Table 3.
Fatal adverse drug reactions reported for medicines prescribed off-label (age) from 1998 to 2007
| Case | ATC | Medicine (s) | ADR(s) reported | Indication for use | Gender | Age (years) |
|---|---|---|---|---|---|---|
| 1 | A07EC02 | Mesalazine | Disseminated intravascular coagulation | Ulcerative enterocolitis | Male | 16 |
| 2 | C01EB16 | Ibuprofen | Necrotizing colitis | Patent ductus arteriosus | Male | 0 |
| 3 | C01EB16 | Ibuprofen | Necrotizing colitis | Patent ductus arteriosus | Male | 0 |
| 4 | C02KX01 | Bosentan | Right ventricular failure | Pulmonary hypertension | Male | 12 |
| 5 | D10BA01 | Isotretinoin | Cardiac failure | Acne | Female | 15 |
| 6 | G03AA09 | Desogestrel/oestrogen | Pulmonary embolism | Hormonal contraception | Female | 17 |
| 7 | G03AA12 | Drospirenon/ethinylestradiol | Pulmonary embolism | Hormonal contraception | Female | 17 |
| 8 | G03AA10 | Norgestimat/ethinylestradiol | Brain stem thrombosis | Hormonal contraception | Female | 17 |
| 9 | G03AA09 | Ethinylestradiol/desogestrel | Pulmonary embolism | Hormonal contraception | Female | 17 |
| 10 | H02AB04 | Methylprednisolone | Bradycardia, cardiac arrest.bronchospasm | Status asthmaticus | Female | 15 |
| 11 | L01BA01 | Methotrexate | Guillain-Barre syndrome | NA | Male | 11 |
| 12 | L01XE02 | Gefitinib | Toxic epidermal necrolysis | Adrenal carcinoma | Male | 15 |
| 13 | N03AX | Felbamat | Sudden death | NA | Female | 17 |
NA Information not available.