Many widely-used blood pressure medications should include a “black box” warning about the “increased risk of serious side effects with no added benefit when using the drugs in combination,” according a petition filed with the FDA by the prominent consumer watch dog group Public Citizen. A black box is the strongest warning the FDA can require on a prescription medication.
In its petition filed on October 4, Public Citizen is demanding the FDA require that new warnings be provided for a total of 19 different blood pressure medications— including drugs such as Tekturna, Avapro and Accupril.
Although combining blood pressure drugs has become a common practice, as Public Citizen points out, the practice may result in severe and potentially life-threatening side effects. Furthermore, major studies show that combining the drugs does not provide any clinically significant benefit.
The drugs in question are known as angiotensin-converting enzyme (ACE) inhibitors, angiotensin II receptor blockers (ARBs) and aliskiren. These drugs are commonly used to treat high blood pressure. In fact, ACE inhibitors and ARBs are among the top-selling medications in the country.
Using more than one of these drugs together has become common in recent years due to a theoretical belief that such combination use would confer an added benefit over the use of the drugs individually. However, as pointed out by the petition to the FDA, this theory has been unequivocally disproven in two large studies involving tens of thousands of patients with heart disease and diabetes that failed to show any clinical advantage of combination therapy. On the contrary, the studies showed a higher rate of several life-threatening side effects such as low blood pressure, kidney failure and dangerously high blood potassium levels in patients taking the drugs together compared with patients on only one of the medications.
The petition notes that a third study involving the combined use of the new drug aliskiren with ACE inhibitors and ARBs in patients with diabetes and kidney disease was halted early for identical reasons: a higher rate of the same serious side effects with no added benefit with combination use. An aliskiren/ARB combination drug, Valturna, was withdrawn from the market shortly thereafter.
The petition filed by Public Citizen asserts that “[d]espite this wealth of data, the FDA has failed to respond by adequately warning doctors and patients of the clear danger of the combined use of ACE inhibitors, ARBs and aliskiren.” The petition filed with the FDA by Public Citizen is available online here:
Dangerous Drugs and Medical Malpractice
A patient depends on his physician to stay informed about the dangers of combining medications. When a medical error that should have been avoided occurs and causes a patient injury, it is medical malpractice. Like all other professionals, doctors and nurses should be held accountable when their negligence causes harm. Unfortunately, due to overzealous “tort reform,” successful lobbying by insurance companies and a handful of well-publicized frivolous lawsuits, medical malpractice cases have become increasingly difficult to win.
The attorneys at Heygood, Orr & Pearson have the experience and expertise to assist injured patients with their medical malpractice claims. Our attorneys have successfully represented numerous victims of medical malpractice. Among our attorneys’ recent verdicts, settlements and results are the following:
Jim Orr negotiated a $6.75 million settlement for the family of an 8 year-old child who suffered permanent brain damage due to medical errors occurring at a VA hospital.
Michael Heygood achieved a $2.2 million jury verdict in a medical malpractice lawsuit arising from the premature discharge of a newborn infant from the hospital with low glucose levels.
Eric Pearson argued the appeal in Columbia Medical Center of Las Colinas, Inc. v. Hogue, 271 S.W.3d 238 (Tex. 2009), in which the Texas Supreme Court upheld a gross negligence finding against the defendant hospital in a medical malpractice case and affirmed the jury’s $9 million verdict on behalf of his clients.
At Heygood, Orr & Pearson, we have the knowledge, experience and financial resources necessary to prosecute even the most complex medical negligence case. If you believe you or a loved one has suffered as a result of medical malpractice, please contact us for a free consultation to discuss your legal rights and options.