In clinical trials sponsored by the manufacturers of Saphris, the most common side effects reported by schizophrenia patients were the lack of ability to sit still or remain motionless, diminished oral sensitivity, lethargy, drowsiness, and weight gain.
All atypical antipsychotic medications also carry a "black box" warning, the FDA's stringent warning, alerting health care prescribers about an increased risk of death linked to off-label use of these drugs to treat behavioral problems in elderly individuals with dementia-related psychosis. Saphris is not approved for such patients.
Saphris is made by Schering Plough. Experts at FDA evaluated the data from studies performed by the pharmaceutical company and feel that the drug is safe and effective. The drug will be formally approved for clinical use but will most likely be available for release in a few months.
Final word. Consumers should be aware that out of the three clinical trials sponsored by the pharmaceutical company, positive results were only seen in two out of three trials. No long-term data are available and neither is it known if Saphris works in all patients with Schizophrenia or bipolar disorder. Very little data on the drug is available. Only time will tell if the drug is as good as Schering Plough claims.
http://www.webmd.com/bipolar-disorder/news/20090814/fda-oks-new-schizophrenia-bipolar-drug
Thursday, August 27, 2009
Saphris- a novel drug to treat schizophrenia and bipolar disorder: Part 1
Just a few weeks ago, the FDA approved a new drug called Saphris to treat schizophrenia and bipolar I disorder in adults. Saphris belongs to a class of drugs called atypical antipsychotics. The FDA accepted Saphris based on recent clinical trials in which the medication was much better than placebo at reducing symptoms in patients with schizophrenia and bipolar disorder.
Schizophrenia is a mental disorder that affects about 1% of North Americans and is one of the most common causes of suicide in these individuals. Schizophrenia can present with a range of symptoms that include hearing voices other people do not hear or having false beliefs that others are reading their minds, controlling their thoughts or scheming to harm them. Many schizophrenics are inappropriately suspicious or paranoid.
Bipolar disorder, also acknowledged as manic-depressive illness, is believed to affect about 1% to 3% of individuals in North America. Bipolar I disorder is a chronic, severe, and recurrent mental disorder that induces sporadic periods of depression and increased levels of hyperactivity, restlessness, competing thoughts, rapid speech, impulsive actions, and a diminished need for sleep.
Both schizophrenia and bipolar disorder not only affect the individual but also devastate relationships between families and friends. Despite years of research, the cause of both these disorders remains a puzzle. Even though there are drugs to treat these disorders, many individuals rapidly develop tolerance, have numerous side effects and treatment is life long. The use of drugs to treat schizophrenia and bipolar disorders is essential because they can help these individuals live more independently and even hold jobs.
Schizophrenia is a mental disorder that affects about 1% of North Americans and is one of the most common causes of suicide in these individuals. Schizophrenia can present with a range of symptoms that include hearing voices other people do not hear or having false beliefs that others are reading their minds, controlling their thoughts or scheming to harm them. Many schizophrenics are inappropriately suspicious or paranoid.
Bipolar disorder, also acknowledged as manic-depressive illness, is believed to affect about 1% to 3% of individuals in North America. Bipolar I disorder is a chronic, severe, and recurrent mental disorder that induces sporadic periods of depression and increased levels of hyperactivity, restlessness, competing thoughts, rapid speech, impulsive actions, and a diminished need for sleep.
Both schizophrenia and bipolar disorder not only affect the individual but also devastate relationships between families and friends. Despite years of research, the cause of both these disorders remains a puzzle. Even though there are drugs to treat these disorders, many individuals rapidly develop tolerance, have numerous side effects and treatment is life long. The use of drugs to treat schizophrenia and bipolar disorders is essential because they can help these individuals live more independently and even hold jobs.
Thursday, August 13, 2009
Can Tamoxifen be used to treat Bipolar Disorder? Part 2
In a recently published study from Turkey, close to 50% of manic patients who took the drug tamoxifen had fewer manic episodes during the three weeks of treatment, compared to just 5% of placebo-treated patients. About 25 percent of tamoxifen-treated patients and none of the placebo-treated patients achieved remissions.
At the end of three weeks of treatment, the tamoxifen-treated patients had markedly lower scores on clinical tests designed to measure severity of manic symptoms, while the scores of placebo-treated patients increased slightly. Tamoxifen-treated patients also required less lorazepam in the second and third weeks of the study.
