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this pageFOSAMAX®: A Bone–Building Drug that Can Damage the Jaw
FOSAMAX® (alendronate sodium) is used to prevent and reverse bone loss, called osteoporosis, and to treat Paget’s disease, a disorder marked by bone destruction and deformity. The typical patient taking FOSAMAX® is a postmenopausal woman who is at risk for developing osteoporosis or who has already been diagnosed with the condition. Less commonly, men may also develop osteoporosis.
The use of FOSAMAX® has been linked to osteonecrosis of the jaw. In this illness, the jaw bone decays and becomes exposed, resulting in jaw pain and tooth loss. In advanced cases, the jaw deteriorates completely. At present, there is no cure for this condition, although oral rinses and antibiotics may be useful in controlling inflammation and pain (J Oral Maxillofac Surg., 2005 Nov; 63(11): 1567–75).
Research Confirms the Link Between Bisphosphonates and Jaw Problems
First approved for sale in September, 1995, FOSAMAX® is in the group of drugs known as nitrogen–containing bisphosphonates. Dentists and oral surgeons began to notice the connection between bisphosphonates and jaw osteonecrosis as early as 2001. They now are cautious about performing tooth extractions or other dental procedures on patients taking bisphosphonates, fearing that this work could trigger jaw damage (Spec Care Dentist 2006, Jan–Feb; 26(1): 8–12).
Recent medical journal articles further confirm the connection between drugs such as FOSAMAX® and jaw problems. One study at an oral surgery department of a hospital in Greece mentions the increased number of patients with exposed, dying jaw bones and analyses 11 such cases. These individuals had taken bisphosphonates for at least six months through five years (Int J Oral Maxillofac Surg., 2006 May 8). Another report describes four patients with osteonecrosis of the jaw who had taken bisphosphonates. They had not undergone radiotherapy or had tooth extractions, procedures that some believe aggravate jaw problems in patients taking bisphosphonates (J Oral Pathol Med., 2005 Nov; 34(10): 613–7).
At Long Island Jewish Medical Center in New York, Dr. Salvatore Ruggiero and other researchers reviewed the records of 63 patients with either osteoporosis or cancer who developed osteonecrosis of the jaw during the period from February 2001 through November 2003. All 63 patients had taken bisphosphonates for at least one year (J Oral Maxillofac Surg., 2004 May; 62(5): 527–34). In prior times, the medical center rarely encountered patients with jaw osteonecrosis, generally treating only one or two such cases per year.
A review article from researchers at the School of Dental Medicine at Harvard concludes that patients who receive intravenous injections of bisphosphonates increase their risk of developing osteonecrosis of the jaw by up to 10%. They were not able to calculate the exact increased risk posed by FOSAMAX® and other bisphosphonates that are taken by mouth, but felt that these drugs could cause serious complications and that their use should be very carefully monitored (Ann Intern Med. 2006 May 16;144(10): 753–61).
Merck Prescription Labels Minimize the Risk of Osteonecrosis
FOSAMAX® is manufactured by Merck, the same company that created the dangerous arthritis drug, Vioxx®, which was recalled in September 2004. Merck’s prescribing instructions for FOSAMAX® do mention jaw osteonecrosis, but not in the prominent section entitled “Warnings.” Rather, the information is buried under “Precautions.”
A pamphlet that is handed out to patients states the following about FOSAMAX®: “Rarely, patients have had jaw problems associated with delayed healing and infection, often following tooth extraction.” Besides minimizing the seriousness of jaw osteonecrosis, this information remains hidden as the very last item in a long list of side effects.
FOSAMAX® Side Effects
FOSAMAX®’s side effects can be considerable, even after the patient stops taking the drug. This is because FOSAMAX® and other bisphosphonates are incorporated into the skeleton without being degraded and persist for a long period of time. Alendronate, the main ingredient in FOSAMAX®, has a half life of up to 12 years (Int J Clin Pract Suppl., 1999 Apr; 101: 18–26).
Besides increasing the risk of osteonecrosis of the jaw, FOSAMAX® may cause severe digestive reactions, including irritation, inflammation, or ulcers of the esophagus, which is the tube connecting the throat to the stomach. Patients may also experience pain in the stomach area. Other FOSAMAX® side effects include nausea, vomiting, constipation, diarrhea, gas, headaches and bone, muscle and joint pain.
Your FOSAMAX® Case
Brayton Purcell has been successfully handling medical/legal cases involving defective drugs for over 20 years. Our attorneys are currently evaluating the legal claims of people who have taken FOSAMAX® and developed serious jaw bone complications or osteonecrosis of the jaw.
Please contact us if you or a family member has developed these conditions while taking FOSAMAX® or after you stopped taking the drug. We will review your case free of charge and advise you of your legal choices.
Related Articles
- October 13, 2006
- FOSAMAX® and Jaw Decay: The Dentist’s View