Fosamax study may link the drug to rare femur fracture

36 percent of femur fracture patients in study were taking Fosamax

In June 2008, the Journal of Orthopedic Trauma published an article linking Merck’s Fosamax to a rare type of fracture in the femur. The study looked at 70 patients who experienced a femur fracture and found 36 percent (25) of the patients were taking Fosamax for at least four years.

The femur fractures in the Fosamax patients had distinct characteristics, like a simple fracture with a straight line across the bone and a beak-like overhang on one side. Fosamax patients’ bones also looked strong, as apposed to a typical osteoporotic bone. The study may help determine if Fosamax patients are vulnerable to fractures.

Fosamax has previously been linked to other significant side effects; ongoing litigation against Merck alleges the drug caused osteonecrosis of the jaw – also known as “dead jaw.”

Source: Heather Won Tesoriero, “Side effect watch: femur fractures in Fosamax patients,” Wall Street Journal Health Blog, June 4, 2008.

Despite lack of in-depth review, FDA says bisphosphonate use should continue

Agency unclear on how to interpret serious atrial fibrillation data

On October 1, 2007, the United States Food and Drug Administration (FDA) released its conclusion from an initial review of bisphosphonate drugs. Despite a New England Journal of Medicine article published on May 3, 2007 that raised safety concerns about the drugs, the FDA said doctors and patients should continue their use of the drugs.

The May 2007 article questioned the association of atrial fibrillation, a heart rhythm disorder, with bisphosphonate drugs, which are used primarily to increase bone mass and reduce risks of fracture in osteoporosis patients.

Bisphosphonate drugs include:

• Fosamax
• Fosamax Plus D
• Reclast
• Didronel
• Boniva
• Aredia
• Actonel
• Skelid
• Zometa

The FDA reviewed reports of this association, but did not identify a class of patients who are at an increased risk of developing the heart rhythm disorder. The agency found most cases of atrial fibrillation occurred more than one month after the administration of the drug.

The FDA said it is unclear how to interpret the data on serious atrial fibrillation associated with the drugs. The FDA added it does not believe doctors or patients should change prescribing practices or the use of bisphosphonates. The agency is, however, seeking additional data to perform an in-depth evaluation of the safety issue for the entire class of bisphosphonates.

Source: “Early communication of ongoing safety review,” United States Food and Drug Administration Press Release, October 1, 2007.

Canadian consumers sue Merck over Fosamax drug

Osteoporosis drug may damage jaw bones

A class action lawsuit has been filed against drug manufacturer Merck, alleging the company failed to warn consumers its bone drug Fosamax may damage jaw bones.

On May 28, 2007, a Canadian law firm filed the first complaint over the drug in Canada.

Osteonecrosis of the jaw (ONJ), commonly known as “jaw death” or “phossy jaw,” can cause jaw bones to deteriorate and die. It also causes pain, soft-tissue swelling, infection, loosening of teeth, and exposed bone.

Merck has already been sued in United States courts over risks associated with Fosamax, with complaints filed in New York, Florida, and Tennessee. In 2006, at least 19 lawsuits were transferred to a New York judge. Fosamax has not been recalled in the U.S.

In 1995, Fosamax was approved in Canada for treating osteoporosis, but was connected to an increased risk of developing osteonecrosis, or “jaw death.”

Source: Joe Schneider, “Merck sued in Canadian court over Fosamax drug, law firm says,” Bloomberg.com, May 28, 2007; Dan MacDonald, “Drugmaker faces class-action suit over ‘jaw death’ warnings,” The StarPhoenix, May 29, 2007.

NC oral surgeon warns of dangers from bisphosphonate drugs Fosamax, Aredia, and Zometa

Has seen 24 cases in his practice alone

Dr. Gregory Lutcavage, an oral and facial reconstructive surgeon in Goldsboro, NC, is concerned about Fosamax the drug prescribed to many women after menopause to prevent osteoporosis. Dr. Lutcavage is concerned because several years after they’ve taken the drug, Goldsboro patients may wind up in his office with disfiguring and painful ailments that he may not be able to do anything about: jawbone fractures, and osteonecrosis of the jaw.

