TABLE 6.
Regulatory pharmacovigilance actions based on unknown drug-ADR pairs.
| Unknown drug-ADR pairs | Generated a pharmacovigilance signal (n = 11) | Assessed in periodic pharmacovigilance reports (n = 7) | Added to the SmPC (n = 8) |
|---|---|---|---|
| Alemtuzumab—Lymphohistiocytosis | — | ✓ | ✓ |
| Azithromycin and hydroxychloroquine a —Life-threatening cardiac events | ✓ | — | — |
| Ceftriaxone—Encephalopathy | ✓ | — | ✓ |
| COVID-19 vaccines - Thrombotic events | ✓ | — | — |
| Dabrafenib—Disseminated intravascular coagulation | ✓ | — | — |
| Glatiramer acetate—Hepatitis | — | ✓ | ✓ |
| Levonorgestrel—Arthralgia | ✓ | — | — |
| Metamizole—Mixed liver injury | — | ✓ | ✓ |
| COVID-19 Vaccine (chadox1-S)—Pleuropericarditis | ✓ | — | — |
| Sacubitril/valsartan—Ventricular tachycardia | ✓ | — | — |
| Teriflunomide—Hyperlipidemia | ✓ | — | ✓ |
| Teriflunomide—Mixed liver injury | — | ✓ | ✓ |
| Tocilizumab—Acute pancreatitis | ✓ | — | |
| Tozinameran—Drowsiness | — | ✓ | ✓ |
| Tozinameran—Paresthesia | — | ✓ | ✓ |
| Tozinameran—Worsening of autoimmune hepatitis | ✓ | — | — |
| Tozinameran—Thrombocytopenia | ✓ | — | — |
| Vedolizumab—Gastrointestinal and systemic infections | — | ✓ | — |
a
(Drugs used in the first wave for COVID-19).
SmPC, summary of product characteristics.