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OBJECTIVE: To demonstrate how a web-based intensive monitoring system using the patient as a source of information can be used to gather longitudinal safety data of a drug. Information about the time course of adverse drug reactions (ADRs) is often lacking. If this information would be available, it could help increase patient's adherence to drugs when experiencing an ADR. In this study, pregabalin was used as an example. DESIGN AND METHODS: First-time users of pregabalin were approached in Dutch pharmacies between 1 August 2006 and 31 January 2008. After online registration, patients received questionnaires by email 2 weeks, 6 weeks, 3 months and 6 months after the start of the drug use. Data on patient characteristics, drug use and ADRs were collected and analysed. RESULTS: A total of 1373 patients registered for the pregabalin study. Of these patients, 1051 (76.5%) filled in at least one questionnaire. On an aggregated level, the ADR profile remained relatively stable over time. Incidence densities showed that the five most frequently reported reactions occurred early in the treatment. Initially, the majority of the patients did not undertake any action when experiencing an ADR. Recovery did not seem to be completely dependent of drug cessation. CONCLUSION: With web-based intensive monitoring, it is possible to study the time course of ADRs. This method can be a valuable addition to pharmacovigilance because it can generate other types of information as compared with spontaneous reporting and other intensive monitoring methodologies.

OBJECTIVE: To demonstrate how a web-based intensive monitoring system using the patient as a source of information can be used to gather longitudinal safety data of a drug. Information about the time course of adverse drug reactions (ADRs) is often lacking. If this information would be available, it could help increase patient's adherence to drugs when experiencing an ADR. In this study, pregabalin was used as an example. DESIGN AND METHODS: First-time users of pregabalin were approached in Dutch pharmacies between 1 August 2006 and 31 January 2008. After online registration, patients received questionnaires by email 2 weeks, 6 weeks, 3 months and 6 months after the start of the drug use. Data on patient characteristics, drug use and ADRs were collected and analysed. RESULTS: A total of 1373 patients registered for the pregabalin study. Of these patients, 1051 (76.5%) filled in at least one questionnaire. On an aggregated level, the ADR profile remained relatively stable over time. Incidence densities showed that the five most frequently reported reactions occurred early in the treatment. Initially, the majority of the patients did not undertake any action when experiencing an ADR. Recovery did not seem to be completely dependent of drug cessation. CONCLUSION: With web-based intensive monitoring, it is possible to study the time course of ADRs. This method can be a valuable addition to pharmacovigilance because it can generate other types of information as compared with spontaneous reporting and other intensive monitoring methodologies.

In a 37-year-old female, a combined treatment consisting of chemotherapy and radiation was considered for cervical cancer. However, she was using clozapine for the treatment of schizophrenia. As both clozapine and chemotherapy can induce decrease of white blood cell counts, we had to decide if clozapine and chemotherapy could be safely co-prescribed. Hypotheses concerning the mechanisms underlying clozapine-induced decrease of white blood cell counts and case reports on combining chemotherapy and clozapine are discussed. After cessation of clozapine the psychosis recurred despite treatment with risperidone. The decision was made to administer radiotherapy only and to reinstate the treatment with clozapine. The radiotherapy treatment went according to plan and the psychosis receded.

In a 37-year-old female, a combined treatment consisting of chemotherapy and radiation was considered for cervical cancer. However, she was using clozapine for the treatment of schizophrenia. As both clozapine and chemotherapy can induce decrease of white blood cell counts, we had to decide if clozapine and chemotherapy could be safely co-prescribed. Hypotheses concerning the mechanisms underlying clozapine-induced decrease of white blood cell counts and case reports on combining chemotherapy and clozapine are discussed. After cessation of clozapine the psychosis recurred despite treatment with risperidone. The decision was made to administer radiotherapy only and to reinstate the treatment with clozapine. The radiotherapy treatment went according to plan and the psychosis receded.

