Vasotec (enalapril)
Prinivil, Zestril (lisinopril)
Lotensin (benazepril)
Monopril (fosinopril)
Altace (ramipril)
Accupril (quinapril)
Aceon (perindopril)
Mavik (trandolapril)
Univasc (moexipril)
The alternatives drugs that doctors should prescribe for pregnant women with high blood pressure are diuretics, alpha-methyldopa, some beta-blockers, and the calcium-channel blocker nifedipine, according to FDA officials and Dr Friedman in his editorial.
But the fact remains that drug companies have known that these drugs posed a danger to the fetus and they should have been banned from use by all pregnant women 15 years ago. Claiming the drugs were not dangerous in the first trimester of pregnancy even though they were known to be lethal in the second and third trimesters, was just plain silly.
This is just another blatant example of drug companies putting profits over the lives of patients.
In a review published by Briggs et al in 1998, of 40 newborns exposed to enalapril during the first trimester, four or 10% of the babies, had major birth defects, including two cardiovascular anomalies and one polydactyly.
The results of a study reported in 1998, on 15 newborns exposed to lisinopril during the first trimester, showed two, or 13.3% the infants, to have major birth defects, including one polydactyly, according to Briggs GG, Freeman RK, Yaffe SJ, Drugs in pregnancy and lactation, Baltimore, Md: Williams & Wilkins; 1998.
Intrauterine growth restriction, prematurity, persistence of patent ductus arteriosus, severe neonatal hypotension, neonatal anuria, and neonatal or fetal death have all been observed with the use of ACE inhibitors, reported by Barr M Jr, Teratogen update: angiotensin-converting enzyme inhibitors, Teratology 1994;50:399-409.
In 1997, animal data revealed increased morbidity and mortality in fetuses exposed to ACE inhibitors in utero. Decreased uteroplacental blood flow, low birth weight, hypotension, preterm delivery, and fetal death were noted by Mastrobattista JM. Angiotensin-converting enzyme inhibitors in pregnancy, Semin Perinatol 1997;21:124-34.
In 1994, a prospective placebo-controlled study of baboons was reported that showed a significant increase in fetal death or fetal growth restriction in 4 out of 13 baboons in the group treated with enalapril compared with no events among the controls, according to Harewood WJ, Phippard AF, Duggin GG, Horvath JS, Tiller DJ. Fetotoxicity of angiotensin-converting enzyme inhibition in primate pregnancy: a prospective, placebo-controlled study in baboons (Papio hamadryas), Am J Obstet Gynecol 1994;171:633-42.
The FDA reported known risks back in a 1991 summary of 85 pregnancies during which women were exposed to ACE inhibitors, where 11 deaths occurred, including 6 stillbirths and five neonatal deaths, reported in the Journal Obstet Gynecol 1991;78:128-35.
Twenty-nine cases of perinatal renal failure in association with maternal use of ACE inhibitors were listed by the FDA in 1991. On March 13, 1992, the FDA announced that all ACE inhibitors, "will be required to carry a "boxed warning" on the label for women in the advanced stages of pregnancy."
"At the agency's request," the FDA said, "six pharmaceutical companies are simultaneously sending out a "Dear Doctor" letter emphasizing that women who take the drug in the second and third trimesters of pregnancy are running the risk of causing significant harm to fetuses, including kidney failure and face or skull deformities."
For several years, labeling for ACE inhibitors had warned of the risks, but the FDA noted that additional cases continued to be reported.
"More than 50 cases of fetal harm have been reported over the past several years," it noted. "The warnings in the labeling are therefore being strengthened by including a boxed warning and other changes."
Pharmacists were also alerted to the labeling change and were asked to counsel women of child bearing age who were taking ACE inhibitors. They were also provided stickers that read, "If you become pregnant consult your doctor promptly about switching to a different drug," to place directly on prescription bottles.
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