The only negative of the study was that it only involved 50 patents. However, this is not the first study to show that tamoxifen decreases manic symptoms in individuals with bipolar disorder. A previous National Institute of Mental Health Study reported that 63% of patients had reduced manic symptoms when treated with tamoxifen after three weeks, compared to about less than 10 percent of placebo-treated patients.
Tamoxifen has been observed to be very safe for short-term use. Usually treatment for mania is only used for days or weeks, and once the mania is under control, individuals are then maintained on a variety of mood stabilizers.
The drug tamoxifen is quite effective but its estrogen inhibitory activity is worrisome in the long-term treatment of bipolar individuals. There is experimental evidence that long term use of tamoxifen may induce uterine cancer. That is why tamoxifen is not currently recommended for long-term use. There is currently a search for drugs like tamoxifen but do not have the ability to block estrogen receptors.
The above study will hopefully enable researchers to develop better and safer drugs to help treat bipolar treatments. Researchers are working to find similar drugs which target the exact PKC enzymes associated with mania.
The findings are published in the March issue of the Archives of General Psychiatry.
http://www.webmd.com/bipolar-disorder/news/20080303/tamoxifen-may-help-treat-bipolar-mania?page=2
At the end of three weeks of treatment, the tamoxifen-treated patients had markedly lower scores on clinical tests designed to measure severity of manic symptoms, while the scores of placebo-treated patients increased slightly. Tamoxifen-treated patients also required less lorazepam in the second and third weeks of the study.
The only negative of the study was that it only involved 50 patents. However, this is not the first study to show that tamoxifen decreases manic symptoms in individuals with bipolar disorder. A previous National Institute of Mental Health Study reported that 63% of patients had reduced manic symptoms when treated with tamoxifen after three weeks, compared to about less than 10 percent of placebo-treated patients.
Tamoxifen has been observed to be very safe for short-term use. Usually treatment for mania is only used for days or weeks, and once the mania is under control, individuals are then maintained on a variety of mood stabilizers.
The drug tamoxifen is quite effective but its estrogen inhibitory activity is worrisome in the long-term treatment of bipolar individuals. There is experimental evidence that long term use of tamoxifen may induce uterine cancer. That is why tamoxifen is not currently recommended for long-term use. There is currently a search for drugs like tamoxifen but do not have the ability to block estrogen receptors.
The above study will hopefully enable researchers to develop better and safer drugs to help treat bipolar treatments. Researchers are working to find similar drugs which target the exact PKC enzymes associated with mania.
The findings are published in the March issue of the Archives of General Psychiatry.
http://www.webmd.com/bipolar-disorder/news/20080303/tamoxifen-may-help-treat-bipolar-mania?page=2
Can Tamoxifen be used to treat Bipolar Disorder? Part 1
There are close to 6 million individuals in the US with bipolar disorder. This disorder characterized by severe mood shifts ranging from extreme mania to depression can create havoc in one’s life. Manic episodes may last anywhere from 7 days to several months and the symptoms may range from acute restlessness, trouble sleeping, anxiety, irritability, distractibility and/or paranoia. While the depressive episodes are treatable, the manic phases of bipolar disorders are very difficult to treat. The few drug treatments available to date have to be taken for many weeks and often fail to work or worsen the depression. Even when the treatment works, many individuals rapidly develop resistance to the drugs. During the manic phase of the disorder, individuals may lose their jobs, spend a lot of money, and have poor martial relationships.
For some years now, scientists have been trying to discover treatments that work faster and resolve the bipolar phase without causing excess depression.
Tamoxifen is a widely used drug to treat postmenopausal women who have had breast cancer. Tamoxifen has been used for more than two decades to treat breast cancer. It acts by blocking activity of the hormone estrogen, which stimulates breast cancer growth. Tamoxifen also inhibits a group of enzymes known as protein kinase C, and it was this activity that first fascinated scientists studying bipolar disorder.
Now, there is evidence that perhaps tamoxifen may be useful in the treatment of manic phase of bipolar disorder.
For some years now, scientists have been trying to discover treatments that work faster and resolve the bipolar phase without causing excess depression.
Tamoxifen is a widely used drug to treat postmenopausal women who have had breast cancer. Tamoxifen has been used for more than two decades to treat breast cancer. It acts by blocking activity of the hormone estrogen, which stimulates breast cancer growth. Tamoxifen also inhibits a group of enzymes known as protein kinase C, and it was this activity that first fascinated scientists studying bipolar disorder.
