Articles Posted in Fosamax Side Effects

Some people — especially people needing certain drugs to prolong their lives or end severe pain – think that the FDA drug approval process is slow and tiresome. According to a recent study, the FDA approves drugs faster than either Canada or Europe. Does this surprise you?

Is that good news or bad news?

The Prescription Drug User Fee Act (PDUFA) of 1992 was passed to expand the FDA resources devoted to reviewing applications for novel therapeutics for humans and to ensure drug safety. The FDA is able to collect user fees for each new drug application in order to support what is needed as part of the review process. Nevertheless, performance standards have been associated with higher rates of black box warnings and drug withdrawals.

Uncertainty – that is the last word you want to describe Fosamax, an osteoporosis prevention prescription drug for which you, your wife, or your mother has been taking for the past 3, 5, or more years.

According to a recent Food & Drug Administration review which was published in The New England Journal of Medicine, there is a growing debate over how long women should use drugs like Fosamax.

The debate is not new but the debate is more prominent as a greater number of women and/or their doctors report unusual femur fractures, esophageal cancer, and osteonecrosis of the jaw (when the jawbone crumbles).

These serious and quality of life diminishing side effects are considered rare by the FDA and makers of bisphosphonates but when you consider the millions of women taking this genre of osteoporosis drugs – rare – may still encompass thousands of women and some men. Obviously, the numbers are great enough to prompt investigation.
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You’ve seen the commercials. You are eager to try the once a month medication to treat your osteoporosis and you are ready to ask your doctor for a prescription. However, before you pop that pill in your mouth, it is important to understand the possible side effects of bisphosphonate drugs such as Boniva.

Boniva Bisphosphonate Risks

Bisphosponate osteoporosis drugs pose certain risks and no exception is made for Boniva. New risks recognized by the FDA and included in the warnings for Boniva include:

The Wall Street Journal reports that Merck & Co. won a jury trial in its defense against a lawsuit that alleged the company’s drug Fosamax caused a woman osteonecrosis. The verdict’s announcement was made on Monday, February 14.

A state court jury in Atlantic City, New Jersey rejected claims from a woman from Pennsylvania that Fosamax, which is a drug used to treat osteoporosis, caused her osteonecrosis, a deterioration of the jaw, often referred to as ONJ. The woman also claimed the drug manufacturer failed to warn consumers properly about the risks of the drug and Fosamax side effects. The jury found that the drug did not cause the woman’s jaw and dental problems and that the company “acted properly.” The woman plans to appeal the case, stating the drug maker should not be allowed to keep getting away with hiding the risks of Fosamax.

Merck, which is based in Whitehouse Station, NJ, is currently facing approximately 1,180 cases of users who allege that Fosamax caused ONJ. This trial was the first Fosamax trial in state court. Three cases were previously tried in New York federal court, of which Merck won two and is appealing the loss of the third. In that case, the jury awarded the plaintiff $8 million but the judge reduced the amount to $1.5 million.

This past October, the U.S. Food and Drug Administration (FDA) announced via a press release a label change on drugs approved to treat osteoporosis. Information was required to be added to the Warnings and Precautions sections of the label for Fosamax, among other drugs. The change needed to communicate the risk of typical thigh fractures occurring in patients who take bisphosphonates for osteoporosis. It was also required for patients to receive a medication guide detailing the risks when picking up their prescription for the bisphosphonate product from the pharmacy or their doctor’s office.

Fosamax is a bisphosphonate product and has been linked to many serious side effects. Atypical thigh fractures known as subtrochanteric and diaphyseal femur fractures are rare, accounting for less than one percent of all femur and hip fractures. However, these unusual fractures have been widely reported in patients who have taken or are taking bisphosphonates. Other Fosamax side effects are esophageal cancer, osteonecrosis of the jaw (ONJ or dead jaw syndrome), inflammation of the esophagus, throat, and stomach, and various and sometimes severe muscle, joint, and bone pain, as well as other serious issues.

Over 20 million people have taken Fosamax since it was introduced to public markets in 1995 by Merck and Company, Inc. Numerous lawsuits and class actions have been brought against the drug manufacturer for damage it has caused patients who have taken Fosamax. The FDA recommends that patients whose doctors have prescribed them the bisphosphonate product continue to take their medication unless they are instructed to stop by their physician.

If you ask the drug makers if Fosamax is bad for women, you will probably get a different answer than if you ask the women who have suffered serious side effects and injury consequences from taking Fosamax.

No prescription or over-the-counter drug is foolproof as far as side effects. But when thousands of women start talking to lawyers and start filing lawsuits, then you have to question whether or not Fosamax is bad for women.

Let’s consider the reasons why women are filing Fosamax lawsuits:

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