A press release by GlaxoSmithKline announced that the company is pulling three of its signature products – Super PoliGrip Free, Super PoliGrip Comfort Seal Strips, and Super PoliGrip Powder – while it works on a new zinc-free formula. The company maintained that PoliGrip is safe when used as directed, and that problems only arise when consumers “apply more adhesive than directed [or] use it more than once per day.” GSK says it is halting the manufacture, distribution, and advertising of the named products “as a precautionary measure to minimize any potential risks to these consumers.

The company has faced growing concern over the danger of zinc poisoning. Last October, GSK announcedthat it was placing inserts in all denture packages, warning consumers that excessive zinc intake can lead to “serious health effects.”

That decision was prompted in part by a 2008 article in the medical journal Neurology, which profiled four people who used, on average, two tubes of denture cream per week and suffered varying levels of neurological damage as a result. GSK has stressed that a tube of denture cream should last a month or more, depending on its size.

Zinc is an essential element of a human diet, often grouped with other so-called “good chemicals,” but too much of it can cause anemia, pancreatic diseases, and decreased levels of HDL cholesterol. Additionally, excessive zinc intake can lead to neurological and nerve damage, which in turn can cause numbness, problems balancing or walking, and tingling or weakness in the extremities. In rare cases, users have ended up paralyzed.

An extreme case was Elizabeth Gilley, a 26-year-old woman profiled earlier this month in Time Magazine. Gilley has worn dentures and used denture cream on a daily basis since a genetic condition ate away at her teeth when she was a teenager. Gilley experienced numb extremities and heavy breathing, symptoms which got worse over a six-month period, and eventually caused her to collapse. She is now confined to a wheelchair, and is one of many American consumers who have filed suits against GSK.

Indeed, the company has been named in dozens of lawsuits over the past few years, as has Procter & Gamble, which manufactures rival denture cream Fixodent. Last June, a number of suits against the two companies were consolidated in the U.S. District Court for the Southern District of Florida.

The U.S. Drug Watchdog, a consumer advocacy group, has driven home the urgency of the situation, warning that zinc-laden denture cream could produce “the worst case of zinc poisoning in U.S. history.” The group pointed out that the Food & Drug Administration (FDA) doesn’t require denture cream companies to disclose the danger posed by zinc poisoning.

GSK’s statement urged consumers who have used denture cream “for several years in greater amounts than directed on the package or more than once per day” to stop using the product and talk to their doctor. Consumers who are experiencing signs of zinc poisoning should help seek immediately, and can also call the National Poison Control at 800-222-1222.

By Jon Hood

ConsumerAffairs.com

Why the delay?  From here, it looks like the evidence was pretty damning — failing to release report findings, reshuffling data to hide results, agreeing to a comprehensive study “that would be complete in 2020″.  One motive: GlaxoSmithKline’s patent on Avandia runs out in 2012.  After that?  It’s profits for the drug go down exponentially when there will be a generic version readily available.  So, push out the time of any recall to as close to 2012 as possible, and reap the maximum benefits. 

Now the FDA is saying they will release their findings sometime this summer (even though their medical experts have already been clear that there are excessive risks for taking Avandia over its rival medicines, and no additional benefits.  Again, this brings us closer to the 2012 mark, where GSK can max out it’s profits without competition from generic versions of the drug.

Not to mention, that this delay of both releasing studies and a potential recall will reduce the amount of people who will likely sue, either due to the time lapsing of various states’ Statute of Limitations, or the deaths of potential plaintiffs.

We believe a recall should have already occured, and it is immoral and unethical to be continuing these sales at the expense of unsuspecting doctors and consumers.

If you or someone you love has developed congenitive heart failure or has had a heart attack while they were on Avandia, call the lawyers at Slater, Slater, Rosenberger & Schulman today to discuss your legal rights.  Or fill in the “Contact Us” form on the right and an attorney will contact you shortly.

During the third quarter of 2009, over 300 deaths have allegedly been caused by Avandia.  The New York Times articles cites confidential government reports that state “if every diabetic now taking Avandia were instead given a similar pill named Actos, about 500 heart attacks and 300 cases of heart failure would be averted every month” because of the excessive risk Avandia causes.

The FDA and the federal government has failed to protect its citizens and another corporate giant has failed to live up to its ethical and legal responsibilities.  Thousands of consumers have needlessly suffered and possibly died due to these failures.    While we can only hope that “next time” the Food & Drug Administration and basic corporate ethics will get it right.

If you or someone you love has developed congenitive heart failure or has had a heart attack while they were on Avandia, call the lawyers at Slater, Slater, Rosenberger & Schulman today to discuss your legal rights.  Or fill in the “Contact Us” form on the right and an attorney will contact you shortly.

