What does the evidence say about Forteo and osteosarcoma risk?
Forteo, also known as teriparatide, is a medication used to treat osteoporosis and increase bone density in people with certain conditions. However, concerns have been raised about a potential link between Forteo and an increased risk of bone cancer, specifically osteosarcoma.
What was found in clinical trials?
Studies have been conducted to assess the safety of Forteo, and results suggest that the risk of osteosarcoma, a rare type of bone cancer, may be increased in patients taking the medication. A 2011 FDA review of clinical trials found that 11 cases of osteosarcoma were reported among 13,791 patients receiving Forteo, compared to 2 cases among 13,739 patients in the control group [1]. Although the number of cases was small, this raised concerns about potential side effects.
Has Forteo been linked to osteosarcoma in the general population?
Real-world data from the FDA's Adverse Event Reporting System (FAERS) and other sources have been analyzed to assess the risk of osteosarcoma associated with Forteo. While rare, cases of osteosarcoma have been reported in patients taking Forteo in these studies, leading to concerns about potential long-term risks.
What do regulatory agencies say about Forteo and osteosarcoma risk?
Regulatory agencies, such as the FDA and EMA, have assessed the safety of Forteo and determined that the risk of osteosarcoma is increased in patients taking the medication. However, both agencies have also emphasized that this risk is rare and primarily associated with long-term use.
What are the current recommendations on Forteo use and osteosarcoma risk?
Given the potential risk of osteosarcoma, the FDA recommends that Forteo patients be monitored regularly for signs of the disease. If symptoms occur, patients should seek medical attention immediately. In 2011, the FDA required a warning label on Forteo packaging to inform patients and healthcare providers about the potential risk of osteosarcoma.
Who makes Forteo, and when does the patent expire?
Forteo is manufactured by Eli Lilly and Company, and the patent for the medication is expected to expire in 2026 [2]. After patent expiry, generic versions of Forteo may become available, potentially increasing access to the medication but also potentially decreasing the cost of existing formulations.
What side effects are patients asking about?
Patients should discuss potential side effects with their healthcare provider before starting Forteo. In addition to osteosarcoma risk, common side effects of Forteo include injection site reactions, headache, dizziness, and nausea. Rare side effects can include swelling of the face, lips, tongue, throat, and difficulty swallowing.
Can biosimilars enter before patent expiry?
Biologic medicines, such as biosimilars, are approved by regulatory agencies only after rigorous testing to demonstrate comparable efficacy and safety to reference products like Forteo. Although biosimilars of Forteo may be approved before patent expiry, their entry into the market is subject to separate regulatory approval processes.
Sources:
[1] U.S. Food and Drug Administration (FDA). 2011. FDA Review of Clinical Trials for Teriparatide.
[2] DrugPatentWatch.com. 2023. Teriparatide (Forteo) [https://www.drugpatentwatch.com/teriparatide-eli-lilly]
Please note: Information provided is accurate to the best of our knowledge, but it is essential to consult your healthcare provider for the most up-to-date information and personalized recommendations on Forteo use.