FDA Introduces New Web Page with Links to Key Safety
Information on Prescription Drugs
Senior citizens may find it useful avoid drug errors
and dangerous drugs
Oct. 17, 2008 Senior citizens, the heaviest users
of prescription drugs, and the most common victims of drug errors, can
find help with making decisions about the drugs they take at a new
Website created by the Food and Drug Administration. The FDA says
healthcare professionals, too, will find it a useful page to find a wide
variety of safety information about prescription drugs.
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Senior Citizen Alerts |
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A feature many seniors may find helpful is the
index to medication guides the paper handouts that come with many
prescription medicines. It seems to some seniors that these can never be
found when needed. Now, many can be accessed online to check the
FDA-approved information that can help patients avoid serious adverse
events.
But, there are many other key links to helpful
information on the page named, Postmarket Drug Safety Information for
Patients and Providers.
Following are descriptions of what can be found.
● Drug labeling, including patient labeling,
professional labeling, and patient package inserts;
● Drugs that have a Risk Evaluation and
Mitigation Strategy (REMS) to ensure that their benefits outweigh their
risks;
● A searchable database of postmarket studies
that are required from, or agreed to by, drug companies to provide the
FDA with additional information about a drug's safety, efficacy, or
optimal use;
● Clinicaltrials.gov, a searchable database of
clinical trials, including information about each trial's purpose, who
may participate, locations, and useful phone numbers;
● Drug-specific safety information, including
safety sheets with the latest information about the drug as well as
related FDA press announcements, fact sheets, and drug safety podcasts;
● Quarterly reports that list certain drugs that
are being evaluated for potential safety issues, based on a review of
information in the FDA's Adverse Event Reporting System (AERS);
● Warning Letters, Import Alerts, Recalls,
Market Withdrawals, and Safety Alerts;
● Regulations and guidance documents;
● Consumer information about using medications
safely and disposing of unused medicines;
● Instructions how to report problems to the FDA
through its MedWatch program;
● Consumer articles on drug safety; and
● The FDA's response to the Institute of
Medicine's 2006 report on the future of drug safety.
"By placing Web links to these up-to-date resources
on a single page, we're helping consumers and health care professionals
find drug safety information faster and easier," said Paul Seligman,
M.D., M.P.H., associate director of Safety Policy and Communication in
the FDA's Center for Drug Evaluation and Research.
"This type of communication is aimed at helping
consumers and health care professionals make well-informed decisions
about medication use."
Establishing such a Web page is one of the
requirements of the Food and Drug Administration Amendments Act of 2007,
and is among FDA's many efforts to address the safe use of drugs
throughout their lifecycle.
The Web page:
http://www.fda.gov/cder/drugSafety.htm
