The benefits of drugs made with calcitonin salmon, that is often used to treat osteoporosis in postmenopausal women, may be overshadowed by an increased risk of cancer---according to a staff of reviewers from the U.S. Food and Drug Administration.
These products include Miacalcin injection and nasal spray from Novartis as well as Unigene Laboratory's nasal spray that is distributed by Upsher Smith Laboraties Inc in the U.S. There are also generic forms of calcitonin products that have been made available.
An FDA panel is slated to meet on March 5 to discuss whether the sales of these products should continue after European regulators warned against long-term use of calcitonin after finding evidence that it may contribute to an increased cancer risk.
The European regulators concluded that the risks associated with calcitonin medications outweigh the benefits in regard to osteoporosis treatment and recommended that they should only be authorized for use in Paget's disease, acute bone loss and for cases where a cancer patient has high amounts of calcium in their blood.
The FDA reviewers said that there are still questions that need to be answered in regard to the effectiveness of calcitonin salmon drugs used to reduce fractures as a result of postmenopausal osteoporosis.
Calcitonin salmon is a man-made version of a hormone that is naturally found in salmon, according to Reuters.
And while Novartis said that it "places the highest priority on patient safety and appropriate use of its medicines and is looking forward to the opportunity to engage in the discussion at the upcoming meeting," Upsher Smith and Unigene did not immediately respond to Reuters' request for a comment.
Unigene said that they would not comment on the review because they do not distribute calcitonin in the U.S., according to Reuters.
(SOURCE)