Navigation Links
FDA Announces Series of Changes to the Class of Marketed Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)

The Food and Drug Administration (FDA) today announced a series of important changes pertaining to the marketing of the non-steroidal anti-inflammatory class of drugs, including COX-2 selective and prescription and non-prescription (over-the-counter (OTC)) non-selective NSAID medications. A list of these products is available on the Internet at http://www.fda.gov/cder/drug/infopage/cox2/default.htm.

"Today's actions protect and advance the health of the millions of Americans who rely on these drugs everyday," said Dr. Steven K. Galson, Acting Director of FDA's Center for Drug Evaluation and Research (CDER). "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks."

FDA has asked Pfizer, Inc. to withdraw Bextra (valdecoxib) from the market because the overall risk versus benefit profile for the drug is unfavorable. FDA has also asked Pfizer to include a boxed warning in the Celebrex (celecoxib) label. Pfizer has agreed to suspend sales and marketing of Bextra in the U.S., pending further discussions with the agency. Pfizer has agreed to work with FDA on the boxed warning for Celebrex. FDA is asking manufacturers of all other prescription NSAIDs to revise their labels to include the same boxed warning highlighting the potential for increased risk of cardiovascular (CV) events and gastrointestinal (GI) bleeding associated with their use. Manufacturers of Celebrex and all other prescription NSAIDs will be asked to revise their labeling to include a Medication Guide for patients to help make them aware of the potential for CV and GI adverse events associated with the use of this class of drugs.

In addition, FDA is asking the manufacturers of all OTC NSAIDs to revise their labels to include more specific information about the potential CV and GI risks, and information to assist consumers in the safe use of the drugs. FDA is also asking manufacturers of OTC NSAIDs to include a warning about potential skin reactions. The labeling of the prescription NSAIDs already addresses potential skin reactions.

This current reexamination of the CV risks of NSAIDs began after Merck conducted a voluntary worldwide withdrawal of its COX-2 selective NSAID, Vioxx (rofecoxib), in September 2004. FDA will carefully review any proposal from Merck for resumption of marketing of Vioxx.

These actions are based on the available scientific data, including data accumulated since the drugs were approved. The FDA has carefully considered the presentations, discussions, and recommendations from the joint meeting of the Agency's Arthritis and Drug Safety and Risk Management Advisory Committee held on February 16-18, 2005.

To inform the public and healthcare community of its decisions, FDA today issued a Public Health Advisory (PHA) and updated patient and healthcare practitioner fact sheets.

Additional information about today's announcements is available on FDA's Web site at www.fda.gov/cder. Information can also be obtained by calling 1-888-INFO-FDA (888-463-6332).


'"/>

Source:FDA


Related biology news :

1. Ariadne Genomics Announces the Release of PathwayStudio?Central, Client-Server Software for Biological Pathway Analysis
2. Iron Deficiency Sparks Dramatic Changes In Gene Expression
3. Scientists Propose Sweeping Changes to Naming of Bird Neurosystems to Acknowledge Their True Brainpower
4. Methamphetamine Abuse, HIV Infection Cause Changes in Brain Structure
5. Changes to embryos can elicit change in adult fish
6. Changes in amino acids in the 1918 influenza virus cut transmission
7. PANTHER Protein Classification System Database 5.0
8. FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media
9. HIV Patients May Be at Risk of Heart Problems When Taking Protease Inhibitor Drugs
10. New Drugs For Bad Bugs: UF Approach Could Bolster Antibiotic Arsenal
11. FDA Warns About Antipsychotic Drugs and Elderly
Post Your Comments:
*Name:
*Comment:
*Email:


(Date:8/21/2020)... ... 18, 2020 , ... Sentien Biotechnologies, Inc., a clinical-stage biotechnology ... and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application ... COVID-19. Approval of this IND allows Sentien to initiate a Phase 1/2 study ...
(Date:8/12/2020)... ... August 11, 2020 , ... Both Roche, ... have entered into license agreements with Housey Pharma’s HMI subsidiary to gain access ... J&J have annual Research and Development spending in excess of US $10 billion. ...
(Date:8/5/2020)... ... ... Regenative Labs has received approval from the Centers for Medicare & Medicaid ... Wharton’s jelly allografts to be assigned a Q code and be approved for application ... jelly allograft product to be recognized as a 361 HCT/P by CMS regulated under ...
Breaking Biology News(10 mins):
(Date:8/7/2020)... ... August 06, 2020 , ... VGXI, a highly regarded CDMO ... the purchase of greenfield for a new, expanded manufacturing facility. The site is ... in the initial acquisition, with an option to purchase an additional 21 acres ...
(Date:7/31/2020)... ... July 29, 2020 , ... R3 Stem Cell International is ... $3950. With 50 million stem cells total, patients may choose which extremities they would ... for arthritic joints (BMC Musculoskelet Disord. 2016). At R3 International, umbilical cord tissue is ...
(Date:7/31/2020)... ... July 29, 2020 , ... Anomet Products ... three different materials for use with CRM, neurostimulation, vascular, and related devices. , ... meet specific design requirements, performance, and cost criteria; especially where solid wire is ...
(Date:7/31/2020)... ... July 29, 2020 , ... The SDX® Respiratory Gating ... countries, has reached its 20th anniversary of worldwide use. Introduced in the US ... universities including University of Pennsylvania, University of Michigan, University of Maryland, University of ...
Breaking Biology Technology: