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FDA Drug Warnings - March 2025

elexacaftor–tezacaftor–ivacaftor and ivacaftor

Trikafta

NEW WARNING

The FDA is requiring the prescribing information for Trikafta, a combination drug containing elexacaftor, tezacaftor, and ivacaftor, to carry a Boxed Warning regarding the increased risk of serious, and sometimes fatal, liver injury. The drug combination isn't recommended in patients with Child-Pugh class B liver impairment and shouldn't be used in patients with Child-Pugh class C liver impairment.

The warning includes that patient's prescribed Trikafta should have liver function studies assessed at baseline then monitored monthly for the first 6 months, every 3 months for the next 12 months, and then at least annually. Monitoring should be performed more frequently in patients with a history of liver impairment or elevated baseline liver function studies. Further, therapy should be interrupted for significant elevations in liver function studies or signs or symptoms of liver injury, then the patient followed closely until the abnormalities resolve. Trikafta should only be resumed if the abnormalities resolve and if the benefits of use outweigh the risk.

Patients should be advised to immediately stop Trikafta and seek medical attention for signs or symptoms of liver injury such as new-onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.

Adverse effects from the use of Trikafta should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: March 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer
 

fezolinetant

Veozah

NEW WARNING

The FDA is requiring the prescribing information for fezolinetant to include a Boxed Warning regarding an increased risk of liver toxicity with its use. The warning requires that liver function studies be performed at baseline and that therapy not be started if either ALT or AST is 2 × the upper limit of normal (ULN) or more, or if the total bilirubin is 2 × ULN for the evaluating laboratory.

The Boxed Warning further requires that follow-up liver function studies be performed monthly for the first three months, then at 6 and 9 months after starting therapy, and more frequently if transaminase levels are greater than 3 × ULN. Therapy should be discontinued if transaminase levels are greater than 5 × ULN; or they are greater than 3 × ULN when the total bilirubin level is greater than 2 × ULN.

In addition, the Boxed Warning advises patients to immediately stop the drug and seek medical attention for signs or symptoms suggestive of liver injury such as new-onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.

Adverse effects from the use of fezolinetant should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: March 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer
 

glatiramer acetate

Copaxone, Glatopa

NEW WARNING

The FDA is requiring that the prescribing information for glatiramer acetate products include a Boxed Warning that anaphylaxis can occur at any time during therapy, from first dose to years after the start of therapy. The warning states that the drug is contraindicated in patients with a history of hypersensitivity to glatiramer, including anaphylaxis.

Patients should be monitored for hypersensitivity reactions. If anaphylaxis occurs, the drug must be immediately discontinued and the patient treated as clinically indicated. The drug should be permanently discontinued unless a clear alternative cause of reaction is identified.

The Boxed Warning explains that patients should be aware that symptoms of anaphylaxis (widespread rash; swelling of the face, eyelids, lips, mouth, throat, or tongue; sudden shortness of breath or wheezing; convulsions; trouble swallowing or speaking; fainting, dizziness, or feeling faint) may overlap with those of immediate postinjection reactions. Further, the patient should be advised to stop glatiramer and seek immediate medical attention if anaphylaxis occurs, as prompt identification is important to avoid a delay in treatment.

Adverse effects from the use of glatiramer acetate should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.

