Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Date |
|---|---|---|---|---|
| Live Varicella Vaccine | Varivax | 4.8 Undesirable effects | Syncope | Aug,2023 |
| Escitalopram Oxalate | Entapro | 4.8 Undesirable effects | Hyperprolactinaemia associated with Selective serotonin reuptake inhibitor (SSRIs)/ Serotonin and norepinephrine reuptake inhibitors (SNRIs) | Aug,2023 |
| Eliglustat | Cerdelga | 4.8 Undesirable effects | Cough | Aug,2023 |
| Covid-19 Vaccine (Ad26.Cov2-S [Recombinant]) | Covid-19 Vaccine Janssen | 4.4 Special Warnings and Special Precautions for Use | Risk of Myocarditis and pericarditis | Aug,2023 |
| Morphine Sulfate | Oramorph | 4.4 Special Warnings and Special Precautions for Use , 4.5. Interactions with other medicinal products , 4.8 Undesirable effects | Sleep-related breathing disorders, Severe cutaneous adverse reactions , Hepatobiliary disorders, Opioid Use Disorder (abuse and dependence) Interactions with gabapentin and pregabalin Central sleep apnoea syndrome, Pancreatitis, Spasm of sphincter of Oddi, Acute generalised exanthematous pustulosis , Drug dependence | Aug,2023 |
| Methotrexate | Jylamvo | "4.4 Special warnings and precautions for use , 4.5. Interactions with other medicinal products" | The concomitant use of ciprofloxacin with methotrexate is not recommended , Sleep-related breathing disorders, Severe cutaneous adverse reactions , Hepatobiliary disorders, Opioid Use Disorder (abuse and dependence) | Aug,2023 |