Actos® Damages and Typical Settlements

Actos® Damages and Typical Settlements

The Type 2 diabetes drug Actos is one of a class of drugs known as thiazolidinediones and has recently been linked to an increased risk of bladder cancer, liver disease and cardiovascular issues. The FDA felt that the link between heart failure and Actos was serious enough to require increased warnings on the drug packaging concerning congestive heart failure. According to the Washington Post on 8/05/11, the first of what is expected to be literally thousands of lawsuits was filed alleging the use of Actos resulted in bladder cancer. Takeda Pharmaceuticals, a Japanese corporation is the manufacturer of Actos although it was jointly launched with the American company, Eli Lilly. Actos quickly became a top-seller of the giant pharmaceutical corporations, becoming the tenth best-selling drug in the United States in 2008 with sales over 2.5 billion dollars increasing to a staggering 4.3 billion in 2010.

In June of 2011, Takeda halted its sales of Actos in both France and Germany after receiving considerable pressure from health regulators in both those countries. New Zealand is currently in the process of pulling the drug as well. Since June, both the FDA and the European Medicines Agency have prudently issued warnings regarding the potential risk of bladder cancer for those taking the drug, but are allowing the continuation of sales pending further studies. The FDA has, however, warned doctors not to prescribe the drug for those who have a history of bladder cancer or who currently have bladder cancer.

Actos® European Recall and FDA Stance

Actos® European Recall and FDA Stance

A wave of recent studies which definitively link the prescription drug Actos—prescribed for Type 2 diabetes—to bladder cancer gives a fairly clear indication that Takeda Pharmaceuticals may soon be flooded with Actos lawsuits. August, 2011, saw the first Actos lawsuit filed by a 54-year old woman from Pennsylvania who had taken Actos for over a decade, then was diagnosed with bladder cancer. It is likely this particular victim may end up having her bladder removed and be subject to chemotherapy treatments due to the unexpected and severe side effects of Actos. Although the FDA has made substantial changes in labeling for Actos, they have refused to go as far out on the limb as other countries who have issued recalls of the drug.

France’s Medical Regulatory Agency made the decision to recall Actos once the serious side effects became known. Some 230,000 people regularly take Actos in France, and the possibility of an increase in bladder cancer was felt to be too great to allow patients to continue to take the drug. Soon after, Germany’s health regulators advised physicians to stop prescribing Actos for their patients with Type 2 diabetes due to the potentially dangerous side effects of the drug. These recalls and prohibitions were made after the European Medicines Agency conducted its own study of drugs which contained pioglitazone.

Actos® FDA Safety Review/Warning

Actos® FDA Safety Review/Warning

On June 15, 2011, the United States Food and Drug Administration informed the public that using the drug Actos, commonly prescribed in the treatment of Type 2 diabetes, has been positively associated with an increased risk of bladder cancer. Actos is manufactured by a Japanese pharmaceutical company, Takeda Pharmaceuticals, and is typically sold either as a single-ingredient product or in combination with the drug metformin. Actos is prescribed, along with diet and exercise, to help control blood sugar in adults. Initially the FDA’s safety warnings were based on a five-year interim analysis of an ongoing ten year study regarding the risks for those taking Actos.

While the study at the five-year mark noted an increased risk of bladder cancer among those who had taken Actos in the highest dosages and for the longest periods of time, it was unclear about the overall increased bladder cancer risk. Two other countries, France and Germany, have taken more definitive actions regarding Actos, believing it poses serious health risks. While France has suspended the use of Actos altogether, Germany has recommended to physicians that they not start new patients on the drug. New Zealand is currently in the midst of recalling the drug, yet the FDA continues to maintain that further study is warranted before issuing more stringent warnings.

Actos® Side Effects other than Heart Disease and Bladder Cancer

Actos® Side Effects other than Heart Disease and Bladder Cancer

Osteoporosis and Bone Fractures
While many people are now aware of the association between the Type 2 diabetes drug, Actos, and both bladder cancer and heart disease, there are several other quite serious side effects also associated with the drug. For instance, there is strong evidence to suggest that Actos, like its sister-drug, Avandai, may cause osteoporosis and bone fractures among those taking it, most especially in female patients. In one particular randomized trial which studied patients with Type 2 diabetes who were currently taking Actos, an increased occurrence of bone fractures was observed in the female patients and in a follow-up study at nearly three years, almost 5.1% of the females taking Actos had suffered a bone fracture.

