Public Citizen filed a petition calling for the FDA to require a Darvon and Darvocet recall in 2006, and followed that up with a lawsuit filed last summer against the FDA for failing to act on their petition.

Earlier this year, an FDA advisory committee met and evaluated the safety and risks associated with the powerful painkillers. In the wake of data from Europe that linked Darvon and Darvocet to hundreds of accidental and intentional drug overdoses, the FDA panel voted to recommend the agency withdraw approval for the drugs.

While the FDA usually follows the recommendations of their advisory panels (and they also usually end up acting in accordance with Public Citizen petitions; see the Botox warnings and Levaquin tendon rupture warnings), they are not required to do so. In a statement released yesterday, the FDA said it uses a different measuring stick for determining the benefits and risks of drugs than the advisory committee and Public Citizen:

There are differences in how FDA and those who support the market withdrawal of propoxyphene view the benefit and safety data of this drug. FDA finds there is evidence that propoxyphene can effectively treat pain at recommended doses. FDA also finds that the differences in use patterns between Europe and the United States limit the applicability of the European data to the U.S. population. The U.S. data available to date do not confirm the European findings. Because these data are limited, however, FDA is further investigating the safety concerns with propoxyphene in the United States.

Propoxyphene was first approved for use in medications in 1957. It is an opioid that is used as a painkiller. The new labeling requirements on the medications will include a boxed warning of the risk of overdose, and information in medical guides on overdose risk and the importance of taking proper dosages.

The FDA’s decision may provide some insight into how the agency will handle recent recommendations by its advisory panel that called for a recall of Percocet, Vicodin and other painkillers that contain acetaminophen. The panel narrowly voted that the drugs were dangerous enough that they should be removed from shelves. That panel also voted to restrict the dosage of acetaminophen-based over-the-counter medications, like Tylenol and NyQuil, to 325 milligrams per day.

DARVOCET AND DARVON LAWSUITS

The product liability lawyers at Saiontz & Kirk, P.A. are evaluating the potential for Darvocet and Darvon lawsuits for individuals who have suffered fatal or catastrophic injuries as a result of an accidental overdose. If you, a friend or family member experienced problems as a result of the drugs or other painkillers that contain propoxyphene, request a free consultation and claim evaluation.

>>PRIOR POST (6/11/2008): “>Chantix Stevens-Johnson Syndrome Side Effects
Added to Lawsuit Investigations

Stevens-Johnson Syndrome, commonly referred to as SJS, is a rare skin reaction that can occur as a side effect of several medications. It results in severe rashes and blistering of the skin and mouth, where the skin literally burns from the inside out. It often requires treatment in a hospital intensive care unit (ICU) or burn care unit, and it can result in death. If the top layer of the skin detaches from the lower layers and lesions cover more than 30% of the body, SJS is often diagnosed as Toxic Epidermal Necrolysis (TEN) or Lyell’s Syndrome.

Concerns about potential Chantix and Stevens-Johnson Syndrome arose after an independent report by the Institute for Safe Medication Practices examined FDA adverse event reports involving Chantix from the 4th quarter of 2007. Several users of the stop smoking drug reported suffering severe and debilitating skin reactions consistent with Stevens-Johnson Syndrome.

Last month, the potential Chantix SJS skin reactions were noted on a quarterly report by the FDA of drugs they were investigating for potential health risks that emerged between October 2008 and December 2008. The FDA indicated that Chantix was showing potential signals for “serious skin reactions,” as well as other problems.

According to a press release issued by Pfizer on July 1, 2009, in addition to the boxed warning about behavior changes and suicidal tendencies, the following new information was added to the Warnings and Precautions sections of the Chantix warning label:

Some people can have serious skin reactions while taking CHANTIX, some of which can become life-threatening. These can include rash, swelling, redness, and peeling of the skin. Some people can have allergic reactions to CHANTIX, some of which can be life-threatening and include: swelling of the face, mouth, and throat that can cause trouble breathing. If you have these symptoms or have a rash with peeling skin or blisters in your mouth, stop taking CHANTIX and get medical attention right away.

