Menu
Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications
FDA Side Effect Update: NSAIDs and Life-Threatening Reactions
Safety updates sourced directly from the FDA's Drug Safety Database, presented in clear and accessible language
December 11, 2024
0 Comments
republish
on this page:
Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your NSAIDs medications.
How to Read This Report
This report is prepared using the most recent information posted in the SrLC database. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.
Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.
Side Effect Update for Prescription NSAIDs
Nonsteroidal anti-inflammatory drugs (NSAIDs) are among the most commonly used pain medicines. Available both over-the-counter and in prescription-only formulations, NSAID medications are used to treat fever, muscle pain, arthritis pain, headaches, menstrual cramps, pain caused by injuries or surgery, and more.
NSAID medications may be taken as capsules, tablets, liquid, topical creams, and by I.V. or injection in a hospital setting.
In the fourth quarter of 2022, the FDA reported that it had received a number of NSAID-related adverse events reports for a serious skin reaction called “generalized bullous fixed drug eruption” and that it would “evaluate the need for regulatory action.” Fixed drug eruption is a serious skin rash or blistering reaction to a drug that usually occurs in the same location each time the person uses the medication.
In July 2024, the FDA began to notify NSAID manufacturers that labels should be updated to include warnings about fixed drug eruptions. The required updates only include prescription NSAIDs, not over-the-counter versions like Advil, Aleve, and Motrin. Over-the-counter NSAID labels include a general warning about potential skin reactions, but do not specify the risk of “fixed drug eruptions.”
Starting on November 21, 2024, more than 50 safety updates for prescription NSAIDs were filed with the FDA. Here are descriptions of the updates for some of the more commonly prescribed medications in the category. Please check the SRLC database to search for additional NSAID drugs.
Arthrotec (active ingredient: diclofenac sodium; misoprostol)
Initial FDA Approval: 1997
Side Effect Update Date: November 21, 2024
Medication Description: Treats osteoarthritis and rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers.
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Arthrotec FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Cambia (active ingredient: diclofenac potassium) powder
Initial FDA Approval: 1998
Side Effect Update Date: November 21, 2024
Medication Description: Treats attacks of migraine headaches in adults.
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
Essential Extras: Administered from a one-dose packet with powder that is mixed with water.
FDA Safety Announcement: Cambia FDA Safety Label Change and Revised drug label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Celebrex (active ingredient: celexocib)
Initial FDA Approval: 1998
Side Effect Update Date: November 21, 2024
Medication Description: Treats osteoarthritis (OA), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA) ankylosing spondylitis, acute pain, menstrual cramps.
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
Stay Informed. Sign up for our newsletters.
Independent, science-based journalism delivered directly to your inbox.
FDA Safety Announcement: Celebrex FDA Safety Label Change and Revised drug label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Daypro (active ingredient: oxaprozin) caplets
Initial FDA Approval: 1992
NSAIDs Side Effect Update Date: November 21, 2024
Medication Description: Treats osteoarthritis (OA) and rheumatoid arthritis (RA)
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Daypro FDA Safety Label Change and Revised drug label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Duexis (active ingredient: famotidine; ibuprofen)
Initial FDA Approval: 2011
Side Effect Update Date: November 21, 2024
Medication Description: Treats osteoarthritis (OA) and rheumatoid arthritis (RA) while decreasing the risk of developing an ulcer from ibuprofen use.
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Duexis FDA Safety Label Change and Revised drug label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Feldene (active ingredient: piroxicam)
Initial FDA Approval: 1982
Side Effect Update Date: November 21, 2024
Medication Description: Treats osteoarthritis (OA) and rheumatoid arthritis (RA)
Updated NSAIDs Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Feldene FDA Safety Label Change and Revised drug label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Indocin (indomethacin) oral suspension and indomethacin (indomethacin) (various formulations)
Initial FDA Approval: 1985 (oral suspension formulation); 1965 (capsules)
Side Effect Update Date: November 21, 2024
Medication Description: Treats moderate to severe rheumatoid arthritis (RA) including acute flares; ankylosing spondylitis; osteoarthritis; acute painful shoulder; gouty arthritis
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Indocin Safety Label Change and Revised Drug Label
Indomethacin FDA Safety Label Change and Revised drug label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Meloxicam (active ingredient: meloxicam) oral suspension
Initial FDA Approval: 2004
Side Effect Update Date: November 21, 2024
Medication Description: Treats osteoarthritis (OA), rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA)
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Meloxicam FDA Safety Label Change and Revised Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Naprosyn (naproxen) tablets and EC-NAPROSYN (naproxen) delayed release tablets, and ANAPROX DS (naproxen sodium) tablets
Initial FDA Approval:1976
Side Effect Update Date: November 21, 2024
NSAIDs Description: Treats moderate to severe rheumatoid arthritis (RA); ankylosing spondylitis; osteoarthritis; bursitis; gout; menstrual cramps; pain management.
