Drug Safety Developments

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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Novartis Hid Risks to Protect Sales, Lawyer Says

Quoted from http://www.bloomberg.com/news/2010-11-19/novartis-hid-risks-to-protect-sales-lawyer-says-update1-.html

Novartis Hid Risks to Protect Sales, Lawyer Says

By Jef Feeley and Jerry Adams - Nov 18, 2010 7:05 PM ET

Novartis AG officials hid the health risks of the drugmaker’s bone-strengthening medicines Aredia and Zometa to protect billions of dollars in sales, lawyers for a North Carolina woman said.

Executives of Basel, Switzerland-based Novartis ignored studies showing that some cancer patients taking Aredia and Zometa may suffer irreplaceable jawbone damage, Vernon Glenn, a lawyer for Rita Fussman’s family, told a federal court jury in Winston-Salem, North Carolina. The drugs had $1.5 billion in sales in 2009.

Zometa and Aredia created a “giant money wheel” for Novartis, Glenn said in closing arguments of the trial of a lawsuit by Fussman’s family over damage done to her jaw. Novartis officials were prepared to do whatever it took to “keep the money wheel rolling,” the lawyer said.

The Fussman family’s lawsuit is the third product-liability case to go to trial over the bone-strengthening treatments. Last month, a New Jersey jury rejected a woman’s claims that Aredia and Zometa caused her jaw deterioration. In October 2009, a Montana jury ordered Novartis to pay $3.2 million in damages to a cancer patient who made the same claims over the medicines.

Bruce Berger, a Novartis lawyer, countered in his closing argument that the company provided adequate warnings about the risks the drugs posed to users. Fussman’s jaw problems were unrelated to her use of Zometa, he said. Fussman, who lived in Chapel Hill, North Carolina, died in 2009 of complications from breast cancer.

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Novartis Downplayed Risk of Bone Drugs on Cancer Patients, Lawyer Says

Quoted from http://www.bloomberg.com/news/2010-11-01/novartis-officials-hid-risks-of-bone-drugs-aredia-and-zometa-lawyer-says.html

Novartis Downplayed Risk of Bone Drugs on Cancer Patients, Lawyer Says

By Jef Feeley and Jerry Adams - Nov 1, 2010 7:39 PM ET

Novartis AG officials downplayed risks that the drugmaker’s bone-strengthening medicines Aredia and Zometa could destroy patients’ jaws, a lawyer for a woman suing the company told a North Carolina jury.

Officials of the Basel, Switzerland-based drug company got reports from doctors as early as 2002 that Rita Fussman and other cancer patients taking Aredia and Zometa to prevent bone loss during treatment suffered irreplaceable jawbone damage, Bob Germany, a lawyer for Fussman’s family, said in opening statements in a trial over the medicines. Fussman died in 2009 of complications from breast cancer.

Fussman’s family contends Novartis didn’t adequately warn that Aredia and Zometa could cause disfiguring jaw damage that forced cancer patients such as Fussman to subsist on baby food, Germany told jurors in federal court in Winston-Salem.

Patients and their doctors “were not told the whole story about these drugs,” Germany said. “In fact, we were not told half the story.”

The Fussman family’s lawsuit is the third product-liability case to go to trial over the bone-strengthening treatments, which had 2009 sales of $1.5 billion, according to Novartis’s annual report. Both drugs are still on the market.

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Cancer-Fighting Bone Drugs Might Raise Stroke Risk

Quoted from http://health.usnews.com/health-news/family-health/heart/articles/2010/10/12/cancer-fighting-bone-drugs-might-raise-stroke-risk.html

Cancer-Fighting Bone Drugs Might Raise Stroke Risk

But IV bisphosphonates can also benefit patients, researchers note

Posted: October 12, 2010

By Amanda Gardner
HealthDay Reporter

TUESDAY, Oct. 12 (HealthDay News) -- A new study finds that cancer patients treated with bisphosphonate drugs such as Aredia or Zometa to reduce or delay bone complications from cancer may be at higher risk for the irregular heartbeat known as atrial fibrillation and for a related event, stroke.

In atrial fibrillation, the upper chambers of the heart beat chaotically, causing blood to pool and increasing the potential of clots, stroke, heart failure and death.

However, the bump up in risk with bisphosphonates was "relatively modest," said Dr. James Goodwin, senior author of a paper appearing online Oct. 12 in the Journal of Clinical Oncology.

