because of harm to a fetus or to others as a result of the doctor's act or omission involving his patient.- - - - - - - - - - ranking = 3keywords = physician (Clic here for more details about this article) |
6/6. risk assessment of drug use in pregnancy: prevention of birth defects.Some developmental disorders are preventable by primary prevention, i.e. by avoiding exposure to microorganisms or chemicals that cause developmental disorders. This is not only important for physicians prescribing drugs, midwives monitoring pregnancies, but especially for parents taking the responsibility of having a baby; moreover, this fact is of importance for teratogen information services and public health authorities, both having preventive roles to play. knowledge of the different pre- and postnatal developmental stages and the reproductive cycle is essential to understand this statement. The basic principle in reproductive toxicology and teratology is that the response of an organism to a teratogen depends upon the nature and the dosage of the substance, the stage of development of the embryo/fetus and its genetic make up. Chemical agents of different nature can induce developmental disorders either via the mother and perhaps via the father. The common consent that the vulnerable stage of development is only the first trimester of pregnancy is not correct. From oogenesis and spermatogenesis to at least the first years of life the developing organism is susceptible to harmful effects of chemical agents, including drugs. Developmental disorders include not only malformations visible at birth, but also spontaneous abortions, fetal death and functional deficits including behavioural defects. Studies both in the human and in laboratory animals make it possible to select substances to avoid exposure to developmental toxicants which are already on the market or still under development. This implicates a multi-step procedure leading from risk-evaluation, risk-assessment, and risk-communication to risk-perception and the according action (risk-management).- - - - - - - - - - ranking = 0.5keywords = physician (Clic here for more details about this article) |