Drug Safety Developments

Osteoporosis Drugs Linked to Rare Fractures

Quoted from http://online.wsj.com/article/SB10001424052702304791704577418551357240094.html

Osteoporosis Drugs Linked to Rare Fractures

By JONATHAN D. ROCKOFF

• Updated May 21, 2012, 6:53 p.m. ET

Widely used osteoporosis drugs such as Fosamax and Actonel significantly raise the risk of a rare but serious thigh fracture and that risk rises the longer patients take the medicines, a new study found.

Some women age 50 and older have been taking the drugs for years to prevent common hip, spine and wrist fractures caused by the bone-weakening disease osteoporosis. Yet a small number of these patients have broken a leg by such everyday actions as stepping off a curb, which has raised questions about whether the osteoporosis treatments were responsible.

The new study, published online Monday by the Archives of Internal Medicine, a publication of the American Medical Association, said it found such a link between the drugs and so-called atypical thigh fractures.

Researchers noted that studies support the overall benefits of these osteoporosis medicines to prevent fractures, even if the drugs are taken for only a few years. They also said this type of bone break is very rare. But they said the new findings add to evidence suggesting patients should reconsider taking the drugs after three to five years of use.

 

The drugs belong to a class of medicines called bisphosphonates. Last year, such drugs had $4.2 billion in U.S. sales, according to IMS Health, a data provider.

In 2010, the Food and Drug Administration announced that the labels of these drugs would contain a warning about the potential for the unusual thigh fractures. And last year, a panel of experts convened by the agency expressed concern about atypical fractures, though stopped short of recommending limits on use of the drugs.

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New Cautions About Bisphosphonates

Quoted from http://well.blogs.nytimes.com/2012/05/09/new-cautions-about-long-term-use-of-bone-drugs/

New Cautions About Long-Term Use of Bone Drugs

 

An X-ray shows a fracture in the femur of a woman who used Fosamax for seven years.

By TARA PARKER-POPE| May 9, 2012, 6:32 pm

In an unusual move that may prompt millions of women to rethink their use of popular bone-building drugs, the Food and Drug Administration published an analysis that suggested caution about long-term use of the drugs, but fell short of issuing specific recommendations.

The F.D.A. review, published in The New England Journal of Medicine online on Wednesday, was prompted by a growing debate over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis’s Reclast.

The concern is that after years of use, the drugs may in rare cases actually lead to weaker bones in certain women, contributing to “rare but serious adverse events,” including unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jaw bone.

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Osteoporosis drugs increase risk of eye disease, says Canadian study

Quoted from http://www.thestar.com/news/canada/article/1155306--osteoporosis-drugs-increase-risk-of-eye-disease-says-canadian-study

Osteoporosis drugs increase risk of eye disease, says Canadian study

Published On Mon Apr 2 2012

Theresa Boyle Health Reporter

New Canadian research shows that osteoporosis drugs can increase the risk of serious eye disease.

The findings will no doubt fuel an ongoing debate about whether too many people, particularly post-menopausal women, are being prescribed oral bisphosphonates, said lead author, Dr. Mahyar Etminan, from the University of British Columbia.

The study, published online Monday in the Canadian Medical Association Journal, reveals that the incidence of the inflammatory eye diseases, uveitis and scleritis, is significantly higher for first-time users of these drugs than for non-users.

Oral bisphosphonates are the most commonly prescribed class of drugs used to prevent osteoporosis. They go by such brand names as Fosamax, Actonel and Didrocal and are typically prescribed to post-menopausal women at risk of osteoporosis.

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Bone drugs linked to rare thigh fractures: Health Canada

Quoted from http://www.ctv.ca/CTVNews/Health/20111220/osteoporosis-thigh-bone-femur-fracture-111220/

Bone drugs linked to rare thigh fractures: Health Canada

The Canadian Press

Date: Tuesday Dec. 20, 2011 8:51 AM ET

TORONTO — Health Canada is alerting Canadians that a class of drugs used for osteoporosis is linked to a slightly higher risk of a rare but serious thigh bone fracture known as an atypical femur fracture.

The advice is the result of Health Canada's review of bisphosphonate drugs, which has led to new warnings and precautions for patients and doctors and will lead to new labels for the drugs.

The department says the risk is higher for those taking the drugs, but the benefits of using the medications to avoid other osteoporosis-related fractures outweighs that risk.

Atypical femur fractures are rare, accounting for less than one per cent of all hip and femur fractures.

They can occur with minimal or no impact to the thigh area, and can occur in both legs in the same person.

