Drug Safety Labeling Changes: May 2024 Part 2
Bupropion, cancer drug Imbruvica, R.A. med Xeljanz, fertility treatment follitropin, antipsychotic Rexulti, Philips Respironics Trilogy Evo ventilators
Some bupropion-containing medications (such as antidepressant Wellbutrin and Aplenzin, and weight loss drug Contrave) received safety label changes to add the risk of severe skin disorders, Stevens-Johnson syndrome, acute generalized exanthematous pustulosis, and drug reaction with eosinophilia and systemic symptoms (DRESS).
Wellbutrin:
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=172
Cancer drug Imbruvica (ibrutinib) had a drug safety label update to warn of severe cases of hepatoxicity, including severe, life-threatening, and potentially fatal cases of drug-induced liver injury (DILI). Health care providers are advised to evaluate bilirubin and transaminases at baseline and throughout treatment with Imbruvica. https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=369
Rheumatoid arthritis and ulcerative colitis drug Xeljanz (tofacitinib) and Xeljanz XR, also now approved for juvenile arthritis, had a safety label update to include acne as a side effect.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1236
Fertility drug GONAL-F RFF REDI-JECT (Follitropin Alpha/Beta) had a drug safety label update to warn of vascular disorders, including thromboembolism, ovarian cysts, and ectopic pregnancy. The label now also lists the symptoms of ectopic pregnancy (pregnancy outside your womb).
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=2958
Antidepressant/antipsychotic drug Rexulti (Brexpiprazole) had a drug safety label update to include pediatric trials information to indicate that the effectiveness of REXULTI for the treatment of schizophrenia has not been established in pediatric patients less than 13 years of age and that the safety and effectiveness of REXULTI for the treatment of irritability associated with autism spectrum disorder has not been established in pediatric patients. Also included in the label updates are the results of juvenile animal studies.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=443
Rexulti reviews at Ask a Patient web site
Philips Respironics is providing a crucial software update for its Trilogy Evo continuous ventilators. The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices without the software update may cause serious injuries or death. This applies to products distributed between March 20, 2019 and February 16, 2024, affecting about 90,905 respirators in the U.S., which may be used in institutional or home settings. Due to a software issue, these ventilators can issue a “Battery Depleted” or “Loss of Power” alarm while sufficient power is still available, resulting in a sudden loss of ventilation while the device alarms.
https://www.fda.gov/medical-devices/medical-device-recalls/philips-respironics-inc-recalls-trilogy-evo-continuous-ventilators-due-software-related-possible
Did you miss the May 2024 Part 1 safety updates? Check it out here:
