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FDA’s Continues to Review Safety of Osteoporosis Medications

The Food and Drug Administration (FDA) is reviewing the safety of bisphosphonate drugs. The intended use of these medications is to prevent fractures associated with osteoporosis, most often in postmenopausal women. Some of the most common bisphosphonates approved to treat osteoporosis include Actonel, Aredia, Boniva, Didronel, Fosamax, Skelid, Zometa and Reclast. The safety evaluation of these osteoporosis medications is due to reports of dangerous side effects associated with long-term drug use.

FDA Safety Review and Recommendations

Of the potential side effects being reviewed by the FDA, some of the most serious include increased risk of thighbone fractures, osteonecrosis of the jaw and esophageal cancer. While determining the safety of bisphosphonate use, the FDA looked at studies that examined the link between using the medication and the likelihood of increased risk of injury due to side effects. Two of the largest studies reviewed used data from the same source, the United Kingdom's General Practice Research Database. However, the results were vastly different. With one study finding no increased risk of injury in oral bisphosphonate users and the other finding risks doubled in users of the medications.

At this time, due to the conflicting results, the FDA has concluded that the study results are inconsistent and therefore inconclusive. For this reason, the agency's safety review will be ongoing and may be looking at other studies using different databases to determine the likelihood of risk.

In the meantime, the FDA's advisory committee issued recommendations on bisphosphonate use. The committee was asked to determine if information backed up long-term drug use, if a limited time period of use should be implemented or if users would need a break from the drug to prevent dangerous injuries. The committee concluded that current studies did not provide enough information on risks with long-term use.

However, advisors recommend changes to medication labels. Since some study findings did point to an increased risk of injury with continuing drug use, the FDA advisory committee has urged a clarification on packaging labels that would include the recommended use duration for each drug. The recommendations did not include a specific time period to use in the label clarifications.

Based on the ongoing FDA review, osteoporosis patients using the drugs, or considering future use, should speak to their doctor about the harmful side effects that may be linked to long-term use and whether bisphosphonate medications are the best option for them.

Boniva Risks and Side Effects

One of the commonly prescribed bisphosphonate drugs is Boniva. It works by diminishing cell activity that damages bone in osteoporosis sufferers. Drug makers contend that the ingredients in these drugs, like Boniva, can halt or reverse the effects of the bone degenerative disease. Some potential side effects with Boniva use may be mild, including heartburn, gastrointestinal distress, ulcers, pain when swallowing, limb pain, low blood calcium levels and flu-like symptoms. Unfortunately, though Boniva has helped many people, such a powerful drug has also been shown to have increased risks of dangerous side effects in some users. Severe side effects may include:


    • Osteonecrosis of the jaw (dead jaw)
    • Loose teeth, swelling or infection of gums
    • Hip or femur fractures
    • Exposed bone
    • Musculoskeletal pain
    • Atrial Fibrillation
    • Esophageal cancer (throat cancer)

    Some of the side effects that may be linked with long-term bisphosphonate use may be less serious and treatable. Some of the more dangerous side effects may result in severe pain, extensive medical treatment, hospitalization and even death. If you are taking medication for your osteoporosis and are experiencing symptoms of any possible side effects, it is imperative that you speak to your doctor immediately.

    Recourse if You've Been Injured

    An individual taking the drug Boniva, or another bisphosphonate medication, who suffers injury as a result may have a personal injury claim against the pharmaceutical company. Drug makers may be held liable for dangerous side effects and injuries associated with using their products. Injured parties may be entitled to compensation for losses such as past and future medical costs, lost wages, loss of future earnings, physical impairment and pain and suffering. If a patient dies as a result of his or her injuries, the victim's loved ones may also have a claim against the pharmaceutical company for wrongful death.

    If you or a loved one has suffered an osteoporosis drug-related injury, you should know that you have rights. Speak to an attorney experienced in dangerous and defective drug matters to answer your questions and learn more about your legal options.

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