Drug Safety Labeling Changes: May 2024 Part 1
Psoriasis med Otezla and Pain meds Oxycodone and Roxycodone
Plaque psoriasis drug Otezla (Apremilast) had a safety label update to provide clinical trials results that show weight loss side effect. In the trial, adults that showed weight loss of 5 – 10% of body weight occurred in 12% of patients taking the drug compared with 5% of those patients treated with placebo. In the pediatric trial of patients age 6 to 17 years old, weight decrease also occurred in 12% of subjects taking the drug compared with 2.5% of those subjects treated with placebo. Providers are advised to closely monitor growth (height and weight) in OTEZLA-treated pediatric patients.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=1122
Read patient reviews of Otezla on Ask a Patient website
Patients on Ask a Patient are fairly satisfied with Celgene’s Otezla; it has an average rating of 3.2 on a scale of 1 -5.
Opioid pain drugs Oyxodone (oxycodone hydrochloride), Oxycontin, Roxicodone, Percodan, and similar drugs had safety label updates to provide lactation study results. The labels say that drug presence can be detected in breast milk but dosages of less than 60mg per day are unlikely to result in clinically relevant exposures in breastfed infants. Many women are prescribed the medications for postpartum pain and post-C-section surgery.
https://www.accessdata.fda.gov/scripts/cder/safetylabelingchanges/index.cfm?event=searchdetail.page&DrugNameID=681