Updated NSAIDs Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Naprosyn FDA Safety Label Change and Revised Drug Label (covers all 3 versions of naproxen)
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Zipsor (diclofenac potassium) tablets
Initial FDA Approval: 1988
Side Effect Update Date: November 21, 2024
NSAIDs Description: Treats mild to moderate acute (not chronic) pain in adults and children age 12 and up.
Updated Side Effects/Safety Information: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.
FDA Safety Announcement: Zipsor FDA Safety Label Change and Revised Drug Label
The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.
Essential Safety Extras for All NSAIDs Prescription Drugs:
All include a boxed warning for “serious cardiovascular and gastrointestinal events.”
FDA NSAIDs Safety Communication: FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes
In October 2020, the FDA released a safety communication stating that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.
FDA safety information page on NSAIDs: Nonsteroidal Anti-inflammatory Drugs (NSAIDs) | FDA
- DRUG SAFETY-RELATED LABELING CHANGES (SRLC)
- DRUGS@FDA: FDA APPROVED DRUGS
- ORANGE BOOK: APPROVED DRUG PRODUCTS WITH THERAPEUTIC EQUIVALENCE EVALUATIONS
- NATIONAL LIBRARY OF MEDICINE’S DAILYMED DRUG LABEL DATABASE
- MERRIAM-WEBSTER MEDICAL DICTIONARY
- Ghlichloo, I., & Gerriets, V. (2023, May 1). Nonsteroidal Anti-Inflammatory Drugs (NSAIDs). StatPearls – NCBI Bookshelf
- Research, C. F. D. E. A. (2023, April 5). October – December 2022 | Potential Signals of Serious Risks/New Safety Information identified by the FDA Adverse Event Reporting System (FAERS). U.S. Food And Drug Administration
- Fixed drug eruption: MedlinePlus Medical Encyclopedia Image. (n.d.)
- Liberatore, M. A. (2024). NDA 018147/S-053. U.S. Food and Drug Administration
DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.
While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual’s medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.
on this page:
RECOMMENDED:
DONATE:
Help fund our fight for improved medication safety and transparency by supporting our independent journalism.
Give NowStay Informed. Sign up for our newsletters.
Independent, science-based journalism delivered directly to your inbox.
We seek to create a world where there are safer medications for all and where all people are fully informed about their medication benefits and side effects, using our explanatory and investigative journalism to both inform and stimulate public discussion to drive toward solutions.
WEBINARS
Learn about your medications and treatment options straight from independent experts.
WATCH
Article HTML
<!-- wp:paragraph -->
<p>Welcome to the FDA Side Effects Update. This series is designed to keep you informed about the latest safety advisories and newly documented side effects of your NSAIDs medications.</p>
<!-- /wp:paragraph -->
<!-- wp:heading -->
<h2 class="wp-block-heading" id="h.bfs426nnx0aa">How to Read This Report</h2>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p>This report is prepared using the most recent information posted in the <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm" target="_blank" rel="noreferrer noopener">SrLC database</a>. It highlights recent safety labeling changes. It includes only newly reported side effects and safety information; additional side effects and warnings will appear on the drug label. Not all recent changes to the SrLC database or the label may be listed here. For all changes and the complete list of warnings and side effects, please click on the drug label link.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>Each of the items (approval and update dates, drug names, etc.) contained in this report are obtained from the SrLC. The side effects and medication descriptions are simplified and made clearer, if needed. Sometimes, additional sources, like a medical dictionary, may be used to translate technical medical phrases. Other sources (company news, FDA press releases, etc.) may be used to learn about some label changes.</p>
<!-- /wp:paragraph -->
<!-- wp:heading -->
<h2 class="wp-block-heading" id="h.zd2zum7l65mt">Side Effect Update for Prescription NSAIDs</h2>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><a href="https://www.ncbi.nlm.nih.gov/books/NBK547742/" target="_blank" rel="noreferrer noopener">Nonsteroidal anti-inflammatory drugs (NSAIDs)</a> are among the most commonly used pain medicines. Available both over-the-counter and in prescription-only formulations, NSAID medications are used to treat fever, muscle pain, arthritis pain, headaches, menstrual cramps, pain caused by injuries or surgery, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>NSAID<a href="https://medshadow.org/nsaids/" target="_blank" rel="noreferrer noopener"> medications</a> may be taken as capsules, tablets, liquid, topical creams, and by I.V. or injection in a hospital setting.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>In the fourth quarter of 2022, the <a href="https://www.fda.gov/drugs/fdas-adverse-event-reporting-system-faers/october-december-2022-potential-signals-serious-risksnew-safety-information-identified-fda-adverse" target="_blank" rel="noreferrer noopener">FDA reported</a> that it had received a number of NSAID-related adverse events reports for a serious skin reaction called “generalized bullous fixed drug eruption” and that it would “evaluate the need for regulatory action.” <a href="https://medlineplus.gov/ency/imagepages/2421.htm" target="_blank" rel="noreferrer noopener">Fixed drug eruption</a> is a serious skin rash or blistering reaction to a drug that usually occurs in the same location each time the person uses the medication.