Responding to new information
If we find a new side effect, the actions we take may include carrying out further clinical trials, modifying the prescribing information, and communicating with healthcare professionals and others. In some situations it may be appropriate to stop a clinical trial or withdraw a medicine from the market.
We also provide updates to regulators on the safety of our medicines on more serious safety issues as they arise or through periodic safety update reports. This is governed by local regulation and the frequency depends on the country and how long the medicine has been marketed in that country. For example, in the US, safety reports are required every three months for the first three years. In Europe, reports are required every six months for the first two years. We are fully compliant with the New Pharmacovigilance Legislation in Europe and have implemented the format for safety updates through submission of PBRERs – Periodic Benefit Risk Evaluation Reports.
If further research confirms a link to our medicine, we will update the product label and prescribing information to include warnings on the side effect or to restrict the use of the medicine to certain patient groups. We use journal articles and our sales representatives to make sure doctors are aware of the change.
If we identify a very serious potential side effect we may tell doctors about it before we have confirmed a definite link to our medicine. We use rapid communication channels including emails and letters sent directly to all doctors who may prescribe the product. Other channels could include advertisements in newspapers, radio and television. We work closely with national regulatory agencies and their networks and in the most serious cases, we may withdraw the product from the market.