Osteonecrosis of the jaw is a devastating condition in which the soft tissue inside a person’s jaw dies. Symptoms include jutting and exposed bone, spontaneous jaw fractures, raw and seeping infections, facial collapse and disfigurement. The condition was once known as “fossy jaw” or “phossy jaw” because it developed in workers who were exposed to phosphorus in match-making plants.

A connection has been made between drugs containing bisphosphonates and osteonecrosis of the jaw. Bisphosphonates include Fosamax as well as the intravenous drugs Aredia and Zometa, used in the treatment of cancer. Dr. Lutcavage said that, historically, patients on bisphosphonates may not show the effects of exposure until years of accumulation. The average mean time for patients on the intravenous medications Aredia and Zometa is about a year, but most patients on Fosamax take the drug for as long as three years before the negative effects are seen. In Dr. Lutcavage’s practice, he has seen 24 cases of fractures and osteonecrosis related to bisphosphonate drugs.

Unfortunately for patients, there are no completely effective treatment options. “We’re looking at a loss of jaw,” Dr. Lutcavage said. The treatment options are solely symptomatic. A loss of jaw can be reconstructed with a titanium plate, but once jawbone tissue begins to die, there is no way to halt the process. A person’s jaw, once affected with osteonecrosis, begins to completely break down. Dr. Lutcavage says even titanium plates might not last over the long term because of the deterioration of the bone. Over time, plates and screws may loosen. The only thing a surgeon can do for patients is to “try and get them comfortable again,” Dr. Lutcavage said. “It’s going to get to the point where people will have to live with exposed bone, because we don’t have the treatment.”

Since 2003, more than 3000 cases of osteonecrosis of the jaw have been reported. Dentists are growing increasingly frustrated with the response of drug makers to this issue. “One drug company did not come out with the update to their circular until about three or four months ago,” Dr. Lutcavage said. “We were seeing this three years ago.”

Source: Phyllis Moore, “Doctor warns of drug’s side effects,” Goldsboro News-Argus, July 24, 2006.

Evista may increase the risks of blood clots and strokes in breast-cancer patients

A study investigating whether the osteoporosis-fighting drug Evista could be used as an alterative to tamoxifen for preventing breast cancer found Evista did prevent cancer, but raised the risk of blood clots and fatal strokes in women taking the drug. Evista also did not lower the risk of death, hospitalization, or heart attack.

The study, which involved 10,101 post-menopausal women in 26 countries including the U.S. was published in the July 13, 2006 edition of the New England Journal of Medicine and paid for by Eli Lilly and Co., makers of Evista . Participants either had clogged arteries or multiple heart risk factors and the study was designed to test whether Evista would both lower their risk of getting breast cancer and lower their risk of heart disease. After an average of five years on either Evista or placebo, Evista users had one-third fewer cases of breast cancer, and about half the number of invasive breast cancers; but 59 of 5,044 Evista users had fatal strokes compared to 39 on placebo. This represents a 49 percent greater risk of fatal strokes for patients on Evista . Blood clots in veins, which can potentially travel to the lungs and cause death, were found in 103 women on Evista but only 71 women on placebo.

Marcia Stefanick, disease-prevention researcher at Stanford University School of medicine, said in an editorial in the journal that the “moderate” breast-cancer prevention benefits of Evista “do not seem to justify the risks” of taking the drug for women already prone to heart problems. Dr. Marisa Weiss, a breast-cancer specialist who founded the web site breastcancer.org, agreed. “The cardiac benefit wasn’t there,” Dr. Weiss said. “The side effects were.”

Source: “Cancer drug increases heart risks,” Associated Press,” July 13, 2006, accessed July 17, 2006.

