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Biomedical subjects

E Elefant

Publications and source records attributed to E Elefant.

17 recordsLinked to original sources
PubMed2005

[Isotretinoin: compliance with recommendations in childbearing women].

INTRODUCTION: The aim of this survey is to ascertain if the incidence of isotretinoin exposed pregnancies was reduced by the late recommendations of prescription and issue (AMM modification on 06/08/2001 and 25/09/2001). METHODS: All isotretinoin exposed pregnancies registered by the French Regional Drug Monitoring Centres, the Information Centre for Teratogenic Agents and Roche (Roaccutane), Pierre Fabre (Curacné Gé) and Expanscience (Procuta Gé) laboratories, from January 1st, 1999 to December 31st, 2002, were analysed. Enforcement of the strengthening of isotretinoin prescription recommendations was analysed on a sample of 68 prescriptions from 45 pharmacies throughout France. RESULTS: In 4 years, 103 isotretinoin exposed pregnancies (Roaccutane 97 p. 100, Curacné(R) Gé 3 p. 100) during teratogenic risk period, were registered. Pregnancy started less than one month after isotretinoin stopping (37 p. 100), during the treatment (43 p. 100), or was in progress when the treatment was initiated (20 p. 100). The reason of the 22 lacking contraception was known 12 times, i.e. an absence of prescription (6 times), a refusal to take a prescribed contraception (3 times) and a self-medication (3 times). Among the 71 pregnancies whose contraceptive status is known, 48 p. 100 could had been avoided if recommendations had been followed (pregnancies due to a premature stopping or an absence of contraception). The issue of pregnancies is a voluntary termination in 60 cases (87 p. 100). Malformations frequency is 25 p. 100. Incidence of isotretinoin exposed pregnancies remained stable, 0.26/1000 treated women (vs 0.34 after 2001's AMM modifications). Of 68 prescriptions studied, 23 (24 p. 100) carried all the legal warnings, which is close to the previous survey's results. Contraception was in accordance with the recommendations in 78 p. 100 of cases and women learned and applied information given in 38 p. 100 of cases. At last, only 6 patients (9 p. 100) have both a correctly written prescription, a contraception and a time between the pregnancy test date and prescription and issue dates, in accordance with the licence and have had a correct information and understood it. Regarding the previous survey, pregnancy test before treatment was more often prescribed (96 p. 100 vs 88 p. 100). On the other hand, less women knew the necessity to keep on taking contraception one month after isotretinoin stopping (82 p. 100 vs 93 p. 100). CONCLUSION: Despite 3 successive isotretinoin prescription and issue recommendations strengthening in childbearing women, pregnancies can't be totally avoided. Bad compliance concerns the prescription and/or an incomplete or not understood information by the patient who does not scrupulously apply the care and contraception agreement. However, this study does not allow to assess the proportion of issued prescriptions despite their non-accordance with the licence criteria. The National Commission of Pharmacovigilance did not like to limit isotretinoin prescription to dermatologists only. It estimates that the administrative authority must intensify information by dermatologists, general practitioners and pharmacists, about measures to take to avoid an exposure to isotretinoin during pregnancy.

Abnormalities, Drug-Induced↗
PubMed2004

[Medication and pregnancy counseling, an incomfortable role for the retail pharmacists].

Tragedies subsequent to use of medication at the beginning of pregnancy have given rise to extreme distrust, placing the retail pharmacist in an uncomfortable situation. A survey of pharmacists in France has revealed that pregnant women ask for more information than any other patients, particularly when it comes to continuing medication started before pregnancy. In such cases, 57% of the polled pharmacists recommended discontinuation of the medication. Ninety percent thought they were sufficiently informed and massively recommended a prudent attitude. Their wish was to have an independent high-performance information tool available. There is such a tool: the Teratogenic Agent Information Center, rarely used by pharmacists. With the support of such a structure, 80% would be eager to take on more responsibilities in counseling patients and preventing teratogenic risks, in relation with other healthcare workers, thus guaranteeing high-quality medication counseling.

