Angioneurotic edema attributed to the use of losartan.

BACKGROUND: Angioedema is a well-known adverse effect of angiotensin-converting enzyme inhibitors. The bradykinin accumulation as a result of the decreased degradation of bradykinin is thought to be the causal mechanism. Angiotensin II antagonists seem to have no effect on the degradation of bradykinin. Therefore, it was expected that angioedema would not occur during treatment with losartan potassium, the first orally active angiotensin II antagonist. METHODS: We reviewed the 13 case reports of angioedema associated with the use of losartan reported to Lareb (Netherlands Pharmacovigilance Foundation, Den Bosch) and to the Drug Safety Unit of the Inspectorate for Health Care, Ryswyh, in the Netherlands since the introduction of losartan in 1995 until May 1997. RESULTS: In all 13 cases, a diagnosis of angioedema attributed to the use of losartan seems to be very plausible. In 7 cases the diagnosis could not be confirmed by a physician because the symptoms had already been resolved, but the signs and symptoms clearly indicated angioedema. The adverse reactions occurred within 24 hours to 16 months after the initiation of losartan therapy. Three patients had previously experienced angioedema during treatment with an angiotensin-converting enzyme inhibitor. Eleven of the patients involved were women and 2 were men. CONCLUSIONS: Our observations strongly suggest that the onset of angioedema was associated with the use of losartan. Physicians and pharmacists should be aware of this potentially life-threatening complication. It may be advisable not to prescribe angiotensin II antagonists to patients with a history of angioedema (of whatever origin).

[Neuropsychiatric adverse effects attributed to use of oxybutynin]. / Neuropsychiatrische bijwerkingen toegeschreven aan het gebruik van oxybutynine.

Since 1988, the Netherlands Pharmacovigilance Foundation Lareb and the Inspectorate for Health Care have received 17 reports of patients with neuropsychiatric adverse reactions attributed to the use of oxybutynin hydrochloride. These concerned 6 males and 11 females and 6 out of the 17 patients were children under the age of 13. In all cases patients had been treated according to a normal dosage regimen. Complaints included hallucinations, psychosis, concentration and orientation problems, apathy, listlessness, agitation, drowsiness and sleepiness. Symptoms improved or disappeared in all patients after dose reduction or withdrawal of oxybutynin.