Fosamax suit details risks

Woman joins Florida class-action suit against maker of Fosamax; diagnosed with ONJ after tooth extraction

A Utah woman joined the class action suit brought by Linda Secrest, a 60 year old Florida resident, against Merck and Co., makers of the osteoporosis-fighting drug Fosamax. The woman, Pamela Hines, was diagnosed with osteonecrosis of the jaw (ONJ) after a routine tooth extraction. ONJ is a disfiguring and irreversible breakdown of the jawbone and loss of teeth. Ms. Hines’s mouth failed to heal after her extraction. She visited several doctors before learning her ONJ could be linked to the Fosamax she had taken to prevent the loss of bone she now experiences.

Ms. Hines now weighs only 85 pounds and is forced to receive an intravenous antibiotic to help clear her mouth infection. She is unemployed and has to undergo a hyperbaric treatment five days a week. The treatment requires her to lie in an oxygen-rich, pressurized chamber in order to increase the blood and oxygen pumped to her wounds.

Oral surgeons and dentists are becoming increasingly concerned about the number of ONJ cases they are seeing. The concentration of bisphosphonate, the active ingredient in Fosamax that is also in an intravenous drug has been linked to ONJ in cancer patients on chemotherapy, begins to build up in the bones by the third year on the drug. Many women begin to take Fosamax at the onset of menopause and are encouraged by their doctors and aggressive drug marketing to stay on the drug for many years. Bisphosphonates render the jawbone inert, making it impossible for an oral surgeon to perform an implant or for a dentist to drill to remove infection.

Dr. Robert Marx, chair of the oral and maxillofacial surgery department at the University of Miami medical school, believes that Merck and Co. did not anticipate the extent to which bisphosphonates can affect the jaw compared with other bones in the body. Dr. Marx first raised concern three years ago about the effects of Fosamax on the jaw and says Merck did not do enough testing on the jaw in clinical trials. Marx believes that if Merck had done the additional testing, “They could’ve predicted this might occur.”

Approximately 4.2 million prescriptions for Fosamax were written last year; yet despite a 2004 FDA report by the Office of Drug Safety about the risks of jawbone necrosis with Fosamax as well as Actonel and Boniva, two similar osteoporosis drugs, Merck has never released a “Dear Doctor” letter warning of the ONJ risk associated with its product.

Osteonecrosis “can’t be fixed,” says Hillel Ephros, chair of the St. Joseph’s Regional Medical Center in Paterson, NJ. That makes dentists and oral surgeons wary of even accepting patients who take Fosamax because of the risk that the patient will contract ONJ.

Sources: Carey Hamilton, “Fosamax lawsuit brings risks to light,” Salt Lake Tribune, June 20, 2006, accessed June 22, 2006; Ed Silverman, “Bone-building drugs linked to bone-rotting side effect,” New Jersey Star-Ledger, June 13, 2006, accessed June 22, 2006.

Fosamax suit filed

Lawsuit filed in FL on behalf of 59-year-old female diagnosed with jawbone tissue death while taking osteoporosis drug Fosamax

Linda Secrest, 59, has filed suit against Merck & Co. in federal court in Fort Myers, FL. Ms. Secrest is accusing Merck of failing to warn doctors and patients that Fosamax, the most-prescribed osteoporosis treatment in the U.S. for post-menopausal women, could hamper blood flow to the jaw. Ms. Secrest was diagnosed with jawbone tissue death, or osteonecrosis, in 2005, an irreversible condition.

In July of 2005, the FDA requested that Merck add a warning notice to the labeling for Fosamax warning of the risk of jawbone necrosis. Merck claims that the risk of jawbone necrosis to patients on Fosamax is rare. Ms. Secrest’s suit seeks to represent more than 10 million Fosamax users and it the second of a rumored 200 lawsuits that may be filed in Florida on behalf of Fosamax users.

Ms. Secrest is seeking a change in the prescribing information given by Merck to doctors who recommend Fosamax to their patients and wants Merck to pay for the cost of monitoring her jawbone necrosis.

Source: “Merck Sued Over Fosamax Health Risks,” Bloomberg.com, April 11, 2006.