FDA panel unclear on osteoporosis drug labels

Labels on bisphosphonates, a type of medication used to treat and prevent osteoporosis, should further clarify how long patients can take them, an FDA advisory panel voted today.

But the panel backed off giving any specific time limits.

Bisphosphonates include Aclasta, Actonel, Altevia, Boniva, Fosamax, and Reclast. Four million to 5 million Americans fill prescriptions for the drugs every year, according to the FDA

The FDA convened the meeting because of emerging safety concerns related to long-term use — generally considered more than three to five years — of bisphosphonates.

In particular, the agency has received reports of osteonecrosis, or bone death, of the jaw and unusual fractures of the femur, or thigh bone, in women who had taken the drugs for several years or more.

Meanwhile, some research suggests that because bisphosphonates remain in bone for years, women could still benefit after they stop taking them.

More Information Needed on Labels

The panel, made up of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee, voted 17 to 6 in favor of recommending additional labeling information about the drugs’ long-term safety and effectiveness.

The FDA usually but not always follows its advisory committee’s recommendations.

The agency’s own analysis concluded that in women who continue bisphosphonate therapy after five years of use there’s no clear benefit or evidence of harm and no subset of patients who have a “clear and consistent” reduced fracture risk, FDA scientist Theresa Kehoe, MD, told the panel.

Bisphosphonate labels mention that safety and effectiveness information is based on one to four years — depending on the drug — of clinical trial data, Kehoe said, but optimal length of use is unknown.

“This is really an issue that’s front and center in primary care,” said Douglas Bauer, MD, a University of California, San Francisco, primary care doctor invited by the FDA to address the advisory panel.

While not an ideal study to examine long-term use, the only published study to do so involved Fosamax, Bauer said. That study randomly assigned women who’d taken Fosamax daily for five years in a clinical trial to either continue taking the drug for another five years or stop.

For fractures other than those of the spine, there was no evidence overall of continued benefit after five years, Bauer said.

But there was a 55% reduction in spine fracture risk in women who continued taking Fosamax for the extra five years, said Arthur Santora, executive director of clinical research for diabetes and endocrinology drugs at Merck, which makes the drug.

And in studies of up to 10 years of use, Santora said, there were no reports of jawbone death and no difference in the risk of unusual thigh fractures between women who took the drug and those who didn’t.

Long-Term Use of Bisphosphonates

Panelists noted that it’s difficult to predict which women will benefit from long-term bisphosphonate use. The Fosamax study did find that women’s bone mineral density at the time they discontinued the drug was strongly related to their fracture risk over the next five years, Bauer told panel members.

The findings probably can be generalized to weekly dosing of Fosamax, he said, but it’s unclear how they relate to other bisphosphonates.

Paul Miller, MD, medical director of the Colorado Center for Bone Research, noted that long-term use wasn’t an issue when bisphosphonates first came on the market. At that time, “we didn’t treat a lot of women in their 50s or early 60s with bisphosphonates,” said Miller, who was representing Warner Chilcott, maker of Actonel. “We treated sicker women in their 70s and 80s.”

In July 2002, the first published results from the Women’s Health Initiative changed all that, he said. The study found that Premarin, the top-selling brand of postmenopausal estrogen, increased heart attack, stroke, and breast cancer risk. Postmenopausal women who had been on hormone therapy to protect their bones flooded doctors’ offices in search of an alternative, Miller said.

Most of the bisphosphonate patients who testified before the panel about their unusual thigh fractures said they had started taking the drugs in their 50s or 60s. Some of the women said they’d been prescribed the drugs for osteopenia, which means their bone mineral density was lower than normal but not low enough to be classified as osteoporosis.

Advisory committee member Clifford Rosen, MD, director of the Center for Clinical and translational Research at the Maine Medical Center Research Institute in Scarborough, questioned the wisdom of prescribing bisphosphonates simply to prevent osteoporosis, as opposed to treating it.

