Europe Bans Calcitonin Spray For Cancer Risk

Studies show that there has been an increased risk of cancer associated with the long-term use of intra-nasal calcitonin sprays (the only formulation of calcitonin licensed for osteoporosis). The European Committee on Medicinal Products for Human Use (CHMP) has, therefore, recommended that the intra-nasal calcitonin sprays be withdrawn from the European pharmaceutical market.

What is Calcitonin?

• Calcitonin is a naturally occurring hormone in the human body.
• It helps with regulating calcium levels, and is involved in the bone-building process.
• It is usually taken by shot or nasal spray by women with osteoporosis to help reduce bone loss by slowing down the rate of bone thinning.
• It also relieves pain for spinal compression fracture – when bones in the spine (vertebrae) break and collapse on top of each other.
• Calcitonin can also be used for men with osteoporosis and who have normal levels of testosterone, or whose osteoporosis does not get better with testosterone treatment.

Why is Calcitonin Dangerous?

• The data on the risks and benefits of calcitonin have been reviewed. This includes data from randomized clinical trials with intra-nasal and unlicensed oral calcitonin formulations.
• In such trials, there were occurrences of different types of malignancies, which were observed more frequently in patients treated with calcitonin, compared with a placebo.
• The studies revealed an absolute increased risk of cancer that varied between 0.7% and 2.4%.
• The review concluded that because the increased risk of cancer associated with the long-term use of calcitonin, the benefits no longer outweigh its risks in treating osteoporosis.

Intra-nasal Calcitonin Sprays Have NOT Been Withdrawn in the U.S.

There are two intra-nasal calcitonin sprays in the U.S. currently. One is called Miacalcin, which is developed by Novartis and generic manufacturers, and the second is developed by Upsher-Smith/Unigene and is still under patent. These brands of intra-nasal calcitonin sprays are available in the U.S., and the FDA has not withdrawn these sprays – which have been shown to increase the likelihood of cancer with long-term use. However, the reported increased risk of cancer is not shown to be one of the side-effects of calcitonin on WebMD’s website or on the drug labels.

Canada has acknowledge Europe’s decision to remove the intra-nasal calcitonin spray from its market, and is currently assessing the situation and trying to figure out whether or not to follow suit.

Contact an Experienced Product Liability Attorney

Thomas J. Henry are leaders in the area of drug and product liability litigation. Our Defective Drug and Products Division have extensive knowledge and resources in order to represent our clients efficiently and aggressively. The Defective Drug and Products Division represent a multitude of people who are battling against manufacturers of medical devices and/or defective pharmaceuticals.

If you or a loved one have been injured by or have developed serious side-effects from the use of defective medications or medical devices, contact Thomas J. Henry immediately. We are available 24/7, nights and weekends.