Pharmaceutical Drug Litigation Updates

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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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.

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  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

 

Related Articles

• Study Suggests Osteoporosis Drug Might Treat Loss of Bone in Jaw
• Health Buzz: Osteoporosis Drugs May Increase Risk for Thigh Bone Fracture
• Bone Drugs Linked to Rare Fractures, FDA Warns
• 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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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."

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Bone Drugs Linked to Rare Fractures, FDA Warns

Quoted from http://www.businessweek.com/lifestyle/content/healthday/644359.html

Bone Drugs Linked to Rare Fractures, FDA Warns

Agency to change warning label, issue medication guide for all bisphosphonates used to treat osteoporosis

By Steven Reinberg
HealthDay Reporter

WEDNESDAY, Oct. 13 (HealthDay News) -- People taking drugs called bisphosphonates, such as Fosamax and Boniva, to prevent or treat osteoporosis may be at risk for a rare type of fracture of the thigh bone, U.S. health officials warned Wednesday.

Bisphosphonates work by inhibiting bone loss and have been shown to prevent fractures due to osteoporosis. Whether bisphosphonates are the cause of these rare thigh fractures isn't clear, but they have predominantly been reported in patients taking these drugs, according to the U.S. Food and Drug Administration (FDA).

"FDA is warning again about the possible risk of an uncommon form of fracture in patients who take bisphosphonates to treat or prevent osteoporosis," Rear Admiral Sandra Kweder, M.D., deputy director of CDC's Office of New Drugs, Center for Drug Evaluation and Research, said during an afternoon press conference Wednesday.

The warning will take the form of a label change and a medication guide that patients will receive with their prescription, she said.

One of the unusual features of these atypical thigh fractures, also called atypical femur fractures, is that they are often associated with little or no trauma, Kweder said.

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When Avandia and Other Drugs Cause Problems They Are Supposed to Prevent

Quoted from http://www.nytimes.com/2010/10/17/health/policy/17drug.html

When Drugs Cause Problems They Are Supposed to Prevent

By GINA KOLATA

Published: October 16, 2010

In the past month, the Food and Drug Administration has concluded that in some cases two types of drugs that were supposed to be preventing serious medical problems were, in fact, causing them.

One is bisphosphonates, which is widely used to prevent the fractures, especially of the hip and spine, that are common in people with osteoporosis. Those drugs, like Fosamax, Actonel and Boniva, will now have to carry labels saying they can lead to rare fractures of the thigh bone, a surprising new discovery that came after another surprise — that they can cause a rare degeneration of the jawbone. 

The other is Avandia, which is widely prescribed for diabetics, whose disease puts them at risk for heart attacks and heart failure. Two-thirds of diabetics die of heart problems, and a main reason for taking drugs like Avandia is to protect them from that.

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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."

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