Newsletter

Fosamax can be fatal

Fosamax was designed to help reduce bone loss, especially for people with osteoporosis. However soon after the Food and Drug Administration (FDA) approved it for use in 1995, doctors and dentists started to notice a rise in osteonecrosis of the jaw (ONJ) or “jaw bone death.” In this usually-rare disease, blood vessels in the jaw start to disappear literally killing the cells within the bone itself.

What makes this progressive disease even worse is that it is irreversible. And, because drugs like Fosamax take so long to travel through the body, the process can continue for months – even a year – after the patient stops taking Fosamax.

Fosamax belongs to the family of drugs called bisphosphonates. This man-made chemical is designed to adhere to bone at the cellular level, making it stronger. Patients with osteoporosis or Paget’s disease, both of which can lessen bone density and therefore leads to a higher risk of bone breaks, can actually “reinforce” their bones with this drug and reverse the affects of bone degeneration.

However, as is the case with many drugs, doctors and scientists don’t know precisely how it works. And it is this unawareness of safety issues that often leads to disaster.

The first people found to have ONJ were cancer patients who received bisphosphonates through an IV (and in stronger doses). But health professionals also noted a rise in people who were taking the drug in pill form. Fosamax, the first oral bisphosphonates drug on the market for osteoporosis treatment, was one of the prime suspects.

Despite the overwhelming circumstantial evidence, both the FDA and Fosamax’s manufacturer, Merck, were slow to notify doctors, dentists, and consumers about the possible link. That same year the FDA did cite Merck for improper marketing, stating that the company website “overstates the benefits of Fosamax while minimizing the risks.” One example of this was the fact that Merck listed the serious side effects under a section called “Proven Tolerability.”

Still, it wasn’t until 2004 when a study came out that conclusively proved bisphosphonates like Fosamax caused ONJ that the FDA started to warn the public. The study was released in May, and the FDA sent out its warning to health care professionals on September 24, 2004. Finally in July 2005, over a year after the conclusive study, Merck updated its Fosamax labeling to include ONJ as a possible serious side effect.

If you or a loved one has suffered ONJ or “jaw bone death” after taking Fosamax, contact  a Jim S. Adler & Associates personal injury attorney for free legal advice. We can help you understand what your rights are in your case, and what compensation you may be able to expect from the manufacturer. Negligence in some form is the number one cause of drug injury and death. Submit the details of your Fosamax injury to Jim S. Adler & Associates for a free case review by filling out our online case review form.

 

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