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Regulatory aspects
Pharmacovigilance: towards a better understanding of the benefit to risk ratio
  1. L S Simon
  1. Division of Analgesic, Anti-inflammatory and Ophthalmologic Drug Products, Center for Drug Evaluation and Research ODEV; Food and Drug Administration; Harvard Medical School
  1. Correspondence to:
    Dr L S Simon, 9201 Corporated Blvd, Room N-314, HFD-550, ODEV, CDER, FDA, Rockville, MD 20850, USA;
    simon1{at}cder.fda.gov

https://doi.org/10.1136/ard.61.suppl_2.ii88

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    Pharmacovigilance is a critical component for determining the benefit to risk ratio of treatment. The potential for drug toxicity is determined throughout the lifetime of use of a drug or biological agent, including the development cycle. This includes both the preclinical as well as clinical data. Preclinical data are rarely extensive for biological therapies because it is difficult to study these drugs in animal models, whereas pharmacotoxicology can be very informative in the development of new drugs.

    Toxic events caused by drugs or biological therapies may be identified at any time during treatment, as there is no absolutely safe treatment. There are certain patterns to the onset of these potential events. One pattern of onset for some treatments is early onset. In this situation, if patients continue to take the drug, the incidence of the toxic event may decrease over time. Other toxic events might be delayed and only noted with continued use of a drug. There is a third possible pattern—namely, treatment that induces a chronic but constant event, such as the use of non-selective non-steroidal anti-inflammatory drugs, which are believed to cause one or two gastric ulcers a month …

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