Healthcare Opportunity

The evidence is not unequivocal, but numerous studies have warned of the risks they may pose long-term use of bisphosphonates, a class of drugs commonly used in people with osteoporosis to improve bone quality. The U.S. Food and Drug Administration (FDA, for its acronym in English) has met with a committee of experts to decide if treatment is safe from the fifth year. In Spain, according to some experts, have been required “in excess”.

“Our country is the biggest spender in the world and such drugs, however, is not more records broken,” said Santiago Munoz, president-elect of the Spanish Society of Rheumatology (SER). In order to “prevent and good will,” adds, “have been treated with bisphosphonates for women from the onset of menopause [circumstance that accelerates bone destruction], which were healthy and had had no fracture.”

In recent years, this system is changing. Given the potential adverse effects that may result from this treatment five years, “just type it in groups at risk.”

As explained in this specialist densitometry (test to determine bone mineral density) should not be the sole criterion for prescribing bisphosphonates. There are other risk factors: whether the patient has had a previous fracture, age (increases the chance of osteoporosis), family history of hip fracture, low bone mass, if too thin, if you have diseases that cause osteoporosis ( as rheumatoid arthritis) or taking drugs that increase the likelihood (such as corticosteroids).

“Combining all these aspects, we can get an idea of ​​the risk of fractures, there are also scales that help decide who can benefit most from preventive treatment,” said Dr. Muñoz, also head of Rheumatology, Hospital Infanta Sofia in Madrid.

A review of the adverse effects

According to a review published in ‘Cleveland Clinic Journal, appeared several years ago cases of osteonecrosis of the jaw (death of bone caused by insufficient blood supply) and the FDA asked the manufacturer to include in their labeling information on the risk of this condition.

In the beginning, were related to treatment with bisphosphonates for several years. Then, as the authors remind the University of Washington (Seattle, USA), found that this adverse effect was only present in cancer patients taking these drugs to strengthen bone mass, which was considered an acceptable risk given the benefits potential. “Among those who only had osteoporosis, the disease manifested itself in less than one in 10,000 persons treated.”

Other scientific papers, as published in the Journal of Orthopaedic Trauma ‘, reveal that making long-term bisphosphonates can cause fractures of the femur, a problem that commonly occurs in car accidents in elderly or very weak, not in patients while walking or standing. Of the 20 participants of this study, 19 were women treated with alendronate (one of the most popular bisphosphonate approved since 1995) had been an average of 6.2 years.

How is it possible that a drug that improves the quality of bone can cause a fracture? Review of ‘Cleveland Clinic Journal’ argues that the bone tissue as the skin. When a small alteration in normal conditions, it is repaired, but treatment with bisphosphonates suppress this natural turnover of bone (destruction and continuous training), and these injuries are not only repaired but accumulate.

In fact, this drug “prevents bone loss, but the bone becomes weak and brittle over time,” says rheumatologist Santiago Muñoz.

The problem of the studies conducted so far is that “include a few patients (between 15 and 30) and the results, therefore, are not very significant. Ideally, to analyze thousands of people treated for enough years and through biopsies, “says the doctor. “But this is very complicated to make and difficult from the ethical point of view,” he adds.

There are jobs that even have linked treatment with bisphosphonates for 10 years with esophageal cancer, but are very small and its findings are not conclusive.

Warning and regular monitoring

Under the circumstances, the decision of the FDA responds to a principle of prudence. In 2010, U.S. health officials recommended the periodic review of medical treatments to women who take more than five years taking bisphosphonates. A few months later, the European Medicines Agency (EMA) indicated that all bisphosphonate drugs in its prospectus should include a warning about the risk of fractures. Also invited to “regularly review the need for further treatment, especially after five or more years.”

And at this point are now doctors. When a woman before them who have taken bisphosphonates for some time, “we value your risk factors. If minimal interrupt the treatment and monitor their evolution. If, however, the patient is at high risk of fractures, we shuffle other therapeutic alternatives without bisphosphonate drugs, “said Santiago Muñoz.

Review of ‘Cleveland Clinic Journal’ recalls a study investigating the physiological basis of bisphosphonates and said that after five years with this treatment, the benefit among women who continued taking was greater than in those who quit. An argument therefore supports the discontinuation of the medication or switching to other drugs.