Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Month |
|---|---|---|---|---|
| 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 |
| Levonorgestrel | Mirena | 4.6. Fertility, pregnancy and lactation | "Levonorgestrel is contraindicated for use in pregnant patients it increased risk of miscarriage, sepsis, premature labor, and premature delivery. Lactation: The incidence of uterine perforation appears higher in lactating patients" | Aug,2023 |
| Golimumab | Simponi | 4.6. Fertility, pregnancy and lactation | Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy | Aug,2023 |
| Upadacitinib | Rinvoq | 4.6. Fertility, pregnancy and lactation | Reproted pregnancy adverse evnets from pharmacovigilance safety database, and animal stuieds eports. | Aug,2023 |