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FDA: Concern Over Drugs For Bone Strength

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FDA: Concern Over Drugs For Bone Strength

MIAMI (CBS4) ― A drug promoted to older women to help them deal with aging may in some cases do more harm than good.

Edna Policari said befoe she started taking Boniva to help strengthen her bones, she lived an active life. Now, Policari said she can't even open the refrigerator door without help. She told CBS4 when she asked her doctors if her condition could be related to taking Boniva "they all said no."

A few weeks later, Policari said the Food and Drug Administration issued a warning to doctors, alerting them that Boniva and similar drugs known as bisphosphonates could cause the type of bone pain that Policari was experiencing.

Boniva uses the star power of actress Sally Field to market the drug to women who fear fractures; to find out about these side effects consumers have to read the insert which comes inside the packaging.  

Roche, the manufacturer of Boniva, states: "The risk factors for and incidence of this effect is unknown; such reports have been infrequent."

Doctor Phuli Cohan treats her osteoporosis patients with vitamins and natural hormones. She doesn't prescribe bisphosphonates and said that pain isn't the worst thing that can happen.

"There is actually bone death occurring."

A recent letter in the New England Journal of Medicine suggest that long term use of these drugs may actually increase the risk of fracture in some women. Dr. Cohan showed CBS4 X-rays of a woman whose hip shattered after years on Fosamax, another brand of bisphosphonate.

"People don't want to believe that this is happening, but it is a side effect of the medicine," said Dr. Cohan.

But Merck, the maker of Fosamax, maintains no such link has ever been proven.

"In clinical studies, Fosamax has not been associated with increased fracture risk at any skeletal site," wrote Merck.

Dr. David Hunter said some doctors are now starting to encourage patients to take time off the drug to allow bone cells to rejuvenate, but he believes the benefits outweigh the risk of osteoporosis.

Dr. Cohan notes that this drug has only been on the market for about a decade, and the long term side effects are not known. She says she had feared seeing spontaneous fractures in patients and that "my worst fears have been realized."

CBS4 health specialist Dr. Sean Kenniff said it is important to note that bisphosphonates have been proven to prevent hip fractures, which can be deadly. Most women do not experience serious side effects, so they are advised to not stop taking this medication without speaking with their doctor.

(© MMIX, CBS Broadcasting Inc. All Rights Reserved.)

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