The U.S. Supreme Court next week will begin hearing the case of Wyeth v. Levine, which centers on the question of whether FDA approval of a drug warning label pre-empts product safety suits brought in state courts, the Wall Street Journal reports (Mundy/Wang, Wall Street Journal, 10/27). The case involves Diana Levine, who lost her [...]
Drug Web site raises important questions
October 24, 2008 – 11:50 am
By DAN RODEN, M.D. • October 10, 2008
Dr. Dan Roden is professor of medicine and pharmacology, director of the Oates Institute for Experimental Therapeutics, and assistant vice chancellor for personalized medicine at Vanderbilt University School of Medicine.
The Food and Drug Administration recently announced a public Web site listing potential drug [...]
Researchers Question Wide Use of HPV Vaccines
August 21, 2008 – 1:04 pm
FINALLY!
In June of 2006, my writing partner, Leslie Botha, and I, started writing articles cautioning women against the use of Gardasil® for girls and young women. We cited the limited nature of the clinical trials (the number, and ages of women tested) and the length of time from the clinical trials and the FDA [...]
Your Guide to Reporting Problems to FDA
June 12, 2008 – 11:19 am
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:
June 10, 2008 – 2:46 pm
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
June 7, 2008 – 7:21 am
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 [...]
Surgery Beta Blockers ‘Up Risk’
May 15, 2008 – 6:23 am
The use of beta blocker drugs before surgery to cut the risk of heart problems may be counter-productive, a study suggests.
Researchers found patients given the drugs were a third more likely to die within a month of surgery than those given a dummy pill.
Those on the blood pressure-lowering drugs also had double the risk [...]
A Guide to Drug Safety Terms at FDA
April 11, 2008 – 10:29 am
Inconvenient Woman readers know that I’m not an FDA fan.
In my opinion, the troubled agency’s close ties and financial dependence on Big Pharma
has been weakened its ability to perform its primary function — protecting the public. The FDA’s documented failure to impartially judge the veracity of drug trial results and enforce safety oversight of the [...]