Medpor Nose Implants Subject of New Study

A new study shows that Medpor nose implants have a much higher rate of infections than previously believed. In almost every case of infection found in the study, the implant be

gan poking out through the surgical wound. The study was published in the journal Archives of Facial Plastic Surgery.

By contrast, there were no complications when the surgeons grafted cartilage from the patients’ own bodies, such as nose, ear or rib cartilage.

“The infection rate was extremely high and startling,” said Dr. Andrew Winkler, a plastic surgeon at the University of Colorado in Denver, who led the study.

Grafting cartilage from the patients’ own bodies is not always an option. In those cases, surgeons typically use Medpor or Gore-Tex implants. The study found an infection rate of only 5% with Gore-Tex. However, Gore-Tex and Medpor are different types of implants, and are not interchangeable.

“Whenever you are undergoing a rhinoplasty, make sure you have a very frank conversation with your surgeon,” said Dr. Winkler. “There are always pros and cons.”

Dr. Jeffrey Spiegel, chief of facial plastic and reconstructive surgery at Boston Medical Center, was interviewed by Medcity News about the study.

And when artificial implants get infected, he added, giving antibiotics often is not enough. Instead, the implants will have to be taken out, leading to another surgery.

Spiegel, who was not involved with the new study, said using the patient’s own cartilage

from the body is usually possible, although it takes longer than using a plastic implant. Harvesting that cartilage comes with its own risk of complications, but Spiegel said it is minimal.

“I just don’t see it,” he told Reuters Health.

Nose surgery, also called rhinoplasty, is the cialis most commonly performed type of cosmetic surgery on men or women under the age of thirty-five.

[Part 3 of a series]

So here is what we now know about Avandia:

• The maker of Avandia lied to medical doctors to and told them Avandia had a beneficial cardiovascular profile even though the drug actually incr
  buy softtabs viagra

  eased patients’ risks of getting congestive heart failure.

• To help perpetrate the lie, GSK hid or failed to report congestive heart failure cases to the FDA.
• GSK spent millions actually bribing some doctors to prescribe its drugs.

Most folks would expect that type of behavior to have serious consequences. Fraud and bribery are pretty serious charges, too. And GSK actually agreed to plead guilty to a felony. So what happens to GSK and its guilty employees?

So how many GSK executives are going to jail?

None. Here is what GSK agreed to do: it’s taking $3 billion of its shareholders’ money and paying a fine. What about the GSK employees who were guilty of the illegal conduct? The Justice Department settlement says GSK will withdraw bonuses from top executives if they engaged in or supervised illegal behavior.

That will teach them a lesson, won’t it?

Actually, it will probably teach them the wrong lesson. Most top executives at large corporations get a lot of their compensation in stock or stock options. So if the corporation makes a lot of money and the shares go up, the executives make a lot of money, too.

Did GSK make a lot of money because of its fraudulent, felonious conduct? Yes, it did.

In spite of the $3 billion fine, GSK made a huge amount of money because of its illegal promotion and sales of these drugs. GSK was able to falsely promote Avandia until its sales reached $10.4 billion. Paxil brought in $11.6 billion sales, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a group that consults for drug manufacturers.

Almost $27 billion in drug sales, much of it due to illegal conduct, but the drug maker paid a fine of only $3 billion. It makes it look as if drug companies might just consider fines and settlements a part of the cost of doing business. Perhaps that’s why the CEO of GSK minimized the illegality when he issued a statement commenting on the settlement.

Andrew Witty, the CEO, sought to portray the illegal actions as part of the company’s past.

“Whilst these originate in a different era for the company, they cannot and will not be ignored,” he said in the statement. “On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made.”

If GSK were just one bad apple there would be less cause for concern. But some of the largest drug companies in the world have paid billions of dollars in settlements so far in 2012:

• May 2012 – Abbott Laboratories agreed to pay $1.6 billion to settle charges of illegal marketing of Depakote. (Link to article.)
• June 2012 – AstraZeneca entered a plea of guilty to one felony count of health care fraud and agreed to pay $355 million because of a scheme to illegally market a prostate cancer drug. (Link to article.)
• June 2012 – Johnson & Johnson agreed to plead guilty to a misdemeanor and pay up to $2 billion to settle charges of off-label promotion of its drug Risperdal. (Link to article.)

