The FDA has issued a new warning that a popular class
of osteoporosis
drugs may lead to severe, chronic and even permanent
pain in muscles, joints and bones.
The agency has known of this risk from the drug class
known as bisphosphonates since their approval, and prescribing
instructions for doctors warn of the possibility of
severe pain. But according to the FDA, many doctors
do not appear to be aware that the drugs may be linked
to severe pain in their patients.
The bisphosphonate drug family includes Merck's Fosamax;
Roche and Glaxo SmithKline's Boniva; Novartis' Aredia,
Zometa and Reclast (marketed as Aclasta outside the
United States); Procter & Gamble's Didronel; Sanofi-Aventis'
Skelid; and Actonel, sold by Procter & Gamble and Sanofi-Aventis.
Oral or injected bisphosphonates are prescribed in order
to increase bone mass in osteoporosis patients in order
to reduce the risk of fractures. But according to the
recent FDA warning, patients may develop severe pain
"within days, months or years after starting a bisphosphonate."
In some cases, the pain is so intense that interferes
with day-to-day activities, requiring some patients
to use a walking cane just to get around. (not sure
what he meant to write here)
The warning advises doctors to "consider whether bisphosphonate
use might be responsible for severe musculoskeletal
pain ... and consider temporary or permanent discontinuation
of the drug." In some cases, discontinuing the drug
has led to the disappearance of symptoms, but in others,
patients "have reported slow or incomplete resolution."
The FDA noted that some patients may also develop acute
pain, fever, chills and other symptoms shortly after
starting their prescription, but that these symptoms
usually pass within several days, and no discontinuation
of treatment is required. The chronic
pain described in the current warning is different
from this cluster of symptoms.
The agency has initiated a review into the frequency
of chronic pain in bisphosphonate users. This is in
addition to an ongoing review into whether the drugs
may be causing atrial fibrillation, or a dangerously
fast heartbeat, in some users.