Released: March 2025

Nursing Drug Handbook

© 2025 Wolters Kluwer
 

Drug Warnings Archive

FDA Drug Warnings - March 2025
elexacaftor–tezacaftor–ivacaftor and ivacaftorTrikaftaNEW WARNINGThe FDA is requiring the prescribing information for Trikafta, a combination drug containing elexacaftor, tezacaftor, and ivacaftor, to carry a Boxed Warning regarding the increased risk of serious, and sometimes fatal, liver injury. The drug combination isn't recommended in patients with Child-Pugh class B liver impairment and shouldn't be used in patients with Child-Pugh class C liver impairment.The warning includes that patient's prescribed Trikafta should have liver function studies assessed at baseline then monitored monthly for the first 6 months, every 3 months for the next 12 months, and then at least annually. Monitoring should be performed more frequently in patients with a history of liver impairment or elevated baseline liver function studies. Further, therapy should be interrupted for significant elevations in liver function studies or signs or symptoms of liver injury, then the patient followed closely until the abnormalities resolve. Trikafta should only be resumed if the abnormalities resolve and if the benefits of use outweigh the risk.Patients should be advised to immediately stop Trikafta and seek medical attention for signs or symptoms of liver injury such as new-onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.Adverse effects from the use of Trikafta should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer  fezolinetantVeozahNEW WARNINGThe FDA is requiring the prescribing information for fezolinetant to include a Boxed Warning regarding an increased risk of liver toxicity with its use. The warning requires that liver function studies be performed at baseline and that therapy not be started if either ALT or AST is 2 × the upper limit of normal (ULN) or more, or if the total bilirubin is 2 × ULN for the evaluating laboratory.The Boxed Warning further requires that follow-up liver function studies be performed monthly for the first three months, then at 6 and 9 months after starting therapy, and more frequently if transaminase levels are greater than 3 × ULN. Therapy should be discontinued if transaminase levels are greater than 5 × ULN; or they are greater than 3 × ULN when the total bilirubin level is greater than 2 × ULN.In addition, the Boxed Warning advises patients to immediately stop the drug and seek medical attention for signs or symptoms suggestive of liver injury such as new-onset fatigue, decreased appetite, nausea, vomiting, pruritus, jaundice, pale feces, dark urine, or abdominal pain.Adverse effects from the use of fezolinetant should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer  glatiramer acetateCopaxone, GlatopaNEW WARNINGThe FDA is requiring that the prescribing information for glatiramer acetate products include a Boxed Warning that anaphylaxis can occur at any time during therapy, from first dose to years after the start of therapy. The warning states that the drug is contraindicated in patients with a history of hypersensitivity to glatiramer, including anaphylaxis.Patients should be monitored for hypersensitivity reactions. If anaphylaxis occurs, the drug must be immediately discontinued and the patient treated as clinically indicated. The drug should be permanently discontinued unless a clear alternative cause of reaction is identified.The Boxed Warning explains that patients should be aware that symptoms of anaphylaxis (widespread rash; swelling of the face, eyelids, lips, mouth, throat, or tongue; sudden shortness of breath or wheezing; convulsions; trouble swallowing or speaking; fainting, dizziness, or feeling faint) may overlap with those of immediate postinjection reactions. Further, the patient should be advised to stop glatiramer and seek immediate medical attention if anaphylaxis occurs, as prompt identification is important to avoid a delay in treatment.Adverse effects from the use of glatiramer acetate should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: March 2025Nursing Drug Handbook© 2025 Wolters Kluwer  
FDA Drug Warnings - November 2024
fezolinetantVeozahNEW WARNINGThe Food and Drug Administration has issued a Drug Safety Communication to warn of a rare but serious drug-induced liver injury that may occur with the use of fezolinetant. The FDA is recommending that liver function tests (LFTs) be performed at baseline and that therapy not be started if total bilirubin, ALT, or AST level is 2 or more times the upper limit of normal (ULN) at baseline. In addition, LFTs should be performed monthly for the first three months, then at 6 and 9 months after starting therapy, and more frequently if transaminase levels are greater than three times the ULN. Fezolinetant should be discontinued if transaminase levels are greater than 5 times the ULN, or greater than 3 times the ULN with total bilirubin level greater than 2 times the ULN. Other causes of elevated LFTs should be excluded.Patients should be monitored for and taught to report signs and symptoms of liver toxicity, including nausea, vomiting, itching, light-colored stools, jaundice, dark urine, abdominal swelling, or pain in the right-upper abdomen. Fezolinetant should be discontinued if signs and symptoms of liver toxicity occur.Adverse effects from the use of fezolinetant should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: November 2024Nursing Drug Handbook© 2024 Wolters Kluwer  
FDA Drug Warnings - September 2024