At relatively low doses, bisphosphonates have been widely used for about three decades to treat osteoporosis, mainly in older women.

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Novartis Wins Trial Over Jaw Injury Blamed on Drugs

Quoted from http://www.businessweek.com/news/2010-10-06/novartis-wins-trial-over-jaw-injury-blamed-on-drugs.html

Novartis Wins Trial Over Jaw Injury Blamed on Drugs

October 06, 2010, 7:47 PM EDT

By David Voreacos and Jef Feeley

Oct. 6 (Bloomberg) -- A New Jersey jury ruled that Novartis AG, the Swiss drugmaker, provided adequate warnings about the risk of its bone-strengthening medicines, rejecting a lawsuit by a woman who claimed the drugs destroyed her jaw.

Jane Bessemer, 73, sued Novartis after developing jawbone damage while taking Aredia and Zometa to slow bone loss as she battled breast cancer. Jurors in state court in New Brunswick, New Jersey, deliberated less than three hours today before finding that Novartis provided proper warnings to Bessemer’s doctors about jaw problems linked to Aredia and Zometa.

“There is not anything in this record to show that Novartis deliberately concealed anything,” Joe Hollingsworth, a company attorney, said in his closing argument today.

Bessemer’s suit was the second product-liability case to go to trial over the bone-strengthening treatments, which had 2009 sales of $1.5 billion, according to Novartis’ annual report. Both drugs are still on the market. Last year, a Montana jury ordered Basel, Switzerland-based Novartis to pay $3.2 million in damages to a woman who blamed the drug for damaging her jaw.

Gloria Vanderham, a U.S.-based spokeswoman for Novartis, didn’t immediately return a telephone call for comment about the verdict.

Bessemer, of Brielle, New Jersey, sought unspecified damages for her pain, suffering and loss of enjoyment of life. Her husband, Allan, 75, sought damages for his loss of consortium, society and services.

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Novartis Hid Bone Drugs’ Risks, Lawyer Tells Jury

Quoted from http://www.businessweek.com/news/2010-09-23/novartis-hid-bone-drugs-risks-lawyer-tells-jury.html

Novartis Hid Bone Drugs’ Risks, Lawyer Tells Jury

September 23, 2010, 2:39 PM EDT

By Jef Feeley and Margaret Cronin Fisk

Sept. 23 (Bloomberg) -- Novartis AG officials hid the health risks of the drugmaker’s bone-strengthening medicines Aredia and Zometa, which a woman says destroyed her jaw, a lawyer told a New Jersey jury.

Novartis executives knew as early as 2002 that Jane Bessemer and other cancer patients taking Aredia and Zometa to slow bone loss during treatment may suffer irreplaceable jawbone damage, Bob Germany, a lawyer for the plaintiff, said in opening statements in the trial of Bessemer’s lawsuit over the medicines.

Bessemer and other patients wouldn’t have suffered disfiguring injuries if officials of Basel, Switzerland-based Novartis “had told the public what they knew” about the drugs’ risks, Germany told jurors in New Brunswick, New Jersey, today.

Bessemer’s suit is the second product-liability case to go to trial over the bone-strengthening treatments, which had 2009 sales of $1.5 billion, according to Novartis’ annual report. Both drugs are still on the market. Last year, a Montana jury ordered Novartis to pay $3.2 million in damages to a woman who blamed the drug for damaging her jaw.

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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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Tenn. federal judge refuses to throw out lawsuits by patients claiming jaw damage

Quoted from http://www.chicagotribune.com/business/sns-ap-us-lawsuit-jaw-damage,0,5482412.story

Tenn. federal judge refuses to throw out lawsuits by patients claiming jaw damage

SHEILA BURKE Associated Press

5:49 p.m. CST, March 8, 2010

NASHVILLE, Tenn. (AP) — A federal judge in Nashville has refused to dismiss 40 lawsuits against a Swedish-based pharmaceutical company accused of failing to warn patients that two of its drugs can cause severe deterioration of the jaw.

U.S. District Judge Todd Campbell's ruling last week is the latest blow to Novartis Corp. The company is facing lawsuits from hundreds of patients around the country over its bone-strengthening drugs Aredia and Zometa.

The 40 cases from people treated with the drugs in Florida represent a portion of the more than 600 cases against Novartis in U.S. District Court in Nashville. There are approximately 150 additional cases being handled by a state court in New Jersey.

Trials are set to begin later this year around the country.