CHANTIX STEVENS-JOHNSON SYNDROME (SJS) LAWSUITS

The Chantix lawyers at Saiontz & Kirk, P.A. are reviewing potential Stevens-Syndrome lawsuits for individuals who have been diagnosed with the severe skin reaction, which could involve symptoms like:

• Rash, blisters or red spots on the skin
• Blisters in the mouth, eyes, ears, nose or genital area
• Swelling of the eyelids
• Fever or flu-like symptoms

Potential Chantix lawsuits are also being reviewed for suicides and suicide attempts, new on-set diabetes and catastrophic injuries from a fall or accident caused by seizures, black-outs, vision disturbances or other sudden problems.

To review a potential claim for yourself, a friend or family member, request a free consultation and claim evaluation.

>>FDA ANNOUNCEMENT: Zyban and Chantix Black Box Warning

For over 18 months, the lawyers at Saiontz & Kirk, P.A. have been investigating potential Chantix suicide lawsuits, alleging that Pfizer failed to adequately warn about these problems. After receiving hundreds of reports involving users who suffered severe or fatal injuries from a suicide attempt on Chantix, the FDA is finally requiring Pfizer to take stronger steps to ensure that people are aware of the risk.

The FDA first indicated that they were reviewing the side effects of Chantix in November 2007. In response, Pfizer updated the drug’s label, but provided vague and confusing indications about a connection between Chantix and suicide, suicidal thoughts and other changes in behavior. Since that time the drug maker has made several other updates to the warning label, but the FDA’s actions yesterday make it clear that Pfizer has not done enough to protect the public from the Chantix dangers.

While we have suggested before that a Chantix recall may be necessary, since the risk of suicides and other life-threatening side effects seems to outweigh the minimal benefits that the drug provides over other methods that people can use to stop smoking, Chantix will remain on the market. The FDA suggested that with the stronger warnings, consumers and their doctors will be able to weigh the risk of Chantix side effects against the benefits.

In addition to Chantix, the warning will also be placed on Zyban, another prescription drug for smoking cessation. According to an FDA statement released Wednesday:

The FDA’s request for the additional warnings is based on a review of reports submitted to the agency’s Adverse Event Reporting System since the time the products were marketed and on an analysis of information from clinical trials and scientific literature.

The analyses revealed that some who have taken Chantix and Zyban have reported experiencing unusual changes in behavior, become depressed, or had their depression worsen, and had thoughts of suicide or dying. In many cases, the problems began shortly after starting the medication and ended when the medication was stopped. However, some people continued to have symptoms after stopping the medication. Also, in a few cases, the problems began after the medication was stopped.

CHANTIX SUICIDE ATTORNEYS

Pfizer’s failure to properly research their medication and warn about the Chantix suicide problems when they first placed the drug on the market in 2006, prevented consumers and health care providers from making an informed decision about whether to take the drug. In addition, many consumers who suffered severe or fatal injuries in a suicide or suicide attempt could have contacted their doctors or sought help if they had been notified that the drug may be responsible for their sudden changes in behavior.

The Chantix attorneys at Saiontz & Kirk, P.A. are continuing to review potential cases for individuals throughout the United States. In addition to cases for injuries or death caused by a suicide or suicide attempt on Chantix, lawsuits are also being investigated for new on-onset diabetes from Chantix, serious skin reactions like Stevens-Johnson Syndrome or Toxic Epidermal Necrolysis and accidents or falls caused by seizures, blackouts or other sudden problems.

If you, a friend or family member have a potential Chantix lawsuit, contact our attorneys and request a free consultation and claim evaluation.

