Actos Recall

By carithers Latest Reply 2011-09-16 07:45:45 -0500
Started 2011-09-09 08:14:18 -0500

My Doctor's office called be to inform to stop taking Actos. They said they have a recall on Actos. anyone taking that drug should get in touch with their doctor's office to find out more information.

23 replies

PharmaTree 2011-09-15 12:19:35 -0500 Report

I found a really interesting article about Actos. From the information that I have read about Actos, it is a good thing that your doctor informed you to stop taking this medication. Please read the following article. I found it at


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.

What is 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.

I found it really interesting that the FDA seems to be both the bad guy and the good guy here.

TsalagiLenape 2011-09-16 07:45:45 -0500 Report

Wanishi Wado Thank you! Now I wll get the article printed out mail it to my doctor aka CDE and let her know. Have a great day!:)

carithers 2011-09-15 12:45:53 -0500 Report

What a good article I had fractured a bone in my foot two years ago and they could not tell me why? I wonder if that was related. Anyway this article explains everything.Thank you for posting this information.Good Job!!!!!

MEGriff1950 2011-09-15 11:37:59 -0500 Report

That is too bad for the people who have done so well on it. I hope that all of you can find something else that works as well for you or better.

TsalagiLenape 2011-09-12 08:18:48 -0500 Report

Great! Now what is going to help me control my BG's? Too much stress and no answers! Lovely! Ugh!

carithers 2011-09-12 09:33:09 -0500 Report

I am sure they will find something that is safe for you to use

TsalagiLenape 2011-09-13 08:35:48 -0500 Report

Thank you. I was looking for the article so I can print it out for my doctor. I will have to google it perhaps.

TsalagiLenape 2011-09-13 15:39:20 -0500 Report

well called the doctor or nurse practioner who works with the makers of Actos. She has no info whatsoever. So I am going to give them the URL over the phone. As of now though I was told I would be ok. Hmmm I do wonder. Yes will look over the responses and hope to find something to be useful. Hugs

carithers 2011-09-14 09:36:59 -0500 Report

WOW I live in Miami and my doctor is a young sharp man.He uses his laptop with all his patients information on it.He keeps everything on it even the results from a sensor that was tracking my sugar.

PaulZ 2011-09-15 11:14:03 -0500 Report

be carefull about laptops. They tend to get stolen,like the vetran admins. A few others as well. Good luck.

MEGriff1950 2011-09-15 11:40:47 -0500 Report

Yes I would ask my doctor if his laptop is kept within his office or if he takes it home with him or other places.

carithers 2011-09-15 12:01:50 -0500 Report

I understand what your saying but that not the subject at hand and yes he takes it home and if anyone wants my blood sugar readings fine personal information is kept in my private folder in the office.

TsalagiLenape 2011-09-14 11:09:13 -0500 Report

Well my CDE works with the makers of Actos and the reply was they hadnt heard of anything. So will let them know what is what. I believe I saw the article on American Diabetes Association page as well. Will write your doctors name and the number to pass it on to my CDE. Thanks

carithers 2011-09-15 09:28:55 -0500 Report

I am sorry but I rather not put my doctors information out to CDE. I am not going to take Actos I am going to stick what my doctors says.But you need to follow what your doctor is telling you, I guess or read more information and you decide as an indiv what you want to do. You can ask your doctor if you can try something else you have to be an advocate for your self or get a second opinion.good luck

bamagirlchp 2011-09-12 10:21:52 -0500 Report

I was using Actos for years and. I saw it on the news while at the doctors office. My doctor switched my medicine to glyburide. It's really helping me. Also along with Januvia. I hope this helps.

JulieC 2011-09-11 20:31:37 -0500 Report

I was on that for 1 month..I gained 20lbs and retained water so bad I thought I had conjestive heart failier and went to emergancy room. They told me to get off it right away. That is some really bad stuff!!

GabbyPA 2011-09-10 09:25:32 -0500 Report

Here are some articles on why it is being recalled.

It is not a friendly drug. It helps a lot of people, but it is harming a lot more. Pitty, because it does work, but at what cost.

carithers 2011-09-12 07:46:02 -0500 Report

I read the article good information

bamagirlchp 2011-09-12 10:47:04 -0500 Report

SI was using Actos for years and. I saw it on the news while at the doctors office. My doctor switched my medicine to glyburide. It's really helping me. Also along with Januvia. I hope this helps.