Risks and Benefits
Talking About Risks and Benefits of Our Products
Weighing Risk vs Benefit
The right medicine for the right patient can lead to significant improvements in the patient’s condition, disease or lifestyle. But all physicians understand that products are not without risk and that these risks must be clinically assessed and carefully weighed against the product’s potential benefits each time a patient is treated to help ensure the patient’s safety is put first and to help optimize the outcome for the patient. As a leading multi-specialty health care company, we invest significant resources into assessing the risk/benefit profile of each of our products before and after we bring them to market, developing product labels and educating physicians so they can help patients like you weigh the risks and benefits of treatments and determine what would be best for you. As a patient, you have a very important role to play in educating yourself on available treatment options and discussing the options and risks with your physician. You can find more information about all of Allergan’s products and their risk/benefit profiles here.
Responsible Business Practices
We take many factors into account when assessing the risk/benefit profile of a product. During clinical trials, study protocols are reviewed both within the company and by independent review boards to ensure they are acceptably designed for the stage of development, are based on sound medical science, and communicate to trial subjects both potential benefits and risks of participating in the study prior to their agreeing to take part. In addition, there is careful oversight of the safety of trial subjects during the conduct of the study. Once the results of the trials are available, Allergan next evaluates the benefit provided by the therapy in the context of any risks, and whether this risk-benefit relationship would be acceptable to patients and physicians, including a consideration of currently available therapies for the disease under study. It is also important that both risks and benefits can be appropriately communicated via the product’s label and/or other physician and patient information.
Not Just the Fine Print – Product Labeling
A drug’s label (or package insert) is a visible and accessible tool to help a physician determine whether a particular treatment’s risks outweigh its benefits and if an Allergan product is ultimately the right fit for a patient. Creating the label is in collaboration with regulatory agencies, such as the FDA and European authorities, a process that involves multiple departments at Allergan – including, among others, Research and Development, Quality Assurance, Regulatory Affairs, and the multiple committees that evaluate clinical trials – that are focused on providing physicians with accurate and up-to-date guidance regarding the risk/benefit profile of a product, so they can best advise their patients. In addition to detailing a drug’s approved uses or indications, the label helps define for the physician potential risks of treatment to the patient, including contraindications, warnings of possible serious side effects associated with the use of the product and a list of adverse effects observed in studies of the treatment. In essence, the label is a safety analysis that helps physicians make decisions regarding treatment of their patients.
Once a product is on the market, our responsibility to safety does not end and changes can be made to the label if additional information is obtained once the product is in use. Updates to a product’s label stem from ongoing monitoring of the drug’s safety profile once on the market, which supplement the information obtained from registration clinical trials.
A Personal Decision
Weighing the benefits against the risks of a medication is a personal decision, and one that must be made between you and your doctor. Each treatment decision you make will be unique, as the risk/benefit relationship for a medical product may differ from patient to patient. Some patients may prefer to live with their disease or condition and decide to let it go untreated to avoid the potential of side effects, while others may find the risks to be acceptable given the possible benefit of improving their disease or condition with treatment. Additionally, a patient may deem the risk of certain potential side effects acceptable if a product is the only one available to treat a certain disease; however, it might be unacceptable to another patient and his or her physician if there are other treatment options available. Our responsibility is to provide patients with as safe and as high quality products possible, while also communicating the risks and benefits. It is a responsibility that is taken seriously and reflected in each function of our business; it is an infinite job to provide access to the health care you deserve.