Monday, November 5, 2012

Newer Antidepressants May Be Safe for Parkinson's Patients

Some of the newer antidepressants can help treat depression in people with Parkinson's disease without aggravating other disease symptoms such as tremor or rigidity, researchers have found. Nearly 1 million people in the United States are living with Parkinson's disease, a progressive movement disorder marked by tremor, slowness and/or rigidity. Parkinson's disease and depression tend to travel together, and there has been concern that some of the medications used to treat depression may worsen motor symptoms. A new study published online April 11 and in the April 17 print issue of Neurology shows that this is not the case, at least when it comes to the antidepressants Paxil (paroxetine) and Effexor (venlafaxine). Paxil is in the class of drugs known as SSRIs (selective serotonin reuptake inhibitors) while Effexor is an SNRI (serotonin and norepinephrine reuptake inhibitor). In the new study of 115 people with Parkinson's disease, participants received Paxil, Effexor or an inactive "placebo" pill. The researchers followed-up with patients for 12 weeks and found that both antidepressants improved symptoms of depression without worsening some of the motor symptoms associated with the disease. On average, those people who took Paxil had a 59 percent improvement and those receiving Effexor had a 52 percent improvement in scores on a standardized tool measuring depression. People who received the placebo had a 32 percent improvement. Three other depression-rating scales showed similar results. The drugs did not lead to any worsening in motor symptoms, the investigators noted. Use of antidepressants did not improve anxiety levels, thought processes or overall health-related quality of life among the study participants. Sleep problems were among the most commonly reported side effects. Weight gain was seen with Paxil and at the final study visit, an increase in sitting blood pressure was seen with Effexor, according to the report. "Depression is the number-one factor negatively affecting the quality of life for people with Parkinson's disease," study author Dr. Irene Hegeman Richard, a neurologist at the University of Rochester Medical Center in Rochester, N.Y., said in a university news release. "It causes a great deal of suffering among patients. The great news here is that it's treatable. And when the depression is treated adequately, many of the other symptoms become much more manageable for patients." Depression in Parkinson's disease is caused by the underlying disease process, not the stress of dealing with a chronic disease, she said. Commenting on the study, Dr. Joe Verghese, a neurologist at the Albert Einstein College of Medicine in New York City, said the study provides good news for people with Parkinson's disease and depression. "There is always a concern that we may upset the applecart in Parkinson's by adding a new medication." Dr. Roy Alcalay, an assistant professor of neurology at Columbia University Medical Center in New York City, agreed that treating depression in Parkinson's disease can be a delicate balance. "The new study validates what we have been doing," he said. "The medications used to treat depression in the general population work as well for Parkinson's disease, and there is no evidence that they have bad side effects on motor symptoms." While the new study only looked at two antidepressants, "this doesn't mean that others don't work," Alcalay said. As to the robust placebo effect seen in the new study, he said that "just thinking that they are getting treated often helps people with depression." Treating depression in Parkinson's is important, Alcalay said, and "the study helps us do so in a more educated way." The U.S. National Institutes of Health/National Institute of Neurological Disorders and Stroke and the Johns Hopkins University School of Medicine funded the study. Wyeth Pharmaceuticals provided Effexor XR and the placebo, while GlaxoSmithKline provided Paxil.

