MedWatch Program Research Articles

Summaries of safety labeling changes approved by FDA-Boxed warnings highlights, July-September 2022.

As part of FDA’s MedWatch program, important changes to the safety labeling of drugs and therapeutic biologicals, including boxed warnings, are posted on the agency’s website. Boxed warnings are ordinarily used to highlight (1) an adverse reaction so serious in proportion to the potential benefit from the drug that it is essential that the reaction be considered in assessing the risks and benefits of using the drug, (2) serious adverse reactions that can be prevented or reduced in frequency or severity by appropriate use of the drug, and (3) situations in which FDA approved a drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.1 The following revisions to warnings were implemented in the 3 months ending September 2022. The revised boxed warning emphasizes that diclofenac sodium/misoprostol is contraindicated during pregnancy and is not recommended for use by women of childbearing potential. Prescribers should verify the pregnancy status of females of reproductive potential before initiating therapy and advise them to use effective contraception during treatment.

Possible Increased Risk of Death from Blood Cancer Drug.

The Food and Drug Administration (FDA) is warning that an increased risk of death is possible with the use of duvelisib (Copiktra) compared with the monoclonal antibody ofatumumab in the treatment of chronic lymphocytic leukemia. Serious adverse effects also appear to be more likely with duvelisib use.Nurses should monitor for adverse effects and report them to the FDA's MedWatch program.

FDA Evaluating Possible Serious Risks From Umbralisib.

Initial clinical trial data for umbralisib (Ukoniq), a drug currently approved to treat relapsed or refractory marginal zone lymphoma and relapsed or refractory follicular lymphoma, indicate that umbralisib may increase the risk of death or serious adverse effects when given with a specific monoclonal antibody to treat chronic lymphocytic leukemia.Patients receiving umbralisib to treat lymphomas should be evaluated closely for adverse effects. Nurses and other health care providers should report any of these adverse effects to the Food and Drug Administration's MedWatch program.

Remdesivir Receives Emergency Use Authorization for Severely Ill Patients with COVID-19.

Remdesivir Receives Emergency Use Authorization for Severely Ill Patients with COVID-19.

<p>Opioids and frequency counts in the US Food and Drug Administration Adverse Event Reporting System (FAERS) database: a quantitative view of the epidemic</p>

BackgroundThe U.S. Food and Drug Administration Adverse Event Reporting System (FAERS), contains information on adverse drug events and medication error reports submitted to the FDA through the MedWatch program. A significant number of adverse events reported in the FAERS database have been for opioid use. The objective of this study was to determine the frequency counts and associated deaths of opioid drug names in the FAERS database.MethodsDrug data were obtained from the DRUG and OUTCOME files in the database. Drugs identified included: morphine, fentanyl, oxycodone, hydrocodone, tramadol, hydromorphone, methadone, codeine, oxymorphone, meperidine, propoxyphene, diphenoxylate, and heroin. Frequency counts and concomitant deaths of opioid drug names were determined via the MySQL database management system.ResultsFifteen different opioid drugs identified in the FAERS database were associated with ADEs, including death, and 3 drugs (oxycodone, hydrocodone, fentanyl) accounted for more than half of the reports. The highest frequency count value was 158,181 for oxycodone, which represents approximately 20.2% of the frequency counts for the opioids. The lowest frequency count value was 2,161 for dextromethorphan, which represents approximately 0.3% of the total. The opioid with the highest proportion of deaths to drug count was heroin (71.8%), followed by dextromethorphan (55.6%), methadone (37.2%), morphine (26.8%), and propoxyphene (23.7%).ConclusionThe FAERS database represents an important source for detection and reporting of adverse drug events (ADEs), in particular the opioids and related drugs. It remains a challenge to estimate the true incidence of ADEs for this class of drugs in the general population.

ISMP Adverse Drug Reactions: Pheochromocytoma Crisis Induced by Metoclopramide Baclofen Dependence Following High-Dose Therapy Fatal Cardiotoxicity Following High-Dose Cyclophosphamide Acute Anterograde Amnestic Syndrome Induced by Fentanyl Ivermectin-Induced Toxic Epidermal Necrolysis Pembrolizumab-Induced Type 1 Diabetes.

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. E-mail Dr. Mancano at michael.mancano@temple.edu. Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

ISMP Adverse Drug Reactions: Longitudinal Thumbnail Fissures Due to Erlotinib Priapism Associated With the Use of ExtenZe Blindness From a Nevirapine-Based HAART Regimen Hyperprolactinemia and Galactorrhea Due to Aripiprazole Trypophobia Associated With Gabapentin Coadministered Linezolid and Methadone Cause Serotonin Syndrome.

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. E-mail Dr. Mancano at michael.mancano@temple.edu. Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

Summaries of safety labeling changes approved by FDA-Boxed warnings highlights, July-September 2018.

As part of FDA’s MedWatch program, important changes to the safety labeling of drugs and therapeutic biologics, including boxed warnings, are posted on the agency’s website. Boxed warnings are ordinarily used to highlight (1) an adverse reaction so serious in proportion to the potential benefit

Summaries of safety labeling changes approved by FDA—Boxed warnings highlights, April–June 2018

As part of FDA’s MedWatch program, important changes to the safety labeling of drugs and therapeutic biologics, including boxed warnings, are posted on the agency’s website. Boxed warnings are ordinarily used to highlight (1) an adverse reaction so serious in proportion to the potential benefit

ISMP Adverse Drug Reactions: Lithium-Induced Cardiomyopathy Fixed Drug Eruption Due to Cetirizine, Levocetirizine, and Hydroxyzine Nivolumab-Induced Myasthenia Gravis Nivolumab-Induced Cholangitic Liver Disease Torsade de Pointes Caused by Psychiatric Polypharmacy Trichotillomania Associated With Aripiprazole.

