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 Adverse Cases


Back Reported Adverse Drug Reaction Cases
Sildenafil - Three Years Experience

Sildenafil (Viagra) has now been available in Australia for over 3 years. During that time ADRAC has received 773 reports for sildenafil with it as the only suspected drug in 741. Most of these reports describe reactions that are relatively minor in nature and are consistent with the pharmacology of the drug and the adverse effects observed during clinical trials (see Table 1).

There have been, however, 20 reports describing myocardial infarction which included 4 with a fatal outcome. Nine of the 20 patients had established cardiovascular disease or diabetes, or were at high risk of cardiovascular disease, and one was taking concomitant nitrates. There have also been 26 other reports of chest pain and 10 other reports which described a fatal outcome: 6 sudden unexplained deaths, 2 strokes and 2 subarachnoid haemorrhages. The temporal relationship to the ingestion of sildenafil was often not reported and in only 23 of these 56 cases could it be inferred that the event occurred within 6 hours of the use of the drug.

Because ingestion of sildenafil occurs in the context of sexual intercourse and, in some cases, underlying coronary disease, the contribution of sildenafil to cardiac events is difficult to assess. Information on prior risk factors and accurate details on drug ingestion and timing of the adverse reaction are often lacking. Resolution of the role of sildenafil requires robust epidemiological studies, however a recent publication which shows no evidence for a higher incidence of fatal myocardial infarction or ischaemic heart disease among users of sildenafil provides some reassurance that sildenafil may not be a primary cause of cardiovascular events.1

Table 1
Most Commonly Reported Reactions with Sildenafil

Adverse Reaction

Number of Reports

Headache

233

Flushing

139

Abnormal vision

65

Therapeutic inefficacy

51

Rhinitis

42

Chest pain

34

Dizziness

31

Dyspepsia

28

Nausea

27

Myocardial infarction

20

Abdominal pain

16

Palpitation

16

Priapism

16

Prescribers are reminded that the drug is contraindicated in men for whom sexual intercourse is inadvisable such as those with severe cardiovascular disease, established cardiac failure and unstable angina pectoris. The possibility of undiagnosed cardiovascular disorders in men with erectile dysfunction should be considered before prescribing. Sildenafil has been shown to potentiate the hypotensive effects of both acute and chronic nitrate administration and, therefore, its coadministration with nitrates in any form, either regularly or intermittently, is contraindicated.

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References:
  1. Shakir SAW, Wilton LV, Boshier A, Layton D, Heeley E. Cardiovascular events in users of sildenafil: results from first phase of prescription event monitoring in England. BMJ 2001; 322: 651-2.

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