Do Not Use MIACALCIN Nasal Spray or Other Calcitonin-Containing Drugs for Osteoporosis

Since 1995, Worst Pills, Best Pills News has advised readers that all calcitonin-containing products approved for osteoporosis are Do Not Use drugs because, as was stated then, there is no evidence that they prevent fractures. (See table for a list of available calcitonin products.)

Recent evidence showing serious risks has further heightened concerns about the lack of any clear benefit of the drug for preventing fractures. Despite these concerns, in 2013, more than 700,000 prescriptions were filled in the U.S. for calcitonin-containing nasal sprays, which are approved only for osteoporosis treatment.[1]

Although these drugs have been banned for osteoporosis in Europe (in 2012) and Canada (in 2013) because the risks outweigh the benefits, the Food and Drug Administration (FDA) has, quite recklessly, left calcitonin treatments for osteoporosis on the market, with information and advice sharply contrasting that given to patients in Europe or Canada.

Calcitonin-Containing Drugs

*Do Not Use
**Do Not Use for osteoporosis

Recent regulatory developments for calcitonin-containing products

In July 2012, Health Canada (a regulatory agency similar to the FDA) reported that it was investigating a possible increased risk of cancer with long-term use of calcitonin products.[2]

Also in July 2012, the European Medicines Agency (EMA) issued information concerning the long-term use of calcitonin products and the increased risk of cancer.[3] The EMA stated that these products should be used only for short-term treatment of other bone-related diseases at the lowest effective dose and should not be used for the treatment of osteoporosis. According to the agency, the risk of using calcitonin outweighs its benefit for osteoporosis. In Europe, the product is now available only as an infusion and an injection for other bone diseases and no longer comes in the nasal-spray form.

In July 2013, Health Canada announced that as of Oct. 1, 2013, calcitonin nasal spray would not be authorized for sale in Canada.[4] After reviewing the available data, the agency, like the EMA, concluded that the risk associated with the product was greater than the benefit of using it to treat osteoporosis in postmenopausal women. Calcitonin-containing products other than nasal spray also are no longer indicated for treatment of osteoporosis.

On March 5, 2013, Dr. Sidney Wolfe, then-director of Public Citizen’s Health Research Group, testified before a joint meeting of the FDA’s Reproductive Health Drugs Advisory Committee and its Drug Safety and Risk Management Advisory Committee.[5] Wolfe urged the FDA to follow the EMA’s lead (Canada had not yet taken action) and act promptly to remove nasal calcitonin from the U.S. market.

Evidence presented by the FDA in its background document provided to these advisory committees regarding the risks and benefits of calcitonin-containing products included the following:[6]

• “The overall meta-analyses conducted by the FDA and Novartis [manufacturer of MIACALCIN] show a trend for a higher risk of malignancy for calcitonin-treated patients compared to placebo.”
• “The potential for a cancer risk with calcitonin salmon therapy cannot be ignored. The majority of all calcitonin salmon trials showed an increased risk.”
• “This [negative study] calls into question the reliability of the fracture results of this trial [using nasal spray] and the use of bone mineral density as a surrogate endpoint for fracture risk reduction with calcitonin.” With this statement, the FDA indicated that clinical studies using measurements of bone mineral density alone as a measure of the effectiveness of osteoporosis drugs are insufficient to determine if fractures will be prevented. For all more recently approved osteoporosis drugs, clinical studies had to show fracture reduction as well.
• “Despite three fracture trials conducted, there remain significant questions regarding calcitonin salmon’s effectiveness in reducing fractures in postmenopausal women. This lack of effectiveness when combined with the potential for a cancer risk associated with calcitonin salmon therapy raises concerns about the overall risk and benefit assessment for calcitonin salmon products in the treatment of postmenopausal osteoporosis.”[7]

By a vote of 12 to 9, the advisory committees voted against recommending continued marketing of calcitonin for osteoporosis.[8] Those opposed to the continued marketing stated that the potential cancer risk outweighed the evidence for fracture prevention.[9]

Despite the outcome of the advisory committees’ vote and the FDA staff’s conclusions that the risks outweighed the benefits, the agency ultimately decided to leave calcitonin-containing drugs on the market in the U.S. for treatment of osteoporosis. The FDA’s decision stands in stark contrast to the decisions made by European and Canadian regulators to ban the drugs, which were based on the exact same evidence considered by the FDA.

What You Can Do

Since the EMA and Canada put public health first, their recommendations for patients should trump the dangerous decision of the FDA allowing the continued marketing of calcitonin-containing drugs for osteoporosis, and we quote from the safer EMA recommendations for patients:

“Calcitonin will no longer be used [in the EMA] for the treatment of osteoporosis. Patients being treated for osteoporosis with calcitonin nasal sprays or other formulations are advised to speak to their doctor at a routine appointment [to discuss] suitable alternative treatment.”[10]

References

[1] IMS Data: National Prescription Audit, 2013.

[2] Health Canada. Calcitonin-containing drugs: Health Canada assessing potential cancer risk with long-term use. July 31, 2012. http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2012/15044a-eng.php. Accessed March 25, 2014.

[3] European Medicines Agency. European Medicines Agency recommends limiting long-term use of calcitonin medicines. July 20, 2012, http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2012/07/news_detail_001573.jsp&mid=WC0b01ac058004d5c1. Accessed March 25, 2014.

[4] Health Canada. Important changes to the availability and conditions of use for drugs containing calcitonin. July 31, 2013. http://www.healthycanadians.gc.ca/recall-alert-rappel-avis/hc-sc/2013/34843a-eng.php. Accessed March 25, 2014.

[5] Wolfe S. Testimony of Sidney Wolfe M.D., Health Research Group of Public Citizen: Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committees; Calcitonin. March 5, 2013. http://www.citizen.org/documents/2101.pdf. Accessed March 25, 2014.

[6] Food and Drug Administration. Background document for meeting of Advisory Committee for Reproductive Health Drugs and Drug Safety and Risk Management Advisory Committee. March 5, 2013. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM341779.pdf. Accessed March 25, 2014.

[7] Ibid.

[8] Food and Drug Administration. Summary minutes of the joint meeting of the Advisory Committee for Reproductive Health Drugs and the Drug Safety and Risk Management Advisory Committee. March 5, 2013. http://www.fda.gov/downloads/AdvisoryCommittees/CommitteesMeetingMaterials/Drugs/ReproductiveHealthDrugsAdvisoryCommittee/UCM351017.pdf. Accessed March 25, 2014.

[9] Ibid.

[10] European Medicines Agency. European Medicines Agency recommends limiting long-term use of calcitonin medicines. July 20, 2012 http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/public_health_alerts/2012/07/human_pha_detail_000065.jsp&mid=WC0b01ac058001d126. Accessed March 25, 2014.