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Panel Votes for Label Revision on all Bisphosphonate Drugs


September 9, 2011 New York Times — An advisory panel decided today to update drug labels on osteoporosis medications, with the recommendation of increasing cautionary language. The medications, including Fosamax, Actonel, Boniva and Reclast, have been linked to cases of rare bone fractures and jaw deterioration.

Two advisory panels — the FDA Drug Safety and Risk Management Committee and the Advisory Committee for Reproductive Health Drugs — met jointly today in order to make recommendations regarding the safety of drugs known as bisphosphonates, which are bone-building drugs designed to prevent fractures in aging women with osteoporosis. Osteoporosis is the most common type of bone disease, which causes a thinning and weakening of bones that increases the chances of having a broken bone.

The major concern of the panel was whether or not the drugs were safe for women to take for more than five years. There have been reports among long-term users that they suffered from unusual thigh fractures or degenerative jaw disease.

With about 11 percent of women over 55 taking the drugs, approximately 5 million women in the United States are bisphosphonate patients. Worldwide sales from last year were about $7.6 billion.

In a 17-6 vote, the panelists decided drug labels needed additional information to clarify the benefits and risks of bisphosphonates, depending on the duration of use. The non-FDA experts are encouraging an increase in cautionary language.

While the panel voted to update the drug labeling, they did not specify exactly what additional warnings should be added — nor did they recommend limiting drug use to just five years.

This comes as a lenient decision from the panel, as FDA staff previously suggested in a 45-page report released Wednesday that there was “no significant advantage of continuing drug therapy beyond five years.” After reviewing the clinical research of bisphosphonates, the FDA concluded patients benefited from taking the drug for up to three to five years, but not longer. Any further use may place patients at risk of rare, but serious side effects.

The FDA found about 9% of users took the drug longer than three years and less than 1% took it longer than five years.

Despite the FDA recommendation, the panel only voted on the need to revise the labels. Panelists decided labels should “further clarify the duration of use” of the drugs. This was a vague decision, as the panel gave no recommendations of what the optimal duration of use may be. None of the panel members recommended firm restrictions on long-term use, like a black box warning, which is the sternest warning the FDA will allow a medication to carry and still remain on the market. Named for the black border that usually surrounds the warning test, it’s a warning that the drug may cause serious side effects.

Individual panel members gave additional personal recommendations. Dr. Lewis S. Nelson from the New York University School of Medicine pushed more dramatic label changes, which may include moving the warning statement from the “indications and usage” section to the “warnings” section. Other panelists recommended stronger language, with doctors reviewing usage annually. Finally, several advisors recommended the new labels needed to be more specific about the benefits of use during the first three to five years and about the risks after that.

Several women, including Dr. Jennifer P. Schneider, gave their own testimonies to the panel regarding their injuries. The majority of the women took the drug for longer than five years and for a pre-osteoporosis condition called osteopenia, which is characterized by low bone mineral density.

Schneider, who reviewed 111 cases herself, had her thigh break in the middle of a New York subway.

As a whole, the committee did agree on one recommendation. The committee pushed for additional study on the overall effectiveness of bisphosphonates in preventing bone fractures. They also recommended the FDA do additional research into why the drugs are being prescribed to women as a preventative measure, when women do not have osteoporosis.

While the FDA does not have to follow the recommendation of the advisory panel, it usually does. The FDA is expected to release a revised label in November.

Bisphosphonate Drugs

The following are drugs belonging to the bisphosphonate family:


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