FDA Alerts and Warnings about ACE Inhibitors

The FDA is a governmental agency charged with overseeing the quality and health standards regarding food, drugs, medical devices, animal feed, cosmetics and the like that can cause harm to users if certain health standards are not met.  The FDA must approve any and all new lines of these products before they can be legally sold to the public. 

As part of its drug oversight function, the FDA has had several opportunities to review the benefits and potential risks involving ACE Inhibitors, a class of drugs used primarily to treat high blood pressure.  As such, there have been several risks identified, and as a result there have been several FDA alerts and warnings about ACE Inhibitors. 

Below are a few of the many examples of FDA alerts and warnings about ACE Inhibitors, taken directly from the FDA’s Web site. 

March 14, 2006 - Avapro 

Use in Pregnancy

When used in pregnancy during the second and third trimesters, drugs that act directly on the rennin-angiotensin system can cause injury and even death to the developing fetus.  When pregnancy is detected, Avapro should be discontinued as soon as possible. 

November, 25 2003 - Solvay Pharmaceuticals

Intestinal Angioedema:  Intestinal Angioedema has been reported in patients treated with ACE inhibitors.  These patients presented with abdominal pain (with or without nausea or vomiting); in some cases there was no prior history of facial angioedema and C-1 esterase levels were normal.  The angioedema was diagnosed by procedures including abdominal CT scan or ultrasound, or at surgery, and symptoms resolved after stopping the ACE Inhibitor. 

June 8, 2006 - Reaction to New England Journal of Medicine Study

On June 8, 2006, the New England Journal of Medicine published an article reporting that infants whose mothers had taken an angiotensin-converting enzyme inhibitor (ACE inhibitors) drug during the first trimester of pregnancy had an increased risk of major congenital malformations, compared with infants who had not undergone first trimester exposure to ACE inhibitor drugs. …  Healthcare professionals should take these findings into consideration with other information about a patient’s medical situation during early pregnancy.

Although these are just a few examples of FDA alerts and warnings about ACE Inhibitors, there are many studies and reports of damages as a result of taking these drugs.  If you have been damaged as a result of taking ACE Inhibitors, you need to contact an attorney immediately to protect your rights.