Ace Inhibitor Lawsuit

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With the growing use of ACE inhibitor blood pressure drugs, more and more patients around the country are winding up in emergency rooms suffering from a rare side effect known as angioedema. This condition is similar to hives, except that it causes swelling beneath the skin rather than at the surface. Due to the large number of angioedema cases among ACE inhibitor users, many in the medical community are calling on the U.S. Food & Drug Administration (FDA) to require labels of these drugs to carry a black box warning.

What are ACE Inhibitors, and how do they work?

Angiotensin II is a chemical that causes the muscles surrounding blood vessels to contract, thereby restricting the vessels and elevating blood pressure (hypertension). The chemical is formed from angiotensin I in the blood by an enzyme known as the angiotensin converting enzyme (ACE). ACE inhibitor medications are designed to slow the activity of this enzyme, thereby decreasing the production of angiotensin II. When this occurs, the blood vessels enlarge or dilate, and the patient’s blood pressure returns to normal. This makes it easier for the heart to pump blood, and can improve the function of a failing heart.

The following is a list of the ACE inhibitors that are currently available in the United States:

  • benazepril (Lotensin, Lotensin Hct)
  • captopril (Capoten)
  • enalapril (Vasotec)
  • fosinopril (Monopril)
  • lisinopril (Prinivil, Zestril)
  • moexipril (Univasc)
  • perindopril (Aceon)
  • quinapril (Accupril)
  • ramipril (Altace)
  • trandolapril (Mavik)

Angioedema Overview

Despite these drugs’ considerable effectiveness at treating high blood pressure, ACE inhibitors have been increasingly linked to angioedema. This condition occurs when swelling develops just below the surface of the skin, most often around the lips or eyes. Angioedema is usually caused by an allergic reaction, either to food or prescription medications like ACE inhibitors.

Symptoms of angioedema may include:

  • sudden appearance of red welts (most often near the eyes and lips, but may also appear on the hands, feet, or the inside of the throat)
  • burning, painful, swollen areas
  • itchiness
  • discolored patches or rash on the hands, feet, face, or genitals
  • hoarseness
  • tight or swollen throat
  • breathing trouble
  • fever
  • muscle pain
  • decreased urine
  • weight gain
  • high white blood cell count

Depending on the severity of the reaction, angioedema can take anywhere from minutes to hours to manifest itself. It may affect an area on one side of the body but not the other, or it may affect both. Severe cases of angioedema may cause the throat or tongue to swell, which may cut off the patient’s airway and result in a life-threatening situation.

ACE Inhibitor Side Effects

In addition to having the potential to cause angioedema, ACE inhibitors have also been associated with the following potentially-serious side effects:

  • hypotension (low blood pressure)
  • cough
  • hyperkalemia (elevated blood potassium levels, which can lead to heart attack)
  • headache
  • dizziness
  • fatigue
  • nausea
  • rash
  • taste disturbances
  • renal impairment (kidney problems)
  • renal failure
  • severe allergic reactions

ACE Inhibitor Birth Defects

A new study into the link between the uses of the Ace inhibitor has in fact, revealed starting new evidence that the inhibitors are not safe for women who are pregnant, regardless of which trimester they are in.

“We found there was a three-fold increased [overall] risk of birth defects to infants whose mothers took ACE inhibitors the first trimester, compared to infants whose mothers took no blood-pressure medication,” said study lead author Dr. William O. Cooper, associate professor of pediatrics at Vanderbilt University School of Medicine.

The study found the risk of cardiovascular defects was nearly four times higher in children of women who took ACE inhibitors, compared with children of women who didn’t take any blood-pressure medicine. In addition, central nervous system birth defects were four times higher among the children of women who took ACE inhibitors.

Which Birth Defects have been linked to ACE Inhibitors?

Ace Inhibitors have been linked to the following types of birth defects:

  • cardiovascular defects
  • musculoskeletal defects such as upper limb difficulties
  • gastrointestinal problems
  • central nervous system defects such as spina bifida
  • urologic defects
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