This article evaluates the efficacy, safety, incidence and reason of withdrawal of leflunomide in an outpatient population in Friesland (the Netherlands) with rheumatoid arthritis in a setting of care-as-usual. A large part of the population showed a good or moderate response on leflunomide. Adverse events were generally mild. Most frequently reported were gastrointestinal and dermal events. No potential risk factors for leflunomide withdrawal were found.

This article evaluates the efficacy, safety, incidence and reason of withdrawal of leflunomide in an outpatient population in Friesland (the Netherlands) with rheumatoid arthritis in a setting of care-as-usual. A large part of the population showed a good or moderate response on leflunomide. Adverse events were generally mild. Most frequently reported were gastrointestinal and dermal events. No potential risk factors for leflunomide withdrawal were found.

Objective: To assess whether concerns and problems experienced with drug discontinuation occur more frequently in patients using antidepressants than in patients using benzodiazepines, antipsychotics or non-psychiatric medication. Clinical trials and epidemiological studies have shown that premature discontinuation is a major problem during antidepressant therapy. There is little information on how patients perceive treatment with antidepressants in clinical practice, and it is unclear whether patients perceive discontinuation as a problem. Design and methods: All calls to a Dutch national telephone medicines infotmation service received between 1990 and 2004 were examined retrospectively. Calls about discontinuation were identified and classified either as a genetal question about discontinuation, or as a problem experienced with discontinuation. These calls were grouped into four main classes: antidepressants, antipsychotics, benzodiazepines or non-psychiatric medicines. Results: Of all 39,786 registered phone calls, 6,159 (15-5%) related to antidepressants, 1,658 (4.2%) to antipsychotics and 3,916 (9.8%) to benzodiazepines. Patients calling about antidepressants called about discontinuation three times as often [odds ratio (OR) 2.8; 95% confidence interval (CI95) 2.6-3.0], and reported a problem with discontinuation five times more often (OR 5.4; CI95 4,6-6.3) than patients who called about non-psychiatric medicines. The proportion of questions about discontinuation and problems experienced with discontinuation was also higher in patients calling about benzodiazepines and antipsychotics than in patients calling about non-psychiatric medication. Conclusion: Patients perceive discontinuation of antidepressants, as well as discontinuation of antipsychotics and benzodiazepines, as a problem. Discontinuation seems a general problem for all psychiatric medicines, and needs more attention in the communication between patients and healthcare providers.

Objective: To assess whether concerns and problems experienced with drug discontinuation occur more frequently in patients using antidepressants than in patients using benzodiazepines, antipsychotics or non-psychiatric medication. Clinical trials and epidemiological studies have shown that premature discontinuation is a major problem during antidepressant therapy. There is little information on how patients perceive treatment with antidepressants in clinical practice, and it is unclear whether patients perceive discontinuation as a problem. Design and methods: All calls to a Dutch national telephone medicines infotmation service received between 1990 and 2004 were examined retrospectively. Calls about discontinuation were identified and classified either as a genetal question about discontinuation, or as a problem experienced with discontinuation. These calls were grouped into four main classes: antidepressants, antipsychotics, benzodiazepines or non-psychiatric medicines. Results: Of all 39,786 registered phone calls, 6,159 (15-5%) related to antidepressants, 1,658 (4.2%) to antipsychotics and 3,916 (9.8%) to benzodiazepines. Patients calling about antidepressants called about discontinuation three times as often [odds ratio (OR) 2.8; 95% confidence interval (CI95) 2.6-3.0], and reported a problem with discontinuation five times more often (OR 5.4; CI95 4,6-6.3) than patients who called about non-psychiatric medicines. The proportion of questions about discontinuation and problems experienced with discontinuation was also higher in patients calling about benzodiazepines and antipsychotics than in patients calling about non-psychiatric medication. Conclusion: Patients perceive discontinuation of antidepressants, as well as discontinuation of antipsychotics and benzodiazepines, as a problem. Discontinuation seems a general problem for all psychiatric medicines, and needs more attention in the communication between patients and healthcare providers.

