Yourlawyer.com (Symbyax News) http://www.yourlawyer.com/topics/overview/symbyax Sat, 21 Nov 2009 22:53:39 -0800 pixel-app en FDA Issues Warning on Drug Use by Elderly http://www.yourlawyer.com/articles/read/9593 Mon, 11 Apr 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9593
The Food and Drug Administration is asking manufacturers of atypical anti-psychotic drugs to add to their labeling a boxed warning noting the risks and that the drugs were not approved to treat symptoms of dementia in the elderly.

Elderly patients taking the drugs for dementia-related symptoms should consult with their doctors, the FDA said.

The drugs were approved for treating schizophrenia and mania, and include such brands as Abilify, Zyprexa, Seroquel, Risperdal, Clozaril and Geodon. Symbyax, which is approved for the treatment of depression associated with bipolar disorder, is also included in the advisory.

An analysis of 17 studies covering four drugs showed the rate of death for the elderly patients taking them was about 1.6 to 1.7 times the rate of death for placebo users. The causes of death varied, but most seemed to be either heart-related or from infection.

The FDA doesn't have data to indicate how many elderly patients take this class of drugs, but agency officials believe that such prescriptions are common.

Carole Copeland, spokesman for Eli Lilly and Co., the maker of Zyprexa, said the company contacted doctors last year to alert them to the higher risk of mortality cited Monday by the FDA. She said the company also changed the drug's label last year to reiterate those higher risks. The company will review the FDA's advisory to determine if further changes were needed, she said.

Bristol-Myers Squibb and Otsuka America Pharmaceutical, Inc., which market Abilify, said the companies take the FDA's request seriously and would respond within 30 days. The companies also said a warning was added in February to the package insert accompanying Abilify, which noted a risk of stroke and similar events associated with its use by elderly patients with dementia.]]> Deaths with Antipsychotics in Elderly Patients with Behavioral Disturbances http://www.yourlawyer.com/articles/read/9599 Mon, 11 Apr 2005 00:00:00 -0700 http://www.yourlawyer.com/articles/read/9599
These studies enrolled a total of 5106 patients, and several analyses have demonstrated an approximately 1.6-1.7 fold increase in mortality in these studies. Examination of the specific causes of these deaths revealed that most were either due to heart related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).

The atypical antipsychotics fall into three drug classes based on their chemical structure. Because the increase in mortality was seen with atypical antipsychotic medications in all three chemical classes, the Agency has concluded that the effect is probably related to the common pharmacologic effects of all atypical antipsychotic medications, including those that have not been systematically studied in the dementia population. In addition to the drugs that were studied, the atypical antipsychotic medications include clozapine (Clozaril) and ziprasidone (Geodon).

All of tvhe atypical antipsychotics are approved for the treatment of schizophrenia. None, however, is approved for the treatment of behavioral disorders in patients with dementia. Because of these findings, the Agency will ask the manufacturers of these drugs to include a Boxed Warning in their labeling describing this risk and noting that these drugs are not approved for this indication. Symbyax, a combination product containing olanzapine and fluoxetine, approved for the treatment of depressive episodes associated with bipolar disorder, will also be included in the request.

The Agency is also considering adding a similar warning to the labeling for older antipsychotic medications because the limited data available suggest a similar increase in mortality for these drugs.]]> Symbyax Diabetes Stroke Side Effects Zyprexa Lawyer http://www.yourlawyer.com/topics/overview/symbyax Mon, 11 Apr 2005 00:00:00 -0700 http://www.yourlawyer.com/topics/overview/symbyax DOWNLOAD OUR SYMBYAX INFORMATION PACKAGE 

Injured by Symbyax?

Symbyax is intended for the treatment of depressive episodes associated with bipolar disorder. Symbyax (Generic: Olanzapine and Fluoxetine hci capsules) combines two psychotropic agents, olanzapine (the active ingredient in Zyprexa) and fluoxetine hydrochloride (the active ingredient in Prozac). Olanzapine belongs to the thienobenzodiazepine class. Fluoxetine hydrochloride is a selective serotonin reuptake inhibitor (SSRI).

Currently, Prozac is used for depression, while Zyprexa is used for schizophrenia as well as the short-term treatment of manic episodes. (Incidentally, Zyprexa is also under consideration by the FDA for long-term maintenance of bipolar disorder.)

Common side effects include:
  • Weight gain
  • Sleepiness
  • Diarrhea
  • Dry mouth
  • Increased appetite
  • Weakness
  • Swelling of hands and feet
  • Sore throat
  • Lack of concentration
Other side effects may include:
  • Severe allergic reactions that cause hives, swelling of your face, eyes, mouth, or tongue, trouble breathing or a rash with fever and joint pain.
  • Strokes and "mini-strokes" called transient ischemic attacks (TIAs). These are more common in elderly patients with dementia.
  • High blood sugar or diabetes.
  • Neuroleptic malignant syndrome (NMS). NMS is a rare, but life-threatening reaction to certain medicines for mental problems.
  • Tardive dyskinesia.
  • Low blood pressure.
  • Seizures
If you or a loved one took Symbyax and suffered side effects, please fill out the form at the right for a free case evaluation by a qualified drug side effects attorney.]]>