By Independent Staff WriterDetermining Whether You Have an Actos CaseHundreds
of thousands of patients who have taken the drug Actos over the past
few years—believing the drug to be safe—have been very disillusioned to
find that the drug can have some potentially very serious side effects.
Actos is a drug which was developed for the treatment of Type 2 diabetes
and works by helping the body restore its normal response to insulin,
effectively lowering blood sugar. When high blood sugar is not
consistently controlled, kidney damage, blindness, nerve problems and
even the loss of limbs become possible medical issues. The control of
Type 2 diabetes is also necessary to avoid a debilitating heart attack
or stroke. Therefore, when a drug such as Actos seems to do a good job
of lowering blood sugar, it becomes a very popular prescription drug. So
popular that in spite of the recent rash of lawsuits against Takeda—the
manufacturers of Actos—profits have only been dampened by approximately
13%. The pharmaceutical giant is still enjoys some $2.2 billion dollars
in annual profits, down from an all-time high of over 4 billion dollars
in annual profits. If you have taken Actos you may be wondering whether
you might have an Actos case and be entitled to damages. The
FDA issued a warning which cautions patients with a history, diagnosis
or heightened risk of bladder cancer to consider an alternative diabetes
treatment to Actos. Although this warning sounds fairly mild, drug
safety watchdogs are urging anyone who is currently taking Actos to
speak to their doctor about an alternative drug with less risk factor
and are strongly urging those who have taken the drug in the past to ask
their doctor to set up a bladder cancer screening. The common side
effects of Actos generally include upper respiratory infections,
headache, sinus infection, muscle pain, tooth problems, sore throat and
swelling or water weight gain. Anyone who has had symptoms which can
suggest bladder cancer such as blood in the urine, pain upon urination,
back or stomach pain, or an urgent need to urinate should immediately
seek medical attention. Because Actos has also been tied to an increased
risk of heart failure, any patient who notices swelling of the feet, a
sudden increase in weight and shortness of breath should also seek
immediate medical attention. In conjunction these symptoms can suggest
congestive heart failure and a buildup of fluid in the lungs. In short,
if you took Actos for a period of more than twelve months, or in very
high dosages, you may be eligible to file an Actos lawsuit.
By Independent Staff WriterCould Your Heart Failure Be Linked to Actos?Links
to higher heart disease rates have been associated with the use of
Actos, and, in fact, Actos may cause as many heart problems as
GlaxoSmithKline’s drug, Avandia. The American Heart Association reported
that studies showed patients taking either diabetes drug were at least
four times as likely to experience heart attacks, heart failure or even
death. When a 2007 study on Avandia showed a 43 percent higher chance of
heart attack, Actos quickly became the market leader. A subsequent
study on both drugs showed that 602 Avandia users and 599 Actos users in
the study suffered either a heart attack, heart failure or both, with
217 deaths in each group. The latest study regarding Actos in the
journal Lancet found the risk for heart failure greatest among those
patients with a prior history of heart disease and heart failure,
however overall the relative risk when taking Actos was as much as 72
percent higher than those not taking the drug. Both Glaxo and Takeda
dispute the results of these negative studies, citing a study published
in the Journal of the American Medical Association which suggests Actos
might actually cut the risk of heart attack, stroke and death. Link between Actos and Heart FailureActos
is in a class of drugs known as thiazolidinediones, whose use has long
been attributed to certain liver and cardiovascular health issues. A
listed side effect of Actos includes the threat of congestive heart
failure with the link between Actos and congestive heart failure being
so undeniable that in 2007 the FDA escalated warnings regarding heart
disease when taking the drug. Actos causes the body to retain excess
fluid, leading to swelling and weight gain. This extra body fluid can
worsen some heart problems, leading to heart failure or can actually
cause heart problems. When
Actos causes swelling in the body, this swelling also occurs around the
heart, rendering it unable to effectively pump blood throughout the
body. As fluid builds up around the heart and lungs, it becomes more
difficult for the heart to pump, causing it to become less and less
efficient. This can lead to shortness of breath, trouble breathing when
lying down, a feeling of excessive tiredness or an unusually rapid
increase in weight. After an intense debate over the cardiovascular
risks of Actos, the FDA agreed to surround the heart risk warnings on
Actos with an emphatic black outline commonly known as a black box
warning. This black box warning is the strongest FDA label change which
can be added to any drug on the market. Link Between Actos and Bladder CancerThe
FDA issued its safety announcement regarding the connection between
using Actos for more than one year and the risk of bladder cancer on
June 15, 2011. The bladder lies in the center of the lower part of the
abdomen, and its primary purpose is to store urine prior to excreting it
from the body. When cells in the bladder become cancerous, a tumor can
form. Actos helps diabetics use their own insulin better by hitting at
least two of the three main PPAR receptors known as the Gamma and Alpha
receptors. The Gamma receptor works on glucose while the Alpha receptor
affects cholesterol. Actos appears to have a higher affinity with the
Alpha receptor which is why it does a good job on raising good
cholesterol and lowering triglycerides. It
has been hypothesized that the way in which Actos reacts with these
receptors may also be the reason it contributes to the risk of bladder
cancer. Potential symptoms of bladder cancer include bloody urine,
chronic and persistent infections of the bladder, a strong urge to
urinate or pain and burning during urination. X-rays may reveal an
abnormality in the bladder walls, or red blood cells found in the urine
during lab tests. If the bladder is swelling, a biopsy may be done or a
growth in the bladder could be discovered through a CT or MRI scan.
Bladder cancer is typically treated with removal of the tumor, surgical
removal of all or part of the bladder or with drugs which help the
immune system fight the cancer. Could Actos Damage Your Liver or Kidneys?In
addition to potentially damaging the heart and bladder, Actos may also
be linked to rhabdomyolysis which occurs when muscle fibers rapidly
bread down releasing proteins and myoglobin into the blood stream.
Myoglobin can be toxic to the kidneys, leading to the development of
rhabdomyolysis. Symptoms of this serious kidney disease include muscle
pain or tenderness, stiffness or weakness in the joints and dark-colored
urine. Actos has also been documented to cause elevated liver enzymes, a
precursor to liver damage. Anyone who is considering taking Actos
should have their liver enzymes tested before they start taking the
drug, and should periodically monitor the liver enzymes while on Actos.
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 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 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 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® 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.
