Case study: Sayana (medroxyprogesterone) and muscle loss

Background information

A woman in her thirties received her Sayana injection and then developed a deep hole in her leg in the area where received her injection. In the past, she had used another contraception without experiencing any issues. She did not have any medical problems or allergies and was not overweight. As she was very worried and did not receive any warnings, she decided to submit a Yellow Card report online. 

Response

We carried out further investigations in response to the report from the lady.  We discovered that there were 21 UK cases of suspected muscle loss around the injection area, thought to be connected with medroxyprogesterone. 

In the reports, the side effect start date ranged from the same day as the drug start date up to 58 weeks later. In most cases the patients had no past medical history of muscle loss. 

Based on the safety information we asked the pharmaceutical company to provide a global review of all cases relating to Sayana and injection area reactions. This led to another 94 similar cases of muscle loss related to subcutaneous (injected under the skin) medroxyprogesterone injections. Most cases reported the site of injection as the thigh/leg or abdomen, whether given by healthcare professionals or self-injected. In 23 cases, it was reported that the side effect happened after the first injection of medroxyprogesterone under the skin. 

A total of 123 related cases of medroxyprogesterone injected into muscles were identified through this investigation. The area of injection was reported as the thigh/leg or buttock followed by the arm, in most of the medroxyprogesterone cases. 

Result

Based on this common reaction, regulatory action was taken to add information and warnings to the product information leaflet.   

Important information

Sayana (medroxyprogesterone) is an injected contraceptive that releases the hormone progestogen into your bloodstream to prevent pregnancy. 

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