We take very seriously our commitment to patient safety. We work continuously to identify and minimise the risks and maximise the benefits of each of our medicines – starting with the discovery of a potential new medicine and continuing throughout its development, launch and marketing.
A number of high profile cases in recent years have put the pharmaceutical industry increasingly in the spotlight regarding the safety of medicines, in particular how safety issues are managed during a medicine’s development and beyond.
During the development phase, extensive and rigorous pre-clinical and clinical testing is done to establish a potential new medicine’s safety and efficacy. Some of the largest clinical trials involve tens of thousands of patients. Despite these large studies, not all side effects can be identified - for example, a rare side effect may only occur in one in every 100,000 people, or only become apparent when a medicine has been in use for several years. The continued safety monitoring of medicines after their launch is therefore also an essential part of our responsibility to patients.
This section describes our commitment to putting patient safety first throughout a medicine’s lifecycle, including how we collect and evaluate safety data and how we communicate safety information to support the safe and effective use of our medicines.
Why aren't all medicines made to be safe?
Ideally, a medicine would target only the disease it is meant to treat and not have any other effect. In reality, however, despite the best efforts of scientists, such a medicine does not exist and all medicines have possible side effects that some patients might experience. This is why the safety of any medicine has to be assessed in terms of the treatment benefits it offers relative to the risk of potential side effects.
The level of risk that is considered acceptable will depend, among other things, on the type of disease being treated – for example, in treating life-threatening diseases such as cancer, potentially serious side effects may be judged acceptable because of the beneficial effect of the medicine in saving or extending life. The risks associated with alternative treatments, or no treatment at all, are also important considerations.
What's next in this section
Clinical safety data of a potential medicine is collected and evaluated continuously throughout a candidate drug’s clinical development.Read more
Responding to new information
If we identify a new side effect we take action that may include carrying out further clinical trials or modifying the prescribing information.Read more