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                Postmarket Drug Safety Information for Patients and Providers

Postmarket Drug Safety Information for Patients and Providers

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          Postmarket Drug Safety Information for Patients and Providers
          Nonsteroidal Anti-inflammatory Drugs (NSAIDs)Postmarket Drug Safety Information for Patients and Providers Nonsteroidal Anti-inflammatory Drugs (NSAIDs)
  
  	
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    PrintNonsteroidal anti-inflammatory drugs (NSAIDs) are available by prescription and over-the-counter (OTC). They are used to relieve fever and pain, such as those associated with headaches, colds, flu, and arthritis. Examples of prescription NSAIDs include ibuprofen, naproxen, diclofenac, and celecoxib. Ibuprofen and naproxen are also available OTC at lower strengths.

Information on NSAIDs

Section 505(o)(4) FDAAA Safety Labeling Change Notification for “Use of NSAIDs during pregnancy and potential serious risks of fetal renal dysfunction, oligohydramnios, and neonatal renal impairment”. The SLC notification letter was issued to NSAIDs approved under section 505(b) and certain NSAIDs approved under 505(j)), 12/09/2020).
	FDA Drug Safety Communication: FDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
	FDA Drug Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes
	FDA Drug Safety Communication: FDA has reviewed possible risks of pain medicine use during pregnancy
	COX-2 Selective (includes Bextra, Celebrex, and Vioxx) and Non-Selective Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)Related Information

OTC Drug Facts Label

                                                                                  Content current as of:
      12/31/2020
              
              
Regulated Product(s)
		 DrugsPostmarket Drug Safety Information for Patients and Providers

          
                        Index to Drug-Specific Information
 
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