Adult↗
PubMed2004

[Cancer and pregnancy: risks of exposure to cancer chemotherapy during pregnancy].

Animal studies reveal that almost all antineoplastic agents are teratogenic. But extrapolation to human beings is not simple because of species differences. Few human data are available, most are sporadic case reports. Other toxic effects for the fetus and neonate (intrauterine exposure during second and third trimester) must be taken in consideration when prescribing chemotherapy for pregnant women. Adverse effects observed in adult and children are helpful if data during fetal life are lacking. Long-term studies are needed to evaluate the transplacental effects of chemotherapy during pregnancy; these studies should assess the child's mental and physical development, infertility and the occurrence of second malignancies.

Abnormalities, Drug-Induced↗
PubMed1999

[Pregnancy outcome in inflammatory bowel diseases].

OBJECTIVE: To assess pregnancy outcome in relation to disease activity and maintenance therapy in patients with inflammatory bowel disease. METHODS: A postal questionnaire was sent to every woman of child-bearing age followed for inflammatory bowel disease in three referral centers (Rothschild, Saint-Lazare, Saint-Louis). Response rate was 65%. RESULTS: One hundred and forty-four pregnancies (153 fetuses) in 138 women (122 had Crohn's disease) were reported. Outcome of pregnancy was normal (baby > 2500 g, without malformation) in 115 cases (77%). There were 17 cases of preterm birth (11.5%), 3 cases of hypotrophy, and 14 pregnancy losses (9 miscarriages (6%), 4 therapeutic abortions for major malformation (2.8%)). Percentages of normal pregnancy outcome were not different between patients who continued maintenance therapy and those who stopped: respective percentages were 75 vs 73% in patients receiving mesalamine or olsalazine (n = 30), and 60 vs 75% in patients receiving azathioprine (n = 22). CONCLUSION: In a selected series of women with inflammatory bowel disease, pregnancy outcome is approaching that observed in a normal population, except for an elevated rate of preterm births. There is no need to stop maintenance therapy with 5-aminosalicylates or azathioprine during pregnancy.

Aminosalicylic Acids↗
PubMed1998

Foetal outcome in women with inflammatory bowel disease treated during pregnancy with oral mesalazine microgranules.

BACKGROUND: Little information is available about the safety of high doses of mesalazine during pregnancy. AIM: To study the fate of pregnancy and foetal outcome in women taking 1-4 g/day of mesalazine microgranules for inflammatory bowel disease. PATIENTS AND METHODS: Case reports were collected from the Pharmacovigilance Department of Ferring SA, France, from a survey conducted in three gastroenterology units, and from a teratology information service. The evolution of pregnancy and foetal outcome were assessed by questionnaire. RESULTS: The study covered a total of 123 pregnancies (126 foetuses). Ninety-six women took mesalazine during the first trimester, 85 during the second and 83 during the third. The mean daily dose was 2.1+/-0.8 g; 86 women received <3 g/day (low-dose group), 37 women received > or =3 g/day (high-dose group). The following abnormalities were observed in the low-dose and high-dose groups, respectively: ectopic pregnancy (1/0), spontaneous abortions (1/1), foetal death (0/1), premature deliveries (3/5, P < 0.05), congenital malformations (3/1) and one case of lethal oxalosis. Abnormalities were not considered to be related to mesalazine. CONCLUSIONS: The use of oral mesalazine microgranules during pregnancy is safe at doses < or =2 g/day, and probably also at a dose of 3 g/day.

Adult↗
PubMed1995

Administration of a gonadotropin-releasing hormone agonist during pregnancy: follow-up of 28 pregnancies exposed to triptoreline.

