The warning follows months of scrutiny and calls for the two manufacturers to take action to address the side effects of zinc in Fixodent and Super Poligrip denture cream. For years the products were sold with no warnings or even indication that they contained zinc.

When the products are used over a long period of time, or if too much of the denture cream is applied, high levels of zinc can enter the body. This can deplete copper levels and lead to the development of neuropathy and other neurological injuries.

A number of Fixodent lawsuits and Super Poligrip lawsuits have been filed against Proctor & Gamble and GlaxoSmithKline, alleging that users suffered permanent and disabling problems as a result of the manufacturers’ failure to warn that their denture cream products contained zinc and that use of adhesives could cause zinc poisoning.

In October 2009, GlaxoSmithKline finally added a zinc warning to Super Poligrip, indicating that use of excessive amounts of the adhesive could cause “serious health effects” and last month the company indicated it would discontinue Super Poligrip with zinc in the United States due to the risk of zinc poisoning.

Although the same risk of zinc problems with Fixodent exist, Proctor & Gamble has resisted placing any warnings on their product, claiming that Fixodent does not have as much zinc as Super Poligrip and is safe for use. However, according to a report by NewsInferno.com, new information was added in recent days to Proctor & Gamble’s Fixodent website, DentureLiving.com, warning that zinc is contained in the product and highlighting usage instructions.

The new Fixodent warning reads: “CAUTION: Contains zinc (less than 4%). Some reports suggest that excessive and prolonged zinc intake may be linked to adverse health effects.” The warning recommends that Fixodent be used as directed and that consumers should consult with their doctors if they are using other zinc-based products. It is unclear whether a similar warning and usage instructions will added to Fixodent products themselves.

The recall of Poligrip EX, the Japanese version of the popular denture cream sold as Super Poligrip in the United States, comes after U.K.-based GlaxoSmithKline acknowledged that zinc poisoning from the denture cream can cause serious health problems.

Last month, the company discontinued Super Poligrip with zinc in the United States, but has not issued a recall here. GlaxoSmithKline indicated that the U.S. products will be replaced with zinc-free versions.

The zinc contained in denture cream products can enter the body, especially when too much is used to keep dentures in place. Increased levels of zinc in the body can deplete copper levels, causing a condition known as hypocupremia, which is known to increase the risk of significant neurological problems that can leave users with permanent and debilitating physical injuries. Although the recommended daily allowance of zinc is 11 mg for men and 8 mg for women, with 40 mg being the maximum amount of zinc that can be safely tolerated, some denture creams have been found to expose users to levels as high as 330 mg per day.

Glaxo has only been selling Poligrip EX in Japan since 2007. It has sold about 1.9 million units there since marketing began.

A large number of denture cream lawsuits have been filed against GlaxoSmithKline over its Poligrip cream and against Proctor and Gamble over its Fixodent denture adhesive. About 70 cases filed in federal courts throughout the United States have been centralized in a denture cream multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

Zinc is believed to help with the adhesive properties of the denture creams. However, until recently neither GlaxoSmithKline or Proctor and Gamble had alerted users that zinc was an ingredient in their products.

Prior packaging did not acknowledge that Super PoliGrip contains zinc, which can enter the body when the product is used. If large amounts of the denture cream are used over an extended period of time, or if the product is used together with zinc supplements, high levels of zinc build up in the body. This may result in decreased copper levels in the blood, a condition known as hypocupremia, which may lead to neuropathy and permanent nerve damage.

More than 30 denture cream zinc poisoning lawsuits have been filed in federal court against GlaxoSmithKline over Super Poligrip problems or against Proctor & Gamble over their Fixodent denture cream. The complaints allege that the manufacturers failed to adequately warn about the risk of zinc poisoning.

The new insert about zinc in Super Poligrip warns that the product contains zinc, urging consumers to speak to their doctor before using the denture cream if they are taking daily zinc supplements. The SuperPoligrip zinc warning also indicates that consumers should only use the product as directed, warning that “using excessive amounts of this product over a prolonged period of time has been reported to result in serious health effects from increased zinc intake.”

More detailed information is also provided to instruct users about the proper use of the product, as many denture wearers report using several tubes a week due to ill-fitting dentures. The instructions indicate that a tube should last between 3 and 10 weeks depending on the size.

