Pharmaceutical Drug Litigation Updates

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.

[Article continues at original source]

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.

[Article continues at original source]

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.

[Article continues at original source]

Bone Drugs by Merck, Roche, Novartis May Add Leg Fractures

Quoted from http://www.bloomberg.com/news/2011-02-22/bone-drugs-by-merck-roche-novartis-add-leg-fractures-in-study.html

Bone Drugs by Merck, Roche, Novartis May Add Leg Fractures

By Tom Randall - Feb 22, 2011 4:06 PM ET

Drugs made by Merck & Co., Roche Holding AG and Novartis AG designed to prevent bone breaks in older women may actually increase the risk of a rare form of leg fractures, a study found.

Women ages 68 and older who took the medicines, called bisphosphonates, for five years or more were 2.7 times more likely to be hospitalized for fractures in part of the thigh bone, according to the study, published today in the Journal of the American Medical Association. The bone breaks, known as atypical femur fractures, are rare and the risk is outweighed by the benefits of the drugs for most patients, researchers said.

The U.S. Food and Drug Administration in October changed the warnings on the drug labels for bisphosphonates and notified patients and doctors of an increased risk of the rare bone breaks. The agency continues to study the breaks, which account for less than one percent of hip and femur fractures overall, according to the FDA’s website.

[Article continues at original source]

Osteoporosis drugs and broken bones

Quoted from http://www.sbsun.com/living/ci_16451707

Osteoporosis drugs and broken bones

Joe Graedon and Teresa Graedon Posted: 10/27/2010 07:17:55 PM PDT

Popular osteoporosis drugs are coming under scrutiny. Bisphosphonate drugs such as Actonel, Boniva, Fosamax and Reclast are supposed to build strong bones and prevent fractures.

But an odd thing has happened. During the past few years, evidence has been building that these drugs may increase the risk of an unusual type of fracture (Journal of the American Medical Association, Oct. 6, 2010).

The Food and Drug Administration has just issued a safety announcement warning about "atypical fractures of the thigh." These femur fractures can occur without a fall, collision or trauma. Just walking may bring on this uncommon break.

Readers of this column have been reporting this kind of broken bone for some time: "I had been on Fosamax for seven years when I started having leg pain. The doctors I saw could not find anything wrong. Then one morning in the steam room at the gym, my left femur just snapped in half. It was a weird break, and I had to have a rod put in.

"Less than six months later, I was rushing around my son's kitchen getting my grandkids' breakfast and my right femur broke, making me fall. It broke in the same place as the left, and now I have rods in both legs."

[Article continues at original source]

EU agency starts safety probe of common bone drugs

Quoted from http://www.reuters.com/article/idCNLDE68N18Y20100924

EU agency starts safety probe of common bone drugs

LONDON, Sept 24 (Reuters) - European drugs regulators said they had started a safety review of a class of osteoporosis bone drugs called bisphosphonates after studies suggested a possible link to stress fractures.

The review by the European Medicines Agency follows a statement from the U.S. Food and Drug Administration earlier this month, which said it may require bisphosphonates to carry new information related to unusual femur fractures.

The bisphosphonate class includes Fosamax, made by Merck & Co (MRK.N) and sold generically under the chemical name alendronate, Roche's (ROG.VX) Boniva, Novartis's (NOVN.VX) Reclast, and Warner Chilcott's (WCRX.O) Actonel.

EMA said its Committee for Medicinal Products for Human Use (CHMP) would now review all available data thoroughly to clarify the links and "assess their impact on the balance of risks and benefits of these medicines.

"The Committee has begun looking at the possible increased risk of atypical stress fractures in patients taking bisphosphonate-containing medicines for the treatment and prevention of bone disorders," it said in a statement on Friday.

It said the review was prompted by research studies suggesting that atypical, or unusual, stress factures may be a class effect of bisphosphonates. (Reporting by Kate Kelland, editing by Ben Hirschler)

FDA considers label changes for bisphosphonates

Quoted from http://www.reuters.com/article/idUSTRE68D4BC20100914

FDA considers label changes for bisphosphonates

BOSTON | Tue Sep 14, 2010 1:06pm EDT

BOSTON (Reuters) - The U.S. Food and Drug Administration said on Tuesday it may require a class of osteoporosis drugs known as bisphosphonates to carry new information related to unusual femur fractures.

The FDA's statement follows the release of a report from the American Society of Bone and Mineral Research (ASBMR), which the agency said provides "important perspectives" on the potential association between long-term treatment with bisphosphonates and a rare but serious type of fracture of the thigh bone, or femur.

The bisphosphonate class includes Fosamax, made by Merck & Co Inc and sold generically under the chemical name alendronate; Roche Holding AG's Boniva, Novartis AG's Reclast and Warner Chilcott Plc's Actonel.

Ronald Rogers, a spokesman for Merck, said that in clinical studies involving more than 28,000 patients, Fosamax has not been associated with increased fracture risk at any skeletal site.

"Since bisphosphonates were first approved for the treatment of osteoporosis in 1995, millions of people, primarily women, have been treated," he said in an email.

Officials at Roche, Novartis and Warner Chilcott were not immediately available for a comment.

The FDA said the report from the ASBMR includes a case definition that describes the atypical features of these unusual femur fractures, which it believes will help in identifying cases and reporting on them.

"Although it is not clear if bisphonsphonates are the cause, these unusual femur fractures have been identified in patients taking these drugs," the agency said. "FDA recommends that healthcare professionals be aware of the possible risk of unusual femur fractures in patients taking bisphosphonates."