Health Canada says patients who are currently taking or who took bisphosphonate drugs previously and who notice new or unusual pain in the hip, groin or thigh should talk to their doctor as this may be a sign of an atypical femur fracture.

The U.S. Food and Drug Administration announced similar findings and warnings in a statement issued in October 2010.

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F.D.A. to Review Safety of Popular Bone Drugs

Quoted from http://www.nytimes.com/2011/09/06/health/06bone.html

F.D.A. to Review Safety of Popular Bone Drugs

By DUFF WILSON

Published: September 5, 2011

Two advisory panels of the Food and Drug Administration will consider on Friday whether to recommend requiring women who use popular bone drugs like Fosamax to take “drug holidays” because of rising concerns about rare side effects with long-term use, according to people involved in the review.

Advisory panels to the F.D.A. are looking at the long-term effects of drugs like Fosamax.

The panels and F.D.A. staff members are also expected to conduct a comprehensive safety review of the medical evidence to date, after 16 years of growing use of the drugs, to determine whether they have proved to be safe and effective in use longer than three to five years. The recommendation could affect many of the estimated four million women in the United States who take the drugs, called biphosphonates. Biphosphonates inhibit a bone renewal process called resorption, adding bone mass, but possibly causing brittleness as well.

Fosamax was first approved in 1995 to treat postmenopausal osteoporosis and Paget’s disease of the bone, conditions that weaken bones. It has also been marketed, controversially, for a pre-osteoporosis condition called osteopenia. The Fosamax patent expired in 2008 and generics have flooded the market.

The F.D.A. announced in July that it would convene a joint meeting of advisory committees on drug safety and reproductive health to reconsider osteoporosis drugs after evidence surfaced linking long-term use with unusual breaks of the femur or thigh bone, bone death in the jaw, and possibly esophageal cancer.

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FDA Reviewing Osteoporosis Drugs for Esophageal Cancer Risk

Quoted from http://www.bloomberg.com/news/2011-07-21/fda-reviewing-bisphosphonates-for-esophageal-cancer-in-women.html

FDA Reviewing Osteoporosis Drugs for Esophageal Cancer Risk

By Anna Edney - Jul 21, 2011 5:18 PM ET

U.S. regulators are reviewing oral medicines to combat bone weakening from companies such as Merck & Co. and Roche Holding AG (ROG) for evidence they cause esophageal cancer and say patients should still take the drugs.

The Food and Drug Administration made the comments in an announcement today ahead of a meeting of agency advisers Sept. 9, where they will discuss the safety of the osteoporosis treatments. The agency is reviewing conflicting studies based on U.K. data that found no increased risk and a doubling in the risk of the throat cancer.

More than 40 million people either have osteoporosis in the U.S. or are at high risk because of too low bone mass, according to the National Institutes of Health. The disease is a structural deterioration of tissue that leads to fragile bones and an increased risk for fractures.

“The benefits of oral bisphosphonate drugs in reducing the risk of serious fractures in people with osteoporosis continue to outweigh their potential risks,” the FDA said.

Merck shares rose 59 cents, or 1.7 percent, to $36.18, at 4:15 p.m. in New York Stock Market trading. Roche shares rose 1.8 Swiss francs, or 1.3 percent, to 141.5 francs at the close of Zurich trading.

Differences in methodologies may account for discrepancies in findings, the agency said. The gastrointestinal side effects of bisphosphonates could increase a patient’s likelihood of undergoing an endoscopy that would lead to more cancer detection, the agency said.

Bisphosphonate drugs include Whitehouse Station, New Jersey-based Merck’s Fosamax and Basel, Switzerland-based Roche’s Boniva. The FDA urged those taking the treatment to follow directions carefully, and to take the drug first thing in the morning with a full glass of water.

Bones: Experts rethink long-term use of drugs

Quoted from http://yourlife.usatoday.com/health/medical/story/2011/05/Bones-Experts-rethink-long-term-use-of-drugs/47126182/1

Bones: Experts rethink long-term use of drugs

Bone experts are rethinking the way they treat osteoporosis now that research has linked widely prescribed drugs to rare but serious leg fractures.

• 

  File photo by Brian Branch-Price, AP

  Bisphosphonates, such as Fosamax, are among top-selling drugs for osteoporosis.

By Janice Lloyd, USA TODAY

May 13, 2011

Bisphosphonates, a class of drugs that are highly beneficial in reducing bone fractures in people with osteoporosis, the experts say, should not be prescribed to patients who don't have the disease but are at risk of developing it, as often has been the practice in recent years.

