ACE Inhibitors and Birth Defects

On June 7, 2006, the U.S. Food and Drug Administration (FDA) issued a Public Health Advisory stating the use of angiotensin-converting enzyme (ACE) inhibitors during the first trimester of pregnancy may increase the risk of severe and life-threatening birth defects. The Advisory is the initial reaction to an FDA-funded cohort study using the Tennessee Medicaid Database published June 8, 2006, in the New England Journal of Medicine. Mothers who took these regularly-prescribed blood pressure medicines in their first trimester were more than twice as likely to have children born with serious heart and brain problems than mothers who did not take any blood pressure-lowering medicines.

The Tennessee Medicaid Study involved 29,507 infants born between the years of 1985 and 2000. Major birth defects, including atrial septal defect and ventricular septal defects (sometimes referred to as “hole in the heart”), patent ductus arteriosus (failed closure of a fetal artery in the heart), spina bifida or meningocele (sometimes referred to as “open spinal cord”), and microcephaly (underdevelopment of the brain and skull) were all discovered. There may be other birth defects associated to a lesser degree with the early use of ACE inhibitors, including musculoskeletal defectssuch as upper limb difficulties; gastrointestinal problems; and urologic defects. Fetal exposure to other blood pressure medications during the first trimester, however, did not show any increased risk of birth defects, further lending evidence to the link between ACE inhibitors and serious health complications in newborns.

ACE inhibitors that were sold and are still being prescribed are:

Benazepril (Lotensin® by Novartis)

Captopril (Capoten® by Bristol-Myers Squibb)

Enalapril (Vasotec® by Merck)

Fosinopril (Monopril® by Bristol-Myers Squibb)

Lisinopril (Prinivil® by Merck and Zestril® by Astra-Zeneca)

Moexipril (Univasc® by Schwarz Pharma)

Quinapril (Accupril® by Pfizer)

Perindopril (Aceon® by Rhone-Polenc Rorer)

Ramipril (Altace® by Hoechst Marion Roussel, King Pharmaceuticals)

Trandolapril [Mavik® by Knoll Pharmaceutical (BASF)]

Cory Watson is currently reviewing cases for filing. We are interested in helping women who took an ACE inhibitor during pregnancy, and whose child suffered a serious birth defect.

Cory Watson has extensive medical and scientific material available and an intake and client screening packet for anyone interested. We are making very favorable referral agreements. This litigation will be handled by Ernest Cory and Leila Watson. Please direct any questions you have to them. Additional information regarding this emerging litigation is also available by contacting our Mass Torts Administrator Sonya Cory via email or by calling (800) 852-6299.

For more information on other cases we are handling, contact us at (800) 852-6299 or (205) 328-2200 or via fax at (205) 324-7896 or visit our Web site at www.cwcd.com.

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