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Biomedical subjects

B H Stricker

Publications and source records attributed to B H Stricker.

At least 127 records · Page 7Linked to original sources
PubMed1994

[Skin disorders caused by bismuth oxide (De-Nol)].

Since 1982, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 12 reports of skin reactions attributed to the use of bismuth subcitrate. These concerned 6 women and 6 men with a mean age of 39 years, who developed skin reactions an average of 2 days after starting treatment with bismuth subcitrate: small-patchy or maculopapular exanthema, angioedema, erythema. All patients recovered completely after discontinuing the use of bismuth subcitrate.

Adult↗
PubMed1994

Adverse reactions attributed to sumatriptan. A postmarketing study in general practice.

There are several reports on cardiac adverse reactions attributed to the antimigraine drug sumatriptan in the recent literature. In order to assess the frequency and the character of adverse reactions to sumatriptan, a postmarketing cohort study was performed one year after registration of the drug in The Netherlands. With assistance of 86% of the drug dispensing general practitioners in The Netherlands, 1727 patients who had received sumatriptan were traced in July, 1992. Via their general practitioners, a questionnaire about use of sumatriptan, adverse reactions and other medication was sent to the patients in December 1992. During the study period, seven patients were lost to follow-up. Of the 1720 remaining patients, 1202 (70%) responded to the questionnaire, of whom 1187 had actually used sumatriptan. The most frequently reported suspected adverse reactions were paraesthesiae (139 patients, 95% CI 9.9%-13.5%) and dizziness (96 patients, 95% CI 6.5%-9.7%). Chest pain after use of sumatriptan was reported by 94 patients (7.9%, 95% CI 6.4%-9.4%), and according to the close temporal relationship with the intake of sumatriptan and a positive rechallenge, a causal relationship was probable in most of those patients. The frequency of chest pain attributed to sumatriptan was higher in females (9.0% vs 4.6%; relative risk 1.9, 95% CI 1.1-3.4). Age and hypertension were not associated with chest pain attributed to sumatriptan. Dyspnoea attributed to sumatriptan was reported by 26 patients (2.2%), and was associated with obstructive lung disease (relative risk 5.4 95% CI 1.7-16.9).(ABSTRACT TRUNCATED AT 250 WORDS)

Adult↗
PubMed1994

Communicating a drug alert. A case study on acitretin in The Netherlands.

In October 1990, a recall procedure was initiated for the teratogenic drug acitretin, and the recommended post-therapy contraception period after acitretin therapy was extended from 2 months to 2 years due to the possibility of its conversion to the lipophilic compound etretinate. The aim of the present study was to evaluate the communication procedures and their effects as a drug alert from the health authorities, the pharmaceutical company and professional associations of health professionals to the population at risk. A model was used to evaluate communication between three hierarchical levels. Data were obtained via semi-structured interviews and structured questionnaires. Communication procedures were evaluated according to channel characteristics and by analysis of their contents. The effect was measured as whether the drug dispensers identified acitretin users, contacted physicians, and whether physicians communicated in person with the population at risk. The penetration of direct mail from the health authorities and from the pharmaceutical company ranged from 97-98% and 65-94% at Level 2 (health professionals). The population at risk was informed via personal communication with health professionals, and/or the mass media. Of the women at risk, 19% were contacted by a dermatologist, 30% by their GP, and 39% by the pharmacist. 35% was never informed by any health professional. The Dutch health care system is adequately equipped for effective communication between health authorities, pharmaceutical industry and health professionals.(ABSTRACT TRUNCATED AT 250 WORDS)

Acitretin↗
PubMed1994

A case-control study of drugs and other determinants as potential causes of Guillain-Barré syndrome.

