A

References: Neth J Med 1998 Sep;53(3):109-12 Reviewed: 12/1998

Amiodarone (antiarrhythmic) Bronchiolitis obliterans A case of bronchiolitis obliterans organising pneumonia secondary to amiodarone was described. Though pulmonary toxicity of amiodarone is widely known, such an adverse event has only very rarely been described as associated with this antiarrhythmic drug.

References: Current Problems in Pharmacovigilance 1998 aug; vol.24: 11-14

Alendronate (metabolic) Oesophageal reactions By July 1998, 97 UK reports of oesophageal reactions with alendronate sodium (54 since August 1996) were received, one of which was fatal (although not confirmed as associated with the drug). Around 1-2% of patients taking alendronate sodium may experience oesophageal reactions; this is possibly due to a direct irritation of the oesophageal mucosa. Alendronate sodium should not be chewed or sucked; it should be taken with a full glass of water and the patient should remain upright for at least 30 minutes afterwards. Therefore, use of alendronate sodium is contra-indicated in patients who are unable to sit upright or stand for 30 minutes. Caution is required if the patient is also taking NSAIDs.

References: Australian ADR Bulletin 15(4): 15 (1996) Communication from the German Medical Ass Deutsches Aertzeblatt 93, 25 October 1996. Finley CJ, et al. Angiotensin-converting enzyme inhibitor-induced angioedema - still unrecognized. Am J Emerg Med 10: 550-552 (1992). Reviewed: 12/1997

ACE-Inhibitors (antihypertensives) Angioedema A total of 270 australian patients were reported to experience angioedema with different angiotensin-converting enzyme inhibitors. The Drug Commission of the German Medical Profession has received 79 reports from 1991 to 1996; a notice to health professionals was then issued about the risk of angioedemas associated with the use of ACE-inhibitors. Angioedema appears to be a class effect of these drugs. The onset of angioedema can be either rapid or delayed, with 27% occurring after 6 months or more; although most cases involve swelling of the face, neck or orolaryngeal tissue, it can primarily occur as a visceral disease; recurrent episodes were described in one third of the patients, with a median interval between episodes of 2 weeks. As angioedema of the mouth and neck may be fatal, patients with a history of primary angioedema, with C-1 esterase deficiency, or with hypersensitivity to ACE-inhibitors, should not receive ACE-inhibitors

References: WHO Pharmaceutical Newsletter N° 3-4, 1997 Reviewed: 12/1997

Interaction with antidiabetics An interaction between ACE-inhibitors and antidiabetic drugs (insulin or oral hypoglycaemic agents) may cause hypoglycaemia, especially in patients with renal impairment. These effects are already reported in most Product Information Sheets.

References: BMJ 1998;316:1921-1930 Reviewed: 02/1999

Precautions with ACE inhibitors in patients with unilateral renal artery stenosis  ACE-inhibitors may present a hazard for patients with unsuspected atherosclerotic renovascular disease. Screening for unilateral renal artery stenosis might be wise before treatment is started in patients at high risk. These include hypertensive patients over 50 and those with peripheral vascular disease, diabetes, or coronary artery disease. When renovascular disease is identified the benefits of ACE-inhibitors may still be available if treatment is started after percutaneous transluminal renal angioplasty and stent placement.

References: JAMA 1998; 279: 1200-05 Lancet 1998; 351: 1183 Reviewed: 06/1998

Adverse Drug Reactions Review on ADRs Adverse drug reactions (ADR) are the fourth commonest cause of death in the United States, with more than 100,000 deaths per year, after heart disease, cancer and stroke. In a meta-analysis of 39 prospective studies, the incidence of serious and fatal ADRs was 6.7% among patients admitted to hospital because of an ADR. This impressive figure is higher than expected, and suggests that ADRs are considerably under-reported.

References: BMJ 1998; 316: 1295-1298 Reviewed: 02/1999

Review on ADRs Adverse drug reactions are a major clinical problem, accounting for 2-6% of all hospital admissions. Recent surveys in the United States have indicated that adverse drug events increase the length of hospital stay and costs.

References: Eur J Clin Pharmacol 1999; 54(12): 959-963 Reviewed: 02/1999

Adverse drug events requiring hospital admissions A 1-year prospective collection of data on visits performed at an italian emergency department (5497 patients) showed that 4.3% of cases experienced an adverse drug event; 45 of these patients (19.1%) were subsequently hospitalized, among whom there were five deaths. Adverse drug reactions caused the most frequent drug-related visits to the Emergency Department (63.8%), whereas dose-related therapeutic failures were the main causes of drug-related admissions (55.6%) Although the frequency of drug-drug interactions leading to a visit to the Emergency Department was small (3.8%), this type of event was more severe.

References: FDA - MEDWATCH (april 1997) Drugs 1997; 53: 415-434 Reviewed: 09/1997

Alendronate (metabolic) Warnings Esophageal adverse experiences, such as esophagitis, esophageal ulcers and esophageal erosions, occasionally with bleeding, have been reported in patients receiving treatment with alendronate." However, the results of a 3-year, placebo-controlled, clinical trial showed that alendronate can be administered to patients taking NSAIDs without any increase of upper gastrointestinal adverse events.

References: FDA - MEDWATCH (april 1997) Reviewed: 09/1997

Adverse reactions in clinical trials Treatment of osteoporosis: In the "Vertebral Fracture Study", discontinuation of therapy due to adverse events occurred in 7.6% of patients treated with alendronate for 2-3 years and 9.4% with placebo. Discontinuations due to upper gastrointestinal adverse experiences were 2.6% with either alendronate or placebo. Prevention of Osteoporosis: The safety of alendronate given for 2-3 years in postmenopausal women was similar to placebo. Discontinuation of therapy due to any clinical adverse experience occurred in 7.5% of patients treated with alendronate and 5.7% with placebo. The most frequent adverse reactions were abdominal pain (1.7 % on Aledronate vs 3.4 % on placebo), acid regurgitation (1.4 vs 2.5 %), diarrhea (1.1 vs 1.7 ), dyspepsia (1.9 vs 1.7), nausea (1.4 vs 1.4)

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