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>In July 2024, the FDA <a href="https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/018147Orig1s053ltr.pdf" target="_blank" rel="noreferrer noopener">began to notify</a> NSAID manufacturers that labels should be updated to include warnings about fixed drug eruptions. The required updates only include prescription NSAIDs, not over-the-counter versions like Advil, Aleve, and Motrin. Over-the-counter NSAID labels include a general warning about potential skin reactions, but do not specify the risk of “fixed drug eruptions.”</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>Starting on November 21, 2024, more than 50 safety updates for prescription NSAIDs were filed with the FDA. Here are descriptions of the updates for some of the more commonly prescribed medications in the category. Please check the <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=184" target="_blank" rel="noreferrer noopener">SRLC database</a> to search for additional NSAID drugs.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Arthrotec (active ingredient: diclofenac sodium; misoprostol)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1997</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats osteoarthritis and rheumatoid arthritis in adult patients at high risk of developing NSAID-induced gastric and duodenal ulcers.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=150" target="_blank" rel="noreferrer noopener">Arthrotec FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020607s043lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Cambia (active ingredient: diclofenac potassium) powder</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1998</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats attacks of migraine headaches in adults.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Essential Extras</strong>: Administered from a one-dose packet with powder that is mixed with water.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=152" target="_blank" rel="noreferrer noopener">Cambia FDA Safety</a> Label Change and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022165s016lbl.pdf" target="_blank" rel="noreferrer noopener">Revised drug label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Celebrex (active ingredient: celexocib)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1998</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats osteoarthritis (OA), rheumatoid arthritis (RA), juvenile rheumatoid arthritis (JRA) ankylosing spondylitis, acute pain, menstrual cramps.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=154" target="_blank" rel="noreferrer noopener">Celebrex FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/020998s058lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised drug label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Daypro (active ingredient: oxaprozin) caplets</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1992</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>NSAIDs Side Effect Update Date</strong>: November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats osteoarthritis (OA) and rheumatoid arthritis (RA)</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>:<a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=155" target="_blank" rel="noreferrer noopener"> Daypro FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018841s036lbl.pdf" target="_blank" rel="noreferrer noopener">Revised drug label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Duexis (active ingredient: famotidine; ibuprofen)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2011</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats osteoarthritis (OA) and rheumatoid arthritis (RA) while decreasing the risk of developing an ulcer from ibuprofen use.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>:<a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=155" target="_blank" rel="noreferrer noopener"> Duexis FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022519s014lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised drug label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Feldene (active ingredient: piroxicam)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1982</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats osteoarthritis (OA) and rheumatoid arthritis (RA)</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated NSAIDs Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=177" target="_blank" rel="noreferrer noopener">Feldene FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018147s053lbl.pdf" target="_blank" rel="noreferrer noopener">Revised drug label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Indocin (indomethacin) oral suspension and indomethacin (indomethacin) (various formulations)</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1985 (oral suspension formulation); 1965 (capsules)</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description:</strong> Treats