A Battle Over Oral Bisphosphonates

Bisphosphonate drug Fosamax and the company that produces it is facing a lot of heat over the side effects caused by the drug. In New York City, 67-year-old Florida woman Judith Graves sued Merck, one of the biggest pharmaceutical companies in the world. She claimed that using Fosamax caused her jawbone to deteriorate, a condition known as osteonecrosis of the jaw, or jawbone death. As a result, she had to undergo five major operations to fix the jaw. Merck claimed that Mrs. Gravess jaw condition came about because she took Fosamax with other prescriptions drugs, which weakened her immune system and caused the jaw problems. Ultimately, Graves lost the case, with the jury of seven finding that Fosamax was not a defective product. However, Merck cannot hide the fact that 1,400 other people across the country are siding with Graves, claiming the same thing happened to them. According to the New York Times: The decision represents the second of three bellwether jury trials on this issue to end in Mercks favor. They and other cases are among litigation involving about 1,400 people across the country who have claimed they developed jawbone ailments after taking Fosamax, according to Timothy M. OBrien, Mrs. Gravess lawyer. In a third trial, a judge reduced the jurys award to $1.5 million from $8 million, but both sides want to appeal. Another signature case is set to go to trial in March.

The future of osteoporosis drugs

Though the jury concluded Fosamax is still an effective treatment, many other patients believe otherwise, debating whether or not the benefits outweigh the risks. Even the Food and Drug Administration warned patients in October after evidence was found that Fosamax may lead to thigh fractures after prolonged usage.

Doctors have responded accordingly, the New York Times adds:

But the drugs popularity and effectiveness for generally healthy women without osteoporosis or broken bones have become a source of increasing argument in doctors offices and in courtrooms.

Doctors had already started to review the unlimited use of oral bisphosphonates, said Dr. Elizabeth Shane, a professor of medicine at Columbia University College of Physicians and Surgeons.

Fifteen years ago, she said, the medical community hoped that if women took the drugs before they developed osteoporosis, they would be protected from breaking bones later in life. But doctors have begun waiting longer before prescribing the drugs, she added.

As a result of experiences with bisphosphonates like Mrs. Graves's, studies have been conducted to determine the optimal time for stopping treatment, and for how long. For example, a study at the Loyola University Health System found that taking a drug holiday from osteoporosis drugs will actually protect your bones in the long term because of the dangers of long-term bisphosphonates use.

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