Migraine Guidelines

Dozens of medications are available to prevent debilitating migraine headaches, but most migraine sufferers don't use them, a new study finds. "Approximately 40 percent of people with migraines need preventive treatment, and only about one-third of them are actually getting it," said Dr. Stephen D. Silberstein, co-author of new guidelines developed by the American Academy of Neurology and the American Headache Society. The drugs include prescription, over-the-counter and herbal medications. Which will work best "depends on the patient," said Silberstein, director of the Jefferson Headache Center at Thomas Jefferson University in Philadelphia. The guidelines, published in the April 24 issue of Neurology, were scheduled for presentation at the academy's annual meeting in New Orleans, April 21 to 28. Dr. Brian M. Grosberg, director of the Montefiore Headache Center in New York City, said recent studies have shown that preventive treatment is underutilized by both patients and their physicians. "Although there is no cure for migraine, preventive medications can decrease migraine occurrence by 50 percent or more, as well as reduce the severity and duration of headaches that do occur," said Grosberg, who was not involved with writing the guidelines. Most preventive treatments are taken daily day, unlike medications taken to relieve the pain and other symptoms of a migraine attack once it occurs. According to the American Academy of Neurology, migraines were the cause of more than 3 million emergency room visits in the United States in 2008. Symptoms can include throbbing or pulsing in one area of the head, nausea, vomiting and extreme sensitivity to light and sound. Migraine attacks are more common in women, and may last for hours or days. The new guidelines include information from 29 studies published between 1999 and 2009 that describe effective preventive treatments for migraine. They state that: Among prescription drugs, strong evidence shows that anti-epileptic drugs such as Depakote (divalproex sodium), Topamax (topiramate) and sodium valproate as well as the blood pressure drugs metoprolol (Lopressor, Toprol), propranolol (Inderal) and timolol (Blocadren) -- which belong to the class of medications known as beta blockers -- reduce the number of migraine attacks and their severity. The seizure drug lamotrigine (Lamictal) was not shown to prevent migraine. Frova (frovatriptan), one of a class of drugs originally developed to treat migraines, seems to be effective against menstrual-related migraines. The antidepressant Effexor (venlafaxine) appears to have some preventive benefit. Over-the-counter drugs Motrin (ibuprofen) and Aleve (naproxen) as well as riboflavin (vitamin B2) and the herb butterbur may also play a role in prevention. Silberstein said that that if all the drugs work equally well, people should consider other diseases the drugs treat and use any side effects to your advantage. If you're obese, for example, Topamax might be your best bet as a side effect is weight loss, he said. People with epilepsy should consider Depakote and those with depression an antidepressant such as Effexor, he noted. Grosberg said patients should discuss the options with their doctor. "There are many effective preventive strategies. It's important that the headache sufferer and treating physician work together to find the optimal treatment approach," said Grosberg. "The preventive strategy should always be tailored to the individual patient, bearing in mind personal preference, co-existing medical conditions, frequency of dosing and cost, as well as other factors," he added. Silberstein added that even people who take over-the-counter or herbal treatments should see their doctor for follow-up because all medications can cause side effects or interact with other drugs.

FDA Approves Pristiq

Wyeth Pharmaceuticals, a division of Wyeth , announced today that the U.S. Food and Drug Administration (FDA) has approved Pristiq (desvenlafaxine), a structurally novel, once-daily serotonin-norepinephrine reuptake inhibitor (SNRI), to treat adult patients with major depressive disorder (MDD). Wyeth expects to begin shipping Pristiq to wholesalers beginning in the second quarter of 2008. "We are pleased to be able to bring Pristiq to patients," says Bernard Poussot, President and Chief Executive Officer of Wyeth. "Pristiq is Wyeth's fourth new drug to receive approval in the last twelve months, demonstrating our ability to achieve success through the rigorous scientific process of discovery and development. We look forward to working with FDA and other regulatory authorities around the world to continue to bring important new medicines to patients who need them." "Pristiq is an important new therapeutic option for patients and clinicians because no single therapy works for all people with major depression," says Philip Ninan, M.D., Vice President of Wyeth Medical Affairs, Neuroscience. "Pristiq is approved at a once-daily 50-mg dose that does not require titration, allowing physicians to start their patients at the recommended therapeutic dose. We are encouraged by the tolerability profile seen in clinical studies." FDA approval was subject to several post-marketing commitments, including conducting and submitting data from a new long-term maintenance (relapse prevention) study, a sexual dysfunction study, pediatric studies and a study exploring lower doses. The agency also requested an additional non-clinical toxicity study. The efficacy of Pristiq as a treatment for depression was established in four 8-week, randomized, double-blind, placebo-controlled, fixed-dose studies in adult outpatients who met the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria for MDD. At the recommended dose of 50 mg, the discontinuation rate due to an adverse experience for Pristiq (4.1 percent) was similar to the rate for placebo (3.8 percent). Side effects of many antidepressant therapies can cause some patients to stop taking their medication. The most commonly observed adverse reactions in patients taking Pristiq for MDD in short-term, fixed-dose studies (incidence greater than or equal to 5 percent and at least twice the rate of placebo in the 50 or 100 mg dose groups) were nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence (sleepiness), decreased appetite, anxiety, and specific male sexual function disorders.