OBJECTIVE: To demonstrate how a web-based intensive monitoring system using the patient as a source of information can be used to gather longitudinal safety data of a drug. Information about the time course of adverse drug reactions (ADRs) is often lacking. If this information would be available, it could help increase patient's adherence to drugs when experiencing an ADR. In this study, pregabalin was used as an example. DESIGN AND METHODS: First-time users of pregabalin were approached in Dutch pharmacies between 1 August 2006 and 31 January 2008. After online registration, patients received questionnaires by email 2 weeks, 6 weeks, 3 months and 6 months after the start of the drug use. Data on patient characteristics, drug use and ADRs were collected and analysed. RESULTS: A total of 1373 patients registered for the pregabalin study. Of these patients, 1051 (76.5%) filled in at least one questionnaire. On an aggregated level, the ADR profile remained relatively stable over time. Incidence densities showed that the five most frequently reported reactions occurred early in the treatment. Initially, the majority of the patients did not undertake any action when experiencing an ADR. Recovery did not seem to be completely dependent of drug cessation. CONCLUSION: With web-based intensive monitoring, it is possible to study the time course of ADRs. This method can be a valuable addition to pharmacovigilance because it can generate other types of information as compared with spontaneous reporting and other intensive monitoring methodologies.

Acute heart failure following itraconazole use: a case report A 44year old woman was admitted to the cardiology department of the Medical Centre Leeuwarden, the Netherlands, with acute heart failure. She had developed dyspnoea that began one week after start of itraconazole oral therapy once daily 200 mg for treatment of onychomycosis. Salbutamol and prednisolone were prescribed, but this gave no improvement in the symptoms. She stopped after four weeks with the itraconazole treatment, but seven weeks later she was admitted to the cardiology department with heart failure NYHA class 4. The electrocardiogram showed a moderate left ventricular function, while heart valves and coronary arteries showed no abnormalities in morphology and function. Troponin levels were not elevated. Treatment with candesartan and furosemide started, supported by a reduced intake of fluids and a low sodium diet. Two weeks later the patient was again admitted with dyspnoea. Seven months after the start of the symptoms the patient was still using candesartan. Besides kidney cysts (since 1985) the patient had no other comorbidities and used no medication. Her kidney function was stable for many years [creatinine 62 μmol/L, eGFR 85 mL/(min·1.73 m2)]. The Naranjo score was 4, which indicates itraconazole being a 'possible' cause of the acute heart failure. In several articles itraconazole is mentioned as possible cause of heart failure, but the mechanism is unknown. The side effect does not seem to be related to azole antimycotics in general. In patients with acute heart failure and/or dyspnoea and itraconazole usage, the side effect has to be taken into account in the differential diagnosis as a possible cause.

Objective: To assess whether concerns and problems experienced with drug discontinuation occur more frequently in patients using antidepressants than in patients using benzodiazepines, antipsychotics or non-psychiatric medication. Clinical trials and epidemiological studies have shown that premature discontinuation is a major problem during antidepressant therapy. There is little information on how patients perceive treatment with antidepressants in clinical practice, and it is unclear whether patients perceive discontinuation as a problem. Design and methods: All calls to a Dutch national telephone medicines infotmation service received between 1990 and 2004 were examined retrospectively. Calls about discontinuation were identified and classified either as a genetal question about discontinuation, or as a problem experienced with discontinuation. These calls were grouped into four main classes: antidepressants, antipsychotics, benzodiazepines or non-psychiatric medicines. Results: Of all 39,786 registered phone calls, 6,159 (15-5%) related to antidepressants, 1,658 (4.2%) to antipsychotics and 3,916 (9.8%) to benzodiazepines. Patients calling about antidepressants called about discontinuation three times as often [odds ratio (OR) 2.8; 95% confidence interval (CI95) 2.6-3.0], and reported a problem with discontinuation five times more often (OR 5.4; CI95 4,6-6.3) than patients who called about non-psychiatric medicines. The proportion of questions about discontinuation and problems experienced with discontinuation was also higher in patients calling about benzodiazepines and antipsychotics than in patients calling about non-psychiatric medication. Conclusion: Patients perceive discontinuation of antidepressants, as well as discontinuation of antipsychotics and benzodiazepines, as a problem. Discontinuation seems a general problem for all psychiatric medicines, and needs more attention in the communication between patients and healthcare providers.

