Osteoporosis drug may pose cancer risk reports FDA
A medication to treat osteoporosis, calcitonin salmon, has come under the scrutiny of the US Food and Drug Administration (FDA) because it may increase the risk of cancer. Staff reviewers for the FDA issued the warning in briefing documents on March 1.It noted that the cancer risk raises concerns about the overall risk versus benefit of calcitonin products to treat osteoporosis in postmenopausal women.
Calcitonin salmon is a man-made version of the hormone calcitonin, which is present in salmon. Products that contain calcitonin include Novartis AG’s Miacalcin injection and nasal spray and Unigene Laboratories Inc’s nasal spray. Upsher Smith Laboratories Inc. distributes Unigene’s product in the United States. In addition, generic calcitonin products are available. In addition to a [possible cancer risk, the FDA reviewers said that significant questions remain about calcitonin salmon’s effectiveness in reducing fractures in the treatment of postmenopausal osteoporosis.
An advisory panel to the FDA is scheduled to discuss the products on March 5 and will make a recommendation to the agency on whether to allow the continued marketing of these products for that use.
Calcitonin salmon has also come under the scrutiny of European regulators, last July, they recommended that log-term use of calcitonin be curtailed after a review found evidence of a small increased risk of cancer with long-term use of the drugs. They recommended that calcitonin salmon should only be authorized for short-term use in: Paget’s disease (a chronic bone disorder that can result in enlarged and misshapen bones); for acute bone loss due to sudden immobilization; and for excess calcium in the blood caused by cancer. The regulators claimed that the benefits of calcitonin-containing medicines did not outweigh their risks in the treatment of osteoporosis and that they should no longer be used for this condition.
Osteoporosis is the most common type of bone disease. Researchers estimate that about one out of five American women over the age of 50 have osteoporosis. About half of all women over the age of 50 will have a fracture of the hip, wrist, or vertebra (bones of the spine). Osteoporosis occurs when the body fails to form enough new bone, when too much old bone is reabsorbed by the body, or both.
Calcium and phosphate are two minerals that are essential for normal bone formation. Throughout youth, your body uses these minerals to produce bones. If you do not get enough calcium, or if your body does not absorb enough calcium from the diet, bone production and bone tissues may suffer. As you age, calcium and phosphate may be reabsorbed back into the body from the bones, which makes the bone tissue weaker. This can result in brittle, fragile bones that are more prone to fractures, even without injury.
Usually, the loss occurs gradually over years. Many times, a person will have a fracture before becoming aware that the disease is present. By the time a fracture occurs, the disease is in its advanced stages and damage is severe.
The leading causes of osteoporosis are a drop in estrogen in women at the time of menopause and a drop in testosterone in men. Women over age 50 and men over age 70 have a higher risk for osteoporosis.
Other causes include:
- Being confined to a bed
- Chronic rheumatoid arthritis, chronic kidney disease, eating disorders
- Taking corticosteroid medications (prednisone, methylprednisolone) every day for more than 3 months, or taking some antiseizure drugs
- Caucasian and Asian women, especially those with a family history of osteoporosis, have a greater than average risk of developing osteoporosis. Other risk factors include:
- Absence of menstrual periods (amenorrhea) for long periods of time
- Drinking a large amount of alcohol
- Family history of osteoporosis
- History of hormone treatment for prostate cancer or breast cancer
- Low body weight
- Too little calcium in the diet