>>INFORMATION: Fleet Phospho Soda Problems

According to a report in The News and Advance of Lynchburg, Virginia, despite the Fleet Phospho-soda issues, C.B. Fleet officials maintain that their product is safe when used as directed, and the company is seeking FDA approval to sell them again in a limited manner that they believe will ensure that the products are used in a way that will not pose an increased risk of kidney injury.

A recall for Fleet Phospho Soda was issued in December 2008 after the FDA indicated that double doses being used for colonoscopy prep or other surgical procedures could lead to a form of kidney damage known as acute phosphate nephropathy, which can cause renal failure, dialysis treatment or death.

C.B. Fleet currently faces a number of Fleet Phospho-soda suits alleging that they promoted use of high doses of the laxatives as an alternative to prescription colonoscopy prep products without researching the safety of such use or adequately warning about the risk of kidney injury.

Fleet Phospho-Soda is an oral sodium phosphate-based medication which was only approved for over-the-counter use as a laxative, not to cleanse the bowels before a colonoscopy. Other oral sodium phosphate solutions are available as a prescription, such as Visicol and OsmoPrep, which are approved as bowel cleansers. However, those products contain “black box” warnings, which are the strongest warnings that can be placed on a prescription medication, about the risk of acute phosphate nephropathy and kidney injury.

Fleet officials say they are in discussion with the FDA about possibly making the recalled products available by prescription and with more detailed instructions and warning labels. However, we have raised questions before about why such a product would be approved, since there are already several safer alternatives available that do not contain oral sodium phosphate and do not appear to carry the same risk of kidney damage.

FLEET PHOSPHO SODA ATTORNEYS

The Fleet Phospho-soda attorneys at Saiontz & Kirk, P.A. represent individuals throughout the United States who are pursuing claims against C.B. Fleet over problems allegedly caused by their promotion of double doses of the laxative. Potential Fleet Phospho-soda lawsuits are being reviewed for individuals diagnosed with:

• Acute Phosphate Nephropathy
• Kidney Failure
• Chronic Kidney Disease
• End Stage Renal Failure
• Other Kidney Injury
• Death

If you, a friend or family member have experienced problems, request a free consultation and claim evaluation.

The guidance was released June 12 by the Department of Health and Human Services’ Centers for Medicare and Medicaid Services. It includes a list of things that nursing homes can do to restore dignity and mental well-being to nursing home residents. A large number of the suggestions are geared, for the most part, toward nursing home residents like respected human beings.

The suggestions have a strong emphasis on dignity and independence, without compromising care and safety, with recommendations like:

• Allow residents to dress in their own clothes, as opposed to hospital gowns
• Use napkins instead of bibs, unless requested by the resident
• Avoid standing over residents while they eat
• Grooming residents how they wish to be groomed
• Giving residents the right to choose health care and activities schedules
• Allowing residents the right to choose who they room with.
• Avoid staff conversing in the presence of residents as if the resident is not there.

According to the Medicare guidance:

A personalized, homelike environment recognizes the individuality and autonomy of the resident, provides an opportunity of self-expression, and encourages links with the past and family members. The intent of the word “homelike” in this regulation is that the nursing home should provide an environment as close to that of the environment of a private home as possible. This concept of creating a home setting includes the elimination of institutional odors, and practices to the extent possible.

If staff are required to treat a facility like a home where residents live, then not only could it lead to an increase in personal dignity for those residents, but it could also lead to an increased view of them as dignified and independent people by staff. This could certainly result in a reduction in cases of abuse and neglect.

NURSING HOME RIGHTS LAWYER

The attorneys at Saiontz & Kirk, P.A. investigate potential cases for nursing home abuse and neglect throughout the United States. In many cases where serious injuries are caused by poor care, there is a culture among the nursing home employees where residents are not afforded the respect and dignity that they have earned over their lifetime.

If your friend or family member has suffered a nursing home injury caused by inadequate care, request a free consultation and claim evaluation.

