Sulfa Drugs (Bactrim, Septra, Sulfatrim) and Hypersensitivity; Linezolid (Zyvox) and Rhabdomyolysis: Safety Label Updates June 2024
Sulfa Antibiotics Safety Label Updates
Five sulfa antibiotics had drug labels updated to strengthen warnings about the risk of serious hypersensitivity reactions. Patients are now advised to STOP taking the drug immediately if they experience any clinical signs such as rash, pharyngitis, fever, arthralgia, cough, chest pain, dyspnea, pallor, purpura or jaundice and to contact their healthcare provider as soon as possible. Affected drugs include:
SULFAMETHOXAZOLE AND TRIMETHOPRIM
In addition, the FDA reports that adverse events involving haemophagocytic lymphohistiocytosis have been reported for the sulfa drugs in the FDA’s Adverse Event Reporting system (FAERS). Because these have been identified as “potential signals of serious risks,” the FDA says it is “evaluating the need for regulatory action” for the drugs. Often, regulatory action results in drug safety label updates.
https://www.fda.gov/drugs/questions-and-answers-fdas-adverse-event-reporting-system-faers/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse
Hemophagocytic lymphohistiocytosis is a life threatening immune system reaction affecting both infants and adults that results in multi-organ failure. Read more about the condition in StatPearls:
https://www.ncbi.nlm.nih.gov/books/NBK557776/
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Antibiotic Zyvox (linezolid) and Rhabdomyolysis
Antibiotic Zyvox (linezolid) had a drug safety label update to warn of the risk of rhabdomyolysis. Rhabdomyolysis is the breakdown of muscle tissue that leads to the release of muscle fiber contents into the blood. Once in the blood, the substance, called myoglobin, may cause kidney damage. A telltale sign of this condition is very dark urine.
Patients are advised to discontinue Zyvox and start appropriate therapy if signs of rhabdomyolysis occur. Symptoms may include muscle pain or weakness, dark urine, and elevated creatine phosphokinase. Zyvox is a oxazolidinone-class antibacterial used for certain types of bacterial infections like pneumonia and infections of the skin.
FDA Safety Label Update for Zyvox
Rhabdomyolysis may also be caused by injury or any other condition that damages skeletal muscle. Read more about rhabdomyolysis at Medline Plus:
https://medlineplus.gov/ency/article/000473.htm
A University of Texas study from 2019 analyzed the association between rhabdomyolysis and many available antibiotics from the FDA Adverse Event Report System (FAERS). The study “confirms prior evidence for rhabdomyolysis associations with daptomycin, macrolides, trimethoprim-sulfamethoxazole, linezolid, fluoroquinolones, and cefdinir. This study also identifies previously unknown rhabdomyolysis associations with meropenem, cefditoren, cefaclor, and piperacillin-tazobactam.” The study may be accessed here:
https://pubmed.ncbi.nlm.nih.gov/31673242/
Teng C, Baus C, Wilson JP, Frei CR. Rhabdomyolysis Associations with Antibiotics: A Pharmacovigilance Study of the FDA Adverse Event Reporting System (FAERS). Int J Med Sci. 2019 Oct 15;16(11):1504-1509. doi: 10.7150/ijms.38605. PMID: 31673242; PMCID: PMC6818202.
Read or add your Ratings for Zyvox on Ask a Patient website.
Check out other Drug Safety Label Updates here:
https://news.askapatient.com/s/fda-drug-safety-warnings-for-popular
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