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The European Medicines Agency (EMA), the European Union’s equivalent to the Food and Drug Administration (FDA), reviewed new information on medicines containing the drug calcitonin. Subsequently, more than eight months ago, the EMA found “evidence of a small increased risk of cancer with long-term use of these medicines” and announced that “[because] the nasal spray formulation is solely approved for the treatment of post-menopausal osteoporosis, this formulation is being suspended in the...
The European Medicines Agency (EMA), the European Union’s equivalent to the Food and Drug Administration (FDA), reviewed new information on medicines containing the drug calcitonin. Subsequently, more than eight months ago, the EMA found “evidence of a small increased risk of cancer with long-term use of these medicines” and announced that “[because] the nasal spray formulation is solely approved for the treatment of post-menopausal osteoporosis, this formulation is being suspended in the EU.”
This conclusion was based not only on the possible increased risk of cancer in people using the drugs (MIACALCIN spray, FORTICAL and generic equivalents in the U.S.) but also the fact that previous studies failed to show that the drugs conclusively decreased fracture risk.
Since the EMA’s announcement, approximately 500,000 prescriptions have been filled in the U.S. for these drugs, translating into exposure of 125,000 people — almost entirely women — to drugs deemed unacceptable for women in Europe.
The EMA website states the following information:
- Calcitonin will no longer be used 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, who will recommend suitable alternative treatment.
- Patients receiving injectable calcitonin who have any questions should speak to their doctor or pharmacist.
As is increasingly common in recent years, the FDA is again lagging behind its European counterpart in protecting the public from drugs whose risks outweigh their benefits. (The painkiller propoxyphene [DARVON] and weight-loss drug sibutramine [MERIDIA] also were removed in Europe before their eventual U.S. ban.)
Unless the FDA believes that calcitonin nasal spray is somehow more effective and less likely to cause cancer in U.S. patients than in European patients, the agency must immediately begin the process of removing it from the U.S. market, before tens of thousands of additional women are subjected to its risks.