>>PRIOR POST (3/9/2009): Restore Medical Device Product Liability Lawsuits
Contact Your Legislators

The GAO report was unveiled at a hearing Thursday before the House Energy and Commerce Committee’s health subcommittee, and along with testimony from a panel of experts, made a strong case as to why the health and safety of consumers who make use of medical devices should not rest solely in the hands of the FDA.

The hearings came as lawmakers are considering the Medical Device Safety Act of 2009, which seeks to overturn a 2008 Supreme Court decision (Riegel vs. Medtronic) that protected manufacturers of some medical devices from liability lawsuits as long as their product was approved by the FDA.

The GAO report found problems with the FDA reviewing process, its postmarket surveillance and its ability to inspect medical device manufacturing facilities. In combination with other testimony heard that day, it is clear that the FDA is not currently capable of ensuring that consumers are fully protected from defective devices.

The Medical Device Safety Act faces opposition from Republicans and concerned consumers should contact their representatives to voice their support for the legislation. At the hearings, Republicans brought in former FDA official Philip Phillips to testify that the FDA approval process works. However, Phillips is more of a symbol of the problems than an advocate for the opposition. Phillips consults for ReGen Biologics, Inc., a medical device company whose lobbying tactics for a knee surgery device have led to a congressional investigation of the industry’s influence over the FDA approval process.

ACT NOW TO SUPPORT THE MEDICAL DEVICE SAFETY ACT

To preserve your rights and the right of your friends and family members to pursue a product liability lawsuit for injuries caused by dangerous and defective medical devices, it is important that you contact your Senators and Representative to make sure they understand the importance of supporting the Medical Device Safety Act of 2009.

The civil justice system is an important safeguard to hold companies accountable for decisions that place profits ahead of consumer safety, which we unfortunately see time and time again. Let your voice be heard.

>>FDA LINK: Nestle Toll House Cookie Dough Recall

As of Friday, the FDA and CDC reported that 65 people in 29 different states have reportedly suffered E. Coli food poisoning after eating raw cookie dough manufactured by Nestle under their Toll House brand. However, this likely only represents between 1% and 10% of the true number of food poisoning cases that may have been caused by the cookie dough.

Symptoms of cookie dough food poisoning could include diarrhea and abdominal cramps. The diarrhea usually starts watery and become bloody within 24 hours. While most healthy adults recover fully within a week or so, in severe cases it could result in dehydration or more serious health problems, including a condition known as hemolytic uremia syndrome (HUS), which is associated with kidney failure.

Children, elderly and those with a weak immune system have an increased risk of HUS or more severe food poisoning.

Although the recalled cookie dough products contain information on the packaging that they are not meant to be consumed raw, it is very common for consumers to eat the product uncooked and the warnings are not adequately displayed on the label.

Federal health officials have recommended that people immediately stop eating any Nestle Toll House Cookie Dough products. People should not try cooking the raw cookie dough, as the E. coli bacteria could get on their hands and still infect them. However, non-raw, refrigerated dough products are not impacted by the recall, such as Nestle Toll House cookies or chocolate chips.

COOKIE DOUGH FOOD POISONING LAWYERS

Although Nestle has asked consumers to return any unused packages to their grocer for a full refund, if any illness was experienced after eating the cookie dough, it should be preserved for future testing if you intend to review a potential Nestle Toll House cookie dough recall lawsuit. Any unopened or uneaten portion of remaining packages should be stored in a manner to prevent anyone else from eating them.

To review a potential claim with our lawyers, request a free consultation and claim evaluation.

>>INFORMATION: Zicam Recall Lawsuits

A Zicam recall was issued after the FDA warned consumers not to use the following products:

• Zicam Cold Remedy Nasal Gel
• Zicam Cold Remedy Nasal Swabs
• Zicam Cold Remedy Swabs, Kids Size (Previously Discontinued)

The FDA said that it has received at least 130 reports of users losing there sense of smell as a side effect of Zicam. In some cases these Zicam problems surfaced after only one use, and could leave users with a permanent disability.

