|
|
|
ANTI-DEPRESSANT DRUG SERZONE LINKED TO LIFE-THREATENING LIVER FAILURE
|
Ashcraft & Gerel
LLP
|
|
|
|
ANTI-DEPRESSANT DRUG SERZONE LINKED TO LIFE-THREATENING LIVER FAILURE
[Introduction: Although our offices are located in Maryland (MD), Virginia (VA) and Washington, D.C. (DC), our drug and pharmaceutical practice is national in scope, and our lawyers are handling many drug cases around the country. Therefore, regardless of what state you're in, please complete our inquiry form on this web site or email us so that we can have an attorney from our drug litigation department contact you.
We're sorry, but we are
no longer accepting new Serzone claims.]
Cases of life-threatening liver failure have been reported in patients treated with the anti-depressant Serzone (nefazodone). A new warning regarding the association of Serzone with liver-failure was placed on the drug labeling in January 2002. This action by the manufacturer was prompted by the Food and Drug Administration’s (FDA) warning of December, 2001 in which patients were advised that a rare, but possibly life-threatening liver failure may occur in patients using the drug.
A number of U.S. psychiatrists became concerned about the liver failure problems after Canadian government authorities issued a warning about the drug last summer. The FDA required the manufacturer to put a Black Box Warning on Serzone labeling. The new warning states that the rate of liver failure associated with Serzone use is 3-4 times greater than in those not using the drug. This information was based on post-marketing experience in more than 7.2 million patients in the U.S. According to FDA estimates, the reported rate in the U.S. is about one case of liver-failure for every 250,000 to 300,000 patients using the drug for one year.
The Black Box designation refers to a black outline surrounding a section of the label and of the Physician’s Desk Reference. It is reserved for drugs bearing only the most serious side effects. When doctors see this warning they will not use the drug unless it is being used as a last resort for life-threatening cases.
The liver effects of Serzone range from asymptomatic reversible increases in serum transaminase to cases of liver failure resulting in transplant or death. Individuals with active liver disease or with elevated baseline serum transaminases should not be treated with Serzone. According to the new label, there is no evidence that preexisting liver disease increases the likelihood of developing liver failure; however baseline abnormalities can complicate patient monitoring. The new label continues: "Patients should be advised to be alert for signs and symptoms of liver dysfunction (jaundice, anorexia, gastrointestinal complaints, malaise, etc.) and to report them to their doctor immediately if they occur." Therefore, patients taking Serzone who develop any signs of liver dysfunction should report them to their doctor immediately. These signs include:
Serzone, also known as "nefazodone hydrochloride" is manufactured by BristolMyers Squibb and was first approved by the FDA in 1994. It is used to treat depression and symptoms of anxiety. It is considered an important drug alternative in the treatment of depression because of the fact that it does not cause sexual side effects as frequently as the popular class of drugs called SSRIs (selective serotonin reuptake inhibitors). Serzone is structurally different from other antidepressants (SSRIs, tricyclics, and monoamine oxidase inhibitors [MAOIs]), but like trazodone (Desyrel), Serzone inhibits serotonin reuptake and blocks one type of serotonin receptor. The effectiveness of nefazodone in longterm use (i.e., for more than 6 to 8 weeks) is yet to be evaluated in controlled trials.
Further information can be obtained on the FDA website.
If you think you or a loved one may have suffered an injury or damages as a result of taking Serzone, you owe it to yourself to speak to an experienced drug or pharmaceutical attorney about the possibility of bringing a law suit to recover for your damages and injuries. The attorney will be able to ascertain if you have a claim for which suit can be filed and that can be brought to a successful settlement, verdict, award or other recovery, and the experienced lawyer will be able to advise you on any deadlines for bringing your legal claim for damages. Please contact the law firm of Ashcraft and Gerel, LLP to discuss your case with an experienced drug or pharmaceutical lawyer in our Drug Litigation Department.
Many attorneys and law firms are now, for the first time, becoming involved in drug claims, but Ashcraft & Gerel's lawyers are among the few lawyers in the country who have been actively prosecuting legal cases for pharmaceutical related damage and injury for a very long time, and our attorneys are well situated to see Serzone claims to successful verdicts or settlements.
The lawyers at Ashcraft and Gerel, LLP have been leaders in the prosecution of cases involving unsafe drugs and dangerous medical products. Our attorneys have successfully brought about verdicts, settlements, awards or other recoveries in claims on behalf of clients who have been injured by Fen-Phen, Rezulin, Propulsid, Phenylpropanolamine (PPA), Baycol, breast implants and AIDS tainted blood.
Ashcraft & Gerel is now accepting claims for injuries caused by Serzone. We have been a leader in mass tort and product liability cases and settlements, including Rezulin, Propulsid, Baycol, PPA, asbestos, breast implants and tainted blood. Our lawyers have been at the forefront of the Fen-Phen diet drug claims for over two years, and we are well situated to see the Serzone cases to a successful damage recovery for our clients. We have a toll free number to answer your questions with regard to your specific case. That number is (800) 725-6470. If you would prefer, please feel free to email us or complete the help inquiry form on this web site. Please be sure to include your name, address, telephone number (if you wish to be called), email address and the exact nature of your question so that we can provide you with the specific information you seek.
[ Return to Homepage ] [ Help ] [ Learn About Ashcraft & Gerel ] [ See Our Offices and Attorneys ] [ Email Us ] [ Links ] [Resources] [AG Friends & Associates] [ Contingent Fees in Personal Injury Litigation ] [ Workers' Compensation ] [Maryland Workers' Compensation] [District of Columbia Workers' Compensation] [Virginia Workers' Compensation] [ Product Liability Law ] [ Cerebral Palsy ] [ Medical Malpractice ] [ Automobile Accident Litigation ] [Maryland, Virginia and D.C. Injuries and Accidents] [ Birth Injury Litigation ] [ Social Security Disability ] [ Fen Phen Litigation ] [ Asbestos Litigation ] [ Toxic Tort Litigation ] [ Breast Implant Litigation ] [ Whistle Blower Litigation ] [ Construction Litigation ] [ Railroad Worker (FELA) Litigation ] [ Propulsid Litigation ] [ PPA Litigation ] [ Nursing Home Malpractice ] [ Sulzer Defective Hip Implants ] [ Defense Base Act Claims ] [ Baycol Claims ] [ Other Hip Implant Claims ] [ Thimerosal Mercury Poisoning Autism Claims ] [ Olympus Bronchoscope Claims ] [ Serzone Liver Damage Claims ] [Ephedra Claims] [Crestor Claims] [ Meridia Claims ] [ Lead Paint Claims ] [ Vioxx Claims ] [Celebrex Claims] [Bextra Claims] [Ortho Evra Claims]