EMA Seeks Labeling That Clearly Defines Amount of Sodium in Drugs

June 30, 2015

The amount of sodium contained as an excipient in drugs should be readily available in an understandable format on product labels and package leaflets, the European Medicines Agency says.

Current labeling of sodium as an excipient makes it difficult for patients and prescribers to appreciate which drugs have high levels of sodium, the EMA notes. Proposed labeling updates call for presenting sodium as a proportion of the World Health Organization’s recommended maximum daily intake and defining levels as “high” if the maximum daily dose contains more than 391 mg, which is roughly 20 percent of the WHO recommended amount.

The information is important for people with sodium restricted diets or preexisting cardiovascular disease. Some high sodium-containing products, such as effervescent medicines, are OTC, which limits the chances for a healthcare professional to offer advice to patients on their potential risks, the EMA says in a draft Q&A document issued last week.

The agency is updating the labeling of sodium and other excipients for inclusion in a revised annex to the European Commission’s guideline on excipients on drug labels and package leaflets.

Comments are due by Sept. 30. Read Draft questions and answers on sodium in the context of the revision of the guideline on “Excipients in the label and package leaflet of medicinal products for human use here: www.fdanews.com/6-15-EMA-Sodium.pdf. — Jonathon Shacat