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.

In a statement issued February 19, the ADA points out that a number of recent case reports in scientific literature have described patients with ill-fitting dentures who suffered neurological and hematological problems after using excessive amounts of denture cream with zinc to keep their dentures in place. The ADA notes that while more information is needed in studies to show a causal relationship, swallowing zinc in denture creams can lead to low blood copper levels and neurological damage from zinc poisoning.

Last month GlaxoSmithKline, which manufactures Super Poligrip denture adhesive, announced that it is discontinuing all of its zinc-based denture creams, including Super Poligrip Original, Ultra Fresh and Extra Care. The products will be replaced with zinc free creams in the near future, the company has said. However, Proctor & Gamble, which manufactures Fixodent with zinc, has not indicated any plans to reformulate their product.

The ADA warned denture wearers to see their dentists if their dentures do not fit well, as studies indicate that the problems are linked particularly to patients who have ill-fitting dentures and use excessive amounts of denture cream with zinc.

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.

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.

A growing number of Super Poligrip lawsuits and Fixodent lawsuits have been filed against the manufacturers for failing to adequately warn about the dangers of zinc in denture cream products. All federal denture cream lawsuits have been centralized in a multidistrict litigation (MDL) for coordinated pretrial litigation in the U.S. District Court for the Southern District of Florida.

Super Poligrip Original, Ultra Fresh and Extra Care denture cream products will be removed from shelves and replaced with zinc-free versions, the British drug company announced on Thursday. The product change comes as the company faces mounting Poligrip lawsuits over health problems allegedly caused by zinc in the denture adhesive products. Excess levels of zinc entering the body from the denture cream could cause users to suffer neurological damage from zinc poisoning.

GlaxoSmithKline says that it is discontinuing the products due to the “health problems associated with the long-tern excessive use of our zinc-containing denture adhesive products.” However, the company said it still believes that the products are safe when used in recommended amounts. GlaxoSmithKline has maintained that users are only in danger when they use more than the recommended amount in order to compensate for ill-fitting dentures.

Eventually, GlaxoSmithKline says there will be zinc-free versions of all of the discontinued denture creams, but did not announce when those products would be available. There is already a Super Poligrip Free on the market, which does not contain zinc. The replacement products will be clearly marked as being zinc-free, the company said.

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

Proctor & Gamble officials say they have no plans to discontinue Fixodent, maintaining that it has half the zinc as Super Poligrip and is safe for use. Both companies have faced calls from critics for zinc to be removed from the products, which previously contained no warnings about the risk of zinc poisoning.

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.

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.

In October, GlaxoSmithKline added a new Super Poligrip zinc warning to the denture cream, notifying consumers that the product contains zinc and that excessive use of the cream could result in serious health effects.

The Poligrip lawsuit was filed in Miami by the family of Rodney Urbanek, who died in 2008 at age 64. The denture adhesive cream contains high levels of zinc, and GlaxoSmithKline failed to warn consumers about the risk of serious health problems when too much zinc accumulates in the body, according to the complaint.

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

While all of the Fixodent suits and Super Poligrip suits involve similar allegations that the manufacturers failed to warn that high amounts of zinc are contained in the denture adhesive creams, Urbanek’s lawsuit is believed to be the first wrongful death lawsuit brought to bear on one of the companies due to zinc poisoning from denture cream.

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.

In October, GlaxoSmithKline added a new Super Poligrip zinc warning to the denture cream, notifying consumers that the product contains zinc and that excessive use of the cream could result in serious health effects. Prior packaging did not even acknowledge that the denture cream contained zinc, let alone discuss denture cream zinc side effects.

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.

In an order issued June 9, 2009, the Panel found that centralization of the cases in an MDL, or Multidistrict Litigation, is appropriate due to the common questions of fact involved in the various cases. The panel rejected an argument by Proctor & Gamble, the makers of Fixodent, that individual issues, dental and medical histories, and specific injuries were reason to consider the cases too different to consolidate.

There are currently at least 12 denture cream poisoning lawsuits pending in 11 different districts throughout the United States. Ten of the cases are Super Poligrip lawsuits filed against GlaxoSmithKline and the other two cases are Fixodent lawsuits against Proctor & Gamble.

The cases all allege that the high amounts of zinc contained in Fixodent and Poligrip can be absorbed into the body when large amounts of the denture adhesive cream is used or if it is used over a long period of time. This can cause increased zinc levels in the body and deplete copper, causing a condition known as hypocupremia, which is known to cause significant neurological problems in humans.

Plaintiffs claim to have suffered a variety of injuries from denture adhesive zinc poisoning, including neuropathy, myelopathy, anemia, bone marrow failure, central nervous system deficits and other irreversible neurological injuries. Symptoms of the denture cream problems could include numbness, tingling, pain, weakness, loss of sensation, loss of balance, paralysis or difficulty breathing.

In addition to the Poligrip and Fixodent lawsuits currently pending in federal court, any new cases filed will be transferred to Judge Altonaga, where they will be handled in a coordinated manner during pretrial litigation to avoid duplicative discovery, inconsistent rulings from different judges and to server the convenience of the parties, witnesses, attorneys and the court.

The denture cream lawsuit alleges that Super Poligrip contains zinc, which can enter the body at high and dangerous levels, potentially resulting in zinc poisoning and depleted copper levels. This can cause a number of neurological symptoms generally referred to as neuropathy.

Super Poligrip, which is manufactured by GlaxoSmithKline, is an adhesive cream used to help hold dentures in place. It is sold over-the-counter, and is classified by the FDA as a low-risk medical device, which means that Glaxo is not required to list the ingredients on the product label.

The Super Poligrip lawsuit was filed on behalf of Horace Daniels and Theodore Micklazavage, together with their respective spouses, alleging that GlaxoSmithKline failed to warn about the risk of zinc poisoning from the denture cream or that the Super PoliGrip even contains zinc. They also alleged that Glaxo failed to inform the plaintiffs about the correct dosage and use of Super PoliGrip, which resulted in overuse and excessive absorption zinc.

Daniels, who is 72 years old and received dentures about 8 years ago, alleged that his use of Super PoliGrip resulted in a diagnosis of copper-deficiency-induced myelopathy, resulting in permanent neurological and other injuries that impact his day to day life.

Micklasavage, who is 57 years old and has worn dentures for approximately 10 years, alleged that he was diagnosed with hyperzincemia due to Super PoliGrip, which have left him with similar neurological damage.

Excess exposure to zinc in Super PoliGrip has been associated with symptoms like weakness in the hands, arms or legs, poor balance, lack of coordination, pain, numbness, tingling, burning sensation, the feeling of warning gloves or socks and other problems.

Complaints have been filed over similar problems with Fixodent, a different type of denture cream that also contains zinc.

Last week, the U.S. Judicial Panel on Multidistrict Litigation held hearings about whether to consolidate all federal lawsuits against GlaxoSmithKline and Proctor & Gamble, the makers of Fixodent. At the time the petition was filed, there were 11 individual denture cream lawsuits involving zinc poisoning pending in different districts throughout the United States. Nine of the cases are Poligrip lawsuits and the other two cases involve the use of Fixodent.