None of these guilty pleas, fines or settlements would not have occurred without whistleblower lawsuits started by employees or former employees of the drug companies.

So one can’t lightly dismiss charges made by Dr. Helen Ge, the former medical researcher who helped test Actos for Takeda, in her whistleblower lawsuit (see Actos whistleblower lawsuit excerpts here). Although Dr. Ge may be making up all the (very specific) charges in her lawsuit, she and her lawyers are certainly acting as if Takeda hid bladder cancer and heart risks from the FDA.

In this country, one is presumed innocent until proven guilty, and Dr. Ge will have to prove her claims in a court of law. But that doesn’t mean that people who are taking Actos can’t consider the culture of fraud at so many drug companies, and the claims Dr. Ge has made, when they choose whether to talk with their physicians about switching from Actos to another drug.

[End of series on diabetes drugs.]

AVANDIA is a registered trademarks of GlaxoSmithKline. ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.Rich Text AreaToolbarBold (Ctrl + B)Italic (Ctrl + I)Strikethrough (Alt + Shift + D)Unordered list (Alt + Shift + U)Ordered list (Alt + Shift + O)Blockquote (Alt + Shift + Q)Align Left (Alt + Shift + L)Align Center (Alt + Shift + C)Align Right (Alt + Shift + R)Insert/edit link (Alt + Shift + A)Unlink (Alt + Shift + S)Insert More Tag (Alt + Shift + T)Proofread WritingToggle fullscreen mode (Alt + Shift + G)Show/Hide Kitchen Sink (Alt + Shift + Z)
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[Part 3 of a series]
So here is what we now know about Avandia:
The maker of Avandia lied to medical doctors to and told them Avandia had a beneficial cardiovascular profile even though the drug actually increased patients’ risks of getting congestive heart failure.
To help perpetrate the lie, GSK hid or failed to report congestive heart failure cases to the FDA.
GSK spent millions actually bribing some doctors to prescribe its drugs.
Most folks would expect that type of behavior to have serious consequences. Fraud and bribery are pretty serious charges, too. And GSK actually agreed to plead guilty to a felony. So what happens to GSK and its guilty employees?
So how many GSK executives are going to jail?
None. Here is what GSK agreed to do: it’s taking $3 billion of its shareholders’ money and paying a fine. What about the GSK employees who were guilty of the illegal conduct? The Justice Department settlement says GSK will withdraw bonuses from top executives if they engaged in or supervised illegal behavior.
That will teach them a lesson, won’t it?
Actually, it will probably teach them the wrong lesson. Most top executives at large corporations get a lot of their compensation in stock or stock options. So if the corporation makes a lot of money and the shares go up, the executives make a lot of money, too.
Did GSK make a lot of money because of its fraudulent, felonious conduct? Yes, it did.
In spite of the $3 billion fine, GSK made a huge amount of money because of its illegal promotion and sales of these drugs. GSK was able to falsely promote Avandia until its sales reached $10.4 billion. Paxil brought in $11.6 billion sales, and Wellbutrin sales were $5.9 billion during the years covered by the settlement, according to IMS Health, a group that consults for drug manufacturers.
Almost $27 billion in drug sales, much of it due to illegal conduct, but the drug maker paid a fine of only $3 billion. It

makes it look as if drug companies might just consider fines and settlements a part of the cost of doing business. Perhaps that’s why the CEO of GSK minimized the illegality when he issued a statement commenting on the settlement.
Andrew Witty, the CEO, sought to portray the illegal actions as part of the company’s past.
“Whilst these originate in a different era for the company, they cannot and will not be ignored,” he said in the statement. “On behalf of GSK, I want to express our regret and reiterate that we have learned from the mistakes that were made.”
If GSK were just one bad apple there would be less cause for concern. But some of the largest drug companies in the world have paid billions of dollars in settlements so far in 2012:
May 2012 – Abbott Laboratories agreed to pay $1.6 billion to settle charges of illegal marketing of Depakote. (Link to article.)
June 2012 – AstraZeneca entered a plea of guilty to one felony count of health care fraud and agreed to pay $355 million because of a scheme to illegally market a prostate cancer drug. (Link to article.)
June 2012 – Johnson & Johnson agreed to plead guilty to a misdemeanor and pay up to $2 billion to settle charges of off-label promotion of its drug Risperdal. (Link to article.)
None buy viagra online of these guilty pleas, fines or settlements would not have occurred without whistleblower lawsuits started by employees or former employees of the drug companies.
So one can’t lightly dismiss charges made by Dr. Helen Ge, the former medical researcher who helped test Actos for Takeda, in her whistleblower lawsuit (see Actos whistleblower lawsuit excerpts here). Although Dr. Ge may be making up all the (very specific) charges in her lawsuit, she and her lawyers are certainly acting as if Takeda hid bladder cancer and heart risks from the FDA.
In this country, one is presumed innocent until proven guilty, and Dr. Ge will have to prove her claims in a court of law. But that doesn’t mean that people who are taking Actos can’t consider the culture of fraud at so many drug companies, and the claims Dr. Ge has made, when they choose whether to talk with their physicians about switching from Actos to another drug.
[End of series on diabetes drugs.]
AVANDIA is a registered trademarks of GlaxoSmithKline. ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.
Path:

