Posts for the 'Headlines' Category
Chantix Stevens-Johnson Syndrome Side Effects Added to Warning Label
Since the Chantix black box warning was announced earlier this week, the focus has been on the increased risk of suicides and other behavior changes. However, Pfizer also quietly added new information to less prominent areas of the label about reports of serious skin reactions, such as Stevens-Johnson Syndrome, which our Chantix lawyers have been investigating for over a year.
>>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.
Black Box Chantix and Zyban Suicide Warnings Ordered by FDA
The FDA announced yesterday that the makers of the stop-smoking drugs Chantix and Zyban are being required to put information about the risk of behavior changes, depression, hostility and suicidal thoughts in a black box on the warning label, which is the strongest warning that can be placed on a prescription medication.
>>FDA ANNOUNCEMENT: Zyban and Chantix Black Box Warning
Fleet Phospho Soda Problems Not Deterring Manufacturer From Pushing to Reintroduce Laxative
C.B. Fleet, the maker of Fleet Phospho Soda laxatives, maintains that their products are safe even though they issued a recall issued last year due to a risk of kidney damage and the company faces a growing number of lawsuits alleging that they failed to adequately warn about the risk of problems from Fleet Phospho-soda.
>>INFORMATION: Fleet Phospho Soda Problems
Congressional Hearing Highlights Need to Restore Medical Device Lawsuit Rights
A congressional hearing last week illuminated serious deficiencies in the FDA’s process of reviewing and approving medical devices. The hearing, which included a damning report by the Government Accountability Office, made it clear that consumers need Congress to restore their right to hold medical device manufacturers accountable for defective products, by passing the Medical Device Safety Act of 2009.
>>PRIOR POST (3/9/2009): Restore Medical Device Product Liability Lawsuits
Contact Your Legislators
Nestle Toll House Cookie Dough Recall Lawsuits: Food Poisoning
The food poisoning lawyers at Saiontz & Kirk, P.A. are reviewing potential Nestle Toll House Cookie Dough recall lawsuits for individuals who have required hospital treatment after eating any raw, refrigerated cookie dough products made by Nestle USA. A nationwide cookie dough recall was issued on June 19, 2009 after people throughout the United States have reported suffering from food poisoning.
>>FDA LINK: Nestle Toll House Cookie Dough Recall
Zicam Recall Lawsuit: FDA Halts Marketing Due to Loss of Sense of Smell
The use of nasal gel and spray versions of the cold remedy Zicam can cause long-lasting or permanent loss of smell, leading the FDA to warn the manufacturer that they are no longer permitted to sell certain products in the United States until they provide data establishing that they are safe and effective. The Zicam recall lawyers at Saiontz & Kirk, P.A. are reviewing potential lawsuits for individuals who have lost their sense of smell or taste after using the over-the-counter cold remedy.
>>INFORMATION: Zicam Recall Lawsuits
Chinese Drywall Lawsuits Consolidated in Louisiana
All federal Chinese drywall lawsuits filed on behalf of homeowners throughout the United States will be consolidated in the Eastern District of Louisiana for pretrial proceedings. The cases will be handled as part of an MDL, or Multidistrict Litigation, throughout discovery and pretrial motions, where they will be coordinated in a manner similar to how a Chinese drywall class action lawsuit would be handled. However, the cases will all remain individual lawsuits despite the consolidation.
Denture Cream Class Action: Fixodent and Poligrip Lawsuits Consolidated in MDL
A panel of U.S. judges has agreed to centralize all federal denture cream lawsuits against the makers of Super Poligrip and Fixodent in a Multidistrict Litigation (MDL). Although the cases will all be consolidated and handled in a manner similar to how a denture cream class action lawsuit would be handled during discovery, the lawsuits will still remain individual claims and if they do not settle or resolve during pretrial litigation, they will be returned back to the original courts where they were filed for trial.
Reglan Lawsuits Will Proceed Without Consolidation
A growing number of Reglan lawsuits have been filed or are being investigated throughout the United States following the addition of a “black box” warning earlier this year about the increased risk of tardive dyskinesia with Reglan (Metoclopramide). However, the U.S. Judicial Panel on Multidistrict Litigation has determined that it is not necessary to consolidate the cases in a manner similar to how a Reglan class action lawsuit would be handled for pretrial litigation, and the cases will proceed individually in various through the court system.
Stevens-Johnson Syndrome Skin Reactions Linked to Several Drugs: FDA Reports
The FDA released their quarterly list of drugs that are being investigating for potential health risks, and a number of the drugs listed had potential signals for Stevens-Johnson Syndrome side effects or other severe skin reactions.
