Europe watchdog advises suspending 'risky' osteoporosis drug

January 10, 2014

A committee of Europe's medicines watchdog on Friday recommended suspending the use of an osteoporosis drug, saying the risks, including heart attacks, outweighed the benefits.

The drug, Protelos/Osseor, is prescribed for people with the bone-crumbling disease who often suffer debilitating fractures.

A product of French firm Servier Laboratories, the medicine is said to make bones stronger and prevent breaks.

But the PRAC risk assessment committee of the European Medicines Agency (EMA) said the risks of serious , including heart attacks, blood clots and blocked arteries, were just too great.

For every 1,000 treated patients, there were four additional cases of serious heart problems and four of clotting among people using Protelos/Osseor compared to those given a placebo or dummy treatment.

Other risks include seizures and liver inflammation.

As an osteoporosis treatment, the drug has shown a "modest effect"—preventing about five non-spinal bone fractures, 15 and 0.4 hip fractures per 1,000 patients, the committee said.

"The PRAC weighed the benefits of the medicine against the known risks and concluded that the balance was no longer favourable, and recommended Protelos/Osseor be suspended until there are new data showing a favourable balance in a defined patient group," a statement said.

The recommendation will next be considered by the EMA's Committee for Medicinal Products for Human Use for a final decision.

Servier in a statement informed national health agencies of Friday's announcement, and said it would provide further information once the EMA review is concluded.

Explore further: Acne pill benefits outweigh blood clot risk: EU agency

Related Stories

Acne pill benefits outweigh blood clot risk: EU agency

May 17, 2013
Europe's medicines watchdog said Friday the benefits of acne drug Diane-35, also widely used as a contraceptive, outweigh the risk of developing blood clots in the veins—when correctly prescribed.

EU drug agency rejects French request on birth pills

October 11, 2013
The European Medicines Agency (EMA) on Friday rejected a French request to tighten prescription guidelines on types of birth-control pills linked with a relatively higher risk of blood clots.

Acne pill benefits outweigh blood clot risk, EU body says

May 30, 2013
An EU medicines watchdog on Thursday endorsed the safety of acne drug Diane-35, also widely used as a contraceptive, despite protests from France, which has suspended its use.

New IOF review provides guidance on fracture prevention in cancer-associated bone disease

November 1, 2013
Cancer is a health burden of increasing importance which affects close to 13 million people globally. Bone is often affected in these patients, frequently because of bone metastases, or as a result of anti-cancer therapies ...

Alendronate reduces adjacent-level vertebral fractures

December 30, 2013
(HealthDay)—For females with osteoporosis, the rate of adjacent-level vertebral fractures is relatively low, with reduced odds with bisphosphonate therapy, according to a study published in the Dec. 1 issue of Spine.

Development of new diabetes drug halted by maker

July 10, 2013
(HealthDay)—The development of what might have become a significant diabetes drug has been halted by its maker amid concerns that the medication raises the risk for fractures, kidney problems and heart failure in those ...

Recommended for you

In most surgery patients, length of opioid prescription, number of refills spell highest risk for misuse

January 17, 2018
The possible link between physicians' opioid prescription patterns and subsequent abuse has occupied the attention of a nation in the throes of an opioid crisis looking for ways to stem what experts have dubbed an epidemic. ...

Patients receive most opioids at the doctor's office, not the ER

January 16, 2018
Around the country, state legislatures and hospitals have tightened emergency room prescribing guidelines for opioids to curb the addiction epidemic, but a new USC study shows that approach diverts attention from the main ...

FDA bans use of opioid-containing cough meds by kids

January 12, 2018
(HealthDay)—Trying to put a dent in the ongoing opioid addiction crisis, the U.S. Food and Drug Administration on Thursday slapped strict new restrictions on the use of opioid-containing cold and cough products by kids.

Taking ibuprofen for long periods found to alter human testicular physiology

January 9, 2018
A team of researchers from Denmark and France has found that taking regular doses of the pain reliever ibuprofen over a long period of time can lead to a disorder in men called compensated hypogonadism. In their paper published ...

Nearly one-third of Canadians have used opioids: study

January 9, 2018
Nearly one in three Canadians (29 percent) have used "some form of opioids" in the past five years, according to data released Tuesday as widespread fentanyl overdoses continue to kill.

Growing opioid epidemic forcing more children into foster care

January 8, 2018
The opioid epidemic has become so severe it's considered a national public health emergency. Addiction to prescription painkillers, such as oxycodone and morphine, has contributed to a dramatic rise in overdose deaths and ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.