Fosamax encounters trouble with the FDA

Since the FDA approved Fosamax for the public in 1995, numerous articles have surfaced reporting Fosamax causing severe side-effects such as femur fracturing in long-term use. These side-effects were not disclosed to the medical community and did not come up in the FDA’s research. So, for many years the FDA was not swayed to revisit their decision until now. The reason is that two studies published by the American Academy of Orthopaedic Surgeons have strongly suggested a link between bisphosphonate drugs (including Fosamax) and developing brittle bones.

When concerns of Fosamax and other bisphosphonates causing femur fractures in women being treated for osteoporosis rose in 2008, the FDA requested reports from the drugs’ manufacturers. After reviewing these reports the agency determined that the “review of this data did not show an increase in this risk in women using these medications.”

Still, numerous reports in prominent publications such as the NY Times and ABC news have suggested a link between brittle bones and long-term Fosamax use, and despite this, the FDA did not taken any kind of significant action. The Wall Street Journal reported in March of 2010 that the FDA would finally revisit bisphosphonates and stated that, “the agency said it would work closely with outside experts, including members of the recently convened American Society of Bone and Mineral Research's Subtrochanteric Femoral Fracture Task Force, to gather additional information.”

With this new study, the FDA is triple checking these drugs for connections between long-term use and brittle bones. The study focuses strictly on the possible connection between femur fracturing and long-term bisphosphonate drug use (WSJ.com).

Bisphosphonates are used to slow down the natural remodeling process that the bones go through constantly. In normal human bones, bone cells die and are reabsorbed into the body at the very moment that newborn bone cells take their place. This balance is essential to our daily life, and it keeps our bones healthy and strong. With bone conditions like osteoporosis, the balance is thrown off. Instead of one new bone cell instantly replacing one old bone cell, the body cannot produce a new bone cell in time. So, the bones lose integrity. Bisphosphonates slow down the absorbing of dead bone cells. In theory, this gives the body more time to produce new bone cells, and keeps the integrity intact. One of the deciding factors for the FDA to revisit bisphosphonate drugs is a study from the American Academy of Orthopaedic Surgeons, which stated that, “In the early treatment period, patients using bisphosphonates experienced improvements in all parameters, including decreased buckling ratio and increased cross-sectional area…however, after four years of use, these trends reversed, revealing an association between prolonged therapy and declining cortical bone structural integrity."

If the FDA ever determines that femur fracturing is a significant threat to long-term use of bisphosphonates, they may order a recall. This would not be a new experience for Merck & Co. (the manufacturer of Fosamax).  In 2004, Merck & Co. recalled one of their biggest money making drugs, Vioxx, because of the increased risk of heart attack it was found to cause. In the case of Vioxx, the FDA admitted to have had lapses in the agencies actions, and should have ordered a recall sooner (NY Times.com). Only time will tell what the FDA will find and whether it prompts a recall for yet another Merck & Co. drug.

Compensation is available for those that have been injured by Fosamax

Weitz & Luxenberg wants you to know that you have the option to pursue compensation for injuries sustained because of Fosamax use.  Lawsuits have already been filed against Merck & Co., and the company has already paid $8 million in compensation. Weitz & Luxenberg wants to help those injured by Fosamax seek the compensation they deserve. Compensation can be award for:

• Medical expenses
• Hospitalization costs
• Surgery costs
• Canceled reservations due to injuries
• Hired help to aid in the recovery
• General pain and suffering

There is no need to wait to pursue legal actions against Merck & Co. Contact Weitz & Luxenberg today for a free, no obligation, legal consultation.

Sources:

The Wall Street Journal: http://online.wsj.com/article/SB10001424052748703976804575114181349999398.html

The New York Times: http://www.nytimes.com/2005/03/02/politics/02fda.html

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see also:

Fosamax and the FDA FDA Conducts Further Research on Fosamax
FDA Looks into Fosamax

FDA Warning FDA Warning: Fosamax causes femur fracture and brittle bones
FDA releases warnings concerning the connection between Fosamax and femur fracture