(Part 2 in a series)

Part 1 in this series about diabetes drug safety listed some of the illegal conduct that the maker of Avandia admitted to when it agreed to plead guilty to a felony count of violating U.S. law and pay a $3 billion fine. But

Part 1 didn’t give the details. The details are shocking.

GSK lied to medical doctors to increase sales of Avandia.

The

Justice Department said:

• GSK lied to medical doctors about Avandia’s safety, making them believe it was safer than it really was.
• GSK said Avandia had a positive cholesterol profile, despite having no controlled studies to support that claim.
• GSK sponsored programs telling doctors that Avandia had cardiovascular benefits despite warnings on the FDA-approved label that the drug actually had cardiovascular risks.

The last allegation alone is enough to call into question the value of FDA labels. It’s almost unbelievable: GSK invited doctors to programs where GSK told medical doctors that Avandia was safe for patients’ hearts even though the FDA label said Avandia was risky for patients’ hearts.

What made GSK believe it could boost sales of Avandia by hosting programs for doctors and telling them lies that contradicted the FDA label? Two possibilities come to mind:

• GSK believed
  buy cialis online

  that medical doctors don’t read FDA labels. This seems to be the most likely explanation. Most doctors are busy, and some of them prescribe dozens of different drugs every day. FDA labels are long. It would be time-consuming to read all of them. (The current version of the official Actos FDA warning label for doctors is 43 pages long). So GSK thought it could lie to these busy doctors and get away with it, or

• GSK believed it had “bought” the loyalty of the doctors, so they would prescribe GSK drugs even if they were riskier than other drugs. It’s worth noting that some doctors got Hawaiian vacations and other perks from GSK (more on that below).

Avandia’s manufacturer bribed medical doctors.

Carmin M. Ortiz, the U.S. attorney in Massachusetts. was quoted in an article that GSK spent millions of dollars bribing doctors to prescribe its drugs:

“GSK’s sales force bribed physicians to prescribe GSK products using every imaginable form of high priced entertainment, from Hawaiian vacations to paying doctors millions of dollars to go on speaking tours to a European pheasant hunt to tickets to Madonna concerts, and this is just to name a few,”

GSK failed to report congestive heart failure to the FDA.

Federal prosecutors said GSK failed to report data from studies detailing safety risks to the FDA.

[End of Part 2. Check back tomorrow for Part 3 of the series.]

AVANDIA is a registered trademarks of GlaxoSmithKline. ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.

Competition between the makers of diabetes drugs Avandia and Actos has been deadly serious. Are global drug companies out of control?

(Part 1 of a series.)

On July 2, 2012, t

he U.S. Justice Department announced that the maker of Avandia, GlaxoSmithKline (“GSK”), had agreed to plead guilty to a felony and pay a $3 billion

fine for violating U.S. prescription drug laws. GSK violated the laws by refusing to tell the FDA about Avandia patients who developed congestive heart failure. GSK also used illegal tactics, including bribery of medical doctors, to convince medical doctors to prescribe Avandia, Paxil, and Wellbutrin.

The FDA severely restricted sales of Avandia in 2010 after a study showed the drug had a serious risk of causing congestive heart failure in patients taking Avandia.

It would be understandable if GSK’s admissions about its illegal marketing of Avandia were to cause concern about the safety of Actos, the main competitor of Avandia.

