Merck & Co., already battered by Vioxx lawsuits, is preparing for a blizzard of litigation from patients claiming they were harmed by Fosamax, the company's hot-selling osteoporosis drug.
The drugmaker says it has put aside $48 million to set up a defense fund for cases alleging Fosamax causes a condition known as osteonecrosis, or a decaying of the jaw bone.
Merck CEO Richard Clark said the company now faces about 104 cases over Fosamax, the bulk of which have been filed in federal court. He added that the first of these cases will likely not go to trial until 2008.
Fosamax has been on the market for over 10 years and that reported cases of osteonecrosis were very rare, Clark emphasized in a recent conference call with Wall Street analysts.
As of Dec. 31, Merck faced approximately 27,400 cases over Vioxx, while about 4,000 claims have been dismissed. The company said it spent about $500 million on legal costs for Vioxx in 2006.
Necrosis
The connection of Fosamax to necrosis began to surface about five years ago when oral surgeons and dentists began noticing a higher than expected incidence of jaw decay in those taking Fosamax.
Initially it was thought that the drug posed a risk only to cancer patients. But more recently, oral surgeons have become convinced that Fosamax and similar drugs can cause the painful and dangerous jawbone death for other patients when taken over a long period of time.
The American Association of Endondontists recently issued a statement recommending that dental surgeons should check on whether patients take Fosamax prior to working on their teeth.
Also, the Food and Drug Administration has ordered the makers of Fosamax and other bisphosphonates to list osteonecrosis in its precautions on package inserts. However, many medical authorities think the risk for those taking oral, as opposed to intravenous, medications is relatively slim.
Doctors have had their doubts about Fosamax for quite some time.
"Many people believe that these drugs are 'bone builders,' but the evidence shows they are actually bone hardeners," wrote Dr. Susan M. Ott in the Annals of Internal Medicine in 2004, pointing out that they depress "the bone resorption rate as well as the bone formation rate" and "bones could become brittle with long-term accumulation."
A recent issue of JAMA reported on long-term effects of using Fosamax. Critics noted the study was funded by Merck and was "designed jointly" by Merck and non-Merck employees.
The osteoporosis market has grown exponentially since Fosamax and other bisphosphonates hit the market in the mid-1990s.
This is partly due to the aging of the population but critics say the number of diagnosed cases -- from half a million to 3.6 million -- correlates closely to the introduction and promotion of Fosamax.
Merck even went into the bone-density-measuring-equipment business, to help find previously unsuspected cases of low bone mass.
Other Side Effects
Other side effects and symptoms can also occur when using Fosamax, including:
• Severe digestive reactions including nausea, heartburn, stomach pain, diarrhea, and muscle cramps
• Inflammation, irritation or ulceration of the esophagus
• Chest Pain, heartburn or difficulty swallowing
• Blood clotting disorders
• Anemia
• Dental problems
• Numbness, tight muscles in the face as well as seizures
• Irritability and unusual thoughts or behaviors.
Adding to the already long list of reactions to the drug, one must also stay upright for at least 30 minutes after taking the medication or severe reactions can occur.
Moreover, any antacids, supplements or medicines that contain aluminum, calcium, magnesium or other minerals can interfere with how the body absorbs Fosamax. The medication may also be harmful to an unborn baby and therefore should not be used by pregnant women.