Case study: Phenytoin and purple glove syndrome

Background information

A female patient in her sixties contacted a pharmacist about redness and swelling in her right arm.  She was taking phenytoin injections for treatment of a serious epileptic condition. This was later diagnosed as purple glove syndrome. The swelling can lead to the tissue death due to lack of blood supply and this can sometimes lead to disability. The pharmacist referred the patient for urgent medical treatment but also reported this to the pharmaceutical company that manufactured the medicine. The company also sent the report to us, as required by law. 

Response

Through routine assessment by our experts, this report was assessed alongside three other UK reports. and 17 other adverse reaction reports from other countries. Following review of this issue we asked the pharmaceutical company to do a worldwide review of their own safety data. 

Result

This review resulted in the addition of purple glove syndrome and warnings under possible side effects of the phenytoin to the patient information leaflet. Although it is unknown how often you may get purple glove syndrome, in most cases, the condition is temporary. 

Important information

Epilepsy is a common condition that affects the brain and causes frequent seizures.  Seizures are bursts of electrical activity in the brain that temporarily affect how it works. They can cause a wide range of symptoms. 

Purple glove syndrome is a rare condition where there is discolouration, build-up of fluid in tissue which can result in swelling, and blister formation on the hand.

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