In a 37-year-old female, a combined treatment consisting of chemotherapy and radiation was considered for cervical cancer. However, she was using clozapine for the treatment of schizophrenia. As both clozapine and chemotherapy can induce decrease of white blood cell counts, we had to decide if clozapine and chemotherapy could be safely co-prescribed. Hypotheses concerning the mechanisms underlying clozapine-induced decrease of white blood cell counts and case reports on combining chemotherapy and clozapine are discussed. After cessation of clozapine the psychosis recurred despite treatment with risperidone. The decision was made to administer radiotherapy only and to reinstate the treatment with clozapine. The radiotherapy treatment went according to plan and the psychosis receded.

Acute heart failure following itraconazole use: a case report A 44year old woman was admitted to the cardiology department of the Medical Centre Leeuwarden, the Netherlands, with acute heart failure. She had developed dyspnoea that began one week after start of itraconazole oral therapy once daily 200 mg for treatment of onychomycosis. Salbutamol and prednisolone were prescribed, but this gave no improvement in the symptoms. She stopped after four weeks with the itraconazole treatment, but seven weeks later she was admitted to the cardiology department with heart failure NYHA class 4. The electrocardiogram showed a moderate left ventricular function, while heart valves and coronary arteries showed no abnormalities in morphology and function. Troponin levels were not elevated. Treatment with candesartan and furosemide started, supported by a reduced intake of fluids and a low sodium diet. Two weeks later the patient was again admitted with dyspnoea. Seven months after the start of the symptoms the patient was still using candesartan. Besides kidney cysts (since 1985) the patient had no other comorbidities and used no medication. Her kidney function was stable for many years [creatinine 62 μmol/L, eGFR 85 mL/(min·1.73 m2)]. The Naranjo score was 4, which indicates itraconazole being a 'possible' cause of the acute heart failure. In several articles itraconazole is mentioned as possible cause of heart failure, but the mechanism is unknown. The side effect does not seem to be related to azole antimycotics in general. In patients with acute heart failure and/or dyspnoea and itraconazole usage, the side effect has to be taken into account in the differential diagnosis as a possible cause.

Acute heart failure following itraconazole use: a case report A 44year old woman was admitted to the cardiology department of the Medical Centre Leeuwarden, the Netherlands, with acute heart failure. She had developed dyspnoea that began one week after start of itraconazole oral therapy once daily 200 mg for treatment of onychomycosis. Salbutamol and prednisolone were prescribed, but this gave no improvement in the symptoms. She stopped after four weeks with the itraconazole treatment, but seven weeks later she was admitted to the cardiology department with heart failure NYHA class 4. The electrocardiogram showed a moderate left ventricular function, while heart valves and coronary arteries showed no abnormalities in morphology and function. Troponin levels were not elevated. Treatment with candesartan and furosemide started, supported by a reduced intake of fluids and a low sodium diet. Two weeks later the patient was again admitted with dyspnoea. Seven months after the start of the symptoms the patient was still using candesartan. Besides kidney cysts (since 1985) the patient had no other comorbidities and used no medication. Her kidney function was stable for many years [creatinine 62 μmol/L, eGFR 85 mL/(min·1.73 m2)]. The Naranjo score was 4, which indicates itraconazole being a 'possible' cause of the acute heart failure. In several articles itraconazole is mentioned as possible cause of heart failure, but the mechanism is unknown. The side effect does not seem to be related to azole antimycotics in general. In patients with acute heart failure and/or dyspnoea and itraconazole usage, the side effect has to be taken into account in the differential diagnosis as a possible cause.

This article evaluates the efficacy, safety, incidence and reason of withdrawal of leflunomide in an outpatient population in Friesland (the Netherlands) with rheumatoid arthritis in a setting of care-as-usual. A large part of the population showed a good or moderate response on leflunomide. Adverse events were generally mild. Most frequently reported were gastrointestinal and dermal events. No potential risk factors for leflunomide withdrawal were found.