Postmarketing Reporting of Adverse Drug Reactions to the FDA: An Overview of the 1985 FDA Guideline

Sills, Judith M.; Faich, Gerald A.; Milstien, Julie B.; Turner, Wayne M.

doi:10.1177/009286158602000206

Cited by 20 publications

(2 citation statements)

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“…Nonserious and labeled serious ADRs are included in a periodic report sent to the FDA quarterly for the first 3 years after approval of the new drug application and annually thereafter by the manufacturer. 22,23 Spontaneous reports severely underestimate the true incidence of ADRs. 24 It was estimated that only about 1-10% of unwanted effects are reported, 24,25 and nonserious ones are likely to be reported even less frequently than serious ones.…”

Section: Collection During the Postmarketing Phasementioning

confidence: 99%

Problems Assessing Nonserious Adverse Drug Reactions: Antidepressant Drug Therapy and Sexual Dysfunction

Michels

1999

Pharmacotherapy

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Adverse drug reactions (ADRs) pose a challenge to prescribing physicians, especially when they considerably compromise the patient's quality of life and thus affect compliance. Adverse events that do not pose a severe threat to the patient's health and are therefore considered nonserious are understudied in pharmacotherapy. Such events are seldom systematically assessed, and frequency figures are usually not reliable. An example of a nonserious ADR is sexual dysfunction associated with antidepressant therapy. This is a problem of considerable importance to patients, yet its incidence is underestimated in product information. Incidence data on sexual dysfunction would assist physicians' decision making and improve care. It is suggested that premarketing and postmarketing clinical trials and pharmacoepidemiologic studies include systematic assessment of selected and important nonserious adverse effects to provide more accurate estimates of their true incidence; and that product labeling be regularly updated to reflect postmarketing experience.

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Section: Collection During the Postmarketing Phasementioning

confidence: 99%

Problems Assessing Nonserious Adverse Drug Reactions: Antidepressant Drug Therapy and Sexual Dysfunction

Michels

1999

Pharmacotherapy

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“…The regulatory basis and the process for collecting ADE reports have been dis cussed in previous articles (3,4). One of these included definitions of terms that are relevant to this article (4).…”

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confidence: 99%

Completeness of Adverse Drug Experience Reporting by Manufacturers to the FDA

Britt

Knapp

Anello

et al. 1991

Drug Information Journal

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This project evaluated the completeness of manufacturer adverse drug experience (ADE) reports on computerized fields on the FDA-1639form for which completion is not required for data entry, (eg, age, sex, ADE onset date). The completion rate of such fields was determined for domestic, spontaneous, health professionalsubmitted ADE reports during 1986-1989. This project was limited to 20 manufac turers submitting the largest number of reports. Completion rates were computed for total reports and 15-day reports. A completion rate was defined for each field for each manufacturer as the number of times the field was filled in divided by the total number of reports. In general, the completion rate was higher for 15-day reports than total reports. Because there were manufacturers with >90% completion rates, other manufactur ers should concentrate on improving their completion rates. Consideration should be given to 15-day reports; they are used by FDA in the signaling of monitored adverse reactions.

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US initiatives in post-marketing drug surveillance

Faich¹

1988

The Focus for Pharmaceutical Knowledge

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Postmarketing Reporting of Adverse Drug Reactions to the FDA: An Overview of the 1985 FDA Guideline

Cited by 20 publications

References 0 publications

Problems Assessing Nonserious Adverse Drug Reactions: Antidepressant Drug Therapy and Sexual Dysfunction

Problems Assessing Nonserious Adverse Drug Reactions: Antidepressant Drug Therapy and Sexual Dysfunction

Completeness of Adverse Drug Experience Reporting by Manufacturers to the FDA

US initiatives in post-marketing drug surveillance

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