USA. New US FDA labelling rules for over-the-counter (OTC) drugs will increase safety for patients with certain medical conditions. Warning and content labelling will be strengthened for oral OTC drugs that contain calcium, sodium, magnesium or potassium above specific levels, as they could be harmful to patients with special sensitivities. The FDA has also proposed an extension to the sodium-labelling rules to include OTC rectal drugs containing sodium phosphates, as there may be a risk of serious electrolyte imbalances in patients with certain underlying medical conditions. The new rules came into effect on 23 April 2004, with full compliance required by 25 September 2005.
FDA News, 25 March 2004. Available from URL: http://www.fda.gov