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category archive listing Category Archives: FDA Press Release

Coffee benefits your health and protects against many diseases.

Posted by H. Sandra Chevalier-Batik

Why is there resistance to the idea that coffee benefits your health?
Here’s why.
Almost thirty years ago researchers at Harvard University announced a connection between coffee consumption and cancer.
A few years later they retracted the study and recognized that the findings were flawed.
However, since that first study and the media frenzy that followed, coffee has been […]

Antipsychotics — Increased Risk of Mortality In Elderly Patients Treated for Dementia-related psychosis

Posted by H. Sandra Chevalier-Batik

Information for Healthcare Professionals — Antipsychotics
FDA ALERT [6/16/2008]:  FDA is notifying healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. 
In April 2005, FDA notified healthcare professionals that […]

Better Information for Pregnant Women

Posted by H. Sandra Chevalier-Batik

Pregnant Women to Benefit from Better Information

Printer-friendly PDF (310 KB)

On this page:

Why FDA is Taking Action
Labeling Background
Look of the New Labeling
What’s Next?

The Food and Drug Administration (FDA) has taken action to give women and their health care professionals better information about the effects of medicines when used by a woman who is pregnant or […]

Your Guide to Reporting Problems to FDA

Posted by H. Sandra Chevalier-Batik

Reporting any adverse events (unexpected side effects) to FDA after using a medical product, or other problems with any products that the agency regulates.

Printer-friendly PDF (366 KB)

On this page:

Tips for Reporting
Quick-Reference Chart for Reporting Problems to FDA
Types of Problems FDA Doesn’t Handle

Consumers play an important public health role by reporting to the Food and Drug […]

FDA 101:

Posted by H. Sandra Chevalier-Batik

How to Use the Consumer Complaint System and MedWatch

On this page:

Consumer Complaint Reporting
Reporting Problems Can Spur Action
MedWatch Reporting
How to Report to MedWatch
Problems to Report to MedWatch
Reporting Emergencies
FDA Consumer Complaint Coordinators (regions and telephone numbers)

If you have a complaint about a product regulated by the Food and Drug Administration (FDA), the agency wants to hear […]

The FDA Fails To Protect Patient Rights

Posted by H. Sandra Chevalier-Batik

The Food and Drug Administration should rethink its rejection of the Declaration of Helsinki.
Later this year, the US Food and Drug Administration (FDA) will adopt new standards for human clinical trials conducted without its advance sign-off in foreign countries. The rules will govern whether data from such trials can be used in applications to market […]

FDA Admits Dental Mercury Poses Health Risk To Pregnant Women And Children

Posted by H. Sandra Chevalier-Batik

Following the settlement of a lawsuit earlier this week, the US Food and Drug Administration (FDA) has updated its consumer advice on mercury amalgam to say that it poses health risks to pregnant women, children, and the unborn.
The updated consumer advice, which is in the FDA’s Center for Devices and Radiological Health (CDRH) section of […]

FDA to Merck — Correct Vaccine Plant Faults

Posted by H. Sandra Chevalier-Batik

The Food and Drug Administration has ordered Merck & Co. to correct numerous manufacturing deficiencies at its main vaccine plant, the latest in a string of setbacks for the drug maker.
The FDA released a warning letter sent to Merck’s chief executive, Richard T. Clark, that states FDA inspectors determined manufacturing rules are not being followed […]

Contaminated Nipple Cream

Posted by H. Sandra Chevalier-Batik

Do not use or buy Mommy’s Bliss Nipple Cream
The Food and Drug Administration (FDA) is warning people not to use or buy Mommy’s Bliss Nipple Cream because the product contains potentially harmful ingredients that may cause respiratory problems or vomiting and diarrhea in infants.
Marketed by MOM Enterprises Inc. in San Rafael, Calif., the product […]

FDA Warns Consumers Against Using Mommy’s Bliss Nipple Cream

Posted by H. Sandra Chevalier-Batik

FDA News

FOR IMMEDIATE RELEASE
May 23, 2008

Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA

FDA Warns Consumers Against Using Mommy’s Bliss Nipple Cream
Product can be harmful to nursing infants
The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy’s […]