Warning over allergic reactions to strontium ranelate
Women taking strontium ranelate who develop a rash should stop taking the drug immediately and seek medical advice, the Medicines
and Healthcare products Regulatory Agency warned last week.
Marketed as Protelos in the UK, strontium ranelate is a non-hormonal
medicine used to treat postmenopausal osteoporosis. Concerns have been
raised about the risk of severe allergic reactions associated with its
use. To date, 16 cases of drug rash with eosinophilia and systemic symptoms
(DRESS), two of which were fatal, have been reported to the European
Medicines Agency (EMEA).
DRESS is a serious and life-threatening allergic reaction, which starts
with a rash, accompanied by fever, swollen glands, increased white cell
count and affects the liver, kidneys and lungs.
The reported reactions started within three to six weeks of initiating
strontium ranelate.
The MHRA says that if treatment is stopped and corticosteroids administered
symptoms usually improve but recovery can be slow and symptoms may return.
Once strontium ranelate has been stopped it should not be restarted,
it said.
The EMEA has recommended that warnings concerning the risk of severe
hypersensitivity reactions should be included in the summary of product
characteristics and patient information leaflet for Protelos.
|
The
Pharmaceutical Journal
Acrobat
Reader