velaglucerase alfaVprivNEW WARNINGThe FDA has required prescribing information for velaglucerase alfa, a replacement enzyme used to treat type 1 Gaucher disease, to include a boxed warning about the risk for hypersensitivity reactions including anaphylaxis. Anaphylaxis has occurred in patients on enzyme replacement drugs early in therapy and after extended use.The boxed warning includes that the drug should be initiated in a health care setting with medical monitoring and readily available support measures, including cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (such as anaphylaxis) occurs, the drug infusion should be discontinued and appropriate medical treatment, including epinephrine, initiated.Patients should be advised of the risk of life-threating hypersensitivity reactions and to seek immediate medical attention if symptoms occur.Adverse effects from the use of velaglucerase alfa should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: September 2024Nursing Drug Handbook© 2024 Wolters Kluwer  sebelipase alphaKanumaNEW WARNINGThe FDA has required prescribing information for sebelipase alfa, a replacement enzyme used to treat lysosomal acid lipase deficiency, to include a boxed warning about the risk of hypersensitivity reactions including anaphylaxis. Anaphylaxis has occurred in patients on enzyme replacement drugs early in therapy and after extended use.The boxed warning includes that the drug should be initiated in a health care setting with medical monitoring and readily available support measures, including cardiopulmonary resuscitation equipment. If a severe hypersensitivity reaction (such as anaphylaxis) occurs, the drug infusion should be discontinued and appropriate medical treatment, including epinephrine, initiated.Patients should be advised of the risk of life-threating hypersensitivity reactions and to seek immediate medical attention if symptoms occur.Adverse effects from the use of sebelipase alfa should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: September 2024Nursing Drug Handbook© 2024 Wolters Kluwer
FDA Drug Warnings - April 2024
axicabtagene ciloleucelYescartatisagenlecleucelKymriahNEW WARNINGThe FDA has required prescribing information for B-cell maturation antigen (BCMA)-directed and CD19-directed genetically modified autologous chimeric antigen receptor T-cell immunotherapies to be revised to include a Boxed Warning related to the risk of T-cell malignancies. The warning states that T-cell malignancies have occurred after treatment with these immunotherapies and that serious outcomes, including hospitalization and death, have occurred.Health care providers are directed to provide lifelong monitoring of patients for secondary malignancies, including T-cell malignancies, after treatment with BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies. Patients should be advised of the risk for secondary malignancies and that lifelong monitoring is necessary.Adverse effects from the use of BCMA- and CD19-directed genetically modified autologous T-cell immunotherapies should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: April 2024Nursing Drug Handbook© 2024 Wolters Kluwer
FDA Drug Warnings - March 2024
denosumabProliaNEW WARNINGThe FDA is requiring the prescribing information for denosumab (Prolia) include a Boxed Warning stating that Prolia increases the risk of severe hypocalcemia in patients with advanced chronic kidney disease (CKD), especially those patients on dialysis. Hypocalcemia resulting in hospitalization, life-threatening events and death have occurred. Chronic kidney disease–mineral bone disorder (CKD–MBD) markedly increases the risk of hypocalcemia.Symptoms of severe hypocalcemia can include confusion, seizures, irregular heart rhythm, fainting, facial twitching, uncontrolled muscle spasms, or weakness, tingling or numbness. However, some patients may be asymptomatic.Health care providers should evaluate patients with advanced CKD for CKD–MBD before the start of treatment. Treatment with Prolia in patients with advanced CKD should be supervised by a health care provider with expertise in the diagnosis and management of CKD–MBD. Patients should be prescribed an adequate intake of calcium and vitamin D during treatment and taught to monitor for and report symptoms of hypocalcemia. Calcium levels should be monitored closely, and hypocalcemia corrected prior to and during treatment.Adverse effects from the use of Prolia should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: March 2024Nursing Drug Handbook© 2024 Wolters Kluwer
FDA Drug Warnings - February 2024
clobazam and levetiracetamVarious manufacturersNEW WARNINGThe FDA has issued a drug safety communication to alert patients and health care professionals to the risk of drug reactions with eosinophilia and systemic symptoms (DRESS) associated with the use of antiseizure medications clobazam (Onafi, Sympazan) and levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam). The occurrence of DRESS is rare but serious and can become life-threatening if not identified and treated promptly. It can start as a rash and quickly progress, causing liver, kidney, lung, heart, or pancreas injury; hospitalization; and death.Health care professionals should monitor for DRESS (facial swelling, fever, rash, swollen lymph nodes, painful oral sores or sores around the eyes, sore throat, trouble swallowing or breathing, unusual bruising or bleeding, severe weakness or fatigue, or severe muscle pain). Signs and symptoms often begin 2 to 8 weeks after initiation of the drug. Symptoms and their severity can widely vary. Patients should be instructed to watch for signs and symptoms of DRESS and to stop the drug and seek immediate medical attention for suspected DRESS.Adverse effects from the use of clobazam or levetiracetam should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: February 2024Nursing Drug Handbook© 2024 Wolters Kluwer
