US panel sees risk in long-used osteoporosis drug

March 5, 2013 by Matthew Perrone

A panel of U.S. government health experts says a long-established bone strengthening drug should no longer be used by women because there is little evidence it works and it may actually increase the risk of cancer.

The Food and Drug Administration panel voted 12-9 that the risks of the inhalable osteoporosis drug outweigh its benefits when used to treat brittle bones.

The drug, known chemically as calcitonin salmon, has been prescribed for osteoporosis in postmenopausal women since the 1980s. Currently, Novartis and Upsher-Smith market the drug in nasal spray form as Miacalcin and Fortical, respectively.

But health authorities around the world have been reviewing the drug's safety after two recent studies showed a slightly higher rate of cancer among patients taking calcitonin pills. The drug is also available as an injection to treat other conditions, including excess calcium in the blood.

The European Medicines Agency concluded last July that calcitonin should no longer be used to treat osteoporosis, due to the drug's cancer risk.

An internal FDA memo released ahead of Tuesday's meeting said it's difficult to draw a direct link between the drug and cancer. However, "the potential for a cancer risk with calcitonin salmon therapy cannot be ignored. The majority of all calcitonin salmon trials showed an increased risk estimate."

A narrow majority of panelists voted against continued use of the drug, pointing out that the drug has not been shown very effective at preventing bone fractures.

"I think the cancer risk seems to be low, but it tips the balance for this drug, which has very little evidence of efficacy," said Amy Whitaker, a professor at the University of Chicago.

But other panelists said the drugs are an important option for patients who have bad reactions to newer drugs, including bisphosphonate drugs like Fosamax.

"We have a whole lot of patients who can't take the other drugs, and I think our patients would be in worse shape without this," said Bart Clark, professor at the Mayo Clinic College of Medicine.

Calcitonin salmon is a manmade version of a hormone found in the salmon fish.

Prescriptions for calcitonin have plummeted in recent years amid safety concerns about the drugs. Between 2006 and 2011 the number of U.S. patients receiving the drug fell 51 percent to 205,000.

The FDA approved the drugs from Novartis and Upsher-Smith based on studies showing that they increased bone mineral density. However, no studies have definitely shown that higher density actually reduces bone fractures. The largest study of calcitonin, which followed 1,200 women for about five years, was plagued by logistical problems, including a high level of patients who dropped out.

The FDA often approves drugs based on so-called surrogate endpoints, or initial measures that suggest the drug will make real improvements in patient health. In cancer drugs, for example, tumor shrinkage is considered a predictor of longer survival.

Drugmakers favor the approach because it helps them get products to market sooner. But it has proven problematic for the FDA when drugs do not live up to their initial promise.

The FDA panel was nearly unanimous that any future calcitonin drugs should be required to show real effectiveness in preventing bone fractures. The group voted 20-1 in favor of such a requirement.

The FDA does not have to follow the advice of its panels, though it often does.

Explore further: Drug prevents bone loss side effects of breast cancer medication

shares

Related Stories

Drug prevents bone loss side effects of breast cancer medication

October 10, 2011
A new study has found that an osteoporosis drug protects against the bone damaging side effects of certain breast cancer medications. Published early online in Cancer, a peer-reviewed journal of the American Cancer Society, ...

FDA approves drug for older women experiencing painful sex

February 26, 2013
(HealthDay)—The U.S. Food and Drug Administration has approved a new drug to treat postmenopausal women who experience pain during sex, the agency announced Tuesday.

FDA panel backs Pfizer drug for kidney cancer

December 7, 2011
(AP) -- A panel of advisers to the Food and Drug Administration voted Wednesday that the benefits of a Pfizer kidney cancer drug outweigh its risks, according to a company spokeswoman.

Study: Bone drug boosts breast cancer survival

December 9, 2011
(AP) -- Doctors were mostly hoping to prevent complications and relapses when they gave young women a medicine to keep their bones strong during breast cancer treatment. Seven years later, they found it did more than that: ...

Tamoxifen trial should prompt breast cancer patients to reconsider treatment options

December 6, 2012
A groundbreaking clinical trial involving the breast cancer drug tamoxifen should prompt certain breast cancer patients to reconsider their treatment options, according to Loyola University Medical Center breast cancer specialist ...

FDA panel wants limits on hydrocodone painkillers

January 25, 2013
Federal health advisors want new restrictions on hydrocodone, the highly addictive ingredient found in Vicodin and other widely abused prescription painkillers.

Recommended for you

Study suggests ending opioid epidemic will take years

July 20, 2017
The question of how to stem the nation's opioid epidemic now has a major detailed response. A new study chaired by University of Virginia School of Law Professor Richard Bonnie provides extensive recommendations for curbing ...

Team-based model reduces prescription opioid use among patients with chronic pain by 40 percent

July 17, 2017
A new, team-based, primary care model is decreasing prescription opioid use among patients with chronic pain by 40 percent, according to a new study out of Boston Medical Center's Grayken Center for Addiction Medicine, which ...

Private clinics' peddling of unproven stem cell treatments is unsafe and unethical

July 7, 2017
Stem cell science is an area of medical research that continues to offer great promise. But as this week's paper in Science Translational Medicine highlights, a growing number of clinics around the globe, including in Australia, ...

Popular heartburn drugs linked to higher death risk

July 4, 2017
Popular heartburn drugs called proton pump inhibitors (PPIs) have been linked to a variety of health problems, including serious kidney damage, bone fractures and dementia. Now, a new study from Washington University School ...

Most reproductive-age women using opioids also use another substance

June 30, 2017
The majority of reproductive-age and pregnant women who use opioids for non-medical purposes also use at least one other substance, ranging from nicotine or alcohol to cocaine, according to a University of Pittsburgh Graduate ...

At-risk chronic pain patients taper opioids successfully with psychological tools

June 28, 2017
Psychological support and new coping skills are helping patients at high risk of developing chronic pain and long-term, high-dose opioid use taper their opioids and rebuild their lives with activities that are meaningful ...

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.