Government Resource MedWatch E-list. Citation Text: United States Food and Drug Administration; FDA. Copy Citation Save Save to your library Print Share Facebook Twitter Linkedin Copy URL March 6, 2005 United States Food and Drug Administration; FDA. Joining this forum will assist subscribers in keeping aware of safety alerts issued by the U.S. Food and Drug Administration (FDA) resulting from MedWatch reports. Subscription information Save Save to your library Print Share Facebook Twitter Linkedin Copy URL Cite Citation Citation Text: United States Food and Drug Administration; FDA. Copy Citation Related Resources From the Same Author(s) New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients. September 29, 2010 Serious medication errors from intravenous administration of nimodipine oral capsules. August 11, 2010 FDA Pharmacists Help Consumers Use Medicines Safely. 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March 11, 2015 Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning. March 4, 2015 FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved. January 13, 2016 FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam). June 3, 2015 Five Medication Safety Tips for Older Adults. February 15, 2024 OpenFDA. June 11, 2014 Be an Active Member of Your Health Care Team. May 21, 2014 SmartTots. April 13, 2011 Lock it Up: Medicine Safety in Your Home. November 30, 2011 BeSafeRx: Know Your Online Pharmacy. October 10, 2012 Teaching Kids About Using Medicine Safely. February 29, 2012 Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors. October 10, 2018 Information for healthcare professionals: risk of transmission of blood-borne pathogens from shared use of insulin pens. April 8, 2009 FDA MedWatch and Patient Safety Tutorial. December 10, 2008 Shelhigh, Inc. implantable medical devices. May 2, 2007 FDA 101: How to Use the Consumer Complaint System and MedWatch. June 25, 2008 Important information for the safe use of Tussionex Pennkinetic Extended-Release Suspension. March 26, 2008 FDA Patient Safety News. A Video News Show for Health Professionals. March 6, 2005 Analysis of iatrogenic and in-hospital medication errors reported to United States poison centers: a retrospective observational study. June 24, 2020 Antidepressant and antipsychotic medication errors reported to United States poison control centers. November 28, 2018 Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. 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February 10, 2021 FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only. February 3, 2021 Hospira issues a voluntary nationwide recall for one lot of 0.5% Bupivacaine Hydrochloride Injection, USP and one lot of 1% Lidocaine HCl Injection, USP due to mislabeling. May 19, 2021 Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication. October 20, 2021 Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers. November 11, 2020 FDA advises health care professionals and patients about insulin pen packaging and dispensing. October 28, 2020 FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing. February 24, 2022 - February 24, 2022 Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11. 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December 19, 2012 Kadcyla (ado-trastuzumab emtansine): drug safety communication—potential medication errors resulting from name confusion. May 15, 2013 Luer Connector Misconnections: Under-Recognized but Potentially Dangerous Events. August 15, 2012 Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume. May 30, 2012 Safety Problems With Your Child's Medical Device? July 31, 2013 Reprocessing of Reusable Medical Devices. January 11, 2012 A Review of FDA’s Approach to Medical Product Shortages. November 16, 2011 Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays. November 7, 2012 Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. February 20, 2013 Accidental exposures to fentanyl patches continue to be deadly to children. 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January 13, 2016 Infections associated with reprocessed flexible bronchoscopes. September 30, 2015 View More See More About The Topic Health Care Providers Patients Medication Safety
New dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients. September 29, 2010
Serious medication errors from intravenous administration of nimodipine oral capsules. August 11, 2010
FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. April 8, 2020
Benzocaine sprays marketed under different names, including Hurricaine, Topex, and Cetacaine. February 22, 2006
Medication errors resulting from confusion between risperidone (Risperdal) and ropinirole (Requip). June 22, 2011
FDA requires label warnings to prohibit sharing of multi-dose diabetes pen devices among patients. March 11, 2015
Design of endoscopic retrograde cholangiopancreatography (ERCP) duodenoscopes may impede effective cleaning. March 4, 2015
FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved. January 13, 2016
FDA cautions about dose confusion and medication errors for antibacterial drug Zerbaxa (ceftolozane and tazobactam). June 3, 2015
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors. October 10, 2018
Information for healthcare professionals: risk of transmission of blood-borne pathogens from shared use of insulin pens. April 8, 2009
Important information for the safe use of Tussionex Pennkinetic Extended-Release Suspension. March 26, 2008
Analysis of iatrogenic and in-hospital medication errors reported to United States poison centers: a retrospective observational study. June 24, 2020
Antidepressant and antipsychotic medication errors reported to United States poison control centers. November 28, 2018
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. January 13, 2021
Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance for Industry. December 23, 2020
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry. May 25, 2022
Medication Safety During the COVID-19 Pandemic: What Have We Learned in the United States. June 23, 2020
Safety Considerations for Product Design to Minimize Medication Errors: Guidance for Industry. January 9, 2013
Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment. June 2, 2021
Outpatient insulin-related adverse events due to mix-up errors: findings from two national surveillance systems, United States, 2012-2017. March 24, 2021