FDA Drug Warnings - June 2023
onasemnogene abeparvovec-xioiZolgensmaNEW WARNINGThe FDA has required the Boxed Warning in the prescribing information for onasemnogene abeparvovec-xioi be expanded to include that the drug may cause acute liver failure with fatal outcomes. In addition, assessments of liver function by clinical exam and blood work (AST, ALT, total bilirubin, PT) should occur before the infusion and continue to be monitored for at least 3 months after infusion and as clinically indicated.  Adverse effects from the use of onasemnogene abeparvovec-xioi should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: June 2023Nursing Drug Handbook© 2023 Wolters Kluwer  opioid drug classVarious manufacturersNEW WARNINGThe FDA has issued a Drug Safety Communication regarding all opioid medications. The FDA is requiring updates to the prescribing information for all opioid pain medications to provide additional guidance for safe use. Opioid medications include:buprenorphinebutorphanol tartratecodeine phosphate–acetaminophencodeine sulfatebutalbital–acetaminophen–caffeine–codeine–phosphate butalbital–aspirin–caffeine–codeine phosphatefentaNYL citrateHYDROcodone bitartrateHYDROcodone bitartrate–acetaminophenHYDROcodone bitartrate–ibuprofenHYDROmorphone hydrochloridemeperidine hydrochloridemethadone hydrochloridemorphine hydrochloridenalbuphine hydrochlorideoliceridineoxyCODONEoxyCODONE hydrochlorideoxyCODONE hydrochloride–acetaminophenoxyCODONE hydrochloride–aspirinoxyMORphone hydrochlorideSUFentaniltapentadol hydrochloridetraMADol hydrochloridetraMADol hydrochloride–acetaminophen Highlights of the changes include that the prescribing information should state: the risk of overdose increases as the dosage increases for all opioid medications.immediate-release formulations shouldn't be used for an extended time unless the individual patient's pain remains severe enough to require them and alternative treatment options aren't providing relief.for acute pain, immediate-release formulations may only be needed for a few days.extended-release or long-acting formulations should be reserved for severe and persistent pain that requires a daily opioid for an extended time and that they shouldn't be used on an as-needed basis.opioids may cause opioid-induced hyperalgesia (OIH), symptoms of which include increased pain level with opioid dose increase, decreased pain level with opioid dose reduction or pain from ordinarily nonpainful stimuli without underlying disease progression, opioid tolerance or withdrawal, or addictive behavior. If OIH is suspected, the opioid dose should be decreased, or the patient switched to an alternative opioid. The Drug Safety Communication includes that health care providers should encourage patients to read the Medication Guide they receive with their filled prescription in addition to teaching the patient safe drug administration, storage, and disposal.  Adverse effects from the use of opioids should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: June 2023Nursing Drug Handbook© 2023 Wolters Kluwer
FDA Drug Warnings - January 2023
denosumabProliaNEW WARNINGThe FDA released a Drug Safety Communication to alert health care providers and patients on dialysis that denosumab may increase the risk of hypocalcemia. Severe and symptomatic hypocalcemia, including episodes requiring hospitalization and leading to death, have occurred. Prescribers should consider the risks of hypocalcemia before use in this patient population. Adequate calcium and vitamin D supplementation and frequent blood calcium monitoring may help decrease the likelihood or severity of these risks.Patients on dialysis should be advised to immediately seek help if they experience symptoms of hypocalcemia such as unusual tingling or numbness in the hands, arms, legs, or feet; painful muscle spasms or cramps; laryngeal or lung spasms causing difficulty breathing; vomiting; seizures; or irregular heart rhythm.Adverse effects from the use of denosumab should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787. Released: January 2023Nursing Drug Handbook© 2023 Wolters Kluwer
FDA Drug Warnings - June 2022
buprenorphineTransmucosal (buccal film or sublingual) NEW WARNINGThe FDA has published a Drug Safety Communication warning that dental problems have occurred with use of buprenorphine products that are dissolved in the mouth. Tooth decay, cavities, oral infections, and loss of teeth have been reported, even in patients with no history of dental issues. The FDA is requiring a warning be added to buprenorphine prescribing information.Prior to use of the transmucosal products, the health care provider should obtain an oral health history and refer patients to a dentist as soon as possible after starting the drug for a baseline dental evaluation, caries risk assessment, and caries preventative plan, and to encourage regular dental follow up.Patients using the transmucosal formulations should be instructed to allow the drug to completely dissolve then gently rinse their teeth and gums with water and swallow the water. Patients should wait at least one hour before brushing their teeth.Adverse effects from the use of transmucosal buprenorphine should be reported to the FDA's MedWatch Adverse Event Reporting Program either online, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mail at MedWatch 5600 Fishers Lane Rockville, MD 20852-9787.Released: June 2022Nursing Drug Handbook© 2022 Wolters Kluwer
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