And osteoporosis patients should talk to their doctors about taking a "holiday" from the drugs after two or three years on the medications, says Ken Lyles, director of geriatrics research at Duke University. The drugs can be taken intermittently after several years, he says.

"This is a change, absolutely," says Lyles, a member of the American Society of Bone and Mineral Research. "I look at it as a positive thing. We're learning more. We have good drugs, but we need to know how to use them correctly."...

 

Bisphosphonates (Fosamax, Reclast, Actonel, Boniva) are among the top-selling drugs in the country. Annual sales exceed $3.5 billion, according to IMS Health, a research firm that tracks prescriptions. The Food and Drug Administration in November warned about potential risks of atypical femur fractures when taking the drugs, and a Swedish study last week in The New England Journal of Medicine called for "intermittent use" because of a reduced risk of fracture after taking a break from the drugs.

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Study Finds Slight Risk of Rare Fractures From Bone Drugs

Quoted from http://health.usnews.com/health-news/family-health/bones-joints-and-muscles/articles/2011/05/04/study-finds-slight-risk-of-rare-fractures-from-bone-drugs

Study Finds Slight Risk of Rare Fractures From Bone Drugs

Benefits of bisphosphonates in preventing most fractures outweigh risk, experts say

 

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• Health Buzz: Popular Osteoporosis Drugs Linked to Cancer Risk

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, May 4 (HealthDay News) -- Bone-building drugs called bisphosphonates have been linked to rare fractures of the thigh bone, but Swedish researchers report that the risk is so small that most patients needn't worry.

Bisphosphonates include the widely used medications Fosamax, Boniva and Actonel, which are typically taken by people with osteoporosis to increase bone strength and prevent fractures.

"Osteoporotic fractures are quite common and bisphosphonates reduce this risk a lot, but the price you have to pay for that is a small risk in getting a so-called fatigue fracture," said lead researcher Dr. Per Aspenberg, a professor of orthopedics at Linkoping University.

"These findings must be seen in the context of the debate that has been going on for the past year," he added. "Our data argues very strongly for a causal relationship."

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Revisiting Bone Drugs and Femur Fractures

Quoted from http://www.nytimes.com/2011/03/08/health/08brody-bone.html

Revisiting Bone Drugs and Femur Fractures

By JANE E. BRODY

Published: March 6, 2011

Nearly six years ago in this column, I discussed what was then a little-known problem associated with long-term use of bisphosphonates, the valuable drugs that protect against fractures caused by bone loss. The drugs, among them Fosamax, Actonel and Boniva, can slow bone loss, increase bone density and cut fracture rates in half in women with established osteoporosis.

Enlarge This Image

The femur of Dr. Jennifer Schneider of Tucson, an internist who after seven years on Fosamax suffered a nontraumatic femur fracture that took two years to heal.

Reports had begun to emerge that some women taking bisphosphonates for many years suffered an unusual fracture of the femur, the long bone of the thigh. There was little or no trauma; in most cases the women were simply standing or walking when the femur snapped in half. In some, breaks occurred in both thighs, and many of the fractures were unusually slow to heal.

Experts think the fractures happened because of the way the drugs work: by slowing the rate of bone remodeling, the normal process by which injured bone heals. As a result, microfractures that occur through normal wear and tear are not repaired. Although bone density may be normal, the bone can become brittle and crack under minor stress.

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Rare Fractures Linked To Drugs For Weak Bones

Quoted from http://www.npr.org/2011/02/28/134064950/rare-fractures-linked-to-drugs-for-weak-bones

 

Rare Fractures Linked To Drugs For Weak Bones

by Richard Knox

February 28, 2011

Listen to the Story

 

Dr. Jennifer Schneider was on a New York City subway when the train jolted and she shifted her weight onto her right leg. Suddenly, her thighbone snapped and she collapsed to the floor.

"I could hear it and I could feel it," Schneider says. "I knew it was broken, instantly. I could not understand how this possibly could have happened from standing on a train."

Curiously, the break was not the usual kind of hip fracture associated with older bones. Those involve the ball-shaped head of the femur, or the narrow neck just below the head.

Schneider's fracture occurred further down, just at the part of the femur that's usually the strongest.

Conflicting Studies

Schneider was one of the first women to suffer from one of these unusual fractures among patients who've been taking osteoporosis drugs called bisphosphonates for years. Or at least her case was one of the first reported in a medical journal, back in early 2006.

Since then, orthopedic surgeons and bone specialists have been seeing more of these unusual fractures among long-term users of bisphosphonate drugs such as Fosamax, Actonel, Boniva and Reclast.

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