FDA Cautions against Prolonged Use of Bone Drugs

FDA Cautions against Prolonged Use of Bone Drugs | Pintas & Mullins Law Firm

Yet another health warning for bisphosphonate drugs such as Fosamax. The New York Times is reporting new information about the potential dangers associated with long-term use of these bone drugs.

An independent review by the FDA recently revealed that women taking these drugs for three to five years experienced few, if any, benefits. However, prolonged use of bone drugs could lead to weaker bones and cause rare fractures and side effects. These include femur fractures, esophageal cancer and osteonecrosis of the jaw or rotting of the jaw bone. Other common side effects are joint pain, muscle pain, and atrial fibrillation.

As drug recall lawyers, we are deeply concerned about the serious health effects that drugs like Fosamax can have. The FDA’s Medication Guide for Fosamax alerts bone drug patients to look for the following serious side effects:

  • Esophagus problems
  • Low calcium levels in your blood (hypocalcemia)
  • Bone, joint, or muscle pain
  • Severe jaw bone problems (osteonecrosis)
  • Unusual thigh bone fractures

The FDA’s recent findings have doctors rethinking prescriptions for patients at risk of osteoporosis.

In another article published in The New England Journal of Medicine, physicians offer more specific conclusions. They point out that patients diagnosed with osteoporosis and risk spinal fracture could see some benefit from a bone drug. However, women with moderate bone density should not continue long-term use of the drug. In fact, researchers say that up to 70 percent of women currently on the drug should stop taking it after three to five years in order to avoid serious harm.

All of these conclusions are based on studies led by the University of California, San Francisco. Clinical trails of Fosamax and another bone drug conducted over the course of 10 years showed that women benefited from reduced fracture risks during the first three to four years. There was little or no gain for users who continued taking the drug for the next five to ten years.

According to the U.S. Department of Health and Human Services, patients in hospitals are victims of about 1.9 million adverse drug events each year. Generic drugs are widely used because they are less expensive and seen as a way to reduce healthcare expenses, while facilitating access to important treatments.

Fosamax has recently come under the public spotlight due to some very serious medical risks associated with the drug. Fosamax lawsuits continue to be filed, blaming the drug manufacturer for concealing dangerous risks about spontaneous femur fractures and related health problems.

As Fosamax lawyers, we understand that it is the responsibility of pharmaceutical companies, pharmacies, and healthcare providers to evaluate a drug thoroughly before it is launched to innocent consumers. Clinical trials must show how effective a drug is for a particular disease and also explain the potential harm that can result from its use. 

Generally, results from pre-marketing clinical trials are sufficient to get a drug passed for license approval. But the inclusion or exclusion criteria of the study may prevent the detection of some serious adverse drug reactions. Therefore, it is up to the authorities to establish a proper monitoring system to minimize the risks associated with such generic drugs. They must also seek to improve public awareness, and take timely steps to protect public health.

Keep in mind, if you or someone you love is a victim of the adverse effects of Fosamax, filing a drug recall lawsuit can get you the compensation that you are entitled to.