Table 2.
Cardiovascular drugs with studies performed for pediatric exclusivity that have resulted in labeling changes
| Drug name, trade (generic) | Indication studied | Trial “N” | Safety extension phase | Label date | New pediatric information on drug label | ||||
|---|---|---|---|---|---|---|---|---|---|
| PK | Dose | Safety | Liquid suspension | Efficacy demonstrated | |||||
|
| |||||||||
| Betapace (sotalol) | Arrhythmia | 25 | − | 10/01 | + | + | + | + | Not evaluated |
|
| |||||||||
| Vasotec (enalapril) | Hypertension | 110 | − | 02/01 | + | + | + | + | Yes |
|
| |||||||||
| Monopril (fosinopril) | Hypertension | 252 | + (1 yr) | 05/03 | + | + | + | − | No |
|
| |||||||||
| Prinivil (Lisinopril) | Hypertension | 115 | − | 05/03 | + | + | + | + | Yes (6–16 yrs) |
|
| |||||||||
| Zestril (Lisinopril) | Hypertension | 115 | − | 07/03 | + | + | + | + | Yes (6–16 yrs) |
|
| |||||||||
| Norvasc (amlodipine) | Hypertension | 268 | − | 01/04 | + | + | + | − | No |
|
| |||||||||
| Lotensin (benazepril) | Hypertension | 144 | − | 03/04 | + | − | + | + | No |
|
| |||||||||
| Cozaar (losartan) | Hypertension | 177 | − | 03/04 | + | + | + | + | Yes (6–16 yrs) |
|
| |||||||||
| Avapro (irbesartan) | Hypertension | ? | − | 03/06 | − | − | − | − | No |
|
| |||||||||
| Diovan (valsartan) | Hypertension | 351 | − | 11/07 | + | + | + | + | Yes |
|
| |||||||||
| Inspira (eplerenone) | Hypertension | 304 | + (1 yr) | 01/08 | + | − | + | − | No |
|
| |||||||||
| Atacand (candesartan) | Hypertension | 333 | + (1 yr) | 10/09 | + | + | + | + | Yes |
|
| |||||||||
| Benicar (olmesartan) | Hypertension | 302 | − | 02/10 | + | + | + | + | Yes (> 6yrs) |
|
| |||||||||
| Corlopam (fenoldopam) | Hypertension | 77 | − | 04/04 | + | + | + | − | Yes |
|
| |||||||||
| Nitropress (Na nitroprusside) | Hypertension | 266 | − | 11/13 | + | + | + | − | Yes |
|
| |||||||||
| Toprol XL (metoprolol) | Hypertension | 144 | − | 11/13 | + | − | + | − | No |
|
| |||||||||
| Mevacor (lovastatin) | Heterozygous familial hypercholesterolemia | 180 | + (48 wk) | 02/02 | − | + | + | − | Yes (10–17yrs) |
|
| |||||||||
| Lipitor (atorvastatin) | Heterozygous familial hypercholesterolemia | 187 | + (1 yr) | 10/02 | − | + | + | − | Yes (10–17yrs) |
|
| |||||||||
| Pravachol (pravastatin) | Heterozygous familial hypercholesterolemia | 214 | + (2yr) | 10/02 | − | + | + | − | Yes (8–18yrs) |
|
| |||||||||
| Zocor (simvastatin) | Heterozygous familial hypercholesterolemia | 175 | + (48 wk) | 10/02 | − | + | + | − | Yes (10–17 yrs) |
|
| |||||||||
| Lescol (fluvastatin) | Heterozygous familial hypercholesterolemia | 114 | + (2 yr) | 04/06 | − | + | + | − | Yes (10–16yrs) |
|
| |||||||||
| Zetia and Vytorin (ezetimibe ± simvastatin) | Heterozygous familial hypercholesterolemia | 248 | + (33 wk) | 06/08 | − | + | + | − | Yes (10–17yrs) |
|
| |||||||||
| Welchol (colesevelam) | Heterozygous familial hypercholesterolemia | 194 | + (29 wk) | 10/09 | − | + | + | + | Yes (10–17yrs) |
|
| |||||||||
| Crestor (rosuvastatin) | Heterozygous familial hypercholesterolemia | 176 | + (1 yr) | 10/09 | − | + | + | − | Yes (10–17yrs) |
|
| |||||||||
| Revatio (sildenafil) | Pulmonary arterial hypertension | 184 | + (2 yr) | 08/12 | − | − | + | + | No |
|
| |||||||||
| Plavix (clopidogrel) | Prevention of shunt thrombosis | 1006 | − | 05/11 | − | − | − | − | No |
|
| |||||||||
| Coreg (carvedilol) | Heart failure | 161 | + (8 mo) | 02/07 | − | − | + | − | No |
? Irbesartan trials remain unpublished and details are not readily available