If you or a loved one have taken Fosamax and are experiencing unusual pain in the thigh or hip, you should contact your doctor. If you have been injured as a result of Fosamax side effects such as low-energy femur fractures, contact us or call toll free 1-800-448-0883 for a free consultation and case evaluation by our drug recall attorneys.
Fosamax® (alendronate), a prescription drug manufactured by Merck, is used to treat osteoporosis, a disease in which bones become increasingly fragile. Drugs like Fosamax, called bisphosphonates, are prescribed to increase bone density, but recent evidence indicates it may have the opposite effect and destroy bone. A 2004 FDA analysis linked bisphosphonates to osteonecrosis of the jaw (ONJ). ONJ is an irreversible condition in which the jawbone dies and is unable to regenerate,
Fosamax is the most commonly dispensed bisphosphonate in the United States: 22 million prescriptions were written in 2004. Bisphosphonates, once taken, remain in the bones indefinitely.
Symptoms of ONJ include the following:
- Loose teeth
- Jaw pain
- Exposed bone
- Severe mouth infections
- Swelling in the mouth
- Mouth ulcers and sores
Fosamax Lawsuit Progress
The drug manufacturer Merck & Co. is currently facing thousands of lawsuits over allegations that their osteoporosis drug Fosamax is the cause of jaw necrosis. Most of the cases are pending in the multi-district litigation (MDL) No. 1789 in the Southern District of New York. Judge Keenan is presiding over the MDL cases.
The first trial ended in a mistrial. However, on retrial, the jury reached an $8 million verdict for Mrs. Shirley Boles. The second case was Maley v. Merck, and it concluded with a defense verdict. The third case also ended in Merck’s favor. However, Merck still faces close to 900 Fosamax lawsuits filed by what may be as many as 2,000 plaintiffs. Merck has spent approximately $150 million defending Fosamax. Ironically, it spent zero on studying Fosamax
The plaintiffs in the Fosamax lawsuits are alleging that Merck failed to warn both patients and doctors that the drug may inhibit blood flow to the jaw area, which in turn lead to jawbone-tissue necrosis, commonly referred to as osteonecrosis of the jaw, or ONJ.
Merck’s Additional Problem – Low Energy Femur Fractures
A panel of experts calls for Merck to warn about the risk of Femur-Fracture and Fosamax use. The commonly prescribed osteoporosis drug, Fosamax, manufactured by the Pharmaceutical Company, Merck, has been linked to a rare type of femur fracture according to a study in the 2008 June Issue of the Journal of Orthopedic Trauma. The study found that twenty-five (25), out of seventy (70) patients who experienced low-energy femur fractures, took Fosamax for four years or more. Nineteen (19) of the twenty-five (25) Fosamax patients' fractures had distinct characteristics. It was a simple fracture with a straight line across the bone and a beak-like overhang on one side. The patients' bone appeared strong, unlike osteoporotic bone.
Fosamax is a bisphosphonate. It is prescribed to strengthen bones and prevent osteoporosis. A growing concern about its suspected link to low-energy femur (thigh bone) fractures prompted an investigative report by ABC World News Tonight on March 8, 2010.
The FDA has stated that it is investigating the suspected link between the use of Fosamax and an increase of low-energy femur shaft and subtrochanteric (thigh bone) fractures. In a statement, the FDA said it has not identified a link between the drug and the femur fractures, but it continues to study the issue with the assistance of experts from outside agencies including the American Society of Bone and Mineral Research Subtrochanteric Femoral Fracture Task Force.
Recently, Merck updated its Adverse Reaction section of the Fosamax Label to include information about low-energy femoral shaft (thigh bone) fractures.
If you or a loved one have taken Fosamax and are experiencing unusual pain in the thigh or hip, you should contact your doctor. . If you have been injured as a result of Fosamax side effects such as low-energy femur fractures, contact us or call toll free 1-800-448-0883 for a free consultation and case evaluation by our drug recall attorneys.
Additional Information on Fosamax® & the Increased Risk of Osteonecrosis of the Jaw:
- Fosamax Side Effects
- Fosamax Defined & Related Articles
- Merck Gets its Way in the Fosamax Femur Fracture Litigation
- F.D.A. to Review Safety of Popular Bone Drugs, New York Times, 6 Sept 2011
- Fosamax Drug Holidays May Not Be Enough
- New Cautions About Long-Term Use of Bone Drugs, New York Times, 9 May 2012
- Continuing Bisphosphonate Treatment for Osteoporosis - For Whom and for How Long?, New England Journal of Medicine, 9 May 2012
- Bisphosphonates for Osteoporosis - Where Do We Go from Here? New England Journal of Medicine, 10 May 2012
- Fosamax: FDA Conducts Review Confirming Long-Term Use Has No Benefit, 11 May 2012
- Osteoporosis Drugs Linked to Rare Fractures, The Wall Street Journal|Health, 21 May 2012
- Litigation Update: Fosamax – Femurs and Jaw Bones, 4 Dec 2012