Table 4.
Comparison of selected drugs from Drug Safety Update alerts produced for the populations of interest and the YC reports received during the years 2001–10
| Medication | Cohort | Drug alert reason (date) | ADR (number and date) reported to YC from that cohort |
|---|---|---|---|
| Lopinavir and ritonavir | Neonate | Neonatal administration error (October 2007) | 0 |
| Codeine | Neonate and infant | Transplacental fatality (November 2007), Restricted use in children <12 years (June and July 2013) | 0 |
| Ceftriaxone | Neonate | Incompatible with calcium infusions (October 2009) | 0 |
| Domperidone | Neonate and infant | Cardiac side effects (May 2012, May and September 2014) | 10 (2001 (diarrhoea), 2004 (dystonia) 2005 (irritability & gynaecomastia), 2006 × 5 (death out of hospital; trembling and muscle spasm; deranged LFTs; drowsiness with O2 requirement; worsening dystonia), 2010 × 2 (pruritis and increased instability)) |
| Caffeine | Neonate | Check dose as two forms (August 2008, September 2008, June 2012), Single form now used (August 2013) | 5 (2001 × 3 (all extravasations with tissue injury), 2007 (tachycardia and tachypnoea), 2010 (vasoconstriction)) |
| Corticosteroids (including individual drug names) | Neonate | Psychiatric side effects (September 2007) | 3 (2007 × 3 (Cushing's, Benign Intracranial Hypertension × 2)) |
| Codeine | Transmammary | Neonatal death following maternal use (November 2007, October 2010, December 2012, June 2013, July 2013) | None |
| ACE inhibitors and angiotensin II receptor antagonists | Transmammary | Updated advice during breastfeeding – not recommended but not contraindicated (July 2009) | None |
| Antipsychotics | Transplacental | Increased extrapyramidal and/or withdrawal ADRs in infants if used in third trimester (September 2011) | 9 (2004 (Lethargy [olanzapine]), 2005 (gastroschisis [haloperidol]), 2006 (agitation [olanzapine]), 2007 (macrosomia [olanzapine]), 2008 × 2 (both congenital anomalies [olanzapine]), 2009 × 2 (failure to thrive [quetiapine], congenital anomaly [quetiapine]), 2010 (congenital anomaly [quetiapine) |
| Sodium Valproate | Transplacental | Avoid in pregnant women unless no alternative (November 2013) | 2001 (congenital anomaly), (2005 × 2 (jittery, floppy with abnormal LFTs), 2006 (congenital anomaly), 2007 (fetal anticonvulsant syndrome) |