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