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FDA Drug Warnings - March 2024


denosumab

Prolia

NEW WARNING

The 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 2024

Nursing Drug Handbook

© 2024 Wolters Kluwer

Drug Warnings Archive


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 - 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