MedWatch - Revision history

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	~~'''MedWatch''' is the [[United States]] [[Food~~ and ~~Drug Administration]]'s (FDA)~~ program for reporting serious reactions, product quality problems, therapeutic inequivalence, and product use errors with human medical products, including drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).		{{short description\|FDA safety information and adverse event reporting program}}
			{{Use American English\|date=October 2023}}
			{{Use mdy dates\|date=October 2023}}

	~~== History ==~~		[[File:Medwatch-Logo.svg\|thumb\|right\|The MedWatch logo]]
	~~The MedWatch system was established in 1993 by the FDA under the direction of then Commissioner~~ [[~~David A~~. ~~Kessler~~]]~~. The program's purpose is to educate health care professionals and the public about the importance of reporting serious problems to FDA, and to make doing so as easy and convenient as possible.~~

	~~== Reporting ==~~		'''MedWatch''' is the [[United States Food and Drug Administration\|FDA]]'s program for reporting adverse events and safety information related to [[pharmaceutical drugs]], [[medical devices]], and other [[healthcare products]]. Established in 1993, MedWatch serves as a critical component of the FDA's post-market surveillance efforts, allowing healthcare professionals and consumers to report issues that may not have been apparent during pre-market testing.
	~~Health professionals are strongly encouraged to report adverse events via~~ MedWatch~~. Patients can also report~~ adverse events ~~directly~~, ~~either online~~, ~~by mail~~, ~~or by fax~~.

	== ~~Impact~~ ==		==Purpose and Function==
	MedWatch ~~reports have led~~ to ~~changes in product labeling,~~ product ~~recalls, and other FDA safety alerts~~. The program ~~has been credited with identifying significant public health issues related~~ to ~~medical products.~~		MedWatch is designed to enhance the safety of medical products by collecting and analyzing data on adverse events and product problems. The program aims to:

	== ~~See also~~ ==		* Facilitate the reporting of adverse events and product quality issues by healthcare professionals and consumers.
	* ~~[[Pharmacovigilance]]~~		* Provide timely safety information to the public and healthcare community.
	* ~~[[Adverse event]]~~		* Support the FDA's regulatory actions to improve product safety.
	* ~~[[Food~~ and ~~Drug Administration]]~~
			==Reporting Process==
			Reports to MedWatch can be submitted by healthcare professionals, patients, and consumers. The reporting process is streamlined to encourage participation and can be done online, by mail, or by fax. The FDA encourages reporting of:

			* Serious adverse events
			* Product quality problems
			* Product use errors
			* Therapeutic failures

			==Impact on Public Health==
			MedWatch plays a vital role in protecting public health by identifying potential safety issues with medical products. The data collected through MedWatch can lead to:

			* Labeling changes to provide better safety information.
			* Product recalls or withdrawals from the market.
			* Safety alerts and communications to inform the public and healthcare providers.

			==Educational Initiatives==
			The FDA also uses MedWatch as a platform for educational initiatives aimed at healthcare professionals and the public. These initiatives include:

			* MedWatch Safety Alerts: Notifications about potential safety issues with medical products.
			* MedWatchLearn: An online learning tool to educate healthcare professionals and consumers on how to report adverse events effectively.

			==Challenges and Limitations==
			While MedWatch is a valuable tool for post-market surveillance, it faces several challenges, including:

	~~== References ==~~		* Underreporting: Not all adverse events are reported, which can limit the data's comprehensiveness.
	~~<references />~~		* Data quality: Reports can vary in detail and accuracy, affecting the ability to draw definitive conclusions.

	== ~~External links~~ ==		==Related Pages==
	* [~~https://www.fda.gov/safety/medwatch-fda-safety-information-~~and~~-adverse-event-reporting-program Official MedWatch website~~]		* [[United States Food and Drug Administration]]
			* [[Pharmacovigilance]]
			* [[Adverse drug reaction]]
			* [[Drug recall]]

	[[Category:Food and Drug Administration]]		[[Category:Food and Drug Administration]]
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	[[Category:~~Medical and health organizations based~~ in the United States]]		[[Category:Health in the United States]]
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'''MedWatch''' is the [[United States]] [[Food and Drug Administration]]'s (FDA) program for reporting serious reactions, product quality problems, therapeutic inequivalence, and product use errors with human medical products, including drugs, biologics, medical and radiation-emitting devices, and special nutritional products (e.g., medical foods, dietary supplements and infant formulas).

== History ==
The MedWatch system was established in 1993 by the FDA under the direction of then Commissioner [[David A. Kessler]]. The program's purpose is to educate health care professionals and the public about the importance of reporting serious problems to FDA, and to make doing so as easy and convenient as possible.

== Reporting ==
Health professionals are strongly encouraged to report adverse events via MedWatch. Patients can also report adverse events directly, either online, by mail, or by fax.

== Impact ==
MedWatch reports have led to changes in product labeling, product recalls, and other FDA safety alerts. The program has been credited with identifying significant public health issues related to medical products.

== See also ==
* [[Pharmacovigilance]]
* [[Adverse event]]
* [[Food and Drug Administration]]

== References ==
<references />

== External links ==
* [https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program Official MedWatch website]

[[Category:Food and Drug Administration]]
[[Category:Pharmacovigilance]]
[[Category:Medical and health organizations based in the United States]]
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