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By Barutello V., Terracini S.

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These findings provide reassur­ ance about the safety of donepezil in patients taking concomitant cardioactive medications.  An 82-year-old patient with Alzheimer’s dis­ ease developed complete atrioventricular block and a ventricular tachyarrhythmia with dizziness and syncope 1 month after starting donepezil. A temporary ventricular pacing catheter placed in the right ventricle restored sinus rhythm on the fourth day (71A). Nervous system Leg pain has been attrib­ uted to donepezil (72A).  An 85-year-old woman with a 4-year history of Alzheimer’s dementia and glaucoma and hypertension controlled with timolol eyedrops and candesartan, respectively, was given donepezil 5 mg/day, gradually increasing to 10 mg/day; within 10 days of the increase in dose she developed bilateral leg pain, which was continuous, severe in the morning, and reducing in severity by evening, resulting in severe distress.

2. Cone M. Regulatory update: the longawaited MedDRA has arrived! Good Clin Pract J 1999;6(1):42–3. 3. Wood KL. The Medical Dictionary for Drug Regulatory Affairs (MEDDRA) project. Pharmacoepidemiol Drug Saf 1994;3: 7–13. 4. Huntley K, Veverka MJ, Golden M. The FDA’s Medical Dictionary for Drug Regula­ tory Affairs alpha test. Drug Inf J 1995;29 (4):1133–43. 5. Brown EG, Clark E. Evaluation of MedDRA in representing medicinal product data 6. 7. 8. 9. sheet information. Pharmac Med 1996;10:111–8.

In 11 of these 31 cases there was a positive dechallenge; of these, 1 patient had recurrence of ecchymosis on rechallenge. In the remaining 10 cases with a positive dechallenge, either the outcome of rechal­ lenge was unknown or rechallenge was not performed. In two of these cases either aspirin or co-trimoxazole had also been used. The time to onset for these events was 1–86 days. Four patients developed bruising within 2 days of starting sibutramine. The case with a positive rechallenge developed ecchymosis 86 days after starting sibutra­ mine.

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