Although the FDA never approved Zicam because it is classified as a homeopathic product, these safety issues now require the manufacturer to go through a formal review process before they will be permitted to market Zicam again.

Given the minimal benefits of the product, which is used to reduce the severity of a self-resolving condition like the common cold, it seems unlikely that the FDA would approve the cold remedy.

The confirmed reports only represent a small number of actual problems experienced by Zicam users. It is generally accepted with prescription medications that reported adverse effects typically only represent between 1% and 10% of all occurrences. However, with an over-the-counter product like Zicam, which is not used under a doctor’s direction, the 130 reports likely only represent a fraction of 1% of the number of users who experienced Zicam smell problems.

ZICAM RECALL LAWYERS

Matrixx Initiatives, the manufacturer of Zicam, was aware of the reported problems were users suffered loss of smell or taste after using their product, but they failed to take steps to protect consumers or adequately warn about this potential side effect.

The attorneys at Saiontz & Kirk, P.A. are reviewing potential claims throughout the United States for individuals who have suffered permanent and severe loss of smell or taste, to determine if financial compensation may be available through a Zicam lawsuit. To review a potential case, request a free consultation and claim evaluation.

Potentially hundreds of Chinese drywall lawsuits could eventually be filed on behalf of homeowners throughout the United States. All of the cases share factual questions about drywall manufactured in China and imported into the United States earlier this year that contain high levels of corrosive chemicals.

The Chinese drywall problems have caused particular issues in the southeastern portion of the country, where more humid weather has increased the risk of the drywall emitting strong sulfur smells and corrosive gases that destroy air conditioner coils, electrical wiring, copper pipes and household appliances. The toxic drywall has also been associated with reports of various health issues for residents exposed to the gases.

Our Chinese drywall attorneys believe that transferring all of the cases to one court for coordinated handling during pretrial litigation will benefit homeowners, as it will eliminate duplicative discovery, ease some of the problems caused by international defendants, prevent inconsistent pretrial rulings and conserve the resources of the parties.

The MDL Panel decided to transfer all pending cases and future Chinese drywall lawsuits that are filed to the U.S. District Court for the Eastern District of Louisiana, where they will be assigned to District Judge Eldon E. Fallon. However, if they do not settle or otherwise resolve during pretrial proceedings, the cases will be transferred back to the original court where they were filed for trial.

According to an order issued June 15, 2009 by the U.S. Judicial Panel on Multidistrict Litigation:

No district is a clear focal point of this litigation. The common manufacturing defendant and its affiliates are foreign entities without a major presence in any of the suggested transferee districts. Most actions also name local entities, such as builders and suppliers, as defendants. All of the suggested districts, particularly those in the southeastern region, have a nexus to the litigation through allegedly affected houses built with the drywall at issue. On balance, we are persuaded that the Eastern District of Louisiana is a preferable transferee forum for this litigation. Centralization in this district permits the Panel to effect the Section 1407 assignment to a judge who has extensive experience in multidistrict litigation as well as the ability and temperament to steer this complex litigation on a steady and expeditious course.

CHINESE DRYWALL CLASS ACTION ATTORNEYS

The lawyers at Saiontz & Kirk, P.A. are investigating potential claims throughout the United States on behalf of individuals who suspect that they may have the defective drywall to determine if financial compensation may be available through a Chinese drywall lawsuit.

To review a potential case with our Chinese drywall class action attorneys, request a free consultation and claim evaluation.

>INFORMATION: Nursing Home Elder Abuse

Unfortunately, elderly abuse is a common problem in the United States, with thousands of cases each year, and likely many more that go unreported. Victims are often ashamed to discuss the abuses inflicted upon them, which can include physical assault, sexual abuse, deprivation of food, neglect, confinement and mental and verbal abuse.

