Friday, October 31, 2008

Fosamax Sales Dive 50% Since Generic Form Was Approved

Merck, maker of osteoporosis drug Fosamax, announced its plans to cut 7,200 more jobs as profits fall from declining sales in its top drug lines. Fosamax, one of Merck’s blockbuster drugs, dropped more than 50% in sales since its patent expired on February 6, 2008. Fosamax has been one of the top 100 most frequently dispensed drugs in the U.S.

The FDA approved Teva Pharmaceuticals USA to produce the first generic form of Fosamax, alendronate sodium tablets. Generic forms of prescription drugs are becoming more widely accepted. 63 percent of prescriptions were filled by generic drugs in 2006 – up from 56% in 2005. According to Gary J. Buehler, R.Ph, director of the FDA's Office of Generic Drugs, "The FDA works to assure the safety and efficacy of generic drugs through a rigorous scientific and regulatory process."

As Merck is showing declining sales, Medicare has announced that it is saving $6 billion in prescription drug costs by shifting to generic forms of drugs like Fosamax. This is down 12% from $50 billion.

In addition to Fosamax declines, Merck’s cholesterol lowering drugs Vytorin and Zetia dropped 15% while Gardasil sales, their vaccine to prevent cervical cancer, dropped 4%.

Merck said that it is looking to change its business model for the future. They want to rely less on large sales pushes and consolidate research on particular diseases in single locations. Additionally, they are planning to focus more on biotechnology drugs made from living cells. These types of drugs are more difficult to replicate than chemical drugs and thus have more profit potential as generic forms are less likely undercut their market.

Have you or someone you know experienced side effects from using Fosamax or the generic form of Fosamax? Please share your thoughts and opinions!

Wednesday, October 29, 2008

Fosamax Makers Face Lawsuits for Osteonecrosis of the Jaw Side Effect

Over 650 lawsuits have been filed by women throughout the United States who have developed osteonecrosis of the jaw after taking bisphosphonates like Fosamax to treat osteoporosis. Osteonecrosis of the jaw is an irreversible bone disease causing the jaw bone to become brittle, die, and sometimes requires partial jaw removal. The first of three court case is planned for August 11, 2009.

Fosamax (alendronic acid), produced by Merck Co., is a bisphosphonate drug used by millions of women to treat osteoporosis as well as Paget’s Disease and other fragile bone conditions. It works by inhibiting osteoclast cells which naturally break down bone and release minerals back into the body. However, in the process, it also effects new bone growth. In order for new bone to be made, osteoclast cells must signal their counterpart, osteoblast cells, which are responsible for building new bone. Thus, new bone growth is inhibited as osteoclast cells absorb Fosamax. As this happens, fewer small blood cells are able to grow and less blood is able to reach bone cells. Eventually this may cause the bone to become brittle and die.

Patients are claiming that Merck has known about this side effect for over five years, but has not provided adequate warning about the risk of osteonecrosis. Over the past few years there has been an increase in the number of jaw osteonecrosis cases noted by dentists. Additionally, there have also been reports of osteonecrosis of the hip, shoulder, and knee.

Osteonecrosis symptoms typically don’t appear until it is too late to reverse the effects. Symptoms may include jaw pain, swelling, infection of the gums, loose teeth, or exposed jaw bone within the mouth. Fosamax patients should avoid any minor dental surgery that may expose the jaw bone like having a tooth pulled. This may prompt infection and prevent healing.

Have you or someone you know experienced or been diagnosed with osteonecrosis after taking Fosamax or any other bisphosphonate? Please share your experiences!

Friday, October 17, 2008

Fosamax May Cause Chronic Irregular Heartbeat

A new study by the University of Washington, published in the Archives of Internal Medicine, found that Fosamax may double your risk of developing chronic atrial fibrillation. Atrial fibrillation is an abnormal heart rhythm resulting in a decreased amount of blood to the body. This can cause dizziness, fainting, fatigue, chest pain, or congestive heart failure. Furthermore, it increases the likeliness of blood clots and possible stroke.

