Fosamax
About Fosomax
Fosamax® (alendronate sodium) is a bisphosphonate drug used for osteoporosis and several other bone diseases and is meant to act as a specific inhibitor of osteoclast-mediated bone resorption. Bisphosphonates are synthetic analogs of pyrophosphate that bind to the hydroxyapatite found in bone. Alendronate sodium is chemically described as (4-amino-1-hydroxybutylidene) bisphosphonic acid monosodium salt trihydrate and is a white, crystalline, nonhygroscopic powder.
Tablets of Fosamax® for oral administration contain 6.53, 13.05 or 52.21 mg of alendronate monosodium salt trihydrate, which is the molar equivalent of 5.0, 10.0 and 40.0 mg, respectively, of free acid, and the following inactive ingredients: microcrystalline cellulose, anhydrous lactose, croscarmellose sodium, and magnesium stearate.
Also, you will find the following inactive ingredients contained in the various formations of the drug: sodium citrate dihydrate and citric acid anhydrous as buffering agents, sodium saccharin, artificial raspberry flavor, carnuba wax and purified water. Sodium propylparaben and sodium butylparaben are added as preservatives.
The empirical formula of alendronate sodium is C4H12NNaO7P2·3H2O and its formula weight is 325.12.
The structural formula is presented to the right.
Fosamax is available in the following dosages:
- Fosamax® solution 70mg/75ml
- Fosamax® tablets 5mg, 10mg, 35mg, 40mg, and 70mg
Currently, Merck holds a patent on Fosamax which is set to expire in 2008. They have lost a series of appeals to block a generic version of the drug from being certified by the US FDA.
The Problem:
Users of Fosamax® have suffered Osteonecrosis of the Jaw (ONJ), also known as Jaw Necrosis, Bis-Phossy Jaw or Dead Jaw. Lawsuits have alleged that Merck, the manufacturer of Fosamax®, failed to properly warn users of this side effect.