Most of the bone fractures were seen in arms and legs, and there was no apparent escalation of fracture occurences among male patients. Because this drug study lasted less than five years, it is strongly believed that a much greater frequency of fractures and osteoporosis would be seen in women taking Actos for longer periods of time. Since men typically have much stronger bones than women, fractures and osteoporosis would probably not have been seen in men who were studied for only a few years. Since broken hipbones happen to be a primary killer of the elderly, seniors should not take Avandia or Actos as their benefits do not appear to outweigh the serious side effects.

Macular Edema
A study presented at the yearly meeting of the American Diabetes Association this past June found that those taking Actos have a three to six times increased risk of developing macular edema. Macular edema causes an eye disease in which the retina swells and thickens and can lead to permanent blindness. Diabetic eye disease is now the most common cause of blindness in those younger than age 65, and although the best way to avoid this particular side-effect of diabetes is by keeping your blood sugar under control, Actos appears to increase the risk of macular edema even though it does control the blood sugar.

Weight Gain
Weight gain also appears to be a side effect of Actos, however it must be noted that there is significant difference between a slow weight gain as the result of the drug and a rapid weight gain which could signal congestive heart failure. Rapid weight gain is any more than five pounds in a week, and should be a reason to consult your physicians immediately. On average, those taking Actos gained from two to six pounds over a period of four months to six months, while those patients not taking Actos lost about three pounds during the same time period.

In patients who were taking both Actos and insulin or other oral diabetes medications, the weight gain increased to between nine and ten pounds on average. Patients taking higher dosages of Actos gained larger amounts of weight than those taking lower doses, however those whose weight gain was related to fluid retention likely suffered more serious cardiovascular problems. Actos has been shown to worsen congestive heart failure or in some cases cause it. A primary initial symptom of congestive heart failure is an unexplained, quick weight gain, so it is important for those taking Actos to monitor their weight regularly.

Liver Disease
Patients who have shown signs of prior liver disease should not take Actos or any other drug in the thiazolidinedione class. These drugs have been definitively associated with significant elevations in liver enzymes, jaundice, liver failure and death due to liver failure. These liver problems have been seen both in long-term and short-term patient use of Actos. Any patients taking Actos should be aware of the potential liver problems, and should report any unexplained nausea, vomiting, fatigue, dark urine or abdominal pain to their physician immediately. If jaundice develops the medication should be immediately discontinued. Those taking Actos who show even a moderate increase in liver enzymes should continue the drug only with their physician’s approval, and with great caution. If Actos use has led to a seriously impaired liver, a liver transplant may be necessary. Conversely, while Actos has been shown to potentially cause liver enzymes to increase to serious levels, there is medical evidence which shows Actos may actually provide beneficial effects in treating fatty liver disease. Several studies have shown that Actos can reduce the liver fats by half in less than half a year.

Other Serious Side Effects
Actos has also been known to cause allergic reactions, blurry vision, easy bruising or bleeding, flu-like symptoms, muscle pain and serious tooth pain and problems. Actos is contraindicated in those who are scheduled for an upcoming surgery or have any type of known allergy to foods, dyes or preservatives. Women who are pregnant or thinking of becoming pregnant, or those who are breastfeeding should not take Actos as it is considered a Pregnancy Category C drug meaning it is not considered safe to take when pregnancy is a possibility. Actos can also pass into breast milk, so should definitely not be taken by women who are currently breastfeeding. Actos can also potentially interact with other prescription drugs as well as non-prescription medications, vitamins and herbal supplements, so it is important that your doctor be aware of everything you take regularly. While bladder cancer and cardiovascular problems are the most serious of the known side effects of Actos, the side effects listed above can also have potentially serious consequences.

FDA Issues Sterner Warnings to Manufacturers of Diabetic Drug Actos

FDA Issues Sterner Warnings to Manufacturers of Diabetic Drug Actos

Although the FDA issued recommendations regarding labeling cautions for the drug Actos to manufacturer Takeda Pharmaceuticals in 2006, following further safety reviews of the drug they have recently issued more stringent instructions to the Japanese company. Actos, also known as pioglitazone is used in the treatment of Type 2 diabetes to help control the levels of sugar in the blood.

