Symbyax depression drug capsules approved by FDA

Tuesday, March 24, 2009, 13:45 by Business Editor

Symbyax, a drug for treatment-resistant bipolar 1 depression got FDA clearance today. Symbyax is the first-ever drug to get official clearance for treatment-resistant bipolar 1 depression. Symbyax, made by ELi Lilly, is a combination of olanzapine and fluoxetine HCl capsules.

Bipolar 1 disorder has two phases: A manic phase and a depressive phase. In the manic phase, the patient is exuberant or irritable and “high”, while in the depressive phase, the person is guilty, anxious, fearful and occasionally has suicidal thoughts. Since Bipolar 1 disorder is noticed often only in the depressive phase, it is often misdiagnosed as Unipolar disorder (which doesn’t have a manic phase). Symbyax anti-depressant from Eli Llly is made to combat the bipolar 1 depression phase.

How does Symbyax capsules and pills work? Depression (or the manic phase) is caused by imbalances in neurotransmitters, which are chemicals within the body, which transmit information from one cell to the other. By restoring the balance of neurotransmitters, Symbyax is believed to treat bipolar 1 depression.
Said Eli Lilly Medical Director Sara Corya: “Living with major depressive disorder is difficult and distressing for anyone, but even more so for patients whose symptoms continue despite treatment. Until today, there has been no approved medication for treatment-resistant depression. Now, after two failed attempts with other antidepressants, doctors and patients have a new treatment option.”

Though Symbyax comes as a boon for patients suffering from treatment-resistant bipolar 1 depression disorder, Eli Lilly has warned against the use of Symbyax pills, tablets or capsules by several categories of people, and has issued detailed warnings about possible side-effects of Symbyax on its website.
Those patients already using, or have recently used Nardil (phenylzine sulfate) and Parnate (tranylcypromine sulfate) are NOT supposed to use Symbyax. These two drugs are already used for treating depression and mental problems. Taking SYMBYAX with an MAOI may cause serious side-effects. Also, after finishing with your Symbyax course of medicine, you are not supposed to use Nardil or Parnate for at least five weeks, says Eli Lilly.

Also, DO NOT use Symbyax, if you are already using a medicine called Mellaril (thioridazine) which is used to treat mental problems. Use of Mellaril and Symbyax simultaneously can cause a heart problem which can be fatal. Do not take Mellaril for at least 5 weeks after you stop taking Symbyax. Besides, Symbyax has not been tested in children below 18. Women pregnant or planning to become pregnant, breast-feeding should not take Symbyax. Also, alert your doctor about high blood sugar or diabetes, family history of diabetes, liver problems, seizures (convulsions or fits), low blood pressure, heart problems or heart attacks, strokes or mini-strokes (also called transient ischemic attacks, TIA) high blood pressure, enlarged prostate, an eye problem called narrow angle glaucoma, a stomach problem called paralytic ileus if you plan to start treatment with Symbyax. Also, those who smoke cigarettes, drink alcohol or exercise often must tell inform their doctors about these habits, so he can suggest the appropriate course and dosage.

Another possible side-effect of Symbyax is suicidal tendencies. This is a side-effect it ironically shares with many other anti-depressants.

Symbyax does not make you feel better immediately – it takes time. The patient should start feeling better in a week’s time, says Eli Lilly. However, it is recommended that those using it do not stop taking Symbyax abruptly. This may lead to drowsiness, nausea or headache. The doctor can help you tone down the dosage, if required, in a phased manner.

A possible side-effect of Symbyax is drowsiness. Also, some patients using Symbyax have been found to suffer from weight gain, diarrhea, dry mouth, increased appetite, feeling weak, swelling of the hands and feet, tremor, sore throat, and trouble concentrating.

Eli Lilly also alerts that those taking Symbyax tablets and capsules should call their doctor if they have thoughts about death or suicide, think they could hurt themselves or others or if they believe that symptoms are becoming worse, or if unwanted any unwanted side effects develop.

Symbyax is a prescription drug; so avoid buying or changing dosage on your own.

Fluoxetine Hydrochloride (brand name Prozac), another anti-depressant from Eli Lilly is in wide acceptance. It belongs to the category of selective serotonin reuptake inhibitors (SSRI).

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