“A prevention indication, I think, is being revisited all the way around, including by the FDA,” Kehoe said in response. “Certainly it’s something we’re struggling with and dealing with.”

Women’s Health pushes out one-shot pregnancy mag Bump

Pacific Magazines is targeting pregnant women with a new one-shot magazine titled Women’s Health Bump.

The extension of Women’s Health will be on sale from next Monday for the next three months at newsagents and selected supermarkets.

Felicity Harley, editor Women’s Health said: “Our research tell us that there is a gap in the market for a magazine that’s just about the woman’s pregnancy experience.”

“Women’s Health Bump won’t tell you about prams, baby bags and cots, but rather it’s the personal journey through the three stages of pregnancy – before, during and after.”

The title will feature editorial on fertility, bump-friendly fitness, health and nutrition as well as beauty, style, sex and love.

Michelle Meyercord, senior vice president, Rodale International added: “Bump is another example of how this team [Women’s Health] has grown this brand and how they continue to make Women’s Health the most relevant and engaging brand for women in Australia.

“We expect it will connect with readers and we are looking at ways we can expand this great idea to markets all around the world.”

Expo teams up with Women’s Wellness Initiative

On Saturday, Oct. 1, the Civic Arena will bring wellness and fashion together under one roof.

As both target the same audience, the 2011 Josephine Expo and Heartland Health’s Women’s Wellness Initiative decided to coordinate their annual events this year.

The ninth Women’s Wellness Initiative, “Just Her Health,” will be held in the south side of the arena. Its doors open at 9 a.m., and Dr. Jane Schwabe will welcome guests at 9:30 a.m.

Venue and time of year rank among the Initiative’s biggest changes. For the past few years, it’s been held at Missouri Western State University and touted as a “holiday prep camp.” Doctors’ panels to discuss women’s health topics, such as arthritis, heart disease, cancer and weight loss, will remain the same. Cardiovascular specialist Dr. Francisco Lammoglia and medical oncologist Dr. Rony Abou-Jawde are among the specialists who will answer questions.

An afternoon panel on weight loss will highlight success stories and surgical options for patients offered by recent hire, bariatric surgeon Dr. Phillip Hornbostel.

“Most people really like it,” Dr. Schwabe said of the physician panels. “They get new information. I think they really like the open forum, asking doctors questions in a not-very-threatening format. So if there’s some question they’ve got that they’re very curious about, we’ll do our best to try to answer it.”

Women who pre-register for the free health event by calling (816) 271-4098 will get a free pass to the Expo. The Initiative will break for the Expo’s fashion show, held at 11 a.m., and give participants time to explore the vendors. Participants are also free to come and go as they please, Dr. Schwabe noted, particularly as this year’s Initiative will be on the same day as Paint the Parkway Pink, and the Initiative doesn’t want to compete with it or the Expo.

Those who bring five or more canned goods to benefit Second Harvest Community Food Bank are invited to attend a Zumba session following the Initiative and the end of the Expo at 4 p.m.

Expo doors open at 10 a.m. for women who do not want to participate in the Wellness Initiative. Tickets cost $5 and can be purchased at Hy-Vee and at the News-Press. Children age 12 and under are free.

The 2011 Expo, with the theme “Just Her Style,” will feature around 100 booths and vendors, along with the East Hills’ sponsored fashion show. The popular show, performed again at 2 p.m., will showcase items from Dillard’s, Sears, J.C. Penney, Charming Charlie and Rue 21, among other stores.

“We see it as no matter what your style is, whether it’s fashion or personal, we’ll have something at the Expo for you,” said Carole Dunn, special projects advertiser for the News-Press and co-coordinator of the event.

One of the sponsors, Randy Reed, will have the Chevy Volt, an electric car, on display. Live music will also be performed throughout the day; The Phil Vandel Band will play at 10 a.m., Marcus Words at noon and the Wood Pile at 3 p.m.