Women who are pregnant should avoid drugs used to treat hypertension, or high blood pressure, because they have been associated with injury and death to developing fetuses. The Food and Drug Administration (FDA) issued a safety communication informing doctors and patients that labeling for Angiotensin Converting Enzyme Inhibitors (ACEI) and Angiotensin Inhibitor Blockers (ARB) will now carry a black box warning about the risk for fetal toxicity. The drug has also be reclassified as a Pregnancy Category D drug, meaning studies prove that using the drugs during pregnancy can cause birth defects.
ACEIs and ARBs are drugs that act directly on the renin-angiotensin system, a hormone system that regulated blood pressure and water balance. Use of these drugs during the second and third trimesters of pregnancy reduces fetal renal function and increases fetal and neonatal morbidity and death. The FDA advises ACEIs and ARBs be discontinued immediately in women as soon as pregnancy is detected.
ACEIs and ARBs include the following medications:
• Accupril (quinapril hydrochloride) 5 mg, 10 mg 20 mg, 40 mg Tablets
• Accuretic (quinapril HCl/ hydrochlorothiazide) 10/12.5 mg, 20/12.5 mg, 20/25 mg Tablets
• Altace (ramipril) 1.25, 2.5, 5, and 10 mg Tablets
• Avalide (irbesartan/hydrochlorothiazide) Tablets, 150/12.5 mg and 300/12.5 mg
• Avapro (irbesartan) 75 mg, 150 mg, and 300 mg Tablets
• Azor (amlodipine/olmesartan) 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
• Benicar HCT (olmesartan medoxomil/hydrochlorothiazide) 20/12.5 mg, 40/12.5 mg, and 40/25 mg Tablets
• Diovan (valsartan) 40 mg, 80 mg, 160 mg, and 320 mg Tablets
• Diovan HCT (valsartan/hydrochlorothiazide) 80/12.5 mg, 160/12.5 mg,160/25 mg, 320/12.5 mg, and 320/25 mg Tablets
• Exforge (amlodipine/valsartan) 5/160 mg, 10/160 mg, 5/320 mg, and 10/320 mg Tablets
• Exforge HCT (amlodipine/valsartan/hydrochlorothiazide) 5/160/12.5 mg, 10/160/12.5 mg, 5/160/25 mg, 10/160/25 mg, and 10/320/25 mg Tablets
• Lotensin (benazapril) 5 mg, 10 mg, 20 mg, and 40 mg Tablets
• Lotensin HCT (benazapril/hydrochlorothiazide) 5/6.25 mg, 10/12.5 mg, 20/12.5 mg, and 25/25/mg Tablets
• Lotrel (amlodipine besylate and benazepril hydrochloride) 2.5/10 mg, 5/10 mg, 5/20 mg, 10/20 mg, 5/40 mg, and 10/40 mg Tablets
• Mavik (trandolapril) 1 mg, 2 mg and 4 mg Tablets
• Micardis (telmisartan) 20 mg, 40 mg, and 80 mg Tablets
• Micardis HCT (telmisartan/hydrochlorothiazide) 40/12.5 mg, 80/12.5 mg, and 80/25 mg Tablets
• Tarka (trandolapril/verapamil hydrochloride) 2/180 mg, 1/240 mg 2/240 mg and 4/240 mg Tablets
• Teveten (eprosartan mesylate) 400 mg and 600 mg Tablets
• Teveten HCT (eprosartan mesylate/hydrochlorothiazide) 600/12.5 mg and 600/25 mg Tablets
• Tribenzor (olmesartan medoxomil/amlodipine/hydrochlorothiazide) 20/5/12.5 mg, 40/5/12.5 mg, 40/5/25 mg, 40/10/12.5 and 40/10/25 mg Tablets
The new safety labels not only include the boxed warning, but also have information about the fetal toxicity risk listed under Warnings, Precautions, and Adverse Reactions sections of the drugs’ safety labels. Information is also included in the patient package insert and the medication guide.
This is only the latest medication to be linked to birth defects. Using antidepressant known as selective serotonin reuptake inhibitors, or SSRIs, during pregnancy can increase the risk of various birth defects, whether the drugs are used early or late in pregnancy. SSRIs include the brand name drugs Paxil, Prozac, Zoloft and Celexa. Reported problems include heart defects and a life threatening lung defect known as persistent pulmonary hypertension, or PPHN.