HEALTH MANAGEMENT. FDA advisers cautiously on bone drug

NOBILITY PHILEX, Maryland | September 9, 2011 8: 24 pm EDT
NOBILITY PHILEX, Maryland (Reuters) - U.S. health advisers rejected it, takes how long women beat a class of drugs by millions to prevent bone fractures, but agreed that the labels uncertainty about the risks and benefits to be modified according to long-term use.
The food and drug had asked Administration to recommend whether a "drug holiday" or some period was justified, for a class of osteoporosis drugs known as bisphosphonates that unusual thigh fractures and other side effects in conjunction was brought two of its consultative bodies.
Now the consultants have at tailored hardened, making changes, on Friday coding with many indicating how often patients require a review they need medicine.
Panelists concerns again and again, that they have not enough evidence, to specific suggestions or conclusions to find, and some awareness of such uncertainties in the term recommended, as well as.
"I don't think that we restrict enough data to anything at this point have", said Dr. Maria Suarez Vacceans, Professor at the University of Texas MD Anderson Cancer Center and a member of.
In the year under review include Merck & co Fosamax, Warner Chilcott ACTONEL, BONIVA Roche and Novartis Reclast. This class of drugs was linked to osteonecrosis of the jaw or jaw bone death and possible increased risk of cancer.
Presented by the FDA and industry not paint studies consultants a coherent picture that whether benefits outweigh the risks bisphosphonates for longer than three to five years or how exactly each of these drugs take influenced various subgroups of patients, said.
"I'm used to dealing with ambiguous situations in a clinical setting, but as a result, this will be at different heights," said Brian Erstad, pharmacy Professor at the University of Arizona and a member of the drug safety and risk management advisory panel.
RISKS & BENEFITS
Some 4.5 million Americans age 55-filled recipes for bisphosphonates in 2009, mostly women after the menopause, osteoporosis, a progressive bone thinning condition that usually caused fractures in the hip, wrist or spine.
The use of drugs said FDA employees unusually femur associated with fractures, and increases the risk of jaw bone death that more people keep them orally. But she said that the evidence of an increased risk of cancer was incompatible.
BONIVA is available as an injection or a tablet, Aclasta is an injection, and other drugs are taken orally.
FDA researchers to stay their use found no advantage on the medication for five years and without loss of effectiveness from discontinued. Pharmaceutical companies, but warned that a comprehensive introduction to a break in the treatment of the FDA may expose patients to more fractures.
"Despite rare side effects, patients, the use of bisphosphonates have fewer fractures and low mortality, and this knowledge must be shared with our patients," said Dr. Robert Adler, an invited speaker and Professor of Endocrinology at the Virginia Commonwealth University.
With millions who reached taking the medication, the sale of Merck's Fosamax $3 billion in 2007, but sales plunged the competition from cheaper generics from early 2008 to $ 926 million in 2010 with the pill.
Analysts said mounting concerns bisphosphonates patients to Amgen Inc new medicine, Prolia, a different kind of osteoporosis drug can drive.
BAD REP
Orrel Lanter Fosamax Merck and the generic version, chemically as alendronate, has known nine years.
"I felt something go" snap-in "my leg." My right foot flopped out on the right side and my leg was a noodle which pain was unbearable, "the adviser told on Friday." In the emergency room was told her that she had an atypical femur fracture, which leads them to years bisphosphonates.
"I was crippled now links through this terrible drug happy healthy, very active in the free woman", Lanter said, which is now 68 and went out of the room, with a stick.
Since Merck Fosamax 1995 obtained the first Bisphosphonate for osteoporosis, the names of the drugs in this class were several reviews and changes.
In 2005, a warning of higher risk of osteonecrosis of the jaw was labels, and added in 2009, a deposit of gastrointestinal side effects. Earlier this year, the labels have been changed to add a warning of atypical femur fractures and Reclast the label now mentions an increased risk of kidney failure.
However, pharmaceutical companies agreed and some of the panelists, that some groups of patients, perhaps the highest risk, could benefit from bone fractures of longer-term use of such drugs.
Whether and how these problems now up to the is
FDA.
(Reporting by Alina Selyukh;) Additional reporting by Ransdell Pierson; (Editing by Tim Dobbyn)

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