After being hospitalized with gallbladder problems in December, Congressman Murtha needed surgery last week at the National Naval Hospital in Bethesda, Md.  He was discharged, but then was hospitalized again two days later when complications developed. According to a source close to Mr. Murtha. doctors inadvertently cut Mr. Murtha’s intestine during the laparoscopic surgery, causing an infection.

In 2002, Rep. Murtha's legislation to create a national monument at the Flight 93 Crash Site in Somerset, PA, was signed into law by President Bush.

If you or someone you love has been a victim of negligent medical care, call the lawyers at Slater, Slater, Rosenberger & Schulman today at (800) 251-6990.  We are here to get you the help you deserve.

As part of the total, Glaxo, the U.K.’s largest drugmaker, so far has paid $200 million to settle Paxil addiction and birth-defect cases and $400 million to end antitrust, fraud and design claims, according to the people and court records.

The $1 billion “would be worse than many people are expecting,” said Navid Malik, an analyst at Matrix Corporate Capital in London. “I don’t think this is within the boundaries of current assumptions for analysts.”

The London-based company hasn’t disclosed the settlement total in company filings. It has made public some accords. Glaxo’s provision for legal and other non-tax disputes as of the end of 2008 was 1.9 billion pounds ($3.09 billion), according to its latest annual report. This included all legal matters, not just Paxil. The company said 112 million pounds of this sum would be “reimbursed by third-party issuers.”

The drugmaker has reduced its insurance coverage to contain costs, “accepting a greater degree of uninsured exposure,” the annual report states. “Recent insurance loss experience, including pharmaceutical product-liability exposures, has increased the cost of, and narrowed the coverage afforded by, insurance for pharmaceutical companies generally,” Glaxo said.

Glaxo Comment

Glaxo declined to confirm the $1 billion figure. “Paxil has been on the market in the U.S. since 1993. Like many other pharmaceutical products, it has been the subject of different kinds of litigation over the years,” Sarah Alspach, a spokeswoman for Glaxo, said in an e-mailed statement. “It would be inappropriate and potentially misleading to aggregate payments in these various types of litigation.”

Chief Executive Officer Andrew Witty has moved to replace revenue lost to generic versions of drugs such as Paxil. Worldwide, Paxil generated about 514 million pounds in sales last year, or 2.1 percent of the total.

Glaxo rose 21 pence to 1,324 pence in London trading after falling 4 pence earlier today. Shares have risen 12 percent in the past year.

About 450 suicide-related Paxil cases were settled. Only about a dozen haven’t been, the people said. The $1 billion total doesn’t include more than 600 claims that Paxil caused birth defects.

Philadelphia Trial

A Philadelphia jury on Oct. 13 found the drugmaker should pay $2.5 million to the family of Lyam Kilker, a 3-year-old boy born with a heart defect after his mother took Paxil while pregnant. Based on that outcome, an analyst estimated the company may potentially face additional verdicts in birth-defect cases waiting to be tried in Pennsylvania.

“A liability totaling $1.5 billion is possible,” Savvas Neophytou, a Panmure Gordon analyst in London, wrote in a note to investors the day after the Kilker verdict. He still recommended buying Glaxo shares because a likely appeal may reduce the amount paid by the company.

In comparison, Pfizer Inc., parent of Wyeth, the maker of diet-drug combination fen-phen, has had to set aside about $21 billion to resolve about 200,000 personal-injury claims over that medicine. Merck & Co. agreed to pay $4.85 billion to resolve more than 48,000 claims over the withdrawn painkiller.

Harris Pogust, an attorney for Paxil plaintiffs, couldn’t confirm the total. He said the amounts are confidential.

Paxil Is Different

“Paxil’s been different from most drugs,” said Pogust, a lawyer from Conshohocken, Pennsylvania, who is handling suicide and withdrawal cases. “You’ve had three major personal injury litigations over one drug — the suicide, the birth defect and the withdrawal cases. To have three significant problems with one drug is really unusual.”

The company had $11.7 billion in U.S. Paxil sales for nine years starting in 1997, according to documents made public this year in a Pennsylvania trial. In 2002, the year before Paxil faced generic competition in the U.S., sales of the drug there were $2.12 billion. Last year, U.S. sales had fallen to $129 million. Through September of this year, sales were $52 million, down 52 percent from the same period in 2008.

Since at least 2003, Glaxo has faced claims in U.S. courts that some Paxil users were subjected to an undisclosed, higher risk for suicide and birth defects.

A Suicide Settlement

The suicide settlements included a suit over the death of a 14-year-old boy who had been taking Paxil for two months. The parents of Scott Cunningham, of Valparaiso, Indiana, sued after the boy hanged himself in 2001. They alleged Glaxo suppressed evidence that Paxil use was linked to the risk of suicide attempts by adolescents. Glaxo denied the allegations, according to court papers.

The family settled its suit in May, according to court filings. Family attorney Bijan Esfandiari confirmed the settlement, saying the amount was confidential.

