Osteoporosis Spray Side Effects Injury Lawsuits. Parker Waichman LLP is investigating potential lawsuits on behalf of individuals who were diagnosed with cancer after taking calcitonin salmon, an inhalable drug used to treat osteoporosis in postmenopausal women. Calcitonin salmon is sold by Novartis under the brand name Miacalcin and also by Upsher-Smith under the brand name Fortical. Reports suggest that calcitonin salmon may lead to an increased risk of cancer. Because of this association, regulators in Europe and a panel of experts in the United States have recommended against using the drug. If you or a loved one suffered from cancer after taking a calcitonin salmon nasal spray such as Miacalcin or Fortical, our attorneys would like to speak with you.
Call Parker Waichman LLP today for a free, no-obligation evaluation of your case.
Osteoporosis Nasal Spray Used in Women Linked to Risk of Cancer
Since the 1980’s calcitonin salmon has been used to treat osteoporosis in women who are at least 5 years postmenopausal and can or do not want to take estrogen products, according to Medline Plus; it is a manmade version of the hormone calcitonin found in salmon fish. Sold under the brand names Miacalcin and Fortical, calcitonin salmon is a nasal spray that is supposed to fight to effects of osteoporosis by preventing bone breakdown and increasing bone density. However, research suggests that this drug is associated with an increased risk of cancer. Because of this observed risk, regulators in Europe and an advisory panel in the United States have recommended against using calcitonin salmon in women.
In July 2012, the European Medicines Agency (EMA) stated that calcitonin salmon should no longer be used be used to treat osteoporosis because of reports indicating that It may increase the risk of cancer. In March 2013, an expert advisory panel for the U.S. Food and Drug Administration (FDA) voted 12 to 9 against using the drug for osteoporosis because there is little evidence the drug works and may increase the likelihood of cancer. An internal FDA memo stated that “the potential for a cancer risk with calcitonin salmon therapy cannot be ignored. The majority of all calcitonin salmon trials showed an increased risk estimate.”
According to CBS, prescriptions for calcitonin salmon have declined dramatically because of safety concerns; the number of US patients taking the medication fell 51 percent between 2006 and 2011 to 205,000. Miacalcin and Fortical were approved by the FDA based on studies showing that they increased bone mineral density, but an increase in density has not actually been shown to reduce bone fractures. Approving a drug based on surrogate endpoints in this manner means that studies backing the drug only measures criteria that is suspected to improve health. This approach is favored by drugmakers because it gets their product out sooner, but it is problematic when drugs prove to be ineffective and/or dangerous.
The FDA advisory panel that advised against calcitonin salmon had a near unanimous vote (20 to 1) that manufacturers should be required to show that the drug is actually effective at preventing bone fractures before placing it on the market.
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