The long-term study looked at 719 women patients who had been diagnosed with atrial fibrillation. Of them, 6.5 percent had taken Fosamax in the past for their osteoporosis. This was significantly higher than the 4.1 percent of women who had taken Fosamax but had not developed an irregular heartbeat. Thus, women who had taken Fosamax were 86 percent more likely to have atrial fibrillation compared to those who had not. Furthermore, the study showed that Fosamax is the sole cause of 3 percent of all cases of this condition.

Case in point, one 67 year old woman found herself in the emergency room for atrial fibrillation after taking Fosamax for seven years to treat mild osteoporosis. She was a nonsmoker, nondrinker and led a healthy lifestyle with exercise and good nutrition. Additionally, there was no history of heart disease in her family.

This study wasn’t the first to find that osteoporosis treating drugs can cause heartbeat abnormalities. A study in 1997 of zoledronate, known by the brand names Aclasta, Reclast, Zomera and Zometa, found this drug to significantly increase the likeliness of developing chronic atrial fibrillation compared to the placebo.

Have you or anyone you know experienced side effects from Fosamax such as atrial fibrillation? Were you warned of the possible unknown side effects of Fosamax by your doctor? Please share your thoughts and experiences!

Friday, October 10, 2008

Rate A Drug is an interesting new site where users from the community rate their experience in using different prescription drugs. Currently there are over 3,000 medications to view and share experiences about. Detailed surveys include things such as drug effectiveness, how much and how long you have been taking the drug, changes in well being, side effects, and user comments about the drug.

This is a good way for patients to stay updated with the most current side effects as well as learn about new alternative treatments. Additionally, after you fill in your experiences with your drug, you will receive your personal risk/benefit analysis based from your question responses. This gives you a score from 1 to 10 for both your side effects and positive effects so that you can see how this drug is working for you and how that compares to other users. It's also great because you can forward all of your surveys along with comments to your doctor, family member or caregiver to keep them informed about any changes in your health caused from existing or new medications.

Go to to take the Fosamax drug survey and see what people are saying about it.

Monday, October 6, 2008

Fosamax Side Effects

Osteoporosis, meaning porous bones, is a disease where the body does not generate new bone minerals as quickly as they are dissolved back into the body. Bones become weak and brittle and the risk of fracture from common day activities increases.

Fosamax is the major pharmaceutical drug used to treat osteoporosis. Fosamax is a bisphosphonate that works by combining with bone tissue to increase and maintain bone density thereby preventing further breakdown of bone minerals.

This is useful in treating osteoporosis, however, as part of its function, Fosamax is difficult for the body to eliminate and can remain in the system for up to ten years after discontinuing treatment.

Fosamax targets all bones in the body whether it is desired or not. Because not all bones are structurally the same throughout, this can cause problems. One adverse effect of this is osteonecrosis of the jaw where there is a loss of blood supplied to the jaw bone. This can cause the jaw bone to “die” making it brittle and ultimately causing it to collapse and need to be surgically removed. Jaw bone death is typically experienced in cancer patients who have been receiving intravenous bisphosphonates (vs. pill form) to treat cancer that has spread to the bones. Bisphosphonates, like Fosamax, prevent small blood vessels from growing, which helps starve and kill cancer cells. Unfortunately, this may also starve bone cells in the process. Patients who undergo dental surgery such as a tooth extraction may also be at a higher risk due to bone exposure during the procedure.

Furthermore, a recent article published in the New England Journal of Medicine (NEJM) stated that, in very rare circumstances, bisphosphonates may cause inflammatory eye disease. Only four cases have been reported, and in all cases they were successfully treated with corticosteroids.

Additional adverse effects may include flu symptoms, irregular heartbeat, or a severe rash. The FDA also recently issued a warning that Fosamax may cause severe bone, joint, and muscle pain.

Have you been diagnosed with osteoporosis? Have you been prescribed Fosamax? If so, have you experienced any side effects? Have you found any alternatives to treating osteoporosis? Share your experiences!