About 150 cases over suicides by Paxil users were settled for an average of about $2 million, and about 300 over suicide attempts settled for an average of $300,000, they said. Some of the claims were resolved before suits were filed, according to the people familiar with the matter.

Glaxo has settled about 10 birth-defect cases, Sean Tracey, a Houston-based lawyer who represented the family of a child victim, said in court Dec. 2. The settlements averaged about $4 million, the people familiar with the cases said.

Unspecified Totals

The company hasn’t specified in regulatory filings the number of suicide, birth-defect and addiction cases settled.

“It’s important to disclose such settlements because it raises the red flag for both doctors and patients that there might be a problem,” said Dan Carlat, a psychiatrist at Tufts University School of Medicine in Boston who writes and edits a blog and a monthly Psychiatry Report. “It would motivate doctors to dig into the literature even more before prescribing these drugs.”

Glaxo paid an average of about $50,000 per case to resolve about 3,200 claims linking Paxil to addiction problems, the people familiar with the cases said.

In its 2008 annual report, company officials said they had reached a “conditional settlement agreement” in January 2006 with Paxil users who alleged they suffered withdrawal symptoms after taking the drug. The case, filed in Los Angeles federal court, was marked closed in court records in February.

No Liability Admission

“Glaxo did not admit liability” in the addiction settlements, the company’s officials said in a March 2009 filing with the U.S. Securities and Exchange Commission.

In one of eight accords unrelated to individual suicide, addiction or birth-defect claims, Glaxo agreed in 2003 to pay $87.6 million to the U.S. and 49 states over claims it repackaged and privately labeled Paxil and another drug, Flonase, to a health maintenance organization at discounted prices.

Glaxo, denying liability, agreed in 2004 to pay $165 million to settle two antitrust suits over allegations it engaged in sham patent infringement litigation to stall approval of generic versions of the drug, court records show.

Of that total, $100 million was for direct purchasers of Paxil, such as drug wholesalers, and $65 million was for indirect buyers, the records show.

New York

In the same year, Glaxo agreed to pay $2.5 million to New York to resolve accusations the company withheld safety data about the antidepressant. The company, calling the claims unfounded, agreed to release safety studies on the medicine’s effect on children.

In 2005, the company added a black-box warning to its Paxil label that the drug increased the risk of suicidal thoughts among adolescents, following a request by the U.S. Food and Drug Administration to do so.

The drugmaker agreed last year to pay $40 million to settle suits by so-called third-party payers, primarily insurance companies that reimbursed parents for their children’s Paxil.

Insurers said Glaxo knew the drug “was neither safe nor effective for the treatment of depression in persons under the age of 18,” U.S. District Judge Michael Davis in Minneapolis said in a September 2008 order approving the accord.

Glaxo “denies any liability,” company spokeswoman Alspach said at the time. “GSK has agreed to the settlement to avoid the costs, burdens and uncertainties of ongoing litigation.”

Reimbursing Parents

In 2006, the company resolved similar claims by consumers for about $64 million, reimbursing parents of patients for money spent on Paxil prescriptions, in an Illinois class-action suit.

Glaxo “denies any liability” in those cases, the company said in its annual report.

In 2001, a jury in Cheyenne, Wyoming, ordered Glaxo to pay $6.4 million to the relatives of a man who shot his family to death and then turned the gun on himself after taking Paxil. The case was settled on confidential terms while on appeal, according to Kevin Colgan, a Glaxo spokesman.

The Philadelphia case is Kilker v. SmithKline Beecham Corp. dba GlaxoSmithKline, 07-001813, Court of Common Pleas, Philadelphia County, Pennsylvania (Philadelphia).

The plaintiff’s four year old son was born with several heart defects. The child spent months in the hospital and has had several surgeries, with more to come. The plaintiffs argued that these defects were caused by her use of Paxil during her pregnancy. The jury found that Paxil did not warn of the potential for these birth effects while taking the drug early in a pregnancy (and still hasn’t admitted the link).

There are hundreds more cases against GlaxoSmithKline that are working their way through the courts, and this first verdict will undoubtedly encourage additional plaintiffs to come forward. Although the $2.5 million settlement is relatively small when compared to the nearly $1 billion per year in revenue Paxil brings in, legal observers were watching this case closely, as any loss or win would have a direct impact on both settlement expectations in related cases as well as the likelihood of other potential victims to bring suit.

But this SHOULD NOT be used as a marketing tool. The convenience factor should not blur the other risks. If someone doesn’t need something as strong as Levaquin, then they shouldn’t be prescribed it. It’s not just the doctors’ fault: The drug companies promote the benefits of these (often costly) drugs without stressing the additional risks over alternatives. But it is also the consumers’ job to be vigilant. Especially now, when you know the dangers. Be aware and that will go a long way towards being safe.

Source: http://www.levaquinblog.com/2009/11/once-a-day/