Drug treatment during pregnancy and isolated orofacial clefts in hungary.

OBJECTIVE: To evaluate the possible association between all kinds of drug treatments during pregnancy and isolated cleft lip with or without cleft palate (CL/P) and posterior cleft palate (PCP) in the offspring. SETTING: The dataset of the large population-based Hungarian Case-Control Surveillance of Congenital Abnormalities, 1980-1996, was evaluated. PARTICIPANTS: One thousand three hundred seventy-four cases with isolated CL/P and 601 with PCP, plus 38,151 population controls (without birth defects) and 20,868 malformed controls with other defects. INTERVENTION: In this observation case-control study the data collection was based on prospective medical records particularly prenatal logbook, retrospective maternal data via a self-reported questionnaire, and home visits of nonresponding mothers. MAIN OUTCOME MEASURES: Isolated CL/P and PCP associated with drug treatments during pregnancy. RESULTS: An increased risk for isolated CL/P was found in cases born to mothers treated with amoxicillin, phenytoin, oxprenolol, and thiethylperazine during the second and third month of pregnancy, i.e., the critical period of isolated CL/P. Risk of isolated PCP was increased in mothers with oxytetracycline and carbamazepine treatment during the third and fourth month of pregnancy, i.e., the critical period of PCP. CONCLUSIONS: This study confirmed the orofacial cleft (OFC) inducing effect of phenytoin, carbamazepine, oxytetracycline, and thiethylperazine and suggested a possible association between OFCs and oxprenolol and amoxicillin. However, drugs may have only a limited role in the origin of isolated OFCs.

Anaphylactic reaction and unrelated, subsequent, known side effects during therapy with thiethylperazine.

We report the first case presenting with successive anaphylactic reaction and extra-pyramidal syndrome after treatment with thiethylperazine maleate (thiethylperazine). Both reactions were caused due to this anti-emetic drug, but an additive effect of clemastine fumarate, prescribed to treat the anaphylactic reaction, is suggested by the sequence of events. We discuss the importance of knowing the pharmacological similitudes of common prescribed drugs in order to avoid the occurrence of side effects.

Case-control study of teratogenic potential of thiethylperazine, an anti-emetic drug.

OBJECTIVE: Thiethylperazine is a commonly used anti-emetic drug during pregnancy in Hungary. One experimental study in mice and rats found an increased occurrence of cleft palate after the use of thiethylperazine during pregnancy but the human data of thiethylperazine have not been reported. Thus, the aim of the study was to investigate the possible human teratogenic effect of thiethylperazine. DESIGN: Case-control approach. SETTING: The teratogenic potential of thiethylperazine was evaluated in the population-based large data set of the Hungarian Case-Control Surveillance of Congenital Abnormalities between 1980 and 1996. SAMPLE: Of 38,151 newborn infants without any congenital abnormalities (control group), 746 (2.0%) had mothers who were treated with thiethylperazine, while of 22,843 cases with congenital abnormalities, 411 (1.8%) had mothers who were treated with thiethylperazine during pregnancy. METHODS: Case-control pair analysis. MAIN OUTCOME MEASURES: Different congenital abnormalities. RESULTS: The pairs of cases with congenital abnormalities and their matched controls without congenital abnormalities were compared and this approach showed a somewhat higher rate of cleft lip +/- palate (OR: 2.0 with 95% CI: 1.0-4.0) in infants born to mothers with thiethylperazine treatment during the first trimester of pregnancy. CONCLUSION: Our data do not indicate clear teratogenic effect of thiethylperazine, however, a weak association was found between thiethylperazine use and cleft lip +/- palate.

Acatisia inducida por tietilperazina en paciente embarazada / Akathisia induced by thiethylperazine in a pregnant patient

La acatisia es un efecto lateral neurológico agudo común a diversos fármacos que actúan a nivel dopaminérgico, su manifestación fundamental es la inquietud psicomotora, es importante diagnosticar y tratar precozmente este síndrome. Tietilperazina es una fenotiazina cuyo efecto antiemético es usado en diversas circunstancias clínicas, presentamos el caso de una paciente hospitalizada por hiperemesis gravídica que es derivada a psiquiatría por la presencia de síntomas aparentemente ansiosos. El examen clínico permite sospechar acatisia por Tietilperazina Torecan®, el cuadro cede completamente con la suspensión del fármaco. Nos parece interesante comunicar este caso por la implicancia para los especialistas.