The Guillain-Barré syndrome is an inflammatory demyelinating polyneuropathy with an acute or subacute onset. The current case-control study was performed to investigate the possible role of drugs and other determinants in the causation of the Guillain-Barré syndrome. Patients were included as cases if they fulfilled the criteria for acute Guillain-Barré syndrome and were unable to walk 10 m independently and had been admitted to the hospital within 2 weeks of onset of the neuropathy. For every case, two controls without the disease were obtained from the general practitioner (GP) of the patient with Guillain-Barré syndrome. Controls had the same type of health care insurance, were of the same gender and age (within 5 years), and resident in the same area. By telephone, the GPs of the patients with Guillain-Barré syndrome were interviewed. There were 71 female and 75 male cases and 142 female and 149 male controls. Significantly more cases than controls had been prescribed drugs in the 3 months prior to the index date and also diagnoses or symptoms in cases were more common. Case patients used significantly more frequently antipropulsives (loperamide), penicillins (amoxicillin with or without clavulanic acid) and vaccines. Female controls used significantly more often oral contraceptives. More cases than controls suffered from infections of the respiratory, gastrointestinal or urinary tract prior to the onset of neurological symptoms. In a logistic regression analysis, symptoms concerning the gastrointestinal and respiratory system were strongly associated with the Guillain-Barré syndrome. The use of oral contraceptives was significantly lower in female cases which could be compatible with the hypothesis that these drugs are protective.

Adult↗
PubMed1994

Hepatic injury caused by benzbromarone.

This case study describes a woman who developed a predominantly hepatocellular injury, approximately 3 months after starting treatment with 100 mg benzbromarone daily. She had also taken 250 mg methyldopa daily for several years. Infections with hepatitis A and B were excluded serologically, no autoantibodies were demonstrated, and ultrasonography and endoscopic retrograde cholangiopancreatography did not show extrahepatic obstruction. The patient recovered after discontinuation of both drugs. Two years later, readministration of benzbromarone was followed by a relapse. Later, methyldopa was used without problems. We conclude that hepatic injury in this patient was caused by benzbromarone.

Aged↗
PubMed1994

Terbinafine-associated hepatic injury.

We describe two cases of terbinafine-associated hepatic injury, in which a mixed cholestatic-hepatocellular type of hepatitis was present. In both cases extrahepatic cholestasis and viral hepatitis were excluded and involvement of other drugs was unlikely. In the first patient all abnormalities have disappeared, but in the second patient alkaline phosphatase, aminotransferase and gamma-glutamyl transferase levels have remained elevated (follow up 3 months after cessation of treatment with terbinafine). Most likely, the terbinafine-associated hepatic injury in these patients was caused by an idiosyncratic rather than a direct hepatotoxic reaction.

Alanine Transaminase↗
PubMed1994

Inability to detect plasma etretinate and acitretin is a poor predictor of the absence of these teratogens in tissue after stopping acitretin treatment.

1. Concentrations of etretinate, acitretin and its main metabolite 13-cis-acitretin were measured in plasma and subcutaneous fat samples from 37 women of childbearing age exposed to acitretin before November 1990. Twenty of the women still used acitretin and 17 had stopped therapy for a period ranging from 1 to 29 months. 2. The prevalences of detectable etretinate concentrations were 45% and 83% in plasma and subcutaneous tissue, respectively, among current acitretin users and 18% and 86% among those who had stopped acitretin therapy. Thus, inability to detect plasma etretinate is a poor predictor of the absence of etretinate in fat. 3. Acitretin and/or etretinate were detectable in fat and in some cases in plasma from women who had ceased acitretin therapy for up to 29 months. 4. We suggest that (cis)-acitretin and etretinate should be monitored in subcutaneous tissue when plasma measurements are negative. The recommended contraception period of 2 years after cessation of acitretin therapy should be reconsidered to avoid the risk of teratogenicity.

Acitretin↗
PubMed1994

Flucloxacillin-associated hepatic injury.

Eleven cases of hepatic injury attributed to the intake of flucloxacillin were reported to the Netherlands Center for Monitoring of Adverse Reactions to Drugs between 1982 and 1992. They concerned four men and seven women, with a mean age of 57 years, treated for 2-28 days with an oral dose varying from 1500-4000 mg per day. Symptoms mostly appeared 10 to 30 days after starting treatment with flucloxacillin. Biochemically, the pattern was compatible with cholestatic hepatitis in seven cases, with a mixed cholestatic-hepatocellular type of injury in one case, a hepatocellular pattern in two cases, and mild liver enzyme elevations in one patient. Two patients died, one due to fatal bleeding from the liver after biopsy, and the second patient to a combination of hepatic and cardiac failure. The other patients recovered, on average 72 days after peaking of serum aminotransferase values. Histology in seven cases showed cholestatic hepatitis in five, with cholangitis or cholangiolitis in four of these patients. In the other two patients, there was centrilobular cholestasis with extensive bridging fibrosis and portal-central bridging necrosis, respectively.

