Actos® and Bladder CancerRecent
studies have shown that patients taking the drug Actos for longer than
one year may suffer significantly increased risks of developing bladder
cancer. The FDA warnings are being issued on the heels of France and
Germany banning the use of Actos, and New Zealand also beginning the
process of removing Actos from patient use. Takeda Pharmaceuticals, the
Japanese corporation who began manufacturing Actos in 1999, is at the
midway point in a ten-year study of the drug’s potentially serious side
effects. While the five-year data shows no clear evidence of an overall
increased risk of bladder cancer, patients who have taken the drug in
the highest dosages or for the longest period of time appeared to be at a
much greater risk of developing bladder cancer. Actos
is in a class of drugs known as thiazolidinediones, and is the second
medication of its class to be associated with serious side effects.
Avandia, the sister-drug of Actos, recently had its use severely
restricted due to evidence of increased heart attack risk and even
death. When metformin alone no longer works well for patients suffering
from type 2 diabetes, doctors typically prescribe a drug such as Actos
which increases the body’s insulin sensitivity, controlling blood sugar
levels in the process. Type 2 diabetes, when left untreated, can
potentially lead to serious health effects such as damage to the retina
which can lead to blindness, injury to the kidneys, impairment of the
nerves which could lead to amputations of limbs and an acceleration of
the development of fat plaques on the interior of the arteries which can
potentially lead to blood clots, blockages, cardiovascular disease,
stroke and a lessening of critical circulation.
Actos® and Congestive Heart FailureThe
drug Actos, also known as pioglitazone is marketed by Takeda
Pharmaceuticals and Eli Lilly for the treatment of Type 2 diabetes. The
drug was approved in 1999, and although the manufacturer touts it as a
miracle drug which has reduced the number of diabetes cases by as much
as 70%, the side effects may far outweigh the benefits. A study done in
2003 by the Mayo Clinic definitively linked Actos to swelling in the
feet, lung fluid retention, shortness of breath and congestive heart
failure. The most recent studies have strongly indicated that Actos may
also be responsible for a number of incidences of bladder cancer in
those who have taken the drug in higher dosages or for longer than
twelve months. The American
Diabetes Association presented a research report at a meeting in San
Diego this past June which reported that Actos enhanced the risk of
macular edema by as much as six times, causing thickening and swelling
of the retina and leading to blindness. Another study which was reported
in the American Heart Association Journal in August, 2010, associated
Actos with an increased risk of death due to congestive heart failure.
Although the FDA had mandated a black box warning for Actos regarding
possible heart failure risks in 2007, the warnings became even more
stringent this past June.
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® 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
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.
Actos® Adverse EffectsMany of us would be very surprised to find that a drug can be approved by the FDA yet still have serious—and undisclosed—side effects. The drug Actos, used in the treatment of Type 2 diabetes, is one such drug. Actos works by decreasing the body’s resistance to insulin as a way of controlling blood sugar levels. Actos is currently being used by millions of people across the globe, with sales jumping from around $2.9 billion in 2006 to over $4.3 billion in 2010. Actos has often been prescribed in place of the drug Avandia, which was found to carry significant risks of heart disease and possibly even death in 2007. Actos, which is manufactured by the Japanese pharmaceutical giant Takeda Pharmaceuticals, has recently fallen under scrutiny as well as studies have linked it to an increased risk of bladder cancer as well as correlating it to other serious diseases such as heart attack, stroke and liver failure. “Minor” Side Effects of ActosThe truth is, all prescription medicines as well as most over-the-counter medications, carry some risk of adverse effects. Fortunately the incidence of serious side effects is rare and for the most part the majority of people have either no side effects or relatively minor ones. Minor side effects associated with Actos include flu-like symptoms, headaches, toothache, sore throat or sinus pain and weight gain. More serious side effects which should prompt the user to seek medical attention include an allergic reaction which includes difficulty breathing or chest tightness, blurry vision, symptoms of heart or liver failure including breathing difficulties, a sudden gain in weight, stomach pains, dark urine, jaundice or vomiting, low blood sugar symptoms such as tremors, anxiety or chills, severe and unusual bone pain and total exhaustion along with feeling weak and shaky.
Actos® and Cardiovascular DangersThe drug Actos, marketed by Takeda Pharmaceutical Corporation, is used in the treatment of Type 2 diabetes. Actos largely replaced its predecessor, Avandia, after Avandia was found to have serious risks of heart attack and heart failure. At the time, it was believed that Actos offered much less risk of cardiovascular damage than Avandia. Actos is used to lessen blood glucose labels and improves how the body handles insulin. Type 2 diabetes, which affects between eighteen and twenty million Americans, can cause loss of sight, kidney trouble and cardiovascular illness if left untreated, however it appears that the treatment may also come with its fair share of serious dangers. Just like Avandia, Actos may carry significant levels of cardiovascular risks, however it has not been associated with heart attack deaths in the same way Avandia has. Although Takeda is in the middle of a ten-year study regarding the safety of Actos, other studies have been conducted as well. One well-known cardiologist, Dr. Steven Nissen of the Clevenland clinic focused his review of Actos dangers, finding that it significantly increases the likelihood of a heart attack by as much as forty-two percent. The FDA issued a black box warning label for Actos in June of 2007 during a House of Representatives hearing. During this hearing the fact that the FDA was aware of the potential cardiovascular risks associated with Actos yet failed to adequately respond was discussed, and since that time both lawmakers and health experts have criticized the FDA for failing to properly safeguard public health.
Actos® and Myocardial InfarctionAfter a Journal of American Medical Association publication of a meta-analysis suggested that long-term use of the diabetes drug Avandia was associated with an increased risk of myocardial infarction, the maker of Avandia, GlaxoSmithKline, declared there was little difference in the safety profile of their drug, Avandia and the “other” drug for Type 2 diabetes, Takeda Pharmaceutical’s Actos. Further studies however have not completely backed up that declaration. In nineteen separate controlled trials, involving over 16,000 patients, the end results demonstrated that while 4.4 percent of the patients who received Actos underwent myocardial infarction or stroke 5.7 percent of patients receiving control therapy suffered a myocardial infarction. In the same studies, serious heart failure was reported in 2.3 percent of those taking Actos, while only occurring in 1.8 percent of those in the control group. The author of the results of the studies, Michael Lincoff, stated that not only does Actos—also known as pioglitazone—not appear to have the same level of detrimental effects as Avandia, but it could potentially have a protective effect on the heart. Takeda Pharmaceuticals, currently struggling under the rash of lawsuits filed against them due to evidence that Actos may significantly increase the risk of bladder cancer, does not believe their drug is responsible for episodes of myocardial infarction, or heart attack.
Actos® European Recall and FDA StanceA 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.
