Alendronate / Fosamax

What is Fosamax? 

Fosamax or Alendronate used by nearly 10 million men and women to help prevent or treat bone loss or osteoporosis, has allegedly been linked to 2,400 incidents of jaw death, jaw bone decay or Osteonecrosis of the jaw since 2001. An additional 120 people taking these drugs in pill form have claimed to have such debilitating pain that they have become bedridden or in need of walkers, crutches or wheelchairs. Moreover, as much as 90 percent of drug side effects may never have been reported to the  Food and Drug Administration, meaning the total number of people suffering from ailments because of Fosamax may be much higher.

Fosamax is the brand name for the drug Alendronate. It belongs to a class of drugs know as bisphosphonates and is approved by the FDA for the treatment of Osteoporosis, or thinning of the bones. Bisphosphonate drugs have been used since 1995 to strengthen bone in women who are losing bone density. The have also been used for nearly 15 years in men and women who have cancer. Other bisphosphonates include Actonel, Boniva, Bonefos, Didronel, Aredia, Skelid and Zometa.

A connection between bisphosphonates such as Fosamax, and Osteonecrosis of the jaw (ONJ) was discovered in 2004. The findings were published in the Journal of Oral and Maxillofacial Surgeons and showed the side effects of Fosamax may include ONJ, a condition commonly called “jaw death.”

Osteonecrosis of the jaw (ONJ) is a disease in which bone tissue in the jaw does not heal after minor traumas. Dental extractions that cause bone to become exposed can lead to fractures and infections often requiring long-term antibiotic therapy and surgery to remove the dead and dying bone tissue. Some researchers and pharmaceutical experts state that prevention and early treatment of patient using Fosamax is critical in the preservation of a healthy jaw bone. Individuals using Fosamax and other bisphosphonates should try to avoid tooth extractions and other major dental work while taking these medications.

Symptoms of “jaw death” include irregular sore with exposed bone, pain or swelling in the infected jaw, infection, possibly with pus, altered sensation - numbness or a heavy sensation.

The highest risk factors for ONJ or jaw death are:

1) taking bisphosphonates like Fosamax, especially in IV form
2) concurrent use of steroids
3) previous history of cancer, osteoporosis or Paget's disease
4) traumatic dental procedure, such as tooth extraction or dental implants.

The following information is a medline publication concerning Alendronate:

Why is this medication prescribed?

Alendronate is used to treat and prevent osteoporosis (a condition in which the bones become thin and weak and break easily) in women who have undergone menopause (change of life; end of menstrual periods). Alendronate is also used to treat osteoporosis in men and women, who are taking corticosteroids (a type of medication that may cause osteoporosis in some patients). Alendronate is also used to treat Paget's disease of bone (a condition in which the bones are soft and weak and may be deformed, painful, or easily broken). Alendronate is in a class of medications called bisphosphonates. It works by preventing bone breakdown and increasing bone density (thickness).

How should this medicine be used?

Alendronate comes as a tablet and a solution (liquid) to take by mouth. The solution is usually taken on an empty stomach once a week in the morning. The 5-mg and 10-mg tablets are usually taken on an empty stomach once a day in the morning, and the 30-mg and 70-mg tablets are usually taken on an empty stomach once a week in the morning. The 40-mg tablets are usually taken once a day in the morning for six months to treat Paget's disease of bone. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take alendronate exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Alendronate may not work properly and may damage the esophagus (tube between the mouth and stomach) or cause sores in the mouth if it is not taken according to the following instructions. Tell your doctor if you do not understand, you do not think you will remember, or you are unable to follow these instructions:

You must take alendronate just after you get out of bed in the morning, before you eat or drink anything. Never take alendronate at bedtime or before you wake up and get out of bed for the day.

Swallow alendronate tablets with a full glass (6–8 ounces, about 1 cup) of plain water. Drink at least a quarter of a cup (2 ounces) of plain water after you drink alendronate liquid. Never take alendronate with tea, coffee, juice, milk, mineral water, sparkling water, or any liquid other than plain water.