Pfizer Vaccine for Kids

Federal health officials on Monday questioned whether to approve an updated version of Pfizer 's best-selling anti-infection vaccine for children, despite company studies that failed to meet certain goals. The Prevnar 13 vaccine reduces risk of infection by 13 varieties of pneumococcal disease, which causes ear infections, meningitis and pneumonia. The new version of the vaccine protects against six more varieties of the disease. But Food and Drug Administration reviewers said that company studies failed to meet the preselected goals for three types of the disease, according to documents posted online. The missed goals were statistical measures for vaccine response selected by the FDA. However, since no other vaccine fights the same strains of the disease as Prevnar, the FDA said the significance of the missed goals "may not be clear." Dr. Emilio Emini, Pfizer's chief of vaccine research, said the missed goals were due to statistical groupings of patients in the study, not a flaw with the vaccine itself. Pfizer's briefing documents note that the World Health Organization's vaccine guidelines say meeting the study goals in question is "desirable, but not an absolute requirement." The FDA will ask a panel of outside vaccine experts to weigh in on the results at a meeting Wednesday. The agency is expected to make its decision on the vaccine by Dec. 30. The FDA is not required to follow the group's advice, though it usually does. Pfizer acquired Prevnar from Wyeth, as part of a $68 billion buyout that closed last month. Prevnar's $2.7 billion in sales last year trailed only those of the antidepressant Effexor for Wyeth. Wyeth applied for approval of Prevnar 13 in March and was granted a priority review from the FDA, which indicates the agency sees the product as a public health priority. Pfizer has said the new vaccine will save lives in the U.S. and in developing countries. "The public health imperative for this vaccine is clearly there," Emini said. "Pneumococcal disease is the number one cause of vaccine-preventable death in world." New York-based Pfizer is seeking FDA approval to market the vaccine for infants and young children and has tested it in more than 7,000 youngsters in 13 major studies. Prevnar has been on the market for more than nine years and is on sale in 95 countries. More than 235 million doses have been distributed, according to the company. The vaccine requires a series of four injections, generally given at 2, 4 and 6 months old and then between 12 and 15 months old. Prevnar 13 also recently received a positive review from a committee of European regulators, setting the stage for approval across the European Union.

Effexor (venlafaxine) for Bipolar Disorder

I think Effexor has been very beneficial for me - I've taken it for about six years. A word of warning: Do NOT let your prescription run out or take yourself off Effexor abruptly! I experienced this by accident while waiting for a mail-order prescription to arrive (my doctor was just moving into a new office and didn't have samples available). Within 2 days, I was a wreck emotionally (depressive, sobbing for no reason), cognitively (all over the place, no concentration), and physically (impaired motor coordination among other things). The "brain shivers" a feeling like an electrical current running from the brain down the spine and back again, are very disconcerting! I got samples from my doctor's former office and was noticeably better within hours of 1 dose. Effexor saved my life. I never knew what I "had" could be cured. I'd tried other antidepressants but they made my anxiety worse or vice versa. Effexor has given me back a will to live. It's lifted the fog of anxiety. I take 150mg. My stress level and blood pressure is WAY down. Someone mentioned strange dreams, I'd like to second that. I have been on Effexor XR for approximately 7 years now. I was started off at 75mg and have since been raised to 225mg over the years. I have had good results on this medication. One downfall is the terrible withdrawals that I experience if I miss a dose. These effects happen within the first couple of hours of not taking it. Terrible headache, foggy feeling, and extreme eye sensitivity. Within a day of a skipped dose I become agitated, argumentative, and defiant. I do not look forward to switching from this medicine to a different one, which my doctor has suggested, due to the withdrawal symptoms.

