Actos Black Box Warning

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The U.S. Food and Drug Administration (FDA) issued an Actos black box warning in 2007. The warning also included certain other drugs used to treat type 2 diabetes. The FDA decided that it would require an Actos black box warning about the possible side effects. The “black box warning” or “black label warning” is the most serious of all advisories issued by the FDA.

Among the problems noted by the Actos black box warning is a risk of congestive heart failure. This is a condition where the patient’s heart becomes unable to properly maintain blood flow. Heart failure complications have solicited an Actos black box warning since this is a fatal condition.

Actos Black Box Warning for Congestive Heart Failure

One of the main reasons for the Actos black box warning is that Actos may cause congestive heart failure. There are a few reasons that congestive heart failure may occur. It usually occurs as a result of weakening or stiffening heart muscles. Another possibility is that body tissues require extra oxygen and the heart is incapable of delivering enough oxygen rich blood to these areas.

The reason why the condition is called congestive heart failure is because fluids may build up in the heart of in other areas of the body. Fluid build-up in the body is known as edema. Sometimes fluid can build up in the lungs. This is called pulmonary edema. Pulmonary edema will decrease a person’s ability to physically exert themselves. Fluids can also build up in the liver or the extremities.

Actos Black Box Warning History

When Actos was first released in 1999, it was claimed to be the safest of the available type 2 diabetes medications available. Initially, there was no Actos black box warning for the medication. However, after about a decade numerous reports were filed with the FDA about all of the medications from the thiazolidinedione (TZD) chemical group. All of these drugs had been linked with an increased risk of congestive heart failure.

A clinical trial was conducted in order to determine if an Actos black box warning would be necessary. The researchers found that Actos patients had a substantially higher chance of developing heart complications compared to other medications. There was also a significantly higher chance of death from heart failure for patients prescribed to Actos. Other countries had uncovered similar results concerning these medications which further warranted the Actos black box warning.

It was not until 2007, when the Journal of the American Medical Association (JAMA) had concluded and published the results that the FDA issued their Actos black box warning. The Actos black box warning stated that TZDs such as Actos can cause or exacerbate congestive heart failure in patients that may be prone to these conditions. It also stated that these effects may be dose dependent and that patients should be carefully monitored to ensure that these problems do not become a serious health risk for patients.

Because of the Actos black box warning, Actos is not recommended for patients with symptomatic heart failure. Furthermore, the Actos black box warning stated that this medication is contraindicated for patients that are established by the New York Heart Association.

Actos Black Box Warning Lawsuits

The manufacturer of Actos, Takeda, has dealt with legal problems concerning the Actos black box warning. It has been alleged that the risk was not clearly indicated to patients being prescribed to the treatment. While there was no Actos black box warning upon the medication’s initial release, there was information concerning the risk hidden in the medical information pamphlet for the drug. Prosecutors claim that this is not a clear enough warning and that an Actos black box warning should have been initially available.

View Sources

  1. Lincoff, Michael, Kathy Wolski, et al. “Pioglitazone and Risk of Cardiovascular Events in Patients With Type 2 Diabetes Mellitus.” Journal of the American Medical Association. N.p., 12 Sep 2007. Web. 9 Apr 2013. http://jama.jamanetwork.com/article.aspx?articleid=208777
  2. Nesto, Richard, David Bell, et al. “Thiazolidinedione Use, Fluid Retention, and Congestive Heart Failure.” American Heart Association. N.p.. Web. 9 Apr 2013. http://circ.ahajournals.org/content/108/23/2941.full
  3. United States. Food and Drug Administration. Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk. 2007. Web. 9 Apr 2013. http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2007/ucm108966.htm
  4. Shiel, William. “Congestive Heart Failure.” Medicine Net. N.p., 28 Jun 2011. Web. 9 Apr 2013. http://www.medicinenet.com/congestive_heart_failure/article.htm
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