Swallow the tablets whole; do not split, chew or crush them. Do not suck on the tablets.

After you take alendronate, do not eat, drink, or take any other medications (including vitamins or antacids) for at least 30 minutes. Do not lie down for at least 30 minutes after you take alendronate. Sit upright or stand upright until at least 30 minutes have passed and you have eaten your first food of the day.

Alendronate controls osteoporosis and Paget's disease of bone but does not cure these conditions. It may take 3 months or longer before your bone density begins to increase. Alendronate helps to treat and prevent osteoporosis only as long as it is taken regularly. Continue to take alendronate even if you feel well. Do not stop taking alendronate without talking to your doctor.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

What special precautions should I follow?

Before taking alendronate,

tell your doctor and pharmacist if you are allergic to alendronate, any other medications, or any of the ingredients in alendronate tablets or liquid. Ask your pharmacist for a list of the ingredients. Tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: aspirin and other nonsteroidal anti-inflammatory medications (NSAIDs) such as ibuprofen (Advil, Motrin) and naproxen (Naprosyn, Aleve); cancer chemotherapy; or oral steroids such as dexamethasone (Decadron, Dexone), methylprednisolone (Medrol), and prednisone (Deltasone). Your doctor may need to change the doses of your medications or monitor you carefully for side effects if you are taking any other medications including supplements, vitamins, or antacids by mouth, take them at least 30 minutes after you take alendronate.  Tell your doctor if you are unable to sit upright or stand upright for at least 30 minutes and if you have or have ever had a low level of calcium in your blood or any problems with your esophagus. Your doctor may tell you that you should not take alendronate. Tell your doctor if are undergoing radiation therapy and if you have or have ever had anemia (condition in which the red blood cells do not bring enough oxygen to all the parts of the body);difficulty swallowing; heartburn; ulcers or other stomach problems;cancer; any type of infection, especially in your mouth;problems with your mouth, teeth, or gums; any condition that stops your blood from clotting normally; or dental or kidney disease. Tell your doctor if you are pregnant or are breast-feeding. Also tell your doctor if you plan to become pregnant at any time in the future, because alendronate may remain in your body for many years after you stop taking it. Call your doctor if you become pregnant during or after your treatment.  You should know that alendronate may cause serious problems with your jaw, especially if you have dental surgery or treatment while you are taking the medication. A dentist should examine your teeth and perform any needed treatments before you start to take alendronate. Be sure to brush your teeth and clean your mouth properly while you are taking alendronate.

Talk to your doctor before having any dental treatments while you are taking this medication. You should know that alendronate may cause serious damage to the lining of your mouth, esophagus, or stomach, especially if you do not take it according to the directions listed in the HOW section above. If you experience any of the following symptoms, stop taking alendronate, and call your doctor immediately: new or worsening heartburn, difficulty swallowing, pain on swallowing, or chest pain.

What side effects can this medication cause?

Alendronate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• nausea
• stomach pain
• constipation
• diarrhea
• gas
• bloating or fullness in the stomach
• change in ability to taste food
• bone, muscle, or joint pain
• headache
• dizziness
• flu-like symptoms

Some side effects can be serious. If you experience any of the following symptoms, call your doctor immediately before you take any more alendronate:

• new or worsening heartburn
• difficulty swallowing
• pain on swallowing
• chest pain
• bloody vomit or vomit that looks like coffee grounds
• black, tarry, or bloody stools
• fever
• blisters or peeling skin
• rash (may be made worse by sunlight)
• itching
• hives
• swelling of eyes, face, lips, tongue, or throat
• difficulty breathing
• hoarseness
• painful or swollen gums
• loosening of the teeth
• numbness or heavy feeling in the jaw
• poor healing of the jaw
• eye pain

Alendronate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.