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September 24, 2013
On August 30, 2013, the Food and Drug Administration (FDA) approved a revision to the Medication Guide accompanying the label of the osteoporosis drug teriparatide (FORTEO)[1], warning patients that the drug presents a risk of a rare, aggressive type of bone cancer called osteosarcoma[2]. Because of this risk, the Medication Guide warns patients not to take teriparatide for more than a total of two years.
The revision, made to the drug’s FDA-approved Medication Guide,...
September 24, 2013
On August 30, 2013, the Food and Drug Administration (FDA) approved a revision to the Medication Guide accompanying the label of the osteoporosis drug teriparatide (FORTEO)[1], warning patients that the drug presents a risk of a rare, aggressive type of bone cancer called osteosarcoma[2]. Because of this risk, the Medication Guide warns patients not to take teriparatide for more than a total of two years.
The revision, made to the drug’s FDA-approved Medication Guide, states that “osteosarcoma has rarely been reported in people who took FORTEO.” (Public Citizen found five cases in the FDA’s adverse event database between approval in 2002 and the end of 2011.)
Public Citizen’s Health Research Group has long categorized teriparatide as a “Do Not Use” drug because it has not been shown to reduce fractures in men and caused bone cancer in animal studies.
In studies performed before teriparatide’s approval by the FDA, rats exposed to the drug developed osteosarcomas[3]. The laboratory rats also developed two other bone tumors, cancerous osteoblastomas and benign osteomas, but there have not yet been warnings about these tumors in humans.
In an effort to track the incidence of osteosarcoma, the drug’s labeling provides a phone number and link to a voluntary patient registry connected to state cancer registries[4]. The hope is that everyone who takes the drug will sign up so that it can ideally be determined whether the patient was or is being treated with teriparatide in cases of osteosarcoma.
Teriparatide also commonly causes joint aches and pain, which may be indistinguishable from early symptoms of a bone tumor such as osteosarcoma.
Be sure to report symptoms to the FDA’s MedWatch Adverse Event reporting program at https://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm or by calling (800) FDA-1088.
References
[1] http://www.accessdata.fda.gov/drugsatfda_docs/appletter/2013/021318Orig1s036ltr.pdf
[2] http://pi.lilly.com/us/forteo-medguide.pdf
[3] http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/021318s036lbl.pdf
[4] http://forteoregistry.rti.org/patients.html; 1-866-382-6813.