Akatisia is an common neurological complication of treatment with dopaminergic drugs, subjetive feeling of restlessness is their main symptom, it's important to recognize this syndrome early and to treat immediately. Thietylperazine is an phenothiazine drug with antiemetic effect used for medical practice, we present a case of 35 years old pregnancy inpatient referred to psychiatrist for anxiety, the diagnosis was akatisia induced by thietylperazide.

Subacute cutaneous lupus erythematosus associated with cinnarizine and thiethylperazine therapy.

We report the case of a woman who developed subacute cutaneous lupus erythematosus (SCLE) after exposure to the sun while taking cinnarizine and thiethylperazine. The patient recalled that 10 years previously, a similar eruption had appeared after sunbathing, while she was taking only cinnarizine. SCLE development in this patient was probably drug related and there is some evidence that cinnarizine played an important pathogenic role.

[Dyskinesis after a single dose of thiethylperazine during the first trimester of pregnancy]. / Dyskinezy po jednorazowym zastosowaniu tietyloperazyny w pierwszym trymestrze ciazy.

A case of a 22-year female patient with poly-symptomatic reversible dyskinetic syndrome following a single thiethylperazine (Torecan) dose is presented. The patient was 10 weeks pregnant. Detoxication abolished extrapyramidal symptoms within 7 hours. Possible mechanism of such an adverse reaction to thiethylperazine is discussed.

The antiemetic efficacy of thiethylperazine and methylprednisolone versus thiethylperazine and placebo in breast cancer patients treated with adjuvant chemotherapy (fluorouracil, doxorubicin and cyclophosphamide). A randomized, double-blind, cross-over trial.

Forty-six women with breast cancer treated with adjuvant FAC (fluorouracil, doxorubicin and cyclophosphamide) entered a multicenter, randomized, double-blind, cross-over trial in which thiethylperazine (T) (6.5 mg p.o every 8 h x 3 days) plus methylprednisolone (MP) (250 mg i.v. x 2 doses) was compared with thiethylperazine plus placebo. Forty-four patients were evaluable for efficacy. T + MP was significantly better in reducing vomiting (p less than 0.01) and nausea (p less than 0.02). The complete protection rate against vomiting was 36% for T + MP compared to 18% for T + placebo, and the percentage of nausea grades 0 + 1 (none or slight) was 59% and 27% respectively. The patient preference after cross-over was strikingly in favor of T + MP (70% versus 13%) (p less than 0.001). The most important side-effects of T + MP were facial flushing (22%) and euphoria (27%). Other side-effects, such as dryness of the mouth and sedation, were common after both treatments. In conclusion, the study suggested that T + MP is superior to T alone in protecting from nausea and vomiting induced by FAC.

[Torecan-induced neuroleptic malignant syndrome].

Neuroleptic malignant syndrome (NMS) is an uncommon, life-threatening complication of treatment with neuroleptic drugs. Its main features are hyperthermia, extrapyramidal signs, and autonomic instability with fluctuating consciousness. It is believed that NMS is related to dopamine receptor blockade in the brain. We describe a case in a 52-year-old diabetic woman who developed NMS after taking Torecan (thiethylperazine), a phenothiazine drug, for 3 months to relieve dizziness. It is important to recognize this syndrome early and to treat immediately.

Torecan, a review of references and clinical control examinations.

The author summarizes the theoretical aspects of vomiting and alleviation of the same by surveying the respective scientific communications with special regard to thiethylperazine. The antiemetic effect of the Hungarian preparation containing thiethyilperazine (Torecan inj., EGIS Pharmaceuticals) is evaluated by the controlled clinical examination of patients receiving combined cytostatic treatment. According to the results Torecan proved to be significantly more effective in the alleviation of the emetic effect of the cytostatics than placebo.

Recurrent dystonic reactions induced by thiethylperazine.

Three attacks of acute dystonia occurred in a 19-year-old male following the initiation and discontinuation of thiethylperazine administered rectally in therapeutic doses. The time course of onset of the attacks and the proposed mechanisms by which dystonia develops are discussed.

Thiethylperazine and tardive dyskinesia.

Over a 14-month period in the outpatient department of a geriatric hospital, 7 female patients over 75 years of age were identified with tardive dyskinesia associated with the use of thiethylperazine. The indication for thiethylperazine treatment had been vertigo or dizziness. 3 of the patients also had symptoms related to cerebral arteriosclerosis and 2 had mild Parkinson's disease without levodopa therapy. None of them were markedly demented nor had chronic psychosis. Tardive dyskinesia appeared after a treatment period of 3 weeks to 6 years. These findings suggest that association of tardive dyskinesia with the use of thiethylperazine is not uncommon in geriatric outpatients.