Case study: Ranitidine and breast disorders

Background information

A hospital doctor completed a Yellow Card report about a baby girl suffering from recurring bleeding from both nipples, for one day every few months. As well as this, the baby was taking ranitidine. The doctor found there was no obvious cause for this and thought it may be related to ranitidine, since it is already known to cause an abnormal size increase of male breasts.  Another Yellow Card report about a man that experienced sore bleeding nipples, who recovered after stopping the medication was received. At the time, the summary of product characteristics (SPC) only listed ‘breast symptoms in men’. 

Investigation

Through routine assessment by our experts, these two Yellow Card reports submitted by doctors launched a review of suspected reports of nipple disorders and the breast size increase. 

Result

As the warnings at the time were considered not enough, wording was updated.  The existing warnings were made clearer within the product information to include breast symptoms and conditions.  The patient information leaflet (PIL) was also updated to include the side effects of ‘breast tenderness and or breast enlargement, breast discharge’. 

Important information

Ranitidine is a medication that reduces the amount of acid in the stomach to relieve heartburn, indigestion and other stomach complaints.

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