Safety Implications of the Over-the-Counter Availability of H2-Antagonists

Abstract

Since the introduction of cimetidine 15 years ago, this drug and the newer histamine H2-receptor antagonists ranitidine, famotidine and nizatidine have proved their value in the treatment of peptic ulcers of the stomach and duodenum, and reflux oesophagitis, At the end of Maret: 1989 cimetidine and ranitidine were transferred from prescription-only to over-the-counter (OTC) status in Denmark, a decision which has attracted international attention. This was followed by a series of investigations to look for any possible consequences on the health of the population. In this article the background of the OTC switch is summarised, and the safety aspects of nonprescription H2-antagonists are discussed on the basis of the existing literature, as well as the Danish experience with these drugs used as self-medication.

Self-Medication of Dyspepsia: How Appropriate Is It?

“…Our results may predict usage patterns of OTC H2-antagonists. Their availability for selfmedication has mostly been supported because they are considered safe (12,19,20). When the evaluation is expanded from the safety aspect to include a rational drug utilization concept, one might argue that rational self-medication of dyspepsia with H2-antagonists is unlikely to occur unless consumers have knowledge of the cause of their symptoms and of the principles of therapeutic treatment for their condition.…”

“…This opinion is justifiable, since in Finland the packages available without prescription are for short-term use and are in insufficient doses to cure ulcers. Their superiority in relieving dyspeptic symptoms compared with antacids has been questioned (1 [8][9][10][11][12][13][14][15][16][17][18][19][20]. According to a recent survey, only 21% of Finnish physicians considered ranitidine and famotidine highly suitable drugs for self-medication (Sihvo, unpublished data).…”

“…In recent years H2-antagonists have also become available OTC in many countries. The first country to do this was Denmark, where cimetidine and ranitidine changed to OTC status in 1989 (12). In Finland ranitidine (150 mg) and farnotidine (10 mg) became available without prescription in June 1996.…”

Are H2 receptor antagonists safe over the counter drugs?

“…Among others, the committee proposed the anti-ulcer drugs in view of their low toxicity, their rare and relatively harmless adverse reactions, and their extensive use. The economic gains were expected to be reduced costs for the government, because general practitioners' income would be reduced, and increased spending on medicines by consumers 3,4…”

“…After five years' availability of cimetidine and ranitidine, over the counter monitoring of adverse drug reactions shows no reason to change the view that these drugs pose no major safety problems 4,5. There has also been no appreciable increase in consumption of the drugs, although a slight increase was seen intermittently in 1991, and the pattern of admissions to hospital for complications of ulcer disease has not changed 4…”