Osteoporosis medications have been in the market for the past 16 years in the U.S., beginning with the launch of alendronate sodium in the mid-1990s.
During the second week of September 2011, two U.S. Food and Drug Administration advisory panels met to review popular bone drugs prescribed for osteoporosis. Their aim was to discuss a possible new recommendation for women currently using osteoporosis medications because of concerns over side effects on long-term use.
The comprehensive safety review sought to determine if it is safe for females to use the bone drugs beyond three to five years.
The FDA recommendation is expected to affect about four million women in the U.S. who take biphosphonates - a class of drug that promotes the bone renewal process by adding bone mass. The reason for the new recommendation, however, is rooted in recently discovered side effects of these types of medicines. Biphosphonates have the potential to cause the bones to become brittle.
The FDA review covered at least four branded bisphosphonates and generic counterparts, used for the treatment and prevention of osteoporosis. It includes alendronate sodium tablets and solution, risedronate and risedronate with calcium, ibandronate sodium tablets and injections and zoledronic acid.
Generic versions of the medication came out in the market after the patent of the branded alendronate, which was launched in 1995, expired in 2008.
Risks for long-term use
Among the reported risks to long-term use of the osteoporosis drugs are jawbone death, or osteonecrosis, unusual broken thigh bones and esophageal cancer. Due to those risks, the FDA ordered the manufacturer of the drugs to add a warning of the higher risks for atypical femur fractures in October 2010 and a warning for osteonecrosis in 2005.
In 2010, the FDA again reviewed the data from all bisphosphonate manufacturers, including case reports and clinical trials, and the regulatory agency failed to find a link between the drugs and increase risk of fracture of the thigh bone.
However, because of continued reports of atypical subtrochanteric femur fractures, the FDA recommended in October of the same year that doctors should discontinue use of the bone drugs for patients who develop bone fractures.
The FDA also warned against the use of zoledronic acid for patients with kidney trouble due to risks of kidney failure.
The five-year limit on use of bone drugs, which some experts have recommended, is because clinical trials did not go beyond five years. One reviewer of the drug warned that women who take them beyond five years are considered guinea pigs.
According to a 2007 edition of The New England Journal of Medicine, another possible side effect of bisphosphonates is increased rate of serious atrial fibrillation for older women with osteoporosis.
The condition, atrial fibrillation, is a heart rhythm disorder which often affects people 64 years old and older. The FDA found that most cases of atrial fibrillation took place more than one month after taking zoledronic acid. However, when compared with patients who took a placebo, the tests showed a similar prevalence of atrial fibrillation.
As a result, the FDA did not recommend patients who took zoledronic acid to change their medication.
Risks versus benefits
Other experts, however, argued that the risks far outweigh the side effects. Were it not for the bone drugs, many women would suffer serious and debilitating fractures of the hip and spine.
Dr. Elizabeth Shane, a bone specialist and co-chairwoman of the task forces on femur and haw issues for the American Society for Bone and Mineral Research told the New York Times, “While we are upset and worried and do not want to do anything that would cause anybody harm, we don’t want to go back to 1990 and just have nothing for osteoporosis.”
As a result of the ASBMR report, the FDA placed the warning on atypical femur fractures. Although Dr. Shane pointed out that some groups did not adopt the society’s recommendation to develop a specific diagnostic code and national registry to track femur fracture cases due to the bone drugs.
Thus, there are speculations that the review panels would recommend some women only to stop taking biphosphonates.
However, Dr. Richard Bockman, who is a member of the FDA Reproductive Health Drugs Advisory Committee, admitted the drug holiday for some women is a “weak escape without the benefit of better science.”
Sales and lawsuits
In 2010, global sales of bone drugs reached $7.6 billion, which went down from a peak of $8.8 billion in 2007.
Due to the side effects, one of the largest pharmaceutical companies has 1,115 lawsuits regarding jaw damage and another 535 for unusual femur fractures and other bone injuries.
One such lawsuit against the firm was filed by a Florida woman who used alendronate sodium from 1998 to 2005. She sued the manufacturer for product liability because she acquired osteonecrosis. The case is pending before the U.S. District Court in Manhattan.
The manufacturer of alendronate sodium has won three of the first lawsuits to go on trial for jaw damage, but lost the fourth and the jury awarded to the complainant $8 million. The pharmaceutical firm is appealing the decision.
Possible outcomes and final thoughts
Consumers, drug manufacturers and the medical community at large are all very anxious to hear the FDA's final recommendation. What is clear in the ongoing debate over the safety of bone drugs is that osteoporosis is a serious and widespread disorder, and that current medications have the potential to negate or worsen the condition.
While some medication works for some women, they could have fatal side effects for others. One way to avoid or delay having to take bone drugs during a person’s senior years is to maintain a healthy lifestyle while still young.
This includes eating a balanced diet, veering away from vices, getting sufficient rest and recreation and engaging in regular physical activities.
Of course, another recommendation is to take vitamins regularly for stronger bones. Current research shows that conditions like osteoporosis can begin to take effect in some women as young as 20 years old. Supplementing the daily diet with bone building nutrients in youth could keep you from having to face the issues with osteoporosis medications in the future.