Yourlawyer.com (Mellaril News) http://www.yourlawyer.com/topics/overview/Mellaril Sat, 21 Nov 2009 19:36:56 -0800 pixel-app en Haldol, Compazine, Other Conventional Antipsychotics Get New Warning on Death Risk http://www.yourlawyer.com/articles/read/14591 Tue, 17 Jun 2008 00:00:00 -0700 http://www.yourlawyer.com/articles/read/14591 antipsychotic drugs - including Haldol, Compazine, Mellaril and Thorazine - pose a risk of deaths when they are given to elderly patients suffering from dementia.  The Food & Drug Administration (FDA) has asked the manufacturers of these antipsychotic drugs to add a black box warning - the agency's strongest safety notice - about this danger to their labels.  

The new black box warning will involve older drugs known as "conventional" antipsychotics.  Antipsychotic drugs commonly are categorized into two classes, the older "conventional" antipsychotics and the newer "atypical" antipsychotics. Both classes of drugs are dopamine receptor antagonists that work by blocking the action of naturally occurring dopamine in the brain. They differ primarily in their side effects, with the atypical drugs having a lower incidence of neurological side effects such as involuntary movements or "tics."  The conventional antipsychotics subject to the new black box warning include:  

  • Compazine (prochlorperazine)
  • Haldol (haloperidol)
  • Loxitane (loxapine)
  • Mellaril (thioridazine)
  • Moban (molindrone)
  • Navane (thithixene)
  • Orap (pimozide)
  • Prolixin (fluphenazine)
  • Stelazine (trifluoperazine)
  • Thorazine (chlorpromazine)
  • Tilafon (perphenazine)

The FDA decided that the new black box warning was needed after two observational epidemiological studies were published that examined the risk of death in elderly patients with dementia who were treated with conventional antipsychotic drugs. The investigators compared the risk for death with use of an atypical antipsychotic versus either no antipsychotic or the use of a conventional antipsychotic.  The agency concluded that these studies, along with the earlier evidence for atypical antipsychotic drugs, suggest that both classes of drugs should be considered to have an increased risk of death when used in elderly patients treated for dementia-related psychosis.

Conventional and atypical  antipsychotic drugs were approved to treat the symptoms of schizophrenia.  They are not FDA -approved for use in the treatment of dementia-related symptoms, which can include forgetfulness, poor memory, and an inability to recognize familiar objects, sounds, or people. However, physicians are free to use approved drugs in any way they see fit - a practice known as off-label use.

The new black box warning for conventional antipsychotic medications indicate that they are associated with an increased risk of death when used in elderly patients treated for dementia-related psychosis. In 2005, the FDA announced similar labeling changes for atypical antipsychotic drugs. The agency has now asked the makers of both classes of antipsychotic  drugs to change labeling so that all of the drugs carry uniform warning language.

]]> Sales Of Anti-psychotic Drug Thioridazine To Be Stopped http://www.yourlawyer.com/articles/read/10643 Thu, 08 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/10643
Thioridazine will continue to be dispensed by pharmacies for a transition period after that date to allow patients sufficient time to consult their health care providers and switch to an alternate medication.

Health Canada has taken this action because manufacturers have failed to provide convincing safety information, requested by the Department, that demonstrates that the drug is safe to use. Questions of safety arose from ongoing concerns about use of the medication and rare occurrences of heart rhythm changes that could be life-threatening.

Health Canada is advising patients who use thioridazine not to stop taking their medication and to consult their physicians or health care providers as soon as possible in order to be switched to an alternate medication or medications.

In June 2005, Health Canada, which had been monitoring the safety of the drug, requested that manufacturers of generic thioridazine provide evidence that the benefits of using the drug outweigh the risks, especially given that potentially safer anti-psychotic medications are available.

Information submitted to Health Canada to date has failed to demonstrate that the benefits outweigh the risks. Health Canada has received reports of three deaths between 2000 and 2005 possibly related to thioridazine, with the most recent death occurring in February 2005.

Health Canada estimates there will be sufficient supplies in pharmacies to allow patients time to change to another product. Should pharmacy supplies be inadequate or if patients are unable to make a safe transition to marketed alternatives, prescribers should contact the Special Access Programme at Health Canada to request temporary access to the drug for individual patients. In most cases, alternative therapies are available to treat schizophrenia. Availability of thioridazine through the Special Access Programme may be an option for patients who cannot be adequately managed on alternative therapies.

Thioridazine has been used in Canada for the treatment of schizophrenia since 1959. The original brand name of thioridazine was Mellaril. In July 2000, Novartis Pharma Canada Inc., the manufacturer of Mellaril, distributed a letter to Canadian health care professionals that discussed safety concerns of potentially life-threatening changes in heart rhythm. Novartis withdrew the drug from the Canadian market in July 2001. The withdrawal was due to issues with changes to labelling and prescribing information that had been requested by Health Canada.

Novartis subsequently advised Health Canada that the company would voluntarily discontinue Mellaril worldwide by June 30, 2005 due to safety concerns. The move by Health Canada to stop the sale of thioridazine follows the Novartis decision.

Since 2001, generic manufacturers have continued to produce thioridazine for the Canadian market. Brand names currently available on the Canadian market include Thioridazine and Apo-thioridazine.]]> Mellaril Thioridazine Side Effect Injury Lawyer http://www.yourlawyer.com/topics/overview/Mellaril Thu, 08 Sep 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/Mellaril DOWNLOAD OUR Mellaril INFORMATION PACKAGE

Injured by Mellaril?

In June 2005, Health Canada asked the manufacturers of Mellaril and generic thioridazine to provide evidence that the benefits of using the drug outweigh the risks. Information submitted to Health Canada failed to demonstrate the drug's safety. Health Canada received reports of three deaths between 2000 and 2005 possibly related to Mellaril, with the most recent death occurring in February 2005. Because Novartis and other manufacturers failed to make convincing safety information available, Health Canada advised the companies that sales were to end by September 30, 2005. Health Canada recommended that patients who use Mellaril seek advice from their doctors in order to be switched to alternate medications.

The FDA sent a letter (http://www.fda.gov/medwatch/SAFETY/2000/mellar.htm) to physicians in July 2000 notifying them that a boxed warning was added to the label of Mellaril (thioridazine HCl).  The warning states that Mellaril, like similar drugs, is associated with torsade de pointes, a type of heart arrhythmia, and sudden death.  The drug prolongs the QTc interval in a dose related manner.  The letter also stated that Mellaril is only indicated only for those schizophrenic patients who fail to respond to other antipsychotic drugs.

If you or a loved one took Mellaril and suffered side effects, please fill out the form at the right for a free lawsuit case evaluation by a qualified drug side effects attorney.]]>