Since 1982, blood-pressure-lowering ACE inhibitor medications like Accupril and Lotensin have been helpful in treating many conditions, particularly those related to cardiovascular disease. Recently, however, a physician from the Mercy Philadelphia Hospital and Mercy Fitzgerald Hospital has alerted the public and other physicians to a serious side effect: angioedema.
As more and more people fill prescriptions for ACE inhibitors, a small subsection of the population is increasingly experiencing angioedema, which is a potentially life-threatening side effect. Interestingly enough, soon after the first ACE inhibitor came on the market, angioedema was recognized and added to the long list of side effect warnings, but now healthcare experts are asking the FDA to increase that warning's visibility, and place it on the outside of the product in a black box warning, which is one of the strongest warnings available.
ACE Inhibitor Side Effect: Life-Threatening Angioedema
According to the Mayo Clinic, ACE inhibitors help relax blood vessels by preventing an enzyme in the body from producing a substance that narrows blood vessels and raises blood pressure. These drugs also increase the availability of "bradykinin," a peptide that causes blood vessels to dilate, lowering blood pressure. These actions helped many patients with heart disease or high blood pressure to avoid heart attacks, strokes, and kidney disease.
Scientists also believe, however, that in some patients, the use of the drug results in too much bradykinin, which makes blood vessels widen until they leak. The fluid seeps into tissues, and can cause swelling so severe, particularly when it occurs around the face and neck, that the patient's tongue and throat close off the airway. To prevent death, doctors have to insert a tube through the patient's nose, mouth, or throat, which is a difficult process that may result in death.
Requests for Black Box Warning
In a letter to the American Journal of Cardiology published March 1, 2012, Dr. James R. Roberts of the Mercy Hospital called attention to ACE inhibitor angioedema, calling it a "silent epidemic" and asking the FDA to require a black box warning about the risk on all these medications. Studies indicate that less than one percent of patients taking the drugs will suffer the side effect, but given the tens of millions of Americans taking the drugs, that's still a significant number at risk.
Dr. Roberts isn't the first to ask for increased attention to this problem, however. In 2002, Boston University emergency medicine physician James A. Feldman petitioned the FDA for the same black box warning. The agency responded that the label already contained enough discussion of angioedema.
Angioedema Difficult To Treat
The other thing that's difficult about this ACE inhibitor side effect is that treatment is slow. Unlike a typical allergic reaction, which can be counteracted with an antihistamine, antihistamines in the case of angioedema can only stop additional swelling. They do nothing to reduce the swelling that's already taken place. Patients have to wait for the fluid to be reabsorbed, and that can take several hours.
For many patients, angioedema occurs soon after they start the medication, but for others, it may appear out of the blue after years with no problems. According to an analysis of a national database presented by Robert Lin, an allergy specialist at New York Downtown Hospital, from 2000 to 2009, hospitalizations for angioedema caused by ACE inhibitors and other heart drugs nearly doubled. For African-Americans, who are more susceptible, the rate more than doubled.
The FDA may believe that the current warning is already enough, but doctors note that patients are not aware of this side effect. They don't know what to do when it happens, and often delay treatment, increasing the risk to their lives. It's these patients, among others, who are particularly justified in seeking compensation in court for their injuries by filing an ACE Inhibitor lawsuit.
Exclusively focused on representing plaintiffs, especially in mass tort litigation, Eric Chaffin prides himself on providing unsurpassed professional legal services in pursuit of the specific goals of his clients and their families. Both his work and his cases have been featured in the national press, including on ABC’s Good Morning America.
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