Appendix 1.
List of Antidiabetic Medications* by Duration of Action (Where Applicable) and U.S. Food and Drug Administration Pregnancy Category and Approval Date
| Medication Class and Name | Duration of Action |
FDA Pregnancy Category |
FDA* Approval Date |
|---|---|---|---|
| Insulin | |||
| Insulin Zinc Extended | Long | B | |
| Insulin Glargine | Long | B | 4/20/2000 |
| Insulin Detemir | Long | B | 6/16/2005 |
| Insulin Aspart | Rapid | B | 6/7/2000 |
| Insulin Lispro | Rapid | B | |
| Insulin Glulisine | Rapid | B | 4/16/2004 |
| Insulin Isophane | Intermediate | B | |
| Insulin Zinc | Intermediate | B | |
| Insulin Regular | Short | B | |
| Insulin Regular Powder Inhale | Short | B | |
| Insulin Isophane and Reg | Varied | B | |
| Insulin Aspart Protamine and Aspart | Varied | B | 11/1/2001 |
| Insulin Lispro Protamine and Lispro | Varied | B | |
| Thiazolidinediones | |||
| Pioglitazone | C | ||
| Rosiglitazone | C | ||
| Troglitazone† | B | ||
| Biguanides | |||
| Metformin | B | ||
| Sulfonylureas | |||
| Acetohexamide | C | ||
| Glipizide | C | ||
| Glyburide | C | ||
| Tolazamide | C | ||
| Glimepiride | C | ||
| Chlorpropamide | C | ||
| Tolbutamide | C | ||
| Dipeptidyl Peptidase-4 Inhibitors | |||
| Saxagliptin | B | 7/31/2009 | |
| Sitagliptin | B | 10/16/2006 | |
| Incretin Mimetic Agents | |||
| Exenatide | C | 4/28/2005 | |
| Alpha Glucosidase Inhibitors | |||
| Miglitol | B | ||
| Acarbose | B | ||
| Meglitinide Analogs | |||
| Repaglinide | C | ||
| Nateglinide | C | 12/22/2000 | |
| Amylin Analog | |||
| Pramlintide | C | 3/16/2005 | |
| Combination Products | |||
| Sitagliptin-Biguanide | B/B | 3/30/2007 | |
| Saxagliptin-Biguanide | B/B | 11/5/2010 | |
| Repaglinide-Biguanide | C/B | 6/23/2008 | |
| Pioglitazone-Biguanide | C/B | 8/29/2005 | |
| Rosiglitazone-Biguanide | C/B | 10/10/2002 | |
| Pioglitazone-Glimepiride | C/C | 7/28/2006 | |
| Rosiglitazone-Glimepiride | C/C | 11/23/2005 | |
| Glipizide-Biguanide | C/B | 10/21/2002 | |
| Glyburide-Biguanide | C/B | 7/31/2000 |
FDA, U.S. Food and Drug Administration.
Approval dates are listed if the approval date was on or after January 1, 2000. Empty cells indicate that the drug was approved before January 1, 2000.
Troglitzone was removed from the U.S. market on March 22, 2000. All other drugs remained on the market from their approval date through the end of the study.
FDA Pregnancy Category B: Either animal-reproduction studies have not demonstrated a fetal risk, but no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the first trimester (and there is no evidence of a risk in later trimesters).
FDA Pregnancy Category C: 1) Animal reproduction studies have shown an adverse event on the fetus (teratogenic or embryocidal or other) and there are no adequate and well-controlled studies in humans, no adequate and well controlled studies in pregnant women, or no animal reproduction studies and no adequate and well-controlled studies in humans. Drugs should be given only if the potential benefit justifies the potential risk to the fetus.