Actos safety concerns became public in 2011 when studies showed bladder cancer and congestive heart failure risks. Those safety concerns were enough to cause an Actos recall in both France and Germany in June 2011. Later that month, the FDA updated the Actos label to include bladder cancer warnings.

The news that GSK fraudulently marketed Avandia and covered-up congestive heart failure risks raises this question:

Did the maker of Actos stoop to the level of GSK to compete with Avandia in the profitable diabetes drug market?

That’s a claim made by

a medical researcher who participated in tests of Actos before the drug obtained FDA approval.

Dr. Helen Ge, a former employee of Actos maker Takeda Pharmaceuticals, filed a whistleblower lawsuit that alleges Takeda refused to tell the FDA about cases of bladder cancer and congestive heart failure because it wanted to make Actos appear safer than Avandia, the biggest rival of Actos. (Here are links to the 116-page Actos whisteleblower lawsuit PDF file and a shorter page with Actos whistleblower lawsuit excerpts.)

Dr. Ge claims that the cancer risks of Actos were known to Takeda as early as the 1990s, after the drug was tested on rats and mice. But, according to Dr. Ge, her superiors insisted that some cases of bladder cancer and congestive heart failure be classified as “unrelated” to the Actos, even though that was false.

Is this simply “how the game is played” by global pharmaceutical companies?

We won’t know whether Dr. Ge is telling the truth about a cover-up of Actos bladder cancer and congestive heart failure risks until her lawsuit goes to trial, or the lawsuit is settled.

The facts of the Avandia case are bad enough. It leaves us asking whether the FDA is up to the job of protecting American citizens from the greed of global drug companies.

[End of Part 1. Please visit tomorrow to read Part 2.]

AVANDIA is a registered trademarks of GlaxoSmithKline. ACTOS is a registered trademark of Takeda Pharmaceutical Company Limited.

“Big money and bad drugs are a dangerous combination,” says Attorney Michael J. Evans, owner of The Law Offices of Michael J. Evans, LLC,, says it’s time for an Actos recall in the United States. Evans posted the argument

in favor of an Actos recall on his website, Michael J. Evans, Law + Marketing + Technology,

Actos Recall Social Media Campaign

To try to build public support for an Actos recall, Evans has started a social media campaign to educate people about the risks of Actos and build support for an Actos Recall. The Actos social media campaign includes the following:

• Recall Actos Facebook Page
• Recall Actos Google+ Page
• RecallActos Twitter account
• Recall Actos website where people can sign a petition asking for an Actos recall

“France and Germany recalled Actos in June 2011 because studies showed the drug increased patients’ risks of bladder cancer and congestive heart failure. But in the U.S.,” Evans said, “the FDA merely issued a warning.

Evans says events of the past three months show that an Actos recall is needed now more than ever. Evans pointed to the following developments as proof that an Actos recall necessary:

• On June 1, 2012 the Los Angeles Times reported that a new study showed that
  viagra

  Actos doubled a person’s risk of getting bladder cancer.

• On June 11, Medpage Today reported on a study that showed users of Actos had more than twice the risk of developing diabetic macular edema than patients who didn’t take Actos. Macular edema causes blurred vision.
• On July 3, 2012, Medline Plus reported on another study confirming the link between Actos
  viagra perscription online

  and bladder cancer.

Evans says that the experience with the diabetes drug Rezulin is very similar to what is happening now with Actos. “in 2000 I started a website to educate the public about the risk of liver failure due to Rezulin. I also offered legal representation to victims of liver failure and their families. The maker of Rezulin resisted a recall even though it was receiving reports of deaths due to liver failure. When the FDA finally insisted on a recall of the drug, 63 Rezulin patients were dead from liver failure. By postponing the recall for as long as it did, the drug maker earned $2.1 billion in sales of Rezulin.”

Evans says a February 14, 2012 Associated Press article says Actos accounted for $3.4 billion in sales in 2011. Evans argues that drug makers who earn huge profits from dangerous drugs are reluctant to take them off the market until called upon to do so by the FDA.

Evans has also created an Actos lawsuit website where people can get a free legal review of their potential Actos lawsuit. Free Actos case evaluations are also available by calling 800-671-0996 toll-free, 24 hours a day, 7 days a week.