Cases investigated by our nursing home abuse lawyers have often uncovered horrific examples of assault, neglect and other abuses that can not only cause serious and life-threatening injuries, but also deprive elderly of the dignity and self-respect they have earned over their life-time,

According to the World Health Organization, 36% of nursing home employees have reported witnessing at least one incident of physical abuse of an elderly resident, 10% admitted having inflicted at least one act of physical abuse on the elderly themselves, and 40% said they had psychologically abused patients.

A 2007 study published in the Journal of American Geriatrics Society found that while only 6% of elderly subjects studied admitted to suffering abuse, detailed interviews and exams discovered that 21% of them likely had been abused.

Even minor instances of abuse can have devastating effects on residents, who may be physically frail, already suffering from medical conditions, or dealing with mental health issues.

Family and friends should always be alert for signs of nursing home elder abuse and neglect, which could include:

• Suspicious bruises or cuts
• Burns
• Unexplained hair loss
• Angry or indifferent attitudes by caregivers
• Sudden changes in attitude by residents toward caregivers
• Poor hygiene
• Dehydration
• Malnutrition

Numerous organizations that advocate for the elderly will participate in June 15 activities to promote awareness of elderly abuse and of programs aimed at eliminating such abuses, and to increase public and political support for those programs. This is the fourth year June 15 has been set aside for such activities. INPEA has posted a community “toolkit” on their website to help other activists worldwide coordinate efforts and effectively spread awareness.

NURSING HOME ELDER ABUSE LAWYERS

If you suspect that a friend, family member or loved one has been the victim of elder abuse or neglect, contact authorities immediately. To review whether potential compensation may be available through a nursing home lawsuit, contact our attorneys to request a free consultation and claim evaluation.

The denture cream poisoning lawyers at Saiontz & Kirk, P.A. represent individuals throughout the country who are pursuing potential zinc poisoning lawsuits over injuries caused by use of Fixodent or Super Poligrip adhesives. As cases are filed in federal courts throughout the country, they will be transferred to the MDL, which was centralized in the U.S. District Court for the Southern District of Florida before U.S. District Judge Cecilia M. Altonaga.

According to the Transfer Order issued June 9, 2009:

On the basis of the papers filed and hearing session held, we find that these actions involve common questions of fact and centralization under Section 1407 in the Southern District of Florida will serve the convenience of the parties and witnesses and promote the just and efficient conduct of this litigation. These actions share questions of fact arising out of the allegation that the levels of zinc contained in certain brands of denture cream can cause copper deficiency and neurological injuries. Centralization under Section 1407 will eliminate duplicative discovery; prevent inconsistent pretrial rulings; and conserve the resources of the parties, their counsel and the judiciary.

While the cases are only consolidated and coordinated for pretrial litigation, most people equate an MDL with being a class action for the denture cream lawsuits. However, the cases will remain individual claims and will be judged independently.

DENTURE CREAM CLASS ACTION LAWYERS

If you, a friend or family member have been diagnosed with zinc poisoning after using Fixodent, Super Poligrip or other types of adhesives, contact our lawyers to determine if compensation may be available through a denture cream class action suit. Symptoms of denture cream poisoning could include:

• Paralysis
• Numbness
• Loss of Sensation
• Tingling or Pain in Hands or Feet
• Muscle Weakness
• Loss of Balance
• Difficulty Walking
• Unexplained Pain or Weakness

>>REQUEST A FREE CONSULTATION<<

The various manufacturers of generic metoclopramide, which is still more commonly known by its brand name “Reglan”, have come under increasing fire recently as a result of their failure to warn that using the gastrointestinal drug for more than 12 weeks substantially increases the risk that users will suffer from tardive dyskinesia, a neurological disorder that causes involuntary and repetitive movements of the lower face and limbs.

The first Reglan lawsuit involving tardive dyskinesia was filed more than 20 years ago, and more than 70 cases have been filed in state and federal courts throughout the United States since then.

