Fda Findingswhen Drugs Break Bad

When diet and exercise aren't enough

Things can go wrong and YOU often end up with a prescription. Can the cure become the disease? Some times, the answer is yes. It is virtually impossible for the FDA to study drugs in all people for an unlimited amount of time. We would all be begging for new therapies and would miss out on some great medicines. Instead of onerous studies, the FDA works with the manufacturor to identify reasonable measurements, reasonable numbers of patients to study and then relies on reports from doctors, pharmacists, nurses and even patients after FDA approval to find out new possible side effects.

Some recent examples include:

1) Bisphosphonates (widely used medicines for osteoporosis like Fosamax, Boniva and Actonel) can rarely cause a serious degeneration of the jaw bone (osteonecrosis) and now have been found (and the label changed) to say that they might actually lead to rare fractures of the thigh--something that this family of medicines seeks to prevent.

2) Diabetes is clearly a risk multiplier for heart disease and Avandia is used to treat diabetes. Recent information showed an association with Avandia and heart risks which prompted European drug regulators to restrict use of Avandia.

While these findings are disturbing, I think they show that the FDA system is working. It also means that you can really be of help if you notice a side effect once you start taking a new medicine.

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