[U.S. Food and Drug  Administration]

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Clinical Impact of Adverse Event Reporting

Dissemination of Safety-Related Information

Keeping medical product labeling/package inserts up to date is an ongoing, dynamic process that depends on new information gleaned from spontaneous adverse event reports. Remaining current with changes in medical product information can be an imposing task for the busy health professional. As a result, an important public health aspect of postmarketing surveillance is the dissemination of safety-related information to the clinical community.

The FDA, in concert with the product's manufacturer, informs health professionals of the most serious and pressing safety issues through such mechanisms as:

Two recent examples demonstrating this educational process are outlined in TABLE 5.

The population of health professionals to whom individual notifications are distributed is not always universal, and is dependent on the medical product and the provider specialties most likely to be involved. As a result, other methods are used to reach the broadest possible health professional audience. The MedWatch column in the FDA Medical Bulletin, which is distributed to 1.2 million health professionals nationwide, seeks to enhance general awareness by summarizing the most recent notifications.

In addition, MedWatch uses its Partner program to disseminate new safety-related information. To date, over 100 health professional organizations have joined FDA as Partners and work with MedWatch to increase awareness of, and participation in, postmarketing surveillance. Notifications like Safety Alerts are provided to the Partners as they are released, with the information in turn distributed by the Partners to their members.

It is important for health professionals to be aware that not all changes in medical product information necessitate use of mechanisms such as a "Dear Health Professional" letter. These are reserved for only the most serious and pressing adverse events. While the Physicians' Desk Reference® contains official labeling for most drugs and can be reviewed periodically for changes, FDA is currently looking at other ways, including the Internet, by which new safety-related information can be made more readily available to health professionals.

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TABLE 5: Examples of Safety-Related FDA Notifications

Retinal Photic Injuries From Operating Microscopes During Cataract Surgery:
Despite all efforts taken to minimize the risks of retinal damage, retinal photic injuries from the light sources used in operating microscopes during cataract surgery and other intraocular procedures may occur. Several factors appear to be important determinants of photic retinal injury. These include: angle of light incidence, light intensity, exposure time, and intensity of the blue light component. FDA recommends several actions to reduce the risk of retinal photic injury and reminds physicians about the reporting requirements of the Safe Medical Devices Act of 1990. [October 16, 1995 FDA Public Health Advisory]

FDA Requires Labeling Change on Lindane-Containing Lice Treatments:
Lindane is generally safe and effective when used according to the approved directions, but its overuse can be harmful. FDA has recommended labeling changes that encourage lindane's use only for patients who have either failed to respond to adequate doses of, or are intolerant of, other approved therapies. In addition, product labeling will advise health care providers and parents not to confuse prolonged itching with reinfestation. The label already warns parents that neurotoxicity is possible for certain patients, especially infants. [April 3, 1996 FDA Talk Paper]

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