FDA Approves Injectable Osteoporosis Drug

Since there are no pills to remember to take, Prolia will help ensure that osteoporosis patients get their medication, and the new drug may prove easier to use than other injectable options, says Dr. Siris. Reclast, for instance, requires doctors to have an infusion chair in their office and requires a test for kidney problems before each dose. Neither of those is necessary with Prolia.

“The idea that I can, at the end of a visit, pull out a syringe, swab some alcohol on a patients’ deltoid muscle, and do it myself without a nurse is attractive to me,” she says.

Prolia will also be the first biologic sold directly to primary care physicians (other than vaccines).

“The other biologic agents used today in medicine are prescribed by specialists such as rheumatologists, endocrinologists, hematologists, and oncologists,” says Nancy Lane, MD, the director of the Center for Healthy Aging at the University of California, Davis. “But for the most part [postmenopausal osteoporosis] is treated by primary care physicians. So this will be an injection in the physician’s office—like a flu shot.”

It is not clear whether Prolia is stronger or more effective than existing osteoporosis drugs, Dr. Lane says.

In the clinical trials submitted to the FDA, the most commonly reported side effects were various types of pain (including back pain), high cholesterol levels, and urinary bladder infections. Rare but more serious side effects included decreased blood calcium levels, infections, the skin infection cellulitis, and eczema. Prolia may also contribute to a severe bone disease (osteonecrosis) that affects the jaw, the FDA noted.

The bone-weakening cells targeted by Prolia also play a role in immunity, so the drug “has the potential to affect multiple layers of the immune system,” according to the FDA’s Center for Drug Evaluation and Research.

“It is also not known whether it will be safe in patients who are taking other biologic agents, like those with rheumatoid arthritis,” says Dr. Lane.

The FDA will require patients who are considering Prolia to receive a guide that explains the risks of the drug.