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 [...]
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 patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 [...]
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 Bliss Nipple Cream, marketed by MOM Enterprises, Inc., [...]
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