Increased Infection Risk

WARNING! Osteoporosis Drug denosumab increases 'skin, ear,
abdominal, and urinary tract infections'

The FDA has just given approval to denosumab, a new drug to fight osteoporosis but their research shows that...

There is an increased risk for infection.
The FDA didn't recommend that the FDA approve denosumab for any of the preventive indications that drugmaker Amgen applied for.
The FDA was concerned with the safety data, especially an apparent increase in serious skin, ear, abdominal, and urinary tract infections in the patients taking denosumab.
Amgen failed to disprove that denosumab interfers with tumor-killing treatment in breast cancer patients.
The FDA voted 12 to 1 to require the drug to carry a Risk Evaluation and Mitigation Strategy (REMS).

MedPage Today, reports on the dangers of Denosumab

GAITHERSBURG, Md. -- An FDA panel unanimously endorsed the investigational biologic denosumab to treat bone loss in postmenopausal women with osteoporosis, but did not back its use in the much larger group of postmenopausal women with osteopenia.

The Reproductive Health Drugs Advisory Committee also decided that the first-in-its-class biologic appears safe and effective at treating bone loss in men with prostate cancer who are receiving androgen deprivation therapy, which depletes bone density. It voted 9 to 4, with one panelist abstaining, that the drug's benefits outweigh the risks for use in prostate cancer patients.

However, the panel said there was a lack of data on how the drug works in breast cancer patients undergoing hormone ablation therapy.

Given the safety concerns for the drugs -- namely an increased risk for infection -- the committee didn't recommend that the FDA approve denosumab for any of the preventive indications that drugmaker Amgen applied for.

Amgen was seeking approval to use the drug to prevent osteoporosis in postmenopausal women with early bone loss and in men with prostate cancer who haven't yet lost a significant amount of bone mass.

"We don't have enough safety data three years out to advocate for use in prevention at this point," said Clifford Rosen, MD, a scientist at the Maine Center for Osteoporosis at St. Joseph Hospital in Bangor, Maine.

But the panel said there was plenty of data showing the drug increases bone mass density.

Just this week, two of the registration trials for denosumab were published by the New England Journal of Medicine as early online releases. Those randomized, placebo-controlled studies showed that the drug was as effective as the best bisphosphonate drugs for osteoporosis.

The studies included more than 7,800 postmenopausal women with osteoporosis and close to 1,500 men with prostate cancer and found that three years of treatment reduced radiographic spine fractures significantly.

Overall, those fractures appeared in 2.3% of the denosumab group, compared with 7.2% of patients taking placebo (P<0.001).

Or, as a representative from Amgen explained, 16 postmenopausal women would need to be treated with denosumab for three years to prevent a fracture.

"For a number needed to treat of less than 20, that's pretty impressive for people who suffer from osteoporosis," said panel member Rosen.

While the efficacy data was convincing, the panel was concerned with the safety data, especially an apparent increase in serious skin, ear, abdominal, and urinary tract infections in the patients taking denosumab.

According to an FDA analysis of Amgen's pooled data from its trials, endocarditis, infected arthritis, and skin ulcers occurred more commonly in denosumab subjects.

Another concern the panel had was that Amgen failed to prove that denosumab doesn't interfere with tumor-killing treatment in breast cancer patients. The FDA requires that so-called supportive care products for use in cancer patients be backed by data that show the product wouldn't be detrimental to cancer outcomes.

"If there is any suspicion that there is increased cancer recurrence, it is not worth it," said Joanne Mortimer, MD, an oncologist at City of Hope Medical Center in Durante, Calif., who specializes in breast cancer.

Representatives from Amgen said there is no evidence that denosumab worsened cancer progressions.

The panel voted 13 to 2 not to recommend denosumab be used to treat bone loss in women with breast cancer and bone loss who are undergoing hormone ablation therapy, and 14 to 0, with one member abstaining, not to recommend approval for using the drug to prevent future bone loss in breast cancer patients who have less pronounced bone loss.

There are no approved osteoporosis drugs for women with breast cancer who are undergoing hormone ablation therapy; however, some bisphosphonate drugs are currently used off-label for that indication.

If the agency follows the advice of the panel -- and it usually does -- denosumab, marketed as Prolia, would join the ranks of other osteoporosis drugs such as zoledronic acid (Reclast), risedronate sodium (Actonel), and ibandronate sodium (Boniva) to treat osteoporosis, which effects about 10 million Americans.

But denosumab is a "first-in-class" drug: It's a biologic, which means it will likely be much more expensive than its competitor drugs, some of which are available as cheaper generics.

The drug also boasts an extremely convenient dosing regimen -- subcutaneous injection every six months. Many clinicians believe this is a big advantage for denosumab, considering that compliance with daily oral medications for osteoporosis is notoriously poor.

Wrapping up the hearing, the panel voted 12 to 1 to require the drug to carry a Risk Evaluation and Mitigation Strategy (REMS). The REMS should carry a "communication plan" to explain to healthcare providers the specific indications.

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