Last month, the U.S. Judicial Panel on Multidistrict Litigation considered a petition to centralize and consolidate 11 currently pending Reglan tardive dyskinesia lawsuits before one judge for pretrial litigation to avoid duplicate discovery, inconsistent rulings and serve the convenience of the parties, attorneys and witnesses. However, in an order issued June 3, 2009, the MDL panel denied the transfer request, stating:

On the basis of the papers filed and hearing session held, we are not persuaded that Section 1407 centralization would serve the convenience of the parties and witnesses or further the just and efficient conduct of this litigation at the present time. The eleven actions at issue do share factual issues as to whether the drug metoclopramide causes neurological injuries (principally, tardive dyskinesia). But there is no single common defendant, and some entities, such as Baxter Healthcare Corp., are named in only one or two actions. Moreover, several of the actions appear to be substantially advanced (five were commenced in either 2006 or 2007). Metoclopramide litigation has a lengthy history, and the record indicates that a significant amount of the common discovery has already taken place. The proponents of centralization have failed to convince us that any remaining common questions of fact among these actions are sufficiently complex and/or numerous to justify Section 1407 transfer at this time. Alternatives to transfer exist that may minimize whatever possibilities there might be of duplicative discovery and/or inconsistent pretrial rulings.

REGLAN LAWYERS FOR TARDIVE DYSKINESIA LAWSUITS

This ruling does not impact potential claimants’ ability to pursue compensation against the manufacturers of metoclopramide drugs for failing to warn about the serious and debilitating Reglan side effects. Potential cases are still being reviewed by our Reglan lawyers and individual lawsuits will proceed in various courts throughout the United States.

If you, a friend or family member have been diagnosed with tardive dyskinesia or another neurological disorder after taking Reglan, request a free consultation and claim evaluation.

In 2007, Congress enacted legislation that requires the FDA to release a list of drugs identified through the Adverse Event Reporting System (AERS), which show potential signs of serious health risks. The FDA releases the list about every three months, and the most recent list released on June 4, 2009, identified 19 different drugs or class of medications.

For the period between October 2008 and December 2008, potential skin problems or Stevens-Johnson Syndrome were identified in association with the use of Chantix, Detrol, Provigil, Nuvigil and hydrochlorothiazide in combination products.

Stevens-Johnson Syndrome, commonly referred to as SJS, is a potentially life-threatening skin condition where the skin burns from the inside out. It is almost always associated with adverse drug reactions, and can lead to severe scarring, disfigurement, blindness, organ failure, breathing disorders and death.

When the skin lesions associated with SJS cover more than 30% of the body, the condition is referred to as Toxic Epidermal Necrolysis, or TEN.

Chantix (varenicline) is a well-known stop-smoking drug manufactured by Pfizer, which is indicated on the list as showing potential signals for “serious skin reactions” as well as several other potential problems. Chantix Stevens-Johnson syndrome reports were first identified early last year in an independent report by the Institute for Safe Medication Practices.

Detrol (tolterodine) is another Pfizer medication, which is prescribed to treat overactive bladders and incontinence. The FDA specifically indicated that the drug has been linked to cases of Stevens-Johnson syndrome and that they are continuing to evaluate the issue to determine the need for any regulatory action.

Provigil (modafinil) was originally identified as having possible connections to SJS and TEN in 2007, after the FDA received six cases of severe skin reactions that included SJS, TRN, and other conditions. Nuvigil (armodafanil) was not mentioned with it at the time, but the FDA put the two drugs together on the potential risks list due to their similarities.

Provigil and Nuvigil already include warnings about potentially severe skin reactions, but FDA says that it is investigating whether more action needs to be taken. Provigil and Nuvigil are used to treat excessive sleepiness due to narcolepsy, sleep apnea or shift work sleep disorder.