Although the recommended daily allowance of zinc is only 11 mg for men and 8 mg for women, with 40 mg being the maximum amount of zinc that can be safely tolerated, some denture creams have been found to expose users to levels as high as 330 mg per day.

Zinc poisoning from Super PoliGrip or Fixodent can result in neuropathy, myelopathy, anemia, bone marrow failure, central nervous system deficits and other neurological injuries, according to lawsuits filed against the manufacturers. Symptoms often involve numbness, tingling, pain, weakness, loss of sensation, loss of balance, paralysis or difficulty breathing.

In June, all Super Poligrip lawsuit and Fixodent lawsuit claims pending in federal courts throughout the United States were consolidated into a multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

On June 9, 2009, the U.S. Judicial Panel on Multidistrict Litigation consolidated 12 cases, including two Fixodent cases against Proctor and Gamble Manufacturing Corp. and ten Super Poligrip cases against GlaxoSmithKline PLC, into a multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

The number of lawsuits now consolidated in the MDL has increased to 33, and denture cream lawyers are continuing to review hundreds of other potential claims to determine if complaints like numbness, tingling, pain, weakness, loss of sensation, loss of balance, paralysis or difficulty breathing may be caused by zinc poisoning from Fixodent or Super PoliGrip.

All of the Fixodent lawsuits and Super Poligrip lawsuits involve similar allegations that the manufacturers failed to warn that high amounts of zinc are contained in the denture adhesive creams, which can be absorbed by the body when a large amount of the product is used or if it is used over a long period of time. Increased levels of zinc in the body can also deplete copper levels, causing a condition known as hypocupremia, which is known to increase the risk of significant neurological problems that can leave users with permanent and debilitating physical injuries.

Although the recommended daily allowance of zinc is 11 mg for men and 8 mg for women, with 40 mg being the maximum amount of zinc that can be safely tolerated, some denture creams have been found to expose users to levels as high as 330 mg per day.

The filing of cases has been slowed by the difficulty consumers have experienced figuring out that they may be eligible to pursue a potential Fixodent or Poligrip lawsuit. Doctors are often not making an immediate connection between the denture adhesive creams and symptoms exhibited by their patients. In addition, if a blood or urine test is not obtained while the products are being used, or within a short amount of time after they are discontinued, zinc levels and copper levels may return to normal even though the consumer has been left with permanent neurological damage.

On June 9, 2009, the Judicial Panel on Multidistrict Litigation centralized all federal denture cream lawsuits before Judge Altonaga in the U.S. District Court for the Southern District of Florida, for coordinated discovery and pretrial litigation.

All of the complaints involve similar allegations that the plaintiffs have suffered severe injuries caused by denture cream zinc poisoning when high amounts of zinc entered their body from the use of Fixodent or Super PoliGrip adhesives. The increased zinc levels in the body can cause copper depletion, known as hypocupremia, which is known to cause permanent neurological problems like neuropathy, numbness, tingling, pain, weakness, loss of sensation, loss of balance, paralysis and difficulty breathing.

According to a Case Management Order issued July 13, 2009, Judge Altonaga appointed two denture cream attorneys, Andy Alonso and Scott Weinstein, to serve as Co-Lead Counsel for all plaintiffs. These attorneys will act as the spokespersons for all plaintiffs at pretrial proceedings and in response to inquiries from the court. They will also be the attorneys who will submit and argue motions, examine witnesses at hearings and negotiate stipulations and potential settlements with the defendants, which would apply to all cases.

The court also appointed 10 lawyers to serve on a Plaintiffs’ Steering Committee (PSC), who will share in the responsibilities for conducting discovery and other work that has the common benefit for all plaintiffs.

There are currently at least 18 individual cases consolidated before Judge Altonaga, including 14 Super PoliGrip lawsuits against GlaxoSmithKline PLC and 4 Fixodent Lawsuits against Proctor & Gamble. In addition, as denture cream lawyers throughout the United States file additional cases in various federal districts throughout the country, they will be transferred to the Southern District of Florida for pretrial proceedings.

Although the lawsuits are consolidated in an MDL, each of the cases remain individual claims and will be returned back to the court where they were originally filed for trial if they cases to do not settle or otherwise resolve during pretrial litigation.

