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Related Experiment Videos

Worldwide safety experience with diclofenac.

M A Catalano

    The American Journal of Medicine
    |April 28, 1986
    PubMed
    Summary
    This summary is machine-generated.

    Diclofenac sodium, used globally since 1974, demonstrates a favorable safety profile. Extensive data shows it is safer than aspirin and comparable to ibuprofen and naproxen for nonsteroidal anti-inflammatory drug (NSAID) use.

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    Area of Science:

    • Pharmacology
    • Drug Safety
    • Clinical Trials

    Background:

    • Diclofenac sodium has been widely used internationally since 1974.
    • Extensive safety data has been compiled from various sources, including clinical trials and post-marketing surveillance.
    • Concerns regarding nonsteroidal anti-inflammatory drugs (NSAIDs) often focus on gastrointestinal, renal, hepatic, and hemostatic effects, as well as use in specific populations.

    Purpose of the Study:

    • To comprehensively review the safety data of diclofenac sodium.
    • To compare the safety profile of diclofenac sodium against other nonsteroidal anti-inflammatory drugs (NSAIDs).
    • To investigate the safety of diclofenac sodium in specific organ systems and patient groups.

    Main Methods:

    • Analysis of data from global clinical trials.

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  • Review of post-marketing surveillance reports.
  • Examination of special safety studies focusing on organ systems and patient demographics.
  • Inclusion of spontaneous adverse drug reaction reports.

    • Main Results:

    • Foreign studies indicate diclofenac sodium is safer and better tolerated than aspirin.
    • Diclofenac sodium's safety is comparable to ibuprofen and naproxen in international studies.
    • US clinical trial data (150 mg daily) showed lower adverse reaction rates compared to other NSAIDs, except naproxen (500 mg daily).
    • Special studies addressed diclofenac's effects on gastrointestinal, renal, hepatic, and hemostatic systems, and its use in children, the elderly, and with concomitant medications.

    Conclusions:

    • Diclofenac sodium possesses a well-documented and favorable safety profile based on extensive global data.
    • The drug is generally safer than aspirin and comparable to other common NSAIDs.
    • Further safety investigations have confirmed its profile across various organ systems and patient populations.