Drugs Safety Labeling Updates
Drugs Safety Labeling Updates
| Scientific Name | Trade Name | Updated Section | Safety-Related Labeling Changes | Month |
|---|---|---|---|---|
| TELMISARTAN | MICARDIS | 4.8. Undesirable Effects | 4.8. Undesirable Effects Hyponatremia | Dec,2022 |
| mercaptopurine | Purinethol | 4.8. Undesirable effects | 4.8. Undesirable effects Erythema nodosum | Dec,2022 |
| upadacitinib | RINVOQ | 4.4. Special warnings and precautions for use 4.8. Undesirable effects | 4.4. Special warnings and precautions for use "Hypersensitivity reactions Serious hyper sensitivity reactions such as anaphylaxis and angioedema have been reported in patients receiving upadacitinib. If a clinically significant hypersensitivity reaction occurs, discontinue upadacitinib and institute appropriate therapy (see sections" 4.8. Undesirable effects Serious hypersensitivity reactions | Dec,2022 |
| Itraconazole | SPORANOX | 4.4 Special warnings and precautions for use | 4.4 Special warnings and precautions for use "Coadministration of specific drugs with itraconazole may result in changes in efficacy of itraconazole and/or the coadministered drug, life -threatening effects and/or sudden death." | Dec,2022 |
| levothyroxine | EUTHYROX | 4.4 Special warnings and precautions for use 4.5 Interaction with other medicinal products and other forms of interaction | 4.4 Special warnings and precautions for use "Interferences with laboratory test: Biotin may interfere with thyroid immunoassays that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results.The risk of interference increases with higher doses of biotin. When interpreting results of laboratory tests, possible biotin interference has to be taken into consideration, especially if a lack of coherence with the clinical presentation is observed. For patients taking biotin-containing products, laboratory personnel should be informed when a thyroid function test is requested. Alternative tests not susceptible to biotin interference should be used, if available" 4.5 Interaction with other medicinal products and other forms of interaction "Interferences with laboratory test: Biotin may interfere with thyroid immunoassays that are based on a biotin/streptavidin interaction, leading to either falsely decreased or falsely increased test results" | Nov,2022 |
| Gabapentin | NEURONTIN | 4.6 Fertility, pregnancy and lactation | 4.6 Fertility, pregnancy and lactation Neonatal withdrawal syndrome | Nov,2022 |