The list also notes that the FDA is investigating Hydrochlorothiazide, a diuretic, in combination with other drugs, as a potential cause of skin reactions, but did not specifically identify Stevens-Johnson Syndrome as a concern. The FDA indicates that they are evaluating whether the current labeling is adequate for the various combination products that contain hydrochlorothiazide.

Inclusion of a drug on the list does not mean that it has serious health risks, just that the FDA is investigating possible risks. The FDA will release individual warnings, notices, or labeling requirements once investigations of the potential risks are completed.

STEVENS-JOHNSON SYNDROME LAWYER

The dangerous drug lawyers at Saiontz & Kirk, P.A. investigate potential Stevens-Johnson Syndrome lawsuits throughout the United States. Free consultations are provided to help determine if compensation may be available as a result of a manufacturer’s failure to warn about this serious and potentially life-threatening side effect.

If you, a friend or family member have suffered from Stevens-Johnson Syndrome (SJS) or Toxic Epidermal Necrolysis (TEN) after taking a prescription medication, request a free claim evaluation.

>>INFORMATION: Denture Cream Poisoning Lawsuits

Studies have associated the use of adhesive denture cream products like Super PoliGrip and Fixodent to high exposure to zinc, which can lead to copper depletion and a number of debilitating neurological disorders like neuropathy, myelopathy, hypocupremia and other problems.

The risk associated with excess levels of zinc entering the body were well known at the time GlaxoSmithKline and Proctor & Gamble added zinc as an ingredient. However, no warnings were ever provided about the risk of denture cream poisoning and they have continued to provide inadequate instructions about the proper use of their products.

Even after reports were received of users suffering from zinc poisoning and a number of lawsuits were filed, steps were still not taken to protect the public. After the filing of one of the first Super PoliGrip lawsuits, Glaxo released the following statement (emphasis added):

GlaxoSmithKline Consumer Healthcare stands by the safety and efficacy of SUPER POLIGRIP®, which is approved and regulated by the Food and Drug Administration (FDA). Although we can’t comment on this person’s claim, we want to assure consumers that SUPER POLIGRIP is safe and effective when used as directed. When someone uses SUPER POLIGRIP for their dentures, the vast majority of the zinc in the product remains in the adhesive and is not released into the mouth. Thus the potential for absorption of zinc throughout the gums is minimal. Although it is expected that a small amount of SUPER POLIGRIP would be swallowed when used as directed, the amount of zinc that is released into the stomach and absorbed into the bloodstream is very small. Therefore, the possibility of experiencing adverse effects from exposure to zinc in SUPER POLIGRIP is highly unlikely when the product is used as directed.

This statement is misleading and attempts to place blame for denture cream poisoning on the users for deviating from directed use. However, the manufacturers take no steps to provide directions that may prevent deviation from directed use or to notify consumers about the risk associated with overuse. In fact, many responsible denture wearers are unknowingly using substantially more of the adhesive cream than they need to, and the manufacturers have to be well aware of this.

Why didn’t Glaxo, or Proctor & Gamble for that matter, come out and take any steps to reduce the overuse of their products and ensure that they are “used as directed.” Unfortunately, it is likely another example of a corporation placing profits before consumer safety, knowing that with proper use consumers will likely only use one or two tubes per month, as opposed to one or two tubes per week (as many do).

FIXODENT AND POLIGRIP DENTURE CREAM POISONING LAWSUITS

The denture cream lawyers at Saiontz & Kirk, P.A. are reviewing potential Super PoliGrip lawsuits and Fixodent lawsuits for users of the adhesive creams who have been diagnosed with zinc poisoning, neuropathy, myelopathy or other neurological injuries, with symptoms like:

• Weakness or Unexplained Pain
• Numbness, Tingling or Burning in the Hands and Feet (some describe it as feeling like they are wearing gloves or socks even when their skin is bare)
• Loss of Sensation
• Poor Balance or Lack of Coordination

To review a potential denture cream poisoning lawsuit and determine if financial compensation may be available, request a free consultation and claim evaluation.