Case study: Labetalol and nipple pain

Background information

A pregnant woman sent a Yellow Card report about crippling nipple pain that she was experiencing. The pain lasted for about 20 minutes each time.  It happened while she was taking labetalol. She had a variety of other symptoms, including a burning sensation, a tingling feeling and the discolouring of nipple skin colour. The woman said that she had the same side effects during a previous pregnancy (when she also took labetalol). 

The woman shared her worries to a few healthcare professionals, none of them knew of any link between the symptoms she was had and labetalol. 

Investigation

A routine safety review by Medicines and Healthcare products Regulatory Agency (MHRA) experts revealed six other similar UK reports of labetalol linked with nipple pain. The Yellow Card reports were received between 2009 and 2017, and all related to pregnant women. Most cases reported that the nipple pain was less after stopping use of the medicine. 

This safety signal was discussed with a team of MHRA experts. They concluded that Breast tissue has changes during pregnancy. Whilst these changes could result in the nipple pain mentioned in the case reports, the start time mentioned in many of the cases were close in time with the changes in nipple colour mentioned by many patients - all of which are a sign of Raynaud’s phenomenon. 

Other Yellow Card reports said the effects happened after the labetalol medication, and some reported recovery after labetalol was stopped. Raynaud’s phenomenon is listed in the product information as a known side effect of labetalol therapy. It was considered possible that this could also occur in the nipples.   

Response

Regulatory action was taken directly by the MHRA.  The pharmaceutical companies were asked to update their patient information leaflet (PIL) for labetalol, adding nipple pain as a possible symptom of Raynaud’s phenomenon.  As this was not listed in the product information (leaflet), the MHRA advised that it must be added. This would help the patients who have less knowledge about the condition. 

Additional information

Raynaud’s phenomenon is a condition where arteries spasm and can cause episodes of reduced blood flow, often to outer parts of the body.  This can result in pain or changes in colour of the area of the skin affected. 

Return to the Yellow Card scheme case studies page or submit a report.