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F.D.A. Approves New Osteoporosis Therapy, a Bone-Growing Drug
  WASHINGTON, Nov. 26 (AP) - The first drug created to stimulate the growth of new bone won Food and Drug Administration approval today to treat osteoporosis, the brittle-bone disease that affects 10 million Americans.
Separately, the drug agency approved a new drug for the treatment of attention deficit hyperactivity disorder, the most commonly diagnosed behavioral disorder of childhood. Both drugs are marketed by Eli Lilly & Company of Indianapolis. The osteoporosis drug, teriparatide, works by increasing the action of osteoblasts, the bone-building cells, causing bones to become denser and more resistant to fractures, officials said.
Agency officials said the drug, given by injection daily, would have a special warning because in laboratory tests it caused cancerous bone tumors in rats. The tumors, however, have not been seen in 2,000 people in clinical trials, officials said.
Lilly will market teriparatide under the brand name Forteo.
"We feel this is an important drug," said Dr. Eric Colman, a team leader in the division of metabolic and endocrine drug products at the food and drug agency. "It is the first approved that stimulates bone formation instead of slowing the breakdown of bone."
As people age, the risk for osteoporosis increases. Over a lifetime, special cells build up and break down bone. The osteoblast cell forms new bone, and the osteoclast dissolves old and worn-out bone tissue. When the process is balanced, bones stay strong and dense.
In many women after menopause and in some men, age brings an imbalance. Osteoclasts tend to become more active, dissolving old bone faster than osteoblasts can build. A result is thin and brittle bones, leading to fractures, particularly of the spine.
Since 1995, drugs like Fosamax have attacked the problem by slowing the action of osteoclasts. The new approach stimulates the osteoblasts.
Dr. Colman said that to bolster the effect patients might use teriparatide with the older approved drugs, because they work with different mechanisms. Labels and instructions for teriparatide will carry a "black box" warning to highlight special concerns. Dr. Colman said the warning would discuss studies that showed some rats injected with teriparatide developed osteosarcomas, a rare and serious bone cancer. Teriparatide, he said, tested for 19 months in 1,637 women and for 10 months in 437 men, with no cases of bone cancer.
Patients showed significant rises in bone density at the spine and hip compared with patients who took just calcium pills and vitamin D.
The studies also found reduced bone fractures among women who took teriparatide compared with those who took a placebo. Fracture risk for men was not studied.
The agency said some patients developed mild side effects, including nausea, dizziness and leg cramps.
Of the 10 million Americans with osteoporosis, 80 percent are women. Brittle bones can lead to small fractures of the vertebrae and a gradual slumping.
Regarding the treatment for attention deficit hyperactivity disorder, commonly called A.D.H.D., the drug is the first for the disorder that is not defined as a stimulant under certain federal laws, meaning that it is exempt from some strict prescription rules. That allows patients to obtain the drug through phone-in refills and samples from doctors.
The drug, whose chemical name is atomoxetine HC1, will be marketed under the brand name Strattera and should be on sale in pharmacies in January, Lilly said.
The treatment is approved for use by children, adolescents and adults for control of symptoms of A.D.H.D., a condition that affects about 12 million Americans, including an estimated 8 million adults. Its symptoms include poor attention and concentration and low impulse control.
Atomoxetine HC1 has not been approved for use by children younger than 6. It is also not approved for use with monoamine oxidase inhibitor, an antidepressant, or in patients with narrow-angle glaucoma.
In drug trials, some children and adolescents experienced side effects like nausea, decreased appetite, vomiting, tiredness and upset stomach.
Among adults, side effects included sleep problems, dry mouth, decreased appetite, upset stomach, nausea, dizziness and sexual disorders.
Copyright The New York Times Company
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