moderate to severe rheumatoid arthritis (RA) including acute flares; ankylosing spondylitis; osteoarthritis; acute painful shoulder; gouty arthritis</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=184" target="_blank" rel="noreferrer noopener">Indocin Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018841s036lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Drug Label</a></p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=189" target="_blank" rel="noreferrer noopener">Indomethacin FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/018851s029lbl.pdf" target="_blank" rel="noreferrer noopener">Revised drug label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Meloxicam (active ingredient: meloxicam) oral suspension</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 2004</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Medication Description</strong>: Treats osteoarthritis (OA), rheumatoid arthritis (RA) and juvenile rheumatoid arthritis (JRA)</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=downloadDetails.page&DrugNameID=3055" target="_blank" rel="noreferrer noopener">Meloxicam FDA Safety Label Change</a> and <a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/021530s020lbl.pdf" target="_blank" rel="noreferrer noopener">Revised Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Naprosyn (naproxen) tablets and EC-NAPROSYN (naproxen) delayed release tablets, and ANAPROX DS (naproxen sodium) tablets</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>:1976</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date:</strong> November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>NSAIDs Description</strong>: Treats moderate to severe rheumatoid arthritis (RA); ankylosing spondylitis; osteoarthritis; bursitis; gout; menstrual cramps; pain management.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated NSAIDs Side Effects/Safety Information:</strong> Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=201" target="_blank" rel="noreferrer noopener">Naprosyn FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/017581s117,018164s067,020067s026lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a> (covers all 3 versions of naproxen)<br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Zipsor (diclofenac potassium) tablets</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p><strong>Initial FDA Approval</strong>: 1988</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Side Effect Update Date</strong>: November 21, 2024</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>NSAIDs Description</strong>: Treats mild to moderate acute (not chronic) pain in adults and children age 12 and up.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>Updated Side Effects/Safety Information</strong>: Warns of the risk of a serious skin reaction called fixed drug eruption (FDE). FDE may present as a more severe variant known as generalized bullous fixed drug eruption (GBFDE), which can be life-threatening.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA Safety Announcement</strong>: <a href="https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=214" target="_blank" rel="noreferrer noopener">Zipsor FDA Safety Label Change</a> and<a href="https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/022202s016lbl.pdf" target="_blank" rel="noreferrer noopener"> Revised Drug Label</a><br>The revised drug label contains a complete list of FDA-approved indications, side effects, warnings, and more.</p>
<!-- /wp:paragraph -->
<!-- wp:heading {"level":3} -->
<h3 class="wp-block-heading">Essential Safety Extras for All NSAIDs Prescription Drugs:</h3>
<!-- /wp:heading -->
<!-- wp:paragraph -->
<p>All include a boxed warning for “serious cardiovascular and gastrointestinal events.”</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA NSAIDs </strong><strong>Safety Communication</strong>: <a href="https://www.fda.gov/drugs/drug-safety-and-availability/fda-drug-safety-communication-fda-strengthens-warning-non-aspirin-nonsteroidal-anti-inflammatory" target="_blank" rel="noreferrer noopener">FDA strengthens warning that non-aspirin nonsteroidal anti-inflammatory drugs (NSAIDs) can cause heart attacks or strokes</a></p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p>In October 2020, the FDA released a safety communication stating that use of NSAIDs around 20 weeks or later in pregnancy may cause rare but serious kidney problems in an unborn baby. This can lead to low levels of amniotic fluid surrounding the baby and possible complications.</p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><a href="https://www.fda.gov/safety/medical-product-safety-information/nonsteroidal-anti-inflammatory-drugs-nsaids-drug-safety-communication-avoid-use-nsaids-pregnancy-20" target="_blank" rel="noreferrer noopener">Nonsteroidal Anti-Inflammatory Drugs (NSAIDs): Drug Safety Communication – Avoid Use of NSAIDs in Pregnancy at 20 Weeks or Later | FDA</a></p>
<!-- /wp:paragraph -->
<!-- wp:paragraph -->
<p><strong>FDA safety information page on NSAIDs</strong>: <a href="https://www.fda.gov/drugs/postmarket-drug-safety-information-patients-and-providers/nonsteroidal-anti-inflammatory-drugs-nsaids" target="_blank" rel="noreferrer noopener">Nonsteroidal Anti-inflammatory Drugs (NSAIDs) | FDA</a></p>
<!-- /wp:paragraph -->