European Union Considers Suspension of Protelos ®/Osseor ® Osteoporosis Medications
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended that strontium ranelate (Protelos/Osseor, Servier) no longer be used to treat osteoporosis .
Last week PRAC issued a press release for the suspension of Protelos/Osseor ® (strontium ranelate) manufactured by Servier, for the treatment of severe osteoporosis. This move comes on the heels of a warning for cardiac events and thromboembolism in some patient populations last April.
In April the CHMP issued the above warnings along with skin reactions, disturbances in consciousness, liver inflammation, seizures and reduced numbers of red blood cells, and at that time, limited its use to those with severe osteoporosis in both men and women who are at high risk for fracture. They also said that patients with heart or circulatory problems should no longer use this drug, but the final decision was left to the treating physician. This risk/benefit assessment involved 7,500 patients and the PRAC found an increase in myocardial infarction in women taking Protelos, but there were no increases in death . In the most recent findings, published on January 10th, 2014, officials felt that the patients using this weren’t being properly monitored due to the drugs long-term use in elder populations and decided to issue this latest warning under formal review. The agency found that there were four or more cardiac events and thromboembolisms in 1,000 patient-years compared to placebo with this medication. Patients taking this medication feel that this isn’t enough to warrant its removal from the market, especially if they don’t have problems with these medical issues, and that elder patients may have these medical problems anyway due to their age, medical history and not the drug. This medication is used in many different age groups and it’s not just for the elder population. Protelos has been on the market since 2004, in the European Union, to reduce the incidence of vertebral and hip fractures in postmenopausal women and was later approved for men.
Protelos (strontium ranelate) is not available in the U.S., but is used in many European countries. It comes in a two gram sachet, of powder, to be mixed and taken in water. Many patients have difficulty with the postural restrictions of bisphosphonates along with many other side effects involving the esophagus and joint pain, and turned to this treatment for its ease of use and lesser side effects. Some feel the risk of myocardial infarction and blood clots, are less worrisome than a major fracture if they have no history of heart disease or thromboembolism. If you have a history of heart disease or blood clots then you probably aren’t taking this mediation, but for those who don’t have these issues, Protelos still remains as their first choice in treatment. Some feel that this is a cost reducing issue since the first line drug in these countries and in particular the United Kingdom is Fosamax (alendronate sodium) which cost the countries National Health Service (NHS) much less than what they pay for Protelos.
And, although strontium ranelate does prevent about 5 nonspinal fractures, 15 spinal fractures, and 0.4 hip fracture for every 1000 patient-years, the committee decided that these benefits did not outweigh the potential risks and therefore the product’s use should be suspended until further data support a benefit in a defined patient group .
If you are taking this medication, you need to discuss this with your physician to see if there is something else you can take to treat your osteoporosis. Professor Terence O’Neill, chairman of the National Osteoporosis Society’s Clinical and Scientific Committee, said: "it is important, however, that people don’t stop taking the drug until they have spoken to their doctor. For most, alternative drug treatments are available to manage their osteoporosis and reduce their risk of fracture . The final decision by PRAC and the Agency’s Committee for Medicinal Products for Human Use (CHMP) is due sometime between January 20th and the 23rd of 2014.
For our readers in the United Kingdom: if you are worried about how this will affect you, our Helpline 0845 450 0230 is open from 9am to 5pm Monday to Friday .
- EU Panel Recommends Suspension of Protelos/Osseor. Medscape. Jan 10, 2014 Retrieved Jan 18,2014 https://www.medscape.com/viewarticle/819007?src=wnl_edit_tpal&uac=99465BN
- Strontium Ranelate (Protelos/Osseor) Restrictions Recommended in EU. Medscape. Apr 12, 2013. Retrieved Jan 18, 2014 https://www.medscape.com/viewarticle/782483
- European Medicines Agency recommends suspension of Protelos (strontium ranelate) National Osteoporosis Society. Jan 10, 2014 Retrieved Jan 18, 2014 https://www.nos.org.uk/page.aspx?pid=325&article=cc60bbe8-0e49-4f3d-b918-840027820b9e
Pam wrote for HealthCentral as a patient expert for Osteoporosis.