Using ventilator splitters during the COVID-19 pandemic--letter to health care providers. February 17, 2021
Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors. January 13, 2016
Safety considerations to mitigate the risks of misconnections with small-bore connectors intended for enteral applications. March 4, 2015
Heparin-containing medical devices and combination products: recommendations for labeling and safety testing. Draft guidance for industry and Food and Drug Administration staff. August 5, 2015
FDA Guidance Document: Hospital Bed System Dimensional and Assessment Guidance to Reduce Entrapment. June 7, 2006
FDA preliminary public health notification: unpredictable events in medical equipment due to new daylight savings time change. January 9, 2005
FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. August 5, 2020
Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings. February 17, 2021
Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling. February 10, 2021
FDA updates vinca alkaloid labeling for preparation in intravenous infusion bags only. February 3, 2021
Hospira issues a voluntary nationwide recall for one lot of 0.5% Bupivacaine Hydrochloride Injection, USP and one lot of 1% Lidocaine HCl Injection, USP due to mislabeling. May 19, 2021
Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication. October 20, 2021
Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers. November 11, 2020
FDA advises health care professionals and patients about insulin pen packaging and dispensing. October 28, 2020
FDA Safety Communication: flexible bronchoscopes and updated recommendations for reprocessing. February 24, 2022 - February 24, 2022
Cardinal Health recalls Argyle UVC insertion tray due to missing instructions for use for the Safety Scalpel N11. September 1, 2021
Use purple bracelets or wristbands only for do not resuscitate status - letter to industry. August 25, 2021
Reporting of death in US Food and Drug Administration medical device adverse event reports in categories other than death. August 11, 2021
FDA alerts health care professionals to the temporary absence of warning statement on the vial caps of two neuromuscular blocking agents. July 15, 2020
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up. October 19, 2022
Clinical Decision Support Software: Guidance for Industry and Food and Drug Administration Staff. October 3, 2022
Implantable infusion pumps in the magnetic resonance (MR) environment: FDA safety communication—important safety precautions. January 25, 2017
FDA Drug Safety Communication: FDA warns about prescribing and dispensing errors resulting from brand name confusion with antidepressant Brintellix (vortioxetine) and antiplatelet Brilinta (ticagrelor). August 12, 2015
FDASIA Health IT Report: Proposed Strategy and Recommendations for a Risk-Based Framework. April 30, 2014
FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy. August 20, 2021
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019
Potentially fatal errors with GDH-PQQ [glucose dehydrogenase pyrroloquinoline quinone] glucose monitoring technology. October 21, 2009
Hydrocodone bitartrate and acetaminophen tablets, phenobarbital tablets by Qualitest: recall—incorrect package labeling. February 16, 2011
Morphine sulfate oral solution 100 mg per 5 mL (20 mg/mL): medication use error—reports of accidental overdose. January 19, 2011
FDA requiring color changes to Duragesic (fentanyl) pain patches to aid safety―emphasizing that accidental exposure to used patches can cause death. October 9, 2013
Important change to heparin container labels to clearly state the total drug strength. December 19, 2012
Kadcyla (ado-trastuzumab emtansine): drug safety communication—potential medication errors resulting from name confusion. May 15, 2013
Hospira Carpuject pre-filled cartridges—drug alert: products may contain more than the intended fill volume. May 30, 2012
Serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal sprays. November 7, 2012
Codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or death. February 20, 2013
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management. November 28, 2018
Medication guides: patient medication information. A proposed rule by the Food and Drug Administration. June 28, 2023
Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Atenolol 25 mg Tablets and Clopidogrel 75 mg Tablets Due to a Label Mix-up. October 19, 2022
Safety Considerations for Container Labels and Carton Labeling Design to Minimize Medication Errors: Guidance for Industry. May 25, 2022
Potential for medication overdose with ENFit low dose tip syringe: FDA Safety Communication. October 20, 2021
FDA Safety Communication: update--robotically-assisted surgical devices in mastectomy. August 20, 2021
Apotex Corp. issues voluntary nationwide recall of Enoxaparin Sodium Injection, USP due to mislabeling of syringe barrel measurement markings. February 17, 2021
Meitheal Pharmaceuticals, Inc. issues voluntary nationwide recall of Cisatracurium Besylate Injection, USP 10mg per 5mL due to mislabeling. February 10, 2021
Best Practices in Developing Proprietary Names for Human Nonprescription Drug Products. January 13, 2021
Best Practices in Developing Proprietary Names for Human Prescription Drug Products Guidance for Industry. December 23, 2020
Potential for false positive results with antigen tests for rapid detection of SARS-CoV-2--letter to clinical laboratory staff and health care providers. November 11, 2020
FDA advises health care professionals and patients about insulin pen packaging and dispensing. October 28, 2020
FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder. August 5, 2020
FDA alerts patients and health care professionals of EpiPen auto-injector errors related to device malfunctions and user administration. April 8, 2020
FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering. April 17, 2019
FDA Safety Communication: use caution with implanted pumps for intrathecal administration of medicines for pain management. November 28, 2018
Differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors. October 10, 2018
Medical gas containers and closures; current good manufacturing practice requirements. November 18, 2016
Computerized Prescriber Order Entry Medication Safety (CPOEMS): Uncovering and Learning From Issues and Errors. January 13, 2016
FDA Drug Safety Communication: FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved. January 13, 2016