About Effexor XR

Effexor XR is contraindicated in patients taking monoamine oxidase inhibitors (MAOIs). Adult and pediatric patients taking antidepressants can experience worsening of their depression and/or the emergence of suicidality. Patients should be observed closely for clinical worsening and suicidality, especially at the beginning of drug therapy, or at the time of increases or decreases in dose. Anxiety, agitation, panic attacks, insomnia, irritability, hostility, impulsivity, akathisia, hypomania, and mania have been reported and may represent precursors to emerging suicidality. Stopping or modifying therapy should be considered especially when symptoms are severe, abrupt in onset, or not part of presenting symptoms. Treatment with venlafaxine is associated with sustained increases in blood pressure (BP) in some patients. Pre-existing hypertension should be controlled. Regular BP monitoring is recommended. Abrupt discontinuation or dose reduction has been associated with discontinuation symptoms. Patients should be counseled on possible discontinuation symptoms and monitored while discontinuing the drug; the dose should be tapered gradually. The most common adverse events reported in Effexor XR short-term placebo-controlled depression, generalized anxiety disorder (GAD), and/or social anxiety disorder trials (incidence greater than or equal to 10% and greater than or equal to 2x that of placebo) were anorexia, asthenia, constipation, dizziness, dry mouth, ejaculation problems, impotence, insomnia, nausea, nervousness, somnolence, and sweating. I've been taking Effexor for about 20 months and it's my MIRACLE! I'm 34 and began taking an medicines since I was 18. I tried Paxil, Zoloft, Buspar, Wellbutrin and finally Effexor. I am so genuinely happy and jubilant I just can't believe it. I'm sure part of it is maturity, life experience and such but WOW. I plan to continue taking it forever as my anxiety is not situational as in some cases. I have a chemical imbalance that will require a medicine forever so this is the one! I've never bee happier! I have used a few different antidepressants over the years, but when I started getting panic attacks my Dr put me on Effexor. It works well for me. Missing a dose is the worst thing though. If I wake up in the morning feeling hung over and dizzy and useless, I know that I forgot my pill the day before. It takes several hours after taking it to begin to feel better. I recently switched to taking it at night because then if I miss a dose the horrible side effects will come at night and I can just take a pill and go to bed, but am finding that if I don't take a sleep aid, I am up after 3 hours (like right now) and end up having to take a nap the next day. I am thinking that I better go back to taking them in the morning.

Effexor XR Approved for the Treatment of Panic Disorder

Wyeth announced today that on November 18, 2005, the U.S. Food and Drug Administration (FDA) approved Effexor XR (venlafaxine HCl) for the treatment of adults with panic disorder. This marks the first antidepressant approved for panic disorder since 2002. Panic disorder affects 2.4 million American adults annually. It is characterized by recurrent, unexpected panic attacks; i.e., a discrete period of intense fear or discomfort in the absence of real danger, where four of 13 specific symptoms such as accelerated heart rate, shortness of breath, trembling or fear of dying develop abruptly, reach a peak within 10 minutes, and are followed by at least one month of persistent concern about having another panic attack. In one study, less than 20 percent of sufferers were diagnosed and treated to remission. Because panic disorder is under recognized and not always treated to remission, patients are likely to experience a chronic and cyclical course of symptoms. "Given the complicated, recurrent nature of panic disorder, it is imperative that physicians have new and effective treatment options, like Effexor XR, to offer patients," says Alexander Bystritsky, M.D., professor of psychiatry at the David Geffen School of Medicine at UCLA and director of the UCLA Anxiety Disorders Program. The efficacy of Effexor XR as a treatment for panic disorder was established in two double-blind, 12-week, placebo-controlled studies. Adult patients received fixed doses of 75 or 150 mg/day in one study and 75 or 225 mg/day in the other study. In these studies, Effexor XR was significantly more effective than placebo at all three doses. In a long-term (26-week), double-blind study, adult patients who had responded to Effexor XR (75 to 225 mg/day) during an initial 12-week open- label phase were randomly assigned to continue the same Effexor XR dose (75, 150 or 225 mg) or switch to placebo for a six-month double-blind treatment phase. Patients who continued to receive Effexor XR experienced a significantly longer time to relapse as compared to those patients who were switched to placebo. Panic disorder may be associated with conditions such as depression or other anxiety disorders. Effexor XR, a serotonin-norepinephrine reuptake inhibitor, is indicated not only for panic disorder but also for the treatment of adults with major depressive disorder, generalized anxiety disorder (GAD) or social anxiety disorder (SAD). Have dealt with GAD anxiety most my life. Started taking Effexor for a Major Depression episode. Doctor stared me slow. 33 mg for 4 weeks, then 75 mg for 3 weeks, then 108 mg for 2 weeks and finally 150 mg. Been on 150 mg about 6 months, some side effects along the way. Just basically feeling "weird" was the worst side effect. Wanted to quit many times along the way, but stuck with it. It doesn't work overnight. Sexual side effect is hard to have a orgasm, but I can deal that if I feel better. Depression is NO fun. Good Luck All. Tomorrow's always can be a better day. GOD Bless.