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FDA Drug Warnings - June 2023


onasemnogene abeparvovec-xioi

Zolgensma

NEW WARNING

The 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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer
 


opioid drug class

Various manufacturers

NEW WARNING

The 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:

  • buprenorphine
  • butorphanol tartrate
  • codeine phosphate–acetaminophen
  • codeine sulfate
  • butalbital–acetaminophen–caffeine–codeine–phosphate 
  • butalbital–aspirin–caffeine–codeine phosphate
  • fentaNYL citrate
  • HYDROcodone bitartrate
  • HYDROcodone bitartrate–acetaminophen
  • HYDROcodone bitartrate–ibuprofen
  • HYDROmorphone hydrochloride
  • meperidine hydrochloride
  • methadone hydrochloride
  • morphine hydrochloride
  • nalbuphine hydrochloride
  • oliceridine
  • oxyCODONE
  • oxyCODONE hydrochloride
  • oxyCODONE hydrochloride–acetaminophen
  • oxyCODONE hydrochloride–aspirin
  • oxyMORphone hydrochloride
  • SUFentanil
  • tapentadol hydrochloride
  • traMADol hydrochloride
  • traMADol 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 2023

Nursing Drug Handbook

© 2023 Wolters Kluwer

Drug Warnings Archive


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 - February 2022
Janus kinase (JAK) inhibitorsVarious manufacturersNEW WARNINGThe FDA has issued a Drug Safety Communication to inform patients and health care providers that the Boxed Warning in the prescribing information for JAK inhibitors indicated for the treatment of arthritis and other inflammatory conditions is being revised.JAK inhibitors include baricitinib (Olumiant), tofacitinib (Xeljanz and Xeljanz XR), and upadacitinib (Rinvoq).The Boxed Warning information related to the risks of serious heart-related events, cancer, blood clots, and death must state that health care providers should consider the benefits and risk for each patient prior to starting or continuing therapy with baricitinib, tofacitinib, and upadacitinib. The risks of these events are increased in patients who are current or past smokers, those with other CV risk factors, those who develop a malignancy, and those with a known malignancy other than successfully treated nonmelanoma skin cancer. Because of these risks, use of these drugs should be reserved for patients who have had an inadequate response or intolerance to one or more tumor necrosis factor blocker.Patients should be advised of the benefits and risk of these drugs and to seek emergency medical attention if they experience signs and symptoms of a heart attack, stroke, or blood clot.Adverse effects from the use of JAK inhibitors 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 2022Nursing Drug Handbook© 2022 Wolters Kluwer