Is it likely that the 2 year limit on Forteo will be extended when it's been on the market longer?

Hi Diane, welcome and thanks for your question.  When Forteo was marketed in Nov 2002, it was with the understanding that it wouldn't be used for more than 2 years within a persons lifetime.  There may be situations were a Dr. will prescribe this beyond the 2 years, but that decision is up to the Dr., patient and insurance.  Since Forteo was only tested for 2 years no one knows what the results would be if taken longer than this.

In my opinion I don't believe the length of time while on the market has anything to do with this ruling possibly being changed.  I have no idea if this stipulation could be changed at some point and the drug treatment period could be extended, but that decision would be up to the FDA.  If at some point we obtain figures on those who truly contracted osteosarcoma from Forteo, that information may have an affect on the treatment period.  At this time we don't know how many patients contracted osteosarcoma from Forteo, and we may not know this for many years, until Eli Lily completes their post-marketing surveilance on osteosarcoma in Forteo users.  Rare cases have been reported, but a direct causality link has not been established yet.  In other words, we don't know if those rare cases of osteosarcoma in Forteo users can be directly linked to the use of the drug since there were other accompanying medical conditions that could cause this cancer on it's own.

Here's the language on this from the FDA, I hope it helps to explain.

Important Prescribing Information on treatment duration regarding FORTEO from the FDA:

"The safety and efficacy of Forteo have not been evaluated beyond 2 years of treatment. Consequently, use of the drug for more than 2 years during a patient's lifetime is not recommended. (FDA, 2009 Important Prescribing Information: pg 10)"

see FDA link:

http://www.fda.gov/downloads/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/UCM173371.pdf

Good luck and please join our discussion on Forteo that provides lots of information at this link.  You can also ask other members questions, at our discussion, or myself and we'd be happy to answer anything you would like us to.