ACE inhibitors (angiotensin-converting enzyme) are used for monitoring blood pressure, treating heart failure and preventing kidney damage in people with hypertension or diabetes. ACE inhibitors have been on the market for 25 years, and work by relaxing blood vessels and increasing blood flow to the heart. Sales of ACE inhibitors last year in the United States topped $3.8 billion, with about 150 million prescriptions filled, according to IMS Health, a pharmaceutical information company. The top-selling ACE Inhibitors include Lotrel, Altace and Lisinopril.
New Data On June 7, 2006 results from a new study determined that children whose mothers took ACE inhibitors within their first trimester were more than twice as likely to be born with severe brain and heart ailments, as compared to those not exposed to any blood pressure-lowering medicines. The latest statistics from a national survey found the number of ACE inhibitor prescriptions given to childbearing women enlarged from 1.4 million in 1995 to 2.7 million in 2002. In the report, researchers examined Medicaid records on 29,507 Tennessee infants born between 1985 and 2000. Out of the 29,507, 411 babies had mothers, who took a blood pressure drug at least once during their first trimester.
FDA Warnings ACE inhibitors currently bear a strong FDA black box warning about their dangers in the later stages of pregnancy. ACE Inhibitors labels also state that the drugs should be stopped upon pregnancy. Hardly any research or data to date is available regarding the side effects of ACE Inhibitors within the first trimester of pregnancy. After this study was released, the FDA said more research is needed before it considers changing the warning label to specifically include the risks during the first trimester.
During the 1990s, the FDA made it mandatory for pharmaceutical companies to put warning stickers on ACE inhibitors after the agency received a few reports from women whose babies were harmed. The label warned that ACE inhibitors could cause skull deformities, kidney failure, lung problems and even fetal death when taken in the last two-thirds of pregnancy.
Based on the new findings, taking these drugs during early pregnancy “cannot be considered safe and should be avoided,” lead researcher Dr. William Cooper, a Vanderbilt University pediatrician, said in Thursday’s New England Journal of Medicine.
Statistics Birth Defects
The study was able to determine that approximately 7% of babies exposed to ACE inhibitors developed major birth defects compared with about 2% whose mothers took no drugs or other blood pressure medication, such as water pills, calcium channel blockers or beta-blockers. Holes in the heart and neurological and kidney problems are the most common birth defects.
Other ACE Inhibitors Capoten (generic: captopril), Lotensin (generic: benazepril), Vasotec (generic: enlapril), Aceon (generic: perindopril), Accupril (generic: quinapril), Univasc (generic: moexipril), Mavik (genric: trandolapril), Monapril (generic: fosinopril)