print this out and widely disseminate for all those you love who are on
meds!!!!
>From: chris at nami.apollonian.com>Subject: NAMI E-News MEDWATCH: Report Adverse Medication Reactions
>Date: Tue, 22 Feb 2000 16:47:15 -0500
>>_______________________________________________________________________
>NAMI E-News February 22, 2000 Vol. 00-92
>_______________________________________________________________________
>>>CONSUMERS AND FAMILY MEMBERS HAVE OPPORTUNITY
>TO DIRECTLY REPORT ADVERSE MEDICATION REACTIONS TO THE FDA
>-------------------------------------------------------
>MEDWATCH - THE FDA MEDICAL PRODUCTS REPORTING PROGRAM
>>MedWatch, an initiative of the Food and Drug Administration (FDA), is a
>program
>designed for reporting serious reactions and problems with medical
>products,
>such as drugs and medical devices, after they are approved and released for
>public use and as they are used in clinical practice. MedWatch facilitates
>timely identification of significant health concerns connected with these
>products to ensure that new safety information is quickly disseminated to
>the
>medical community and results in improved patient care. MedWatch invites
>the
>participation of consumers, health professionals, and manufacturers to make
>these reports over the internet, by phone or mail.
>>NAMI is concerned that the consumer voice is not being widely heard in this
>process. MedWatch provides a mechanism to directly include the experiences
>of
>consumers for ongoing evaluations by the FDA on the safety and
>effectiveness of
>medications.
>>Laws already in place require prescription drug manufacturers to submit to
>the
>FDA Postmarketing Adverse Drug Experience reports. Once new medications
>are
>available to the public, the pharmaceutical manufacturers are instructed to
>file
>reports including information they receive about the safety and efficacy of
>the
>new medications. There are also regulations mandating some reporting
>within
>user facilities, such as hospitals and nursing homes, on deaths and serious
>injuries that result from the use of medical devices. However, provider
>and
>consumer reporting of adverse effects and product problems with medications
>is
>strictly voluntary. MedWatch provides a format for reporting adverse drug
>reactions by consumers and health care professionals directly to the FDA,
>which
>has the authority to take actions to protect the public.
>>MedWatch defines an event as a "serious reaction" if the product caused
>death, a
>life-threatening situation, hospital admission or extended stay, a
>permanent
>disability, birth-defect or the need for medical intervention to prevent
>permanent damage. The FDA uses reports from health care professionals and
>manufacturers to expose problems with products already on the market and to
>take
>corrective action if necessary. In reaction to previous reports, the FDA
>has
>used its authority to make labeling changes, added boxed warnings to labels
>of
>products, and in the most serious cases, authorized product recalls and
>withdrawals from the market.
>>If you experience a serious, unexpected adverse event that you believe may
>be
>related to one or more medications you are taking, you can report this via
>MedWatch.
>>MedWatch can be accessed on the web by going to
>http://www.fda.gov/medwatch/index.html>>To report your adverse effects or problems by phone, call the FDA Office of
>Emergency Operations at (301) 443-1240.
>>If you have additional questions about the medical product which caused
>your
>problem, or if you need additional MedWatch reporting forms, please call
>the FDA
>Office of Consumer Affairs at (800) 532-4440.
>>The FDA stresses that strict confidentiality practices are in place to
>protect
>those who wish to remain anonymous when reporting.
>>>>>-----------------------------------------------------------
>Please forward this email if you know somebody
>who would like to add their name to this mail listing.
>They should visit:
>>http://www.nami.org/update/enewslist.htm>>and simply fill in the form to join the NAMI Electronic News !
>>------------------------------------------------------------
>>If you would like to remove your name from this mail listing, visit
>>http://www.nami.org/update/unsubscribe.html>>and insert the email address you want to remove.
>>Thanks.
>
BETTER LIVING THRU BeTTeR LiVinG!
http://www.interport.net/~rugosa/index.html
Snail me yer rosehips if you like this post!
Give GABRIELLI wines to yer frenz -->> http://www.gabrielliwinery.com
______________________________________________________
Get Your Private, Free Email at http://www.hotmail.com
---
