Case Evaluation

Fosamax: Fosamax Overview

Fosamax Overview

What is Fosamax?

Fosamax (alendronate sodium) is a prescription medicine used to prevent or treat osteoporosis in women after menopause, and to treat osteoporosis in men. Osteoporosis is a medical condition in which the bones become thin and weak and break easily. Osteoporosis may have natural causes or may be found in men and women who have taken corticosteroids.

Fosamax can also be used to treat Paget's disease, a medical condition in which the body replaces healthy bones with weak bones. Fosamax works by preventing bone breakdown and increasing bone density (thickness) in order to make bone stronger and less likely to break. Fosamax is a bisphosphonate drug made by Merck and Company, Inc., and was approved by the U.S. Food and Drug Administration (FDA) in 1999.

Fosamax and Osteonecrosis of the Jaw

There have been recent reports linking Fosamax to a serious side effect called Osteonecrosis of the Jaw (ONJ) or 'jaw death.' ONJ is a medical condition in which the jawbone partially crumbles and dies. ONJ may cause severe pain, loose teeth, exposed bone, loss of function, and disfigurement. Fosamax maker Merck and Company, Inc., has stated that ONJ is a rare side effect, and that in controlled clinical trials involving more than 17,000 patients, there were no reports of ONJ.

Most researchers and doctors interviewed in recent news reports appear to believe that the benefits of bisphosphonate drugs greatly outweigh the risks, and say that they will continue prescribing these medicines to their patients. In the past, it appears that most reported instances of ONJ have been with cancer patients taking bisphosphonate medications intravenously.

Taking Fosamax

Take Fosamax orally with a full glass (6 to 8 oz.) of plain water on an empty stomach. Fosamax should be taken in the morning, at least 30 minutes before taking any food, beverage, or other medicines (such as antacids or calcium and vitamin supplements). Taking other food and beverages within 30 minutes of taking Fosamax will decrease the amount of absorption by the body.

Do not lie down for 30 minutes after taking Fosamax. Remaining upright prevents irritation to the esophagus and allows Fosamax to reach your stomach faster. When taking Fosamax, follow your healthcare professional's orders or the directions on the label. If your dose is different than what is on the label, do not change it unless instructed by your healthcare professional. If you miss a dose of Fosamax, do not take it later in the day. Simply resume your usual schedule the next morning. Do not double dose.

What Should I Tell My Healthcare Professional?

Before or while taking Fosamax, tell your healthcare professional if you:

  • have or have had any unusual or allergic reaction to Fosamax, or if you are allergic to any other substances (foods, preservatives, or dyes)
  • are pregnant, may become pregnant, or are breast-feeding (Fosamax has not yet been tested in pregnant or nursing women, but adverse affects have been shown in animals)
  • have digestion, esophagus, intestine, or stomach problems (taking Fosamax may be harmful to the esophagus, intestine, or stomach, and may worsen any problematic conditions that you may have in these areas)
  • have or have had difficulty swallowing
  • have or have had problems with heartburn, ulcers, low levels of calcium in your blood, frequent muscle cramps or spasms, or osteomalacia (softening of bones due to a lack of vitamin D)
  • are unable to sit or stand upright for 30 minutes, or to feed yourself
  • have kidney problems
  • are on any special diets, such as a low-sodium or low-sugar diet. Your doctor may recommend a balanced diet with an adequate amount of calcium and vitamin D (found in milk and other dairy products) while taking Fosamax

Are There Any Interactions With Drugs or Foods?

Fosamax and certain other medicines can interact with each other. Tell your healthcare professional about all the medicines you take -- including prescription and non-prescription medicines. Be sure to tell your healthcare professional if you take aspirin or products that contain aspirin. Aspirin use with Fosamax may cause or make esophagus, intestine, or stomach problems worse. Also, tell your healthcare professional if you take any of the following:

  • Antacids
  • Non-steroidal anti-inflammatory medications (NSAIDs), such as ibuprofen (Advil, Motrin) and naproxen (Naprosyn, Aleve)
  • Calcium, iron, or potassium supplements
  • Doxycycline (Doryx, Vibramycin)
  • Quinidine (Quinaglute)
  • Tetracycline (Sumycin)

Fosamax - Getting Legal Help While all medications have certain, anticipated side effects, a drug manufacturer has a duty to make its products as reasonably safe as possible, and to inform the medical community and the public of known risks associated with its drugs. If a manufacturer fails to do so, it can be held legally responsible if patients are injured as the result of inadequate warnings or the unreasonably dangerous nature of the drug, under a legal theory called "product liability."

If you or a loved one have experienced any dangerous symptoms or unusual medical conditions while taking Fosamax, you should first contact your doctor or other healthcare professional. You may also wish to meet with an experienced attorney to discuss your options and to protect your right to a legal remedy for any injuries caused by Fosamax use.

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