Protelos, strontium ranelate deaths and side effects

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EMEA Recommends Changes in Product Information for Protelos/Osseor

Due to Risk of Severe Hypersensitivity Reactions

LONDON, U.K. -- November 16, 2007 -- The European Medicines Agency

(EMEA) agrees on the inclusion of warnings concerning the risk of

severe hypersensitivity reactions in the prescribing and patient

information for Protelos/Osseor, as an urgent measure.

These products, which contain strontium ranelate, were approved in

the European Union in September 2004 for the treatment of

postmenopausal osteoporosis to reduce the risk of vertebral and hip

fractures.

Up to now, 16 cases of drug rash with eosinophilia and systemic

symptoms (DRESS) in patients treated with Protelos/Osseor, two of

which were fatal, have been reported to the EMEA, following a total

of around 570,000 patient-years of worldwide exposure. DRESS is a

serious and life-threatening condition. The reported serious

reactions started within 3 to 6 weeks of the initiation of the

treatment, with skin rash, accompanied by a fever, swollen glands,

increased numbers of white cells in the blood and effects on the

liver, kidneys and lung.

Having assessed the newly available data, the Agency's Committee for

Medicinal Products for Human Use (CHMP) has agreed that the product

information be provisionally updated in a rapid procedure to include

warnings on severe hypersensitivity syndromes, including DRESS and

s -Syndrome, in the prescribing and patient information,

as an urgent measure.

Patients are advised to stop treatment with Protelos/Osseor when a

rash occurs and to seek medical advice. Once the treatment has been

stopped, Protelos/Osseor should not be re-introduced.

As for all medicinal products marketed in the European Union, the

CHMP will continue to monitor Protelos/Osseor, and take appropriate

actions if further concerns arise.

Notes:

1. The European Public Assessment Report (EPAR) for Protelos/Osseor

can be found here:

http://www.emea.europa.eu/humandocs/Humans/EPAR/protelos/protelos.htm

2. The revised product information can be found here.

3. A separate question-and-answer document can be found here:

http://www.emea.europa.eu/humandocs/PDFs/EPAR/protelos/Protelos_Q & A_53

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1307en.pdf

4. These changes to the product information have been provisionally

introduced via an 'urgent safety restriction' procedure. These

changes will be formally endorsed by the CHMP via a scientific

opinion at the December plenary meeting.

SOURCE: European Medicines Agency