Case study: Perindopril and Raynaud's phenomenon

Background information

A Yellow Card report was sent in by a man in his sixties who was taking perindopril for high blood pressure. His doctor changed his medicine to another called ramipril but he did remember exactly when. Later, he started having a problem where his fingers would become white, get really cold and feel numb during cold weather. 

 

The man thought the medicine he was taking might be causing some problems.  He had been taking two medicines for a few years and he noticed that his fingers we hurting more often and looking darker in colour. This happened almost every day. His doctor diagnosed his condition as Raynaud’s Condition, which can be caused by certain medicines. 

 

Investigation

We carried out a routine review of this Yellow Card report which involved an additional search for other similar reports of suspected Raynaud's reactions associated with perindopril use. Five additional Yellow Card reports found that perindopril was suspected to cause it. Most people who got sick usually got it within a few days or a week after starting perindopril.  All patients recovered after they stopped taking it. 

 

We discovered noted that Raynaud’s phenomenon is listed as a known side effect for many of the drugs within the same class as perindopril.  However, Raynaud’s phenomenon was not listed in the product information for any perindopril products.   

 

Response

We raised this safety concern with the European Medicines Agency (EMA) who asked the pharmaceutical company to submit a review of all cases of perindopril and Raynaud's phenomenon.  The review was then evaluated by the EMA who requested that the product information for perindopril was updated to include Raynaud's phenomenon as a potential side effect. 

 

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, resulting in pain or changes in colour in the area in which it occurs. After stopping the medicine, the symptoms had almost completely gone away within a few days. 

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