The Fixodent lawsuit was filed on March 13, 2009 in the U.S. District Court for the Southern District of Ohio on behalf of Sherry Mosley and her son, Aaron Mosley.

The complaint alleges that Sherry Mosley used the Fixodent denture adhesive cream several times per day for a number of years to secure her dentures in place. High levels of zinc contained in the product caused her to suffer from zinc toxicity, which caused a decrease in her copper levels, leaving her with neurological damage and injury.

A growing number of similar denture adhesive lawsuits have been filed against Proctor & Gamble over their Fixodent cream, and against GlaxoSmithKline involving their Poligrip and Super Poligrip adhesive. The use of the products have been associated with symptoms like dizziness, lethargy, paralysis, numbness, loss of sensation, tingling in the hands and feet, muscle weakness and other unexplained pain.

The zinc contained in the denture creams are used as a bonding agent. However, the zinc can seep into the body through the gums, or if the product is swallowed, causing high levels of zinc and copper depletion known as hypocupremia, which can cause a host of adverse health effects.

For years, Sherry Mosley complained to her doctors about vague and unusual neuropathic symptoms that left her incapable of performing many daily activities. The 45 year old mother complains that she suffers from chronic weakness, pain, discomfort and burning in her back, legs and other body parts, along with urinary, bladder and gastrointestinal dysfunction.

After she learned of the denture cream side effects causing problems similar to what she was experiencing, Mosley had her blood tested, which confirmed the presence of abnormally high zinc levels and low copper levels.

The denture cream lawsuit over Fixodent indicates that Proctor & Gamble was aware that some portion of the product would get ingested and metabolized in the gastrointestinal tract. The complaint also alleges that before zinc was added to Fixodent it was generally known and accepted in the scientific community that excess zinc in the body could have severe adverse health effects in humans.

Although zinc and copper levels generally return to normal after Fixodent or other denture creams are stopped, the lawsuit indicates that Mosley was left with permanent neurological injury by the time the problems were discovered.

STATUS OF FIXODENT LAWSUITS AND POLIGRIP LAWSUITS:
A growing number of cases have been filed against the manufacturers of these adhesives, and denture cream lawyers are continuing to review potential cases on behalf of people who have been diagnosed with zinc poisoning or other neuropathy problems.

MANUFACTURERS: Two of the most popular denture adhesives sold in the United States that contain high levels of zinc include Proctor and Gamble’s Fixodent and GlaxoSmithKline’s Poligrip and Super Poligrip.

>>CONTACT A DENTURE CREAM LAWYER<<

OVERVIEW OF DENTURE CREAM PROBLEMS: Over 35 million Americans, mainly consisting of the elderly, use denture creams or adhesives to keep their dentures in place. High levels of zinc that are contained in these products may be absorbed into the body through the mouth and gums, potentially causing:

• Zinc Poisoning
• Neuropathy
• Myelopathy
• Anemia
• Bone Marrow Failure
• Central Nervous System Deficits
• Hypocupremia
• Other Neurological Injury

ZINC POISONING LAWSUITS: While the body requires small amounts of zinc, serious and debilitating health problems may occur when high levels are ingested. Increased levels of zinc may also cause reduced copper levels in the blood, known as hypocupremia, which may lead to neuropathy and affect the nerves.

According to a 2001 report by the National Academy of Sciences, 40 mg/day is the highest amount of zinc that can be safely tolerated, but the recommended daily allowance is only 11 mg/day for men and 8 mg/day for women.

Researchers have found that denture adhesive creams like Super Poligrip and Fixodent contain zinc concentrations between 17,000 and 34,000 micrograms per gram. It has been estimated that users of these produts may be exposed to about 330 mg of zinc per day, far higher than the recommended amount or what has been determined to be safe.
 
Zinc toxicity may cause symptoms such as

• Dizziness
• Incontinence
• Lethargy
• Paralysis
• Numbness
• Loss of Sensation
• Tingling in the Hands or Feet
• Muscle Weakness
• Unexplained Pain

 
Blood tests can determine the level of zinc and copper in the body. It is important for a zinc overdose to be promptly detected and treated to reduce the risk of permanent and debilitating injury.