Instructions for drug to prevent back pain, complications of osteoporosis need updating

Sep 14 2011
The Food and Drug Administration (FDA) will update warning labels for bisphosphonates, a class of drugs used to prevent the back pain, pinched nerves and other complications of osteoporosis.

In this disease, the bones begin to weaken and become more likely to break. The most common fractures occur in the hip, wrist and spine. More than 40 million Americans either have the condition or are at high risk, according to the National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), a division of the National Institutes of Health. People who are more likely to get osteoporosis include the elderly, women of Asian or Caucasian descent or individuals of small stature. Others at risk are patients with sedentary lifestyles, smokers, alcoholics, women with low estrogen levels, men with low testosterone and those with deficiencies of calcium and vitamin D, including cases of anorexia nervosa.

People often do not know they have the disease until a bone breaks. Every year, osteoporosis causes 700,000 spine fractures, leading to back pain, according to the American Academy of Orthopaedic Surgeons. Individuals with fractures or certain risk factors can consult a physician for diagnosis, which is often done with a bone density test. However, these tests may not always correctly diagnose women with spine deformities caused by minor fractures because their bones may not appear too different from those of healthy women, according to research sponsored by NIAMS.

The most conservative ways to prevent osteoporosis are through exercises to strengthen the bones and a diet rich in calcium and vitamin D. Certain medications, such as bisphosphonates, have also been prescribed to keep the disease from developing. Studies have shown that while these drugs can help prevent fractures, it is debatable whether they can be as helpful after five years.

Furthermore, this class of drugs has been marred throughout the years by adverse effects. In 2005, labels had been changed to include a risk of death to the jawbone. Bisphosphonates have also been linked to cases of thighbone fractures and esophageal cancer, according to the FDA.

The latest meetings of the FDA were convened to discuss possible risks for certain conditions because of long-term use of bisphosphonates. Initial recommendations were for a "drug holiday," or time limit on taking the medication. However, advisers were not comfortable with the existing clinical evidence to make such a ruling, and instead decided that drug labels will advise people to be extra considerate of the risks and benefits of extended use, as reported by Reuters.

The FDA estimates that seven out of every 100 people in the U.S. have been prescribed bisphosphonates.