Chemical and Drug Induced Liver Injury↗
PubMed1993

Public health problems and the rapid estimation of the size of the population at risk. Torsades de pointes and the use of terfenadine and astemizole in The Netherlands.

Recently, the use of astemizole and terfenadine, both non-sedating H1-antihistamines, caused considerable concern. Several case reports suggested an association of both drugs with an increased risk of torsades de pointes, a special form of ventricular tachycardia. The increased risk of both H1-antihistamines was associated with exposure to supratherapeutic doses; for terfenadine the risk was also associated with concomitant exposure to the cytochrome P-450 inhibitors ketoconazole, erythromycin and cimetidine. To predict the size of the population that runs the risk of developing this potentially fatal adverse reaction in the Netherlands, the prevalence of prescribing supratherapeutic doses and the concomitant exposure to terfenadine and cytochrome P-450 inhibitors was studied. Data were obtained from the PHARMO data base in 1990, a pharmacy-based record linkage system encompassing a catchment population of 300,000 individuals. The results of the study showed that the prescribing of supratherapeutic doses and the concomitant exposure to terfenadine and cytochrome P-450 inhibitors was low. Furthermore, the results of a sensitivity analysis showed that the risk of fatal torsades de pointes has to be as high as 1 in 10,000 to cause one death in the Netherlands in one year.

Adolescent↗
PubMed1993

[Neurological symptoms in newborn infants due to the administration of psychopharmacologic agents during pregnancy].

In the few past years the Netherlands Centre for Monitoring of Adverse Reactions to Drugs and the Teratology Information Service of the National Institute of Public Health and Environmental Protection received several reports of neurological symptoms in neonates, which were the result of maternal treatment with psychotropic drugs during late pregnancy. The results are summarised in this article. The neonatal symptoms (withdrawal symptoms, 'floppy infant syndrome' and extrapyramidal syndrome) are described together with the psychotropic drugs which may cause them.

Antipsychotic Agents↗
PubMed1993

[Recording of possible side effects in the Bureau for Side Effects of Drugs and research activities in 1992].

In 1992, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 1248 reports of suspected adverse reactions. The most important reports concerned chest pain to sumatriptan, cholestatic hepatitis to itraconazole and taste loss to terbinafine. Other important reports pertained to confusion and hallucinations in children on deptropine, postasphyctic encephalopathy of a newborn after intrapartum administration of nalbuphine, torsades de pointes to terodiline, fever to neuroleptics, muscle necrosis to intramuscular administration of diclofenac, gout during use of acetylsalicylic acid, psychic effects of vigabatrine and sudden death during fluorescence angiography. It is the policy of the Netherlands centre to publish as many relevant reports as possible in order to facilitate medical practitioners to adapt their pharmacotherapeutic choice. In close collaboration with several universities, the Netherlands centre currently develops systems and methods for postmarketing surveillance.

Child↗
PubMed1993

[Side effects of cholesterol synthesis inhibitors].

Between December 1989 and December 1992, the Netherlands Centre for Monitoring of Adverse Reactions to Drugs received 142 reports of suspected adverse reactions to simvastatin or pravastatin. In 108 of these, the causal relationship was considered 'definite', 'probable' or 'possible'. The patients were 49 males and 59 females with mean age of 55 and 59 years respectively, with a total of 157 reported suspected adverse reactions. The most important effects reported comprised muscle and vision disorders, interactions with coumarins, liver damage and psychic effects. With the exception of rhabdomyolysis and symptomatic liver damage the adverse effects of cholesterol synthesis inhibitors appear to be fairly innocuous. It should be emphasized, however, that too little is yet known of the psychic and long-term effects for an adequate judgment of the benefit-risk ratio of these agents.

Aged↗
PubMed1993

[Intracranial hemorrhage following use of MAO inhibitor tranylcypromine and beer].

A case is reported of non-fatal acute cerebral haemorrhage in a 47-year-old female who was taking tranylcypromine and who drank 500 ml of normal beer. Since the tyramine contents of several beers, including low alcohol and alcohol free beer, are similar, it is recommended that patients taking tranylcypromine should avoid all kinds of beer.

Beer↗