Approved to treat: Severe pain
Drug category: Opiate analgesics
Year Approved: 2009
Manufacturer: Roxane Laboratories, Inc.
Women who use opioid painkillers such as codeine during the first trimester of pregnancy face a doubled risk of giving birth to babies with serious and life threatening birth defects including:
- Hypoplastic Left Heart Syndrome (HLHS) – doubled risk
- Ventricular Septal Defects
- Atrial Septal Defects
- Tetralogy of Fallot
- Right Ventricular Outflow Tract Obstructions including Pulmonary Valve Stenosis
- Gastroschisis (herniation of the abdominal wall)
- Glaucoma (blocked eye fluid that increases pressure)
- Hydrocephaly (buildup of fluid inside the skull leading to brain swelling).
- Spina Bifida (neural tube defect)
Studies Find Link Between Opioid Medication Exposure and Birth Defects
The U.S. Centers for Disease Control and Prevention (CDC) sponsored a National Birth Defects Prevention Study, the results of which were released in March 2011. The study warned against the use of opioid pain relievers such as Codeine during pregnancy, stating that the drug could increase the chances of a serious birth defect such as congenital heart defects. Drugs included in this CDC report include codeine, oxycodone and hydrocodone.
The U.S. Food and Drug Administration (FDA) has given codeine a Category C rating for pregnant women, given its connection to serious and life-threatening birth defects. The FDA increases the C rating to the more serious D level when a pregnant woman takes codeine for longer than prescribed or in larger doses than intended. While the risk varies for each defect, one thing is clear: women should be warned of these dangerous and potentially fatal side effects before becoming pregnant. Unfortunately, the manufacturers of SSRI anti-depressants are not currently required to warn users of these increased risks and, as a terrible result, babies continue to be harmed.