Affiliation: Medical Products Agency
- Muscle toxicity with statinsKarin Hedenmalm
Clinical Trial Unit, Medical Products Agency, Uppsala, Sweden
Pharmacoepidemiol Drug Saf 19:223-31. 2010..Statins rarely cause serious muscle toxicity and rhabdomyolysis. The aim of our investigation was to identify and quantify potential risk factors for statin-induced rhabdomyolysis...
- Increased liability of tramadol-warfarin interaction in individuals with mutations in the cytochrome P450 2D6 geneKarin Hedenmalm
Drug Epidemiology Unit, Medical Products Agency, 75103 Uppsala, Sweden
Eur J Clin Pharmacol 60:369-72. 2004..This study aimed to investigate the importance of cytochrome P(450) enzymes for the reported interaction between tramadol and warfarin...
- Statin-induced muscle toxicity and susceptibility to malignant hyperthermia and other muscle diseases: a population-based case-control study including 1st and 2nd degree relativesKarin Hedenmalm
Medical Products Agency, Uppsala, Sweden
Eur J Clin Pharmacol 71:117-24. 2015..The aim of the study was to further scrutinize this association in a population-based case-control study including 1st and 2nd degree relatives...
- Prematurely ended phase III trials in Sweden during the years 2002-2008Karin Hedenmalm
Clinical Trial Unit, Medical Products Agency, P O Box 26, 751 03, Uppsala, Sweden
Eur J Clin Pharmacol 67:869-75. 2011..An additional aim was to identify risk factors for a premature ending...
- The conscientious judgement of a DSMB--statistical stopping rules re-examinedKarin Hedenmalm
Clinical Trial Unit, Medical Products Agency, Box 26, 751 03, Uppsala, Sweden
Eur J Clin Pharmacol 64:69-72. 2008..A number of other studies in which complex decisions were made by DSMBs are also reviewed...
- Alopecia associated with treatment with selective serotonin reuptake inhibitors (SSRIs)Karin Hedenmalm
Division of Clinical Pharmacology, Department of Medical Sciences, Uppsala University, Uppsala, Sweden
Pharmacoepidemiol Drug Saf 15:719-25. 2006..To study the association between alopecia and selective serotonin reuptake inhibitors (SSRIs) by estimating reporting rates and by making association comparisons within databases of adverse drug reactions (ADRs)...
- Risk factors for extrapyramidal symptoms during treatment with selective serotonin reuptake inhibitors, including cytochrome P-450 enzyme, and serotonin and dopamine transporter and receptor polymorphismsKarin Hedenmalm
Clinical Trial Unit, Medical Products Agency, Uppsala, Sweden
J Clin Psychopharmacol 26:192-7. 2006..This study aimed to investigate the potential risk factors for EPS associated with SSRIs including polymorphisms of cytochrome P-450 isoenzymes, and serotonin and dopamine transporters and receptors...
- Fatal venous thromboembolism associated with different combined oral contraceptives: a study of incidences and potential biases in spontaneous reportingKarin Hedenmalm
Pharmacovigilance Unit and Clinical Trial Unit, Medical Products Agency, Uppsala, Sweden
Drug Saf 28:907-16. 2005..A further aim is to compare the characteristics of reported and not reported cases...
- [Cardiovascular side-effects of triptanes in migraine exist but are rare. 5-HT receptor mediated extracranial vasoconstriction is the most common cause]K Hedenmalm
Klinisk farmakologi, biverkningssektionen, Läkemedelsverket, Uppsala
Lakartidningen 97:3078-84. 2000..Stroke, a known complication to migraine, has also been reported in patients treated with triptans, but available data do not suggest that triptans, when correctly used, greatly increase the risk...
- Agranulocytosis and other blood dyscrasias associated with dipyrone (metamizole)Karin Hedenmalm
Drug Epidemiology Unit, Medical Products Agency, Box 26, 751 02 Uppsala, Sweden
Eur J Clin Pharmacol 58:265-74. 2002..The aim of the study was to describe the pattern of blood dyscrasias associated with dipyrone, identify possible risk factors and calculate the incidence of agranulocytosis associated with dipyrone...
- Glucose intolerance with atypical antipsychoticsKarin Hedenmalm
Drug Epidemiology Unit, Medical Products Agency, Uppsala, Sweden
Drug Saf 25:1107-16. 2002..Early studies have also suggested an association between use of conventional antipsychotics and the development of glucose intolerance...
- Pulmonary embolism associated with combined oral contraceptives: reporting incidences and potential risk factors for a fatal outcomeKarin Hedenmalm
Pharmacovigilance Unit, Medical Products Agency, Uppsala, Sweden
Acta Obstet Gynecol Scand 83:576-85. 2004..This study aimed to identify such risk factors, and to calculate the reporting rates of fatal and non-fatal PE...
- [Reporting of side-effects--a system in need of improvement. Reporting of a physician questionnaire]Ylva Ekbom
Biverkningsenheten, Läkemedelsverket, Uppsala
Lakartidningen 99:3290-5. 2002..The majority of the physicians who had a computer at work stated that they would like to access the reporting form electronically...
- Antipsychotics associated with pulmonary embolism in a Swedish medicolegal autopsy seriesAnna K Jönsson
Faculty of Health Sciences, Division of Clinical Pharmacology, Linkoping University, Linkoping, Sweden
Int Clin Psychopharmacol 23:263-8. 2008..Pulmonary embolism was overrepresented among medicolegal autopsy cases identified as users of low-potency first-generation and second-generation antipsychotics...
- [Relatively good safety in Swedish phase I trials. A survey of studies reported to the Medical Products Agency during 3 years]Anna Glazer
Lakartidningen 105:2482-4. 2008
- Mortality from venous thromboembolism in young Swedish women and its relation to pregnancy and use of oral contraceptives--an approach to specifying ratesEva Samuelsson
Division of Family Medicine, Department of Public Health and Clinical Medicine, Umea University, Umea, Sweden
Eur J Epidemiol 20:509-16. 2005....
- [A nation-wide survey: striking differences in the diagnostic procedures relating to thrombosis]Ola Björgell
Röntgendiagnostiska avdelningen, Universitetssjukhuset MAS, Malmo
Lakartidningen 99:4469-71. 2002..The interpretation of nonfiling of contrast medium in vein segments on phlebography varied from DVT to no DVT. Most of the phlebographies were performed with digital X-ray technique...
- [Axillary vein thrombosis in a young woman with a contraceptive ring. Prothrombin gene mutation a possible connection]Eva Samuelsson
Umea Universitet, Umea
Lakartidningen 104:32-4. 2007