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. E-mail Dr. Mancano michael.mancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

ISMP Adverse Drug Reactions: Adalimumab-Induced Aseptic Meningitis Pill Desiccant -Induced Acute Hypoxic Respiratory Failure Rivastigmine Patch -Induced Angioedema Acute Liver Failure Due to Etodolac Severe Cognitive Impairment Due to High Free Valproic Acid Levels

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of revention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-ßDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with ur readers. E-mail Dr.Mancanomichael.mancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

Spontaneous Reporting on Adverse Events by Consumers in the United States: An Analysis of the Food and Drug Administration Adverse Event Reporting System Database.

BackgroundVoluntary reports on adverse events (AEs) submitted by consumers have been facilitated through the MedWatch program in the United States (US), but few studies have described the characteristics of voluntary reports.ObjectiveThe aim of this study was to reveal the characteristics of current voluntary reports on AEs reported by consumers and healthcare professionals.MethodsWe performed analysis on voluntary reports of AEs in the US Food and Drug Administration AE Reporting System (FAERS) database submitted in 2016. We compared reports by consumers with those by healthcare professionals.ResultsThe number of voluntary reports by consumers has increased since 2013 in the US. Reports by consumers were different from ones by health professionals in several important aspects such as demographics and outcomes of patients, AEs, and suspect drugs. The proportion of reports on female patients and on disability as a patient outcome were higher in reports by consumers than in those by healthcare professionals. Consumers more frequently reported concomitant drugs compared with healthcare professionals. Time to report varied among the occupations and depending on seriousness of outcomes.ConclusionsOur analysis of voluntary AE reports in the US FAERS database has shown that voluntary reports tended to include AEs related to subjective symptoms, as in some previous studies on patient reporting in the EU. Voluntary reports by consumers seemed to be different from ones by healthcare professionals in important aspects including demographics and reporting behaviors. These findings suggest that the heterogeneities should be addressed appropriately in using spontaneous reports.Electronic supplementary materialThe online version of this article (10.1007/s40801-018-0134-0) contains supplementary material, which is available to authorized users.

ISMP Adverse Drug Reactions: Influenza Vaccine-Induced Stevens-Johnson Syndrome; Vilazodone-Induced Nightmares; Dabigatran-Induced Pustular Eruptions; Neurotoxic and Cardiotoxic Symptoms After Cannabis Concentrate Exposure; Rosuvastatin-Induced Skin Eruption.

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

Summaries of safety labeling changes approved by FDA-Boxed warnings highlights, April-June 2017.

As part of FDA’s MedWatch program, changes to the boxed warnings in the labeling of drugs and therapeutic biologics are compiled quarterly. These and other labeling changes are searchable in the Drug Safety Labeling Changes (SLC) database,[1][1] where data are available to the public in

ISMP Adverse Drug Reactions: Allergic Angina Caused by Fluconazole Rhabdomyolysis Caused by Risperidone High Incidence of Hyponatremia With High-Dose Trimethoprim-Sulfamethoxazole Lithium Carbonate-Induced Hypersalivation Persistent Hemorrhage After Idarucizumab Administration.

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

ISMP Adverse Drug Reactions: Levofloxacin-Induced Neuroexcitation and Hallucinations; Statin-Induced Muscle Rupture; Mefloquine-Induced Rhabdomyolysis; Methimazole-Induced Cholestatic Hepatitis; Decitabine-Induced Hand and Foot Syndrome.

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

ISMP Adverse Drug Reactions

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

ISMP Adverse Drug Reactions.

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers. Write to Dr. Mancano at ISMP, 200 Lakeside Drive, Suite 200, Horsham, PA 19044 (phone: 215-707-4936; e-mail: mmancano@temple.edu). Your report will be published anonymously unless otherwise requested. This feature is provided by the Institute for Safe Medication Practices (ISMP) in cooperation with the FDA's MedWatch program and Temple University School of Pharmacy. ISMP is an FDA MedWatch partner.

Rivaroxaban-Induced DRESS; Serotonin Syndrome Induced by Paliperidone; Piperacillin-Tazobactam–Induced Nephritis and Hepatitis; Brentuximab-Induced Hand-Foot Syndrome; Valproic Acid–Induced Hyperkalemia

The purpose of this feature is to heighten awareness of specific adverse drug reactions (ADRs), discuss methods of prevention, and promote reporting of ADRs to the US Food and Drug Administration's (FDA's) MedWatch program (800-FDA-1088). If you have reported an interesting, preventable ADR to MedWatch, please consider sharing the account with our readers.

Summaries of Safety Labeling Changes Approved by the FDA: Boxed Warnings Highlights October - December 2016.

The FDA's MedWatch program safety labeling changes for boxed warnings are compiled quarterly for drugs and therapeutic biologics where important changes have been made to the safety information. Search of Drug Safety Labeling Changes (SLC) database was conducted on December 31, 2016 for date range "10/1/2016-12/31/2016", labeling section "Boxed Warning". These and other label changes are searchable in the Drug Safety Labeling Changes (SLC) database, where data are available to the public in downloadable and searchable formats. (Drug Safety Labeling Changes are available at: http://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/?source=govdelivery&utm_medium=email&utm_source=govdelivery) Boxed warnings are ordinarily used to highlight either: adverse reactions so serious in proportion to the potential benefit from the drug that it is essential that it be considered in assessing the risks and benefits of using the drug; OR serious adverse reactions that can be prevented/reduced in frequency or severity by appropriate use of the drug; OR FDA approved the drug with restrictions to ensure safe use because FDA concluded that the drug can be safely used only if distribution or use is restricted.