Medicines play an important role in public health, bringing enormous benefits to patients in the fight against disease. However, the use of medicines is not without risk and no drug is completely safe.
Benefits and risks
The safety of a medicine must be described and evaluated in terms of the expected benefits it offers in the treatment of disease relative to the potential risk of unwanted side effects – known as the benefit/risk profile.
Ideally, a medicine would target only the disease or disorder that it is meant to treat and would not have any other effect on the patient. In reality, however, despite the best efforts of scientists, such a medicine does not yet exist and all medicines have possible side effects that some patients might experience.
Healthcare professionals (in consultation with their patients) must weigh the expected benefits of a medicine against its possible side effects, and decide the acceptable level of risk for an individual patient.
The pharmaceutical companies developing and supporting these medicines, in partnership with national health regulatory authorities, have a responsibility to provide healthcare professionals with the information they need to make these case-by-case benefit/risk decisions.
What we believe
At AstraZeneca, we believe that understanding, and communicating the safety profiles of the medicines that we produce are among our most important responsibilities. We also believe:
- These obligations continue over the entire lifespan of our medicines.
- Transparency of clinical benefit/risk information and appropriate, timely, communication of that knowledge as it evolves over time are crucial. Click here to learn more about our clinical trials.
- Drug evaluation never stops, and we must consider new and evolving issues concerning the benefit/risk profile that can be expected with continued experience with any medicine.
- The considerable drug safety knowledge available through clinical trials at product registration must be supplemented by the knowledge gained from further clinical studies, post marketing clinical experience and structured observational research as needed.
- AstraZeneca is working with other pharmaceutical organizations to improve drug safety surveillance and evaluation methodologies.
Furthermore, AstraZeneca acknowledges the critical role of regulatory authorities in safeguarding the public’s health with regard to the safety of medicines. We are therefore committed to a strong, independent FDA, which is why we are a member of the Alliance for a Stronger FDA.