Now, there is evidence that perhaps tamoxifen may be useful in the treatment of manic phase of bipolar disorder.
Friday, August 7, 2009
Does Pregabalin (lyrica) relieve pain in Fibromyalgia? Part 2
The results
Symptomatic pain relief was achieved in patients at all doses of pregabalin when it was compared to the sugar pill. Further, patients with fibromyalgia also showed global mood improvement, and reported good sleeping scores. The two most common side effects of the drug observed in some patients were dizziness and sleepiness. These side effects were more common with higher doses of the drug.
This study supports the use of pregabalin for the treatment of pain and sleep disturbances in patients with fibromyalgia. The drug is relatively safe and does work in a significant majority of patients. However, one should be aware that Lyrica does not come cheap. The average cost for a 150 mg pill taken three times a day for a month ranges from $175-$200.
http://www.mdlinx.com/internalmdlinx/news-article.cfm/2388789
Symptomatic pain relief was achieved in patients at all doses of pregabalin when it was compared to the sugar pill. Further, patients with fibromyalgia also showed global mood improvement, and reported good sleeping scores. The two most common side effects of the drug observed in some patients were dizziness and sleepiness. These side effects were more common with higher doses of the drug.
This study supports the use of pregabalin for the treatment of pain and sleep disturbances in patients with fibromyalgia. The drug is relatively safe and does work in a significant majority of patients. However, one should be aware that Lyrica does not come cheap. The average cost for a 150 mg pill taken three times a day for a month ranges from $175-$200.
http://www.mdlinx.com/internalmdlinx/news-article.cfm/2388789
Does Pregabalin (lyrica) relieve pain in Fibromyalgia? Part 1
The treatment of fibromyalgia has been very disappointing. The disorder is difficult to diagnose, commonly under treated and even less appreciated among health care professionals. Despite decades of research, the pathology is not well understood and treatment is empirical. Most individuals go through a trial and error process until they finally discover something that works. Unfortunately, what may work in one individual generally fails to work in others.
Recently the drug pregabalin (lyrica) was studied to determine its effectiveness in patients with fibromyalgia. Pregabalin is an anti-seizure drug and frequently used to treat various types of pain disorders. Lyrica has also been found effective for generalized anxiety disorder. Pregabalin is marketed by Pfizer under the trade name Lyrica.
In the early 2000s, many anecdotal reports started to appear that Lyrica might be effective for the treatment of chronic pain in disorders such as fibromyalgia and spinal cord injury. Two years ago, pregabalin became the first medication approved by the U.S. Food and Drug Administration specifically for the treatment of fibromyalgia.
One of the reasons why pregabalin is widely prescribed is because it has very low potential for abuse, and has limited dependence liability if misused. It is classified as a Schedule V drug.
To determine whether Lyrica is effective in fibromyalgia, the drug was administered to 748 patients and compared to placebo (sugar pill). Pregabalin at doses of 300 mg/day, 450 mg/day or 600 mg/twice a day was studied for 13 weeks. Besides evaluating its efficacy, side effects, and safety profile of pregabalin was also assessed.
Recently the drug pregabalin (lyrica) was studied to determine its effectiveness in patients with fibromyalgia. Pregabalin is an anti-seizure drug and frequently used to treat various types of pain disorders. Lyrica has also been found effective for generalized anxiety disorder. Pregabalin is marketed by Pfizer under the trade name Lyrica.
In the early 2000s, many anecdotal reports started to appear that Lyrica might be effective for the treatment of chronic pain in disorders such as fibromyalgia and spinal cord injury. Two years ago, pregabalin became the first medication approved by the U.S. Food and Drug Administration specifically for the treatment of fibromyalgia.
One of the reasons why pregabalin is widely prescribed is because it has very low potential for abuse, and has limited dependence liability if misused. It is classified as a Schedule V drug.
To determine whether Lyrica is effective in fibromyalgia, the drug was administered to 748 patients and compared to placebo (sugar pill). Pregabalin at doses of 300 mg/day, 450 mg/day or 600 mg/twice a day was studied for 13 weeks. Besides evaluating its efficacy, side effects, and safety profile of pregabalin was also assessed.
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