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Stories for Reprint
FDA Alert on Osteoporosis Drugs
By Ferdous Al-Faruque, MARRTC Staff
You may have seen ads for Fosamax, Actonel and Boniva. They belong to a group of drugs known as bisphosphonates. Earlier this year the Food and Drug Administration sent out an alert to warn health care professionals and people taking the drugs to be on the lookout for certain side effects.
Bisphosphonates are widely used as treatment to reduce bone loss in osteoporosis and other bone diseases. Over the past few years the FDA has received over a hundred reports of people having severe pains in their body after taking the drugs.
A spokesperson at the FDA says it is hard to know exactly how many people on the drugs have these side effects. "While the FDA has received many reports of severe pain, there is a large amount of use of bisphosphonate drugs as well as considerable underreporting of musculoskeletal pain."
Those who take the drugs may have side effects such as fever, chills, and pain in their bones and muscles. In most cases these side effects quickly go away. However in some cases pain begins days, months or even years after starting the drugs and never goes away. If the medication is stopped, and the pain stops as well, it can imply the pain was due to the drugs.
The FDA is concerned that health care professionals may presume the pain is related to an underlying bone disease rather than a side effect of the drugs. "Some patients have said that their physicians seemed to be unaware of an association (of pain) with bisphosphonate use," says the spokesperson.
The FDA recommends health care professionals review a patient's history of pain to see if drugs may be the cause. They should monitor the patient's pain over time to see if it goes away. If pain persists, health care professionals should take patients off the bisphosphonate drug to see if the pain stops. Finally if it is determined the drug is the source of the pain, health care professionals should discuss with their patients the risks and benefits of continuing the drug versus alternative treatments.
The FDA also says people taking these drugs and experiencing pain should talk to their health care professional.
To understand what bisphosphonates are, we have to understand a little about how the human body works. Our bones are being constantly renewed; as old bone tissue is dissolved away new bone tissue is formed. However, with age the renewal process slows down, and people lose more bone tissue than they are able to replace. Bisphosphonates are able to reduce bone loss, which keeps bones healthier.
The FDA spokesperson was speaking on behalf of the Office of Surveillance and Epidemiology, and the Division of Metabolism and Endocrinology Products at the FDA's Center for Drug Evaluation and Research.
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