OBJECTIVE: To evaluate the teratogenic or fetal risk of a long-acting GnRH agonist (GnRH-a) triptoreline acetate (Decapeptyl; Ipsen-Biotech, Inc., Paris, France), inadvertently administrated in the first weeks of pregnancy. DESIGN: Prospective follow-up of exposed pregnancies and case reports. SETTING: Teratology information service of a public hospital and pharmacovigilance department of the firm. PATIENTS: Inadvertent pregnant women receiving a treatment, mainly for endometriosis or IVF. INTERVENTIONS: Case by case, individual estimations of the risks have been provided. MAIN OUTCOME MEASURE: Each pregnancy issue has been analyzed. RESULTS: No teratogenic or fetal toxic effect has been noted. CONCLUSION: No specific hazard has been observed among newborns after inadvertent exposures to a GnRH-a during the first 20 weeks of pregnancy.

Abnormalities, Drug-Induced↗
PubMed1988

Cholesterol prevents the teratogenic action of AY 9944: importance of the timing of cholesterol supplementation to rats.

These studies were conducted to determine whether dietary cholesterol supplementation could prevent fetal malformations induced by the amphipathic drug AY 9944, which is well known as a cholesterol biosynthesis inhibitor, and to investigate whether the plasma maternal sterol level and the nature of the sterols found in treated Wistar rats could explain this prevention. Pituitary agenesis was the most constant element of holoprosencephaly when AY 9944 was administered on d 4 of gestation at two dosages, 50 or 75 mg/kg. The rate of malformed fetuses was dose related. A strong negative correlation was established between maternal plasma sterol levels on d 10 of gestation (day of pituitary gland formation) and the rate of fetal anomalies (r = -0.97, P less than 0.01). Supplementation of AY 9944-treated rats with cholesterol had an obvious preventive action on fetal malformations. When cholesterol was added to the diet the same day as AY 9944 treatment and maintained until d 15, the prevention of malformations was almost complete. When the supplementation was initiated later, the prevention of anomalies decreased. The nature of plasma maternal sterols shows that the cholesterol supplementation modifies significantly the ratio of cholesterol to 7-dehydrocholesterol in treated rats. Therefore, maternal plasma sterol perturbations may play a role in the teratogenic action of AY 9944.

Abnormalities, Drug-Induced↗
PubMed1986

Semen analysis in Hodgkin's disease before the onset of treatment.

A spermogram was performed before treatment in 57 young patients with Hodgkin's disease. The mean results were normal, and similar to those reported in fertile populations. Nineteen patients had an abnormal spermogram; 12 of these men had had fever recently or were febrile at the time of the exam. When the temperature was below 38.5 degrees C, there was only asthenospermia. With a higher temperature, semen anomalies were more severe, with oligoasthenospermia or even azoospermia. Only five febrile men had a normal spermogram, and all had slight fevers. Therefore, semen anomalies noted in about one third of patients with Hodgkin's disease are probably not due to a disease specific gonadal alteration, but can be attributed to fever which gonadal effects have been recognized for a long time and are well-documented.

Adolescent↗
PubMed1986

Association of microwaves and ionizing radiation: potentiation of teratogenic effects in the rat.

Pregnant Wistar rats were exposed to either microwave-induced hyperthermia or gamma radiation or a combination of both. In microwave-induced hyperthermia, a core temperature of 42 degrees C was slightly teratogenic and a core temperature greater than or equal to 43 degrees C was highly teratogenic. Gamma radiation at 40 cGy was subteratogenic, while a dose of 75 cGy was highly teratogenic. A combination of microwave-induced hyperthermia up to 42 degrees C with 40 cGy of gamma radiation was highly teratogenic, indicating a mutual potentiation of the embryotoxic action of these two teratogens.

Abnormalities, Radiation-Induced↗
PubMed1978

[The fetal hydantoin syndrome (author's transl)].

Two siblings have various congenital malformations due to the teratogenic effect of anticonvulsant drugs. Their mother has a 14-year history of continuous anticonvulsant medication. The malformations noted in the older girl are less and in the 8 years younger sister more extensively developed as well as in the fetal hydantoin syndrome. The causes of different severity of the fetal hydantoin syndrome in two sisters are discussed.

Abnormalities, Drug-Induced↗