drug and pharmaceutical law

Drug Watch: Osteoporosis Drugs Are Giving Women Severe Complications

Today’s post comes from guest author Brenda Fulmer from Pasternack Tilker Ziegler Walsh Stanton & Romano.

Post-menopausal women welcomed the class of drugs called “bisphosphonates,” which purportedly increase bone density by slowing the body’s natural turnover of bone cells and were touted as a safe and effective treatment for osteoporosis and osteopenia. Bisphosphonates are also widely used to treat both male and female patients whose cancer has spread to their bones and by patients who have a progressive bone disease called Paget’s disease.

Many patients who are being prescribed “bisphosphonates” for the treatment and prevention of osteoporosis are unaware of any risks associated with the use of such drugs.

Popular bisphosphonate drugs and their manufacturers include:

Fosamax is also available as the generic drug, alendronate. The drugs are available as pills as well as injections, and may be taken daily, several times per week, monthly, or event annually.

Patients who took these popular osteoporosis drugs have suffered severe bone fractures due to a weakening in bone structures caused by the drugs.

In a sad irony, patients who took these popular osteoporosis drugs in hopes of improving their bone health have actually suffered severe bone fractures, such as atypical femur fractures, due to a weakening in bone structures caused by the drugs. In addition, these bisphosphonate drugs have been linked with osteonecrosis, essentially jawbone death or “bisphossy” jaw, which cause chronic infections, swelling of the face, tooth loss, and often requires significant oral and facial surgeries. Since 2001, more than 2,400 cases of jawbone death have been associated with Fosamax alone. Many patients who are being prescribed “bisphosphonates” for the treatment and prevention of osteoporosis are unaware of any risks associated with the use of such drugs, and that the risks of bisphosphonate drugs to the jaw may last for up to ten years after the drugs are discontinued.

In early 2010, patients were warned that long-term use of Fosamax and other similar bisphosphonate drugs had been linked to the development of atypical femur fractures. These patients have suffered traumatic breaks in their thigh bones or bones due to an internal weakening of the bones. Fosamax, Actonel, Boniva, and other bisphosphonates have also been linked to arrhythmias. There are also ongoing studies to determine whether these drugs also cause esophageal cancer.

Given these severe complications, patients and doctors are questioning whether the long-term use of these drugs provides sufficient benefits which outweigh the associated risks. Patients have been urged to consult with their physicians often to determine whether continued use of these osteoporosis drugs, especially in women with osteopenia rather than osteoporosis, is warranted. The effectiveness of the drugs after use for more than five years is also being questioned.

Brenda Fulmer is a shareholder at the law firm Searcy Denney Scarola Barnhart & Shipley in West Palm Beach and partners with Pasternack Tilker Ziegler Walsh Stanton & Romano in the litigation of drug and pharmaceutical mass tort cases. Ms. Fulmer graduated from the University of South Florida with a B.S. in Finance, and received her Juris Doctor degree cum laude from Stetson University College of Law. For the past 17 years, she has represented thousands of mass torts plaintiffs in both state and federal courts who have been injured by defective medical devices and drugs.