ACTOS
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UPDATE - BLACK BOX WARNING The FDA has requested that a black box warning be added to warn consumers of the serious risks. Learn More > |
Actos
Amidst an intense debate over the safety of Type-2 diabetes drugs, the FDA has asked the makers of Actos to issue a black box warning about the serious risk of adverse cardiovascular events, including heart attack, heart failure, and cardiovascular-related deaths. A black box warning is the strongest FDA-requested label change that can be added to a drug.
The FDA is currently analyzing Actos clinical data to determine whether further regulatory action, such as an Actos recall, is warranted.
Mounting Concerns over Actos Safety
The FDA’s decision to request the addition of an Actos black box warning was announced during a June 2007 US House of Representatives hearing. This hearing was convened in light of concerns that the FDA knew about Actos and Avandia cardiovascular risks, but failed to respond adequately. Several lawmakers and health experts have criticized the FDA for failing to warn the public about known cardiovascular risks associated with Actos and Avandia.
The FDA seems to have had ample evidence about the risks associated with Actos and Avandia. In 2006, FDA drug safety advisor Dr. Rosemary Johann-Liang urged the agency to add a black box warning to Actos and Avandia because of serious cardiovascular risks. Instead of heeding her warning, however, the agency reprimanded Johann-Liang and did nothing to adequately inform consumers about the possible risks associated with Actos and Avandia.
As early as 1999, when Avandia first hit the market, Dr. John Buse, prominent endocrinologist and incoming president of the American Diabetes Association, warned about the cardiovascular risks associated with this class of drugs. Dr. Buse’s concerned were met with threats by the makers of Avandia, who accused Buse of hurting their market prospects. No action was taken to investigate these serious concerns over Actos cardiovascular side effects.
Representative Henry Waxman has accused the FDA of “dropping the ball” with regards to overseeing the safety of Avandia and related drugs like Actos. He has also declared that the FDA’s shortcomings over Avandia and Actos represent a “failure of the current system” to adequately determine and communicate the serious risks associated with widely used prescription medications.
If you or a loved one has suffered a serious cardiovascular-related injury or death while taking Actos, you may wish to contact a qualified and experienced Actos attorney who can evaluate your case to determine your legal rights and options to file an Actos lawsuit. The Actos lawyers at Oshman & Mirisola are here to provide you and your family the help you need at this difficult time.
Actos
Oral diabetes medication Actos (generic name pioglitazone) is made by Takeda Pharmaceutical Company and co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos and related drugs are used to control type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone.
Actos belongs to a class of drugs called Thiazolidinedione drugs, which help to treat Type-2 diabetes by lowering blood glucose levels and increasing the body’s sensitivity to insulin. This drug may be prescribed alone (as Actos) or in combination with other active ingredients such as metformin (sold as Actoplus met) or glimepiride (sold as duetact). A patient’s drug regiment may also include insulin or other medications in addition to those containing pioglitazone.
Type-2 diabetes, which affects approximately 18 to 20 million Americans, is characterized by high blood glucose levels caused by the body’s inability to properly use insulin. This disease, left untreated, can lead to blindness, kidney problems, and cardiovascular disease.
Heart Risks a serious Concern
Actos, and a similar drug marketed as Avandia, have come under serious scrutiny by the FDA, health experts, and consumer advocates because of the significantly increased risk of heart related side effects.
Cardiovascular side effects are of serious concern among diabetic patients because the disease itself increases the risk of cardiovascular complications. In fact, an estimated 65 percent of all Type-2 diabetes related deaths are the result of heart related complications.
Actos Clinical Studies
Concerns over Actos heart attack risks and cardiovascular deaths were the focus of a recent study conducted by prominent cardiologist Dr. Steven Nissen of the Cleveland Clinic. In his meta-analytic review of 42 studies involving Avandia and Actos, Nissen found that these drugs increase the risk of heart attack by 42 percent, compared to the risk for those taking alternative diabetes drugs or a placebo.
In this New England Journal of Medicine study, Dr. Nissen concluded that, “treatment with [Avandia] was associated with a significant increase in the risk of myocardial infarction [heart attack] and with an increase in the risk of death from cardiovascular causes that was of borderline significance.” Because of the similarity between Avandia and Actos, experts believe this risk is similar for Actos.
Dr. Nissen specifically analyzed an Actos study called PROACTIVE (Prospective Pioglitazone Clinical Trial in Macrovascular Events), which found a favorable relationship between use of Actos and the incidence of heart attack, stroke, and death. In additional scientific studies, Actos has been linked to increased risk of heart failure and related problems.
Other Actos Side Effect Risks
Actos cardiovascular risks are not the only serious safety concerns associated with this diabetes medication. Clinical evidence shows that Actos significantly increases the risk of bone fracture, particularly fractures of the distal upper and lower limbs, in female patients. While the mechanism responsible for increased risk of Actos bone fracture is unknown, patients with an increased risk of bone fracture should weigh this side effect risk with potential benefits when considering treatment with Actos.
Post-marketing studies have also shown that patients taking Actos are at an increased risk of suffering from related Actos hepatitis, Actos liver failure, inflammation of the liver, and elevated liver enzymes. Patients using Actos are urged to have their liver enzymes checked periodically.
Are you taking Actos?
If you are taking Actos and are concerned about the risks posed by this medication, it is important to speak with your health care provider. Remember, it is crucial to speak with a qualified physician before changing your treatment regiment or stopping Actos. Patients who choose to continue use of Actos should be aware of the possible side effect risks and the symptoms of these complications.
Patients who develop symptoms of related Actos heart failure, Actos heart attack, or other Actos side effects should immediately contact their health care provider. Such symptoms may include an unusually rapid increase or decrease in weight, fluid retention (edema), shortness of breath, unexplainable fatigue and weakness, confusion and fatigue, and chest pain.
Particularly in the case of heart attack, the symptoms of heart failure can develop rapidly. In most cases, however, the symptoms of heart disease develop over days or even months. Any unusual symptoms that develop while taking Actos should be discussed with your doctor as soon as possible.
As mentioned, as of June 2007, the FDA is still analyzing the data on Actos heart risks in order to determine if further regulatory action is warranted.
Have you been injured by Actos?
If you or a loved one has suffered a serious injury caused by a related Actos side effect, you may be able to seek compensation for your losses and suffering. Please contact the qualified Actos attorneys at Oshman & Mirisola to learn more about your legal rights and options. We offer a free, no-obligation consultation during which we can evaluate your case and determine the best way to help you and your family.
ACTOS CASE EVALUATION