Some patients are reluctant to use drug products because of the risk of side effects. But two things are certain. First, the risk of side effects is never zero. And second, the benefits of using licensed drugs always far outweigh any risk involved.
Drug research and development are very complex processes which are strictly regulated. Before a drug product can be sold, scientists and physicians generally spend ten to twelve years conducting comprehensive tests, analyzing 5,000 to 10,000 substances to check their efficacy and safety. The resulting comprehensive data package – roughly 500,000 pages – is then submitted to the health authorities. Only when the experts at the regulatory authorities have carefully reviewed all the information and approved the drug can it be marketed and made available to the patient.
It is our duty to provide comprehensive information about potential side effects, to both the physicians prescribing the drugs and to the patients themselves, which we do with the pack insert. We also consider it vital that patients talk to their doctors about this aspect.
Ensuring a reasonable risk/benefit ratio for each of our drug products lies at the heart of all our work – throughout the various research stages, during the licensing procedure and beyond. Even after the product has been launched on the market, we continue to collect and continuously evaluate any reported side effects arising from its use and update our product information as required.