Dr. Richard Hoffmann, Ask the Pharmacist, 08/14/12

Q: How long should someone take osteoporosis drugs?

A: This a good question, but there is no clear-cut answer at this point in time. Recently (2012), the FDA provided a Consumer Update regarding this question, which provides useful information about this subject.

If you’re one of the 44 million Americans at risk for osteoporosis — a disease in which bones become weak and are more likely to break — you may be taking bisphosphonates.

This class of drugs has been successfully used since 1995 to slow or inhibit the loss of bone mass.

Doctors commonly prescribe such brand-name drugs as Actonel, Atelvia, Boniva and Fosamax (as well as a number of generic products) for osteoporosis. In fact, more than 150 million prescriptions were dispensed to patients between 2005 and 2009.

Bones go through a continual process of remodeling, in the form of bone resorption (disintegration) and bone formation. Bone loss related to osteoporosis occurs when resorption is greater than formation.

Bisphosphonates decrease bone resorption, thereby slowing bone loss. During treatment, bisphosphonates become part of the newly formed bone and can stay there for years, through many cycles of resorption and formation. 

Patients continue to be exposed to the effects of the drug even long after they’ve stopped taking it.

Bisphosphonate labels have carried a safety warning about severe jawbone decay (osteonecrosis of the jaw) since 2002.

In October 2010, the FDA warned patients and health care professionals about the increased risk of unusual thighbone fractures and directed manufacturers to include the warning in the safety labels and medication guides that come with prescription medications.

The FDA continues to evaluate the possible association of bisphosphonates with esophageal cancer. These associations would suggest that health care professionals may want to reconsider how long patients should continue taking the drugs.

Researchers at the FDA have taken a close look at the long-term benefit of bisphosphonates to treat osteoporosis. Their review of clinical studies measuring the effectiveness of long-term bisphosphonates use shows that some patients may be able to stop using bisphosphonates after three to five years and still continue to benefit from their use.

According to the review, further investigation is needed on the long-term risks and benefits of these drugs.

In view of the above information, decisions to continue treatment must be based on individual assessments of risks and benefits and on patient preference. If you are taking bisphosphonates:

+ Talk to your physician about whether or not you should continue this therapy. Re-evaluate the decision on a periodic basis.

+ Don’t stop taking these (or any) prescribed drugs without talking to your physician first. If you do make the decision to discontinue use, talk to your physician before stopping therapy.

+ Tell your health care professional if you develop new hip or thigh pain (commonly described as dull or aching pain), or have any concerns with your medications.

+ Report unusual side effects of your bisphosphonate medication to the FDA’s MedWatch program.

Richard P. Hoffmann, Pharm.D., has been a pharmacist for more than 40 years. Send questions to him at 2960 E. Coventry Court, Hernando, FL 34442.