[Article continues at original source]

Researchers Puzzled by Role of Osteoporosis Drug in Rare Thighbone Fractures

Quoted from http://www.nytimes.com/2010/03/25/health/25bone.html

Researchers Puzzled by Role of Osteoporosis Drug in Rare Thighbone Fractures

By GINA KOLATA

Published: March 24, 2010

The case reports first surfaced about two years ago and they were frightening. A few orthopedists reported that women taking osteoporosis drugs to prevent broken bones were showing up with rare and serious fractures of their thighbones. The bone was snapping like a twig, sometimes splintering. Often there was no trauma, like a serious fall, to bring it on.

And some of the women were younger, in their 50s, with pre-osteoporosis but without the extremely fragile bones of people with the full-blown degenerative condition.

But case reports can be hard to interpret — they may or may not indicate a real cause and effect. And the Food and Drug Administration says it has not been able to find evidence of an increased risk of the unusual fractures in its analyses, including one of data from makers of bisphosphonates, the osteoporosis drugs.

Now, a paper published online Wednesday in The New England Journal of Medicine, also fails to find clear evidence that bisphosphonates are causing the fractures.

The researchers, led by Dennis M. Black, a professor of epidemiology and biostatistics at the University of California, San Francisco, report that the thighbone fractures are so rare, even in women taking bisphosphonates for up to 10 years, that it is not clear whether the drugs make them more likely. And, they report, if there is a risk, it is far outweighed by the drugs’ clear benefit in preventing fractures of the hip and spine in people with osteoporosis.

Thighbone fractures “are much much less common than typical hip fractures,” said Dr. Elizabeth Shane, a professor of medicine at the College of Physicians and Surgeons at Columbia University, who wrote an editorial accompanying Dr. Black’s paper. “While these fractures are devastating, so are the more common types of hip fractures that are prevented by bisphosphonates.”

[Article continues at original source]

Bisphosphonates and unusual leg breaks

Quoted from http://www.latimes.com/features/health/la-he-closer-20100322,5,4989919.story

Take bisphosphonates, break a leg?

Though two reports contend a connection exists between taking the drugs over a long period of time and getting these fractures, the FDA says so such connection exists.

By Jill U. Adams

Special to the Los Angeles Times

March 22, 2010

Long-term use of osteoporosis drugs seems to change bones in a way that could lead to unusual leg fractures, according to two reports presented earlier this month at a meeting of orthopedic surgeons. Doctors have reported seeing the unusual fractures in some patients on bisphosphonate drugs such as Fosamax.

It seems paradoxical that a medicine designed to protect against bone fractures in fact might be the cause of broken legs. Adding to the confusion, the U.S. Food and Drug Administration released a statement in the same week as the medical conference that said there is no clear connection, based on available evidence, between the bisphosphonates — including Actonel, Boniva and Reclast in addition to Fosamax — and atypical femur fractures.

The unusual bone breaks — called atypical subtrochanteric femur fractures — were first documented in small clinical reports and through the FDA's MedWatch system, which monitors side effects of drugs after they've been approved. Such reports do not necessarily mean the drug is the cause of the problem, but multiple reports of the same side effect with the same drug can spur additional investigation. Other potential side effects of bisphosphonate drugs have been identified through the FDA's reporting system, including serious jaw deterioration and esophageal cancer.

Here's a closer look at what's known about the safety and effectiveness of bisphosphonates.

[Article continues at original source]

FDA rules out bisphosphonate, thigh fracture link

Quoted from http://www.reuters.com/article/idUSN1016397620100310

FDA rules out bisphosphonate, thigh fracture link

Wed Mar 10, 2010 3:56pm EST

By Toni Clarke

BOSTON, March 10 (Reuters) - U.S. regulators said on Wednesday they have found no link between oral bisphosphonate osteoporosis medications such as Merck & Co Inc's (MRK.N) Fosamax and certain thigh bone fractures.

The U.S. Food and Drug Administration issued its statement following the publication of case reports of atypical subtrochanteric femur fractures -- or fractures in the bone just below the hip joint -- in women with osteoporosis using oral bisphosphonates.

Bisphosphonates are a class of drug aimed at preventing bone fractures and offseting bone loss associated with menopause.

They include Fosamax, Roche Holding AG's (ROG.VX) Boniva, Novartis AG's (NOVN.VX) Reclast and Procter and Gamble Co's (PG.N) Actonel.

In June 2008, the FDA requested information from all bisphosphonate drug makers related to these type of fractures. The agency said a review of the data did not show an increased risk for women using the medications.

The FDA said that, although its review of the data did not show a clear connection between bisphosphonates and atypical subtrochanteric femur fractures, the agency is working closely with outside experts to gain more insight into the issue.

Bisphosphonates, which have been on the market for roughly a decade, have raised safety concerns in the past, including heart risks.

But in 2008, the FDA said the drugs showed no overall risk of heart problems. The agency's review followed reports of serious atrial fibrillation, a type of abnormal heartbeat, in the New England Journal of Medicine.

In January, a Manhattan federal judge refused to dismiss a lawsuit alleging that Fosamax caused jaw damage to a woman during the nearly eight years she took the pill.

Merck faces a slew of lawsuits involving almost 900 cases by patients who say Fosamax caused osteonecrosis of the jaw, or death of jaw bone tissue.

The FDA recommended patients keep taking their medication unless told not to by their doctor. It also recommended that healthcare professionals be aware of a "possible risk" of atypical subtrochanteric femur fractures in patients taking oral bisphosphonates.