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The Medical Letter On Drugs and Therapeutics, known for its independence from drug company influence, reviewed ibandronate (BONIVA) in its August 14, 2006, issue. The publication noted that the oral form of this osteoporosis drug had been shown to decrease vertebral fractures, which involve the bones that make up the spine, or vertebrae. The drug did not show any decrease in nonvertebral fractures, such as hip fractures, in postmenopausal women.
Because the drug is relatively new, Public...
The Medical Letter On Drugs and Therapeutics, known for its independence from drug company influence, reviewed ibandronate (BONIVA) in its August 14, 2006, issue. The publication noted that the oral form of this osteoporosis drug had been shown to decrease vertebral fractures, which involve the bones that make up the spine, or vertebrae. The drug did not show any decrease in nonvertebral fractures, such as hip fractures, in postmenopausal women.
Because the drug is relatively new, Public Citizen has recommended that consumers refrain from using ibandronate for seven years. There is no current evidence that the drug offers any unique therapeutic benefit over older osteoporosis drugs, such as alendronate (FOSAMAX) or risedronate (ACTONEL). Also, as discussed in the box to the right, there is the possibility of a previously unknown risk arising, especially in the first seven years after approval.
The Health Research Group’s Seven-Year Rule You should wait at least seven years from the date of FDA approval to take any new drug unless it is one of those rare "breakthrough” drugs that offers you a documented therapeutic advantage over older proven drugs. New drugs are tested in a relatively small number of people before being released, and serious adverse effects or life-threatening drug interactions may not be detected until the new drug has been taken by hundreds of thousands of people. A number of new drugs have been withdrawn within their first seven years after release. Also, warnings about serious new adverse reactions have been added to the labeling of a number of drugs, or new drug interactions have been detected, usually within the first seven years after a drug’s release. |
The Food and Drug Administration (FDA) has approved different forms of ibandronate, produced by Roche Pharmaceuticals Inc. of Nutley, N.J., for the prevention and treatment of osteoporosis. The agency cleared the tablet form of ibandronate for marketing in May 2003. Currently, both a once-a-month 150-milligram tablet and a daily 2.5-milligram tablet are available on the market.
In addition, the FDA approved the injectable form of the drug, given once every three months, in January 2006.
There are no studies available showing that injectable ibandronate decreases fractures in women. The FDA’s approval was based on a study showing that the injectable form of the drug was “not inferior” to oral ibandronate in improving bone mineral density (BMD). BMD is a screening test used to diagnose osteoporosis and give information about bone strength. Many women who are diagnosed as having osteoporosis by this test suffer neither vertebral nor nonvertebral fractures even though their BMD is low.
The study involved 1,358 postmenopausal women diagnosed with osteoporosis. The participants were randomly assigned to receive either three milligrams of injectable ibandronate every three months, two milligrams of the injectable drug every two months, or 2.5 milligrams of oral ibandronate daily. BMD in the spine increased by 4.8 percent in the group that injected three milligrams, by 5.1 percent in the group that injected two milligrams and by 3.8 percent in the group receiving the 2.5 milligram oral tablets. There were 13 fractures confirmed by X-ray in each of the groups receiving the injectable form of ibandronate compared to 17 in the group taking the oral form of the drug.
The Medical Letter editors concluded their review by saying:
Ibandronate (Boniva) is the first bisphosphonate approved for use in osteoporosis as an IV formulation given once every 3 months...IV ibandronate has been shown to be about as effective as oral ibandronate in increasing bone mineral density, but has not been shown to decrease fractures compared to placebo, and neither IV nor oral ibandronate has been shown to decrease nonvertebral fractures. Alendronate or risedronate are preferred for patients who can tolerate them.
A recently recognized serious adverse effect linked to the use of injectable bisphosphonates, such as risedronate or even ibandronate, is osteonecrosis — or partial bone death — of the jaw. On May 5, 2005, the FDA advised dentists and cancer physicians that the professional product labeling, or package inserts, for the injectable bisphosphonate drugs zoledronic acid (ZOMETA) and pamidronate (AREDIA) had been revised to warn about the possibility of osteonecrosis of the jaw (see Worst Pills, Best Pills News August 2005 ). The injectable form of ibandronate, approved in January 2006, shares this warning with zoledronic acid and pamidronate.
The greatest risk of developing osteonecrosis of the jaw appears to be in patients receiving an injectable bisphosphonate who have cancers such as multiple myeloma and cancers that have spread (metastasized) to bone.
The typical signs and symptoms of osteonecrosis of the jaw include, but are not limited to, pain, swelling or infection of the gums, loosening of the teeth, poor healing of the gums, numbness or a feeling of heaviness in the jaw, and drainage and exposed bone. Patients with the least serious form of this condition may not have symptoms, but in the most serious cases, patients may require the removal of sections of the jaw.
What You Can Do
You should not use ibandronate (BONIVA) until May 2010.