Drugs Included, Safety Updates Required
In a letter to Takeda Pharmaceuticals the FDA states that supplemental new drug applications for Actos, Actoplus Met, Actoplus Met XR and Duetact were duly received and processed, and noted receipt of certain amendments and risk evaluation assessments relating to Actos. Takeda was notified of new safety information which the FDA deemed to be a necessary inclusion of any future labeling of Actos. Further, the FDA stated the safety updates must specifically address the potential risk in increase of bladder cancer in those taking higher dosages or taking the drug for extended periods of time.

Specific Changes to Labeling of Actos
The FDA asked that Takeda include under the warnings and precautions area of the Actos label a statement that preclinical and clinical trials had shown pioglitazone users experienced an increase in incidence of bladder cancer. The Actos labels must state that those who have bladder cancer or a prior history of bladder cancer should be extremely cautious when using the drug. The label must additionally state that statistical significance in bladder cancer risk is reached in those patients taking Actos for longer than two years. More specifically, the wording that taking Actos longer than twelve months increases the risk of developing bladder cancer to a 40% statistical probability is to be included.

Takeda Pharmaceuticals Received FDA Instructions for Diabetic Drug Actos

Takeda Pharmaceuticals Received FDA Instructions for Diabetic Drug Actos

The drug Actos, also known as pioglitazone, has recently come under fire due to studies showing a slight increased risk of bladder cancer in those taking high doses of the drug or those who have taken Actos for longer than two years. Manufactured by Takeda Pharmaceuticals of Japan, the drug has shown huge gains in popularity in the past few years as it quickly replaced the drug Avandia which suffered under claims of increased risk of heart attack and death. Actos is Takeda’s tenth best-selling drug, making over $3.4 billion dollars in the past year alone. While the recent safety reviews have alarmed many who are currently taking the drug, in fact there have been safety concerns regarding Actos for several years.

Warnings are Not New
As far back as 2006, the FDA issued instructions to Takeda regarding Actos and ActoPlus Met, advising the company to make specific label changes to the drug’s precautionary statements. These label changes were to specifically include information regarding reports of bladder cancer in those taking Actos. Takeda’s supplemental drug applications regarding Actos were approved conditionally, so long as the agreed-upon text was included in the drug’s labeling.

The FDA stipulated that the final printed label be identical to the proposed labeling changes, and required Takeda to submit an electronic version of the proposed label as well as 20 paper copies and fifteen copies mounted on heavy-weight paper, however final approval was not mandated prior to using the labels. Although these FDA instructions took place nearly five years ago, it was only recently that more stringent warnings regarding Actos were issued.

FDA Approves Cancer Warning for Diabetic Drug Actos

FDA Approves Cancer Warning for Diabetic Drug Actos

The blockbuster drug, Actos, which is prescribed to control Type 2 diabetes, has received new warning language on the label regarding a potential risk of bladder cancer for those taking the drug. Actos, also known as pioglitazone, is manufactured by Takeda Pharmaceuticals, a Japanese-based company, and is currently their best-selling drug, with sales of $3.4 billion last year alone. Sales of Actos had shown a significant upswing due to the fact that its primary competitor—Avandia—has been linked to a higher risk of heart attack and even death. The updated label warnings came on the heels of an EMA safety review of the drug as well as a ten-year study conducted by Takeda. The Takeda study indicated a statistically significant increase in the risk of bladder cancer for those taking the drug for longer than two years.

Other Drugs Containing Pioglitazone
Other than Actos, the drugs ActoPlus Met, ActoPlus Met XR and Duetact will all carry the same warnings due to containing pioglitazone as an active ingredient.  All of these drugs are used to treat Type 2 diabetes, to increase sensitivity to insulin and effectively control blood sugar levels. A combination drug containing metformin and pioglitazone is used for the same purpose, although all these drugs are expected to be used in conjunction with a healthy diet and sensible exercise program.

France and Germany Weigh In
Just this past June, both France and Germany issued recalls of Actos following a public insurance data review which showed a fairly strong correlation between pioglitazone and bladder cancer risk. Suggestions from the EMA study related primarily to including more cautionary warnings on the labels of the drug as well as a six-month review of each patient taking Actos.