About Michael J. Evans (Full Disclosure: Michael J. Evans is the Publisher of ConsumerNews.com)
Michael J. Evans is owner of The Law Offices of Michael J. Evans, LLC., P.O. Box 55055
Birmingham, AL 35255. Evans is an attorney and consumer advocate who has represented thousands of people nationwide who were harmed by drugs and medical devices. Evans helped pioneer national online legal marketing when he and two other attorneys founded the American Legal Alliance in 2000, to enable groups of law firms to use the Internet to offer services to people in need of attorneys nationwide. Evans frequently works with alliances of law firms to represent people nationwide in mass tort cases such defective drug and medical device cases, the BP oil spill, and other mass tort litigation.

Actos® is one of the trade names under which the drug pioglitazone is marketed. ACTOS is a trademark of Takeda Pharmaceutical Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals U.S.A., Inc.

Attorney advertising disclaimer: the attorney responsible for the content of this advertisement is Michael J. Evans. No representation is made that the quality of legal services to be performed is greater than the quality of legal services performed by other lawyers.

“Family members of bladder cancer victims who took the diabetes drug Actos may have valuable legal claims of their own,” says experienced drug litigation attorney Michael J. Evans. Evans says that even though many people have filed lawsuits allegi

ng that the diabetes drug Actos caused bladder cancer, he believes many more people have valuable claims that have not been filed.

Actos Lawsuit Website

That’s why Evans has launched a new Actos Lawsuit website and 24-hour toll-free phone service. Actos patients who developed bladder cancer as well as their family members are welcome to use the Free Actos Lawsuit Review Form, or call the Actos Helpline at 800-671-0996. The phone service is available 24 hours a day, 7 days a week.

Both the Actos Lawsuit website and the 24-hour Actos Helpline are available to people nationwide. Evans is working with a group of attorneys who are involved in Actos lawsuits already filed in federal and state courts. Evans says his goal is to simplify the legal process for bladder cancer victims and their families.

“Some bladder cancer patients are too sick, or have died, and can’t file a lawsuit on their own behalf. But drug makers can’t avoid paying valid claims just because their drugs killed patients or made them too sick to file a lawsuit. Family members can usually act on the bladder cancer victim, and the family member may also have the right to collect money in addition to money collected by the bladder cancer victim (or the estate of the bladder cancer victim). For example, some states allow the recovery of money by spouses, and some allow the recovery by both spouses and children. It’s important for the family members of bladder cancer victims to understand their own rights, as well as the rights of the bladder cancer victim,” Evans said.

Evans says he believes visitors to the website will be especially interested in reading a page containing excerpts from a whistleblower lawsuit filed by Dr. Helen Ge, who was a medical researcher for the maker of Actos during clinical trials before the drug was approved by the FDA.

Dr. Ge’s entire 116-page lawsuit can be downloaded from the Actos Lawsuit website. Dr. Ge’s lawsuit is U.S. ex rel. Helen Ge v. Takeda Pharmaceutical Co., 10-cv-11043, U.S. District Court, District of Massachusetts (Boston).

Evans has taken some of the more interesting allegations of Dr. Ge’s lawsuit and put them on a Actos Whistleblower Lawsuit Excerpts page.

Among the more shocking allegations of the whistleblower lawsuit are these:

• Paragraph 14 alleges: “Actos, however, is not as safe as Takeda has led the FDA, healthcare professionals and the general public to believe. Rather, the FDA and the public were led to believe that Actos is safer because Takeda failed to properly report all of the Actos-related adverse events to the FDA.
• Paragraph 98 alleges that Takeda is guilty of “publicly denying the causal relationship between the Bladder cancer and Actos even though Takeda knew otherwise as far back as the 90′s when Actos was tested in animals and bladder cancer was detected.” Paragraph 98 also alleges that over 100 bladder cancer cases were reported to Takeda, but only 72 were reported to the FDA’s Adverse Event Reporting System (AERS).

Evans says it’s important for the FDA to investigate the truthfulness of Dr. Ge’s allegations before it approves any other drug containing pioglitazone, the active ingredient in Actos. A July 30, 2012 Drug Store News report says, “Takeda announced the resubmission to the Food and Drug Administration of applications for alogliptin and a drug that combines alogliptin with pioglitazone, the active ingredient in the Takeda drug Actos.”

“It’s bad enough that

Actos patients are being exposed to increased risks of bladder cancer and cardiovascular problems,” Evans said. “We certainly don’t need to be approving the sale of another drug containing pioglitazone.”

