In 1995 the FDA approved a new drug for treating osteoporosis. Fosamax was heralded as a major breakthrough.
Before this pill was introduced, there were no easy ways to combat osteoporosis. This condition weakens bones and can lead to life-threatening fractures.
Over the last decade, Fosamax was joined by Actonel and more recently Boniva. All three “bisphosphonates��? work by slowing down cells that break bone down. This allows other cells to build bone and make it stronger. People with osteoporosis who take these medicines are less likely to suffer fractures.
The manufacturers have marketed these drugs aggressively to consumers. Last year more than 30 million prescriptions were filled for such medications. But new safety concerns are worrying patients and doctors.
From the time Fosamax was introduced, patients were warned about the possibility of severe damage to the esophagus if pills got stuck. That’s why people are warned not to lie down for at least 30 minutes after taking their medicine. Now another issue is causing alarm.
There are growing reports that bisphosphonates may lead to a rare but serious complication called osteonecrosis of the jaw. Hundreds, perhaps thousands, of cases of death of part of the jaw bone are surfacing. Many seem to be triggered by dental procedures such as extractions or implants.
One reader who was taking Fosamax experienced this complication after she had a tooth pulled. Many hours of dental surgery and thousands of dollars later, she is still dealing with the consequences.
Doctors and dental surgeons still don’t know how common this problem is or exactly how to treat it. Other concerns are also emerging.
Another reader reported her experience with Boniva: “After my first dose, I experienced shooting pains in my arms and legs for about 6 hours, but considered this to be normal after reading the information in the package. After the second dose, I had violent flu-like symptoms for a 12-hour period: excruciating, unrelenting chills, tremors and spasms; severe aches and pains that encompassed my whole body; fever and intense sweats.
“The next morning I was so drained and debilitated from the episode that I nearly fainted in the shower as I prepared to go to work. For the next three weeks I had low back pain that made me double over after sitting for short periods of time.��? She was so shaken by this experience that she has decided not to continue taking this medicine to prevent osteoporosis.
We also received this disturbing question: “A friend had a heart attack that was attributed to Boniva. Is that possible?��?
There is nothing in the official drug labels about bisphosphonates and heart attacks. Chest pain that could signal severe heartburn might be confused with heart trouble. Then again, until recently there was nothing about osteonecrosis of the jaw.
What is clear is that these medications are not risk free. Complications such as jaw bone death may be very rare, but research is just now getting under way to determine how often they may occur.
These are valuable drugs, especially for people at high risk of bone fractures. A broken hip can be a life-threatening event. But as with Vioxx, it may take years before all serious reactions are detected.

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