Publication details
RIZIKA GENERICKÉ SUBSTITUCE V DŮSLEDKU ZMĚN API V PRŮBĚHU EXSPIRACE LÉČIVÉHO PŘÍPRAVKU
| Title in English | RISKS OF GENERIC SUBSTITUTION DUE TO API CHANGES DURING DRUG EXPIRATION |
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| Authors | |
| Year of publication | 2024 |
| MU Faculty or unit | |
| Citation | |
| Description | Warfarin, a drug with a narrow therapeutic index, exists in two main forms: amorphous (WSA) and clathrate with isopropanol (WSC). Both forms used orally to prevent and treat thromboembolic disease through inhibition of vitamin K-dependent clotting factors. His Warfarin's toria is marked by controversy over its generic substitution. Tablet replacements with WSA and WSC have been associated with cases of increased the risk of bleeding, which has led to a ban on generic substitutions in some countries; including the USA. The reasons for these side effects have been debated, with Differences in the quality of the substance, the content of the drug or the effect of preparation methods. Although the ban on generic substitutes was later lifted in the US, Questions about the safety of generic replacements remain. This is evidenced by the fact that the long-ago withdrawal of some generic products from the US market. |