Evans said that the new Actos Lawsuit website and 800-671-0996 Actos Helpline are intended to simplify things for bladder cancer victims and their families. “It’s hard enough to face the tragedy of bladder cancer without also having to deal with the legal system. It’s our goal to simplify the legal process as much as possible.”

About Michael J. Evans (Full Disclosure: Michael J. Evans is the Publisher of ConsumerNews.com):
Michael J. Evans is owner of The Law Offices of Michael J. Evans, LLC., P.O. Box 55055,
Birmingham, AL 35255. Evans is an attorney and consumer advocate who has represented thousands of people nationwide who were harmed by drugs and medical devices. Evans helped pioneer national online legal marketing when he and two other attorneys founded the American Legal Alliance in 2000, to enable groups of law firms to use the Internet to offer services to people in need of attorneys nationwide. Evans frequently works with alliances of law firms to represent people nationwide in mass tort cases such defective drug and medical device cases, the BP oil spill, and other mass tort litigation.

Actos® is one of the trade names under which the drug pioglitazone is marketed. ACTOS is a trademark of Takeda Pharmaceutical

Company Limited registered with the U.S. Patent and Trademark Office and used under license by Takeda Pharmaceuticals U.S.A., Inc.

Attorney advertising disclaimer: the attorney responsible for the content of this advertisement is Michael J. Evans. No representation is made that the quality of legal services to be performed is greater than the quality of legal services performed by other lawyers.

If the diabetes does not kill you, the bladder cancer might. That’s the gist of a lawsuit, filed April 25 in the Louisiana Western District Court, in which plaintiff Donald Shingleton alleges he suffers from bladder cancer after taking Actos for se

veral years.

Actos is a drug used to control type 2 diabetes. It has been a blockbuster for its maker, Japan-based Takeda which last year logged $4.5 billion in Actos sales.

Diabetes is an ever more common disease in the United States. The American Diabetes Association estimates that nearly 26 million of us – almost 10 percent of the population – suffers from diabetes, a disease characterized by the body’s inability to manufacture or to efficiently use insulin. It is linked to cardiovascular disease, kidney failure and blindness.

Actos bladder cancer lawsuits given MDL treatment in federal court

Shingleton is not alone in claiming an Actos bladder cancer connection. So many Actos bladder cancer cases have been filed, or are expected to, that US Judge Rebecca Doherty now oversees the so-called Multi District Litigation (MDL) for Actos related cases. “This court has been informed by counsel that the number of claims which will be included could reach into the thousands,” Doherty wrote in a recent order naming special masters to help manage the legal traffic jam.

Since the case was assigned MDL status in December, over 200 cases from courts around the nation have been transferred into the Louisiana district

Singleton, in his Actos bladder cancer lawsuit, said he had taken Actos for “many years” and as a result he suffered “life-threatening injuries.” The many other suits are said to make essentially the same allegation.

The FDA, meantime, in June, 2011 issued a Drug Safety Communication that explicitly warns against taking Actos for more than a year because the drug “may be associated with an increased risk of bladder cancer. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”

The FDA warning continued: “FDA is also aware of a recent epidemiological study conducted in France which suggests an increased risk of bladder cancer with pioglitazone [aka Actos]. Based on the results of this study, France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients.”

The FDA warned patients with active bladder cancer not to take Actos.

The FDA advisory did not warn patients with no history of bladder cancer away from Actos.

It added this patient advice for those taking Actos:

“Tell your doctor right away if you have any of the following symptoms of bladder cancer: blood or red color in urine; urgent need to urinate or pain

while urinating; pain in back or lower abdomen.”

A complication is that a drug that had been touted as the successor to Actos – alogliptin, also from Takeda – was turned down by the Food and Drug Administration in late April. The FDA requested more information in the use of the drug outside the US.

This is the second time the FDA has turned down alogliptin. In 2009 it also requested more information.

Actos is scheduled to lose patent protection in the US in late summer.

Two separate studies by Canadian researchers published in May and July 2012 both found evidence supporting the Actos bladder cancer link. The May study found that using Actos for two years doubled a patient’s risk of developing Actos bladder cancer.

Actos bladder cancer risks shown in May 31, 2012 study, establishes Actos bladder cancer risk.

Actos, the trade name for the diabetes drug Pioglitazone, is associated with an increased risk of bladder cancer, finds a study pub

lished on bmj.com today.

