FDA Issues Alert Over Osteoporosis Drugs
4 CommentsBy Ed Silverman // January 7th, 2008 // 12:55 pm
The agency is urging doctors to be on the lookout for the “possibility of severe and sometimes incapacitating bone, joint, and/or muscle (musculoskeletal) pain” in patients taking a group of meds known as bisphosphonates. These include Merck’s Fosamax, Novartis’ Zometa and Reclast; Procter & Gamble’s Actonel and Boniva, which is marketed by Glaxo and Roche.
Although severe musculoskeletal pain is included in the prescribing information for all bisphosphonates, the association between bisphosphonates and severe musculoskeletal pain may be overlooked by healthcare professionals, delaying diagnosis, prolonging pain and/or impairment, and necessitating the use of analgesics, the FDA cautions on its web site.
The severe musculoskeletal pain may occur within days, months, or years after starting a bisphosphonate. Some patients have reported complete relief of symptoms after discontinuing the bisphosphonate, whereas others have reported slow or incomplete resolution, the FDA reports, adding that risk factors for, and incidence of, severe musculoskeletal pain associated with bisphosphonates are unknown.
This is the second time in recent months that bisphosphonates have drawn concern from the FDA. A study last year in The New England Journal of Medicine raised questions about the association of atrial fibrillation with the use of these meds. Last fall, the agency said it reviewed some safety data and requested additional data to further evaluate the risk of atrial fibrillation in patients who take bisphosphonates.
Emalee
I was about to ask for this again becaue of pain in my hips at night! Hum! Guess not. I will ask about it however.
LL
I started taking calcium a little over 10 years ago as I hit menopause age. I also started a beginnings exercise regimen. When I had my bone density scan 2 years ago I had no probems. Just make informed decisions & lifestyle choices, not quick fixes.
Barbara Robbins
I am one of these patients who had a SEVERE reaction to Actonel after taking it for 11 weeks. More than two years later, I am still trying to recover while my osteoporosis is only getting worse despite my best efforts to maintain my bone health. My orthopedist told me Actonel could not be responsible for my problems. I told him I knew it was and that Actonel would become another “Vioxx.” Finally, someone is starting to connect the dots in this problem, just as someone did with Vioxx.
CMc
I have read so much about the problems associated with this class of drugs that I flatly refuse to go on them, despite have been diagnosed with osteoporosis. I have seen a friend go from being a healthy individual who could participate in serious hiking to someone who is in agony most of the time and needs a wheelchair when she goes on vacation. She has also been prescribed prednisone + goodness knows what other drugs for several years now. Not only don’t they help, but appear to have caused other problems. She has seen countless specialists without any definitive diagnosis. I truly believe Fosamax is her problem and have tried to get her to consider this. Unfortunately, none of the physicians she has seen believes this might be the cause. A few websites I have perused are askapatient.com, womentowomen.com/bonehealth and gilliansanson.com. What you read there may well terrify you and certainly reinforce any decision about having nothing to do with these drugs.