FDA issues new warning on long term use of osteoporosis drugs

Following a previous article on the benefits of taking a ‘holiday’ from such drugs there are now two new concerns.


In the USA a warning has been issued that a class of widely prescribed osteoporosis drugs may significantly increase the risk of a rare type of thigh fracture. Indeed the FDA is so concerned that they have ordered a new warning label for all drugs in the bisphosphonate family, including Merck’s Fosamax (marketed generically as alendronate), Roche’s Boniva, Novartis’ Reclast and Warner Chilcott’s Actonel.

That is certainly taking it seriously, but they are also looking to protect the drugs users by also requiring that consumer-friendly guides be distributed with every bisphosphonate prescription to make sure that patients understand the risks and how to minimize them.

The new risk of thigh fracture is worrying because it occurs with little or no preceding trauma and may be preceded for months by a dull, aching pain in the thigh or groin. The agency said that patients experiencing such symptoms should visit a doctor at once to try and prevent a fracture.

The second warning looks to have a rather more substantial and wide ranging impact as the FDA is also directing doctors to reassess whether patients should continue taking the drugs after five or more years. According to the National Osteoporosis Foundation, the drugs appear to offer little or no benefit after this time, while the rate of fractures seems to increase.

This class of drugs has been around for some time and are intended to stop the bone-thinning processes of osteoporosis by interfering with the mechanism by which the body normally breaks down old bone cells and replaces them with new ones. Some doctors now believe that interfering with this process may cause bones to weaken over time, however.

Certainly progesterone pioneer Dr John Lee was very clear in his condemnation of such drugs, arguing that they merely maintained weakened old bone longer and that in order to deal effectively with osteoporosis natural progesterone was needed. This is because bone is a dynamic structure that requires not only the removal of old bone but its replacement with new bone in a continual lifelong process.

These drugs merely slow down the process of bone loss but cannot build new bone as only bio-identical natural progesterone can do this.