The results show that more than two years daily exposure to pioglitazone doubles the risk of Actos bladder cancer.

Actos bladder cancer risks were evaluated in a new study reported in MedpageToday.com on May 31, 2012. The study confirms previous studies showing an Actos bladder cancer risk. According to an excerpt from the article, the Actos bladder cancer risk is clearly established:

Use of the anti-diabetic agent pioglitazone (Actos) is associated with an increased risk of bladder cancer, a nested case-control study confirmed.

Patients with type 2 diabetes who were ever treated with pioglitazone [Actos] had an 83% higher risk for bladder cancer (adjusted rate ratio 1.83, 95% CI 1.10 to 3.05) than those who had never used the thiazolidinedione, according to Laurent Azoulay, PhD, of McGill University in Montreal, and colleagues.

This was a drug-specific effect, because patients taking rosiglitazone (Avandia) did not have an elevated risk (RR 1.14, 95% CI 0.78 to 1.68), the

viagra online pharmacy

researchers reported online in

cialis online

BMJ.

The results of this analysis differed from those of a study being presented this week at the annual meeting of the American Society of Clinical Oncology, which suggested that the bladder cancer risk was a class effect for glitazones.

Other previous efforts to ascertain if pioglitazone [Actos] is associated with bladder cancer have had conflicting results, but the FDA and the Canadian health authorities have added a warning of that risk to the drug’s labeling, and some European countries have restricted its use.

(Emphasis added)

In other articles published today about the study, ScienceCodex reported that the new study shows that 2 years of treatment with Actos doubles the risk of bladder cancer.

(Emphasis added).

Actos Bladder Cancer Resources May 31, 2012:

• Diabetes Drug Actos May Increase Bladder Cancer Odds (MSN Health)
• Diabetes Drug Pioglitazone Associated With Bladder Cancer Risk. (Medical News Today)
• Diabetes drug linked to increased risk of bladder cancer (Science Codex)

Actos lawsuit filed by whistleblower alleges deliberate coverup of Actos side effects.

Actos lawsuit filed by whistleblower recently unsealed by federal court: A whistleblower who filed an actos lawsuit against the maker o

f Actos makes serious allegations about a coverup of the Actos bladder cancer link. (Download a copy of the 111-page Actos lawsuit here). The actos lawsuit was filed by whistleblower Helen Ge, who is a medical doctor and former safety consultant to Takeda Pharmaceuticals.

Dr. Helen Ge’s Actos lawsuit involves Takeda’s failure to report bladder cancer, Congestive Heart Failure (CHF) and other adverse events

for the diabetes drug Actos. In her lawsuit, Dr. Ge alleges shocking misconduct, including these allegations about the Actos bladder cancer risk:

Dr. Ge had direct knowledge of the Actos bladder cancer risk and encountered resistance from her superiors when she tried to report bladder cancer as related to Actos. Dr. Ge claims her supervisors directed her to change her “related” assessment to unrelated. According to her recollection of reviewing Takeda’s adverse event database for Actos, there were more than 100 bladder cancers reported to the company, but only 72 reported to the FDA, which she alleges is a serious discrepancy. Dr. Ge also alleges that carcinogenesis from Actos was discovered during the initial Actos animal studies.

Actos attorneys who have filed Actos lawsuits for people with bladder cancer are taking a long look at Dr.

Ge’s lawsuit. If the allegations of the lawsuit are true, Actos’ manufacturer could be facing substantial compensatory and punitive damages in each bladder cancer victim’s actos lawsuit. A jury would be understandably upset if these allegations are proven:

• That Dr. Ge’s supervisors ordered her to falsely report that side effects related to Actos were “unrelated.”
• That the link between Actos and bladder cancer was shown as early as animal studies, before Actos was ever placed on the market.
• That there were more than 100 Actos bladder cancer cases, but Takeda Pharmaceuticals reported only 72 of them to the FDA.

(Download a copy of the 111-page Actos lawsuit here).

Evidence is building that the use of the diabetes medication Actos (pioglitazone) may be associated with an increased risk of bladder cancer. Actos is a diabetes medication that is manufactured by Takeda Pharmaceuticals, and it is prescribed by doct

ors in accordance with an overall program that includes a healthy diet and a regiment of exercise in an viagra price effort to control the symptoms and problems associated with type 2 diabetes. To date, Actos remains available on the American market.