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Pain News (Page 7)
FDA Medwatch Alert: Duragesic (fentanyl) Patches: Drug Safety Communication - Packaging Changes to Minimize Risk of Accidental Exposure
[Posted 09/23/2013] ISSUE: FDA is requiring color changes to the writing on Duragesic (fentanyl) pain patches so they can be seen more easily. FDA continues to learn of deaths from accidental...
FDA Medwatch Alert: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets
ISSUE: Qualitest, a subsidiary of Endo Health Solutions, issued a voluntary nationwide recall for 101 lots of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. Bottles from the...
FDA Medwatch Alert: Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg (Watson Laboratories): Recall - Potential for Oversized and Superpotent Tablets
ISSUE: Watson Laboratories, Inc. notified the public of a voluntary nationwide recall for two lots of Hydrocodone Bitartrate and APAP Tablets, USP 10 mg/500 mg (Lot Numbers 519406A and 521759A, both...
FDA Medwatch Alert: Qualitest Hydrocodone Bitartrate and Acetaminophen Tablets 10 mg/500 mg: Recall - Potential for Oversized Tablets
ISSUE: Today, Qualitest, a subsidiary of Endo Health Solutions,issued a voluntary, nationwide retail level recall for one lot of Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/500 mg. ...
FDA Approves Mallinckrodt's Exalgo (hydromorphone HCl) Extended-Release Tablets 32 mg (CII) for Opioid-Tolerant Patients with Moderate-to-Severe Chronic Pain
ST. LOUIS--(BUSINESS WIRE)--Aug 27, 2012 - The U.S. Food and Drug Administration (FDA) has notified Mallinckrodt, the pharmaceuticals business of Covidien, that it has approved a 32 mg tablet...
FDA Medwatch Alert: Hospira Hydromorphone Hydrochloride Injection 2 MG/ML, 1 mL fill in 2.5 mL Carpuject: Recall- May Contain More Than The Intended Fill Volume
Issue: Hospira and FDA notified healthcare professional of a nationwide voluntraty recall of one lot of Hydromorphone Injection, USP, 2 mg/mL, (C-II), 1 mL fill in 2.5 mL Carpuject, NDC 0409-1312-30,...
FDA Medwatch Alert: Reumofan Plus: Recall - Undeclared Drug Ingredient
ISSUE: FDA is warning consumers that Reumofan Plus, marketed as a natural dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not...
FDA Medwatch Alert: Hydromorphone Hydrochloride Injection 1 MG/ML, (C-II) 1 ML Fill In 2.5 ML Carpuject: Recall - May Contain More Than the Intended Fill Volume
ISSUE: Hospira, Inc. notified healthcare professionals of a recall of one lot of Hydromorphone Hydrochloride Injection 1 MG/ML, due to reports of a single Carpuject containing more than the 1 mL...
FDA Medwatch Alert: Morphine Sulfate Injection USP, 4 mg/mL (C-II), 1 mL fill in 2.5 mL Carpuject by Hospira, Inc: Recall - May Contain More Than Intended Fill Volume
ISSUE: Customer report of two Carpujects syringes containing more than the 1 mL labeled fill volume. Opioid pain medications such as morphine have life-threatening consequences if overdosed. Those...
Insys Therapeutics Announces FDA Approval of Subsys Fentanyl Sublingual Spray
PHOENIX, Jan 5, 2012 - INSYS Therapeutics announces the US Food and Drug Administration approval of its branded breakthrough cancer pain medication, Subsys fentanyl sublingual spray. SUBSYS is a...
Pacira Pharmaceuticals, Inc. Announces U.S. FDA Approval of Exparel For Postsurgical Pain Management
PARSIPPANY, N.J., Oct. 31, 2011 /PRNewswire via COMTEX/ – Pacira Pharmaceuticals, Inc. announces that the U.S. Food and Drug Administration (FDA) has approved Exparel (bupivacaine liposome...
Nucynta ER (Tapentadol Extended-Release Tablets) Receives FDA Approval for the Management of Moderate to Severe Chronic Pain
Raritan, N.J., August 26, 2011 /PRNewswire/ — Janssen Pharmaceuticals, Inc. today announced the U.S. Food and Drug Administration (FDA) has approved Nucynta ER, an oral analgesic taken twice daily, f...
FDA Approves Lazanda - First Fentanyl Nasal Spray - for the Management of Breakthrough Pain in Cancer Patients
READING, England and BEDMINSTER, N.J., June 30, 2011 /PRNewswire/ – Archimedes Pharma Ltd., and its subsidiary, Archimedes Pharma U.S. Inc., today announced that the U.S. Food and Drug...
FDA Clears Cymbalta to Treat Chronic Musculoskeletal Pain
Indications include osteoarthritis, chronic lower back pain ROCKVILLE, Md., Nov. 4, 2010--The U.S. Food and Drug Administration today approved Cymbalta (duloxetine hydrochloride) to treat chronic...
Cadence Pharmaceuticals Announces FDA Approval of Ofirmev (acetaminophen) injection for the Management of Pain and Fever
SAN DIEGO, Nov. 2, 2010 /PRNewswire-FirstCall/ – Cadence Pharmaceuticals, Inc. announced today that the U.S. Food and Drug Administration (FDA) has granted marketing approval for Ofirmev...
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