TABLE 5.
Characteristics of alerts for drugs under ‘additional monitoring.’
| ADR | Drug | ATC first level | Modification of the SmPC |
|---|---|---|---|
| Osteonecrosis mandibular | Aflibercept | L | Yes |
| Hepatitis and hepatocarcinoma | Direct agent antiviral | J | No |
| Ketoacidosis | Canagliflozin and other gliflozins | A | Yes |
| Limb amputation | No | ||
| Cardiovascular risk and hemorrhage | Cilostazol | C | Yes |
| Hepatitis | Daratumumab | L | Yes |
| Osteonecrosis and hypocalcemia | Denosumab | M | No |
| Neural tube defect | Dolutegravir | J | No |
| Arrhythmia, lymphoma, congenital malformation, skin cancer, and opportunistic infection | Fingolimod | L | Yes |
| Infection | Idelalisib | L | No |
| VHB reactivation | Immunosuppressants | L | No |
| Hypersensitivity | Iron isomalthose | B | No |
| Progressive multifocal leukoencephalopathy | Natalizumab | L | Yes |
| Liver failure and liver decompensation | Paritaprevir/ombitasvir/ritonavir | J | Yes |
| Hepatitis | Pomalidomide | L | Yes |
| Bone fracture and death | Radium dichloride | V | No |
| Ocular and skin pigmentation | Retigabine | N | No |
| Death and respiratory infection | Riociguat | C | Yes |
| Toxicity and inefficacy | Selexipag | L | No |
| Bradycardia and cardiac block | Sofosbuvir/ledipasvir/daclatasvir– amiodarone | J | Yes |
| Cardiovascular risk and skin reaction | Strontium ranelate | M | Market withdrawal |
| Pulmonary thromboembolism and death | Tofacitinib | L | Yes |
| Venous thrombosis and infection | No | ||
| Hepatitis | Tyrosine kinase inhibitors | L | Yes |
SmPC, summary of product characteristics