Monday, November 5, 2012

Indications for SEROQUEL XR

SEROQUEL XR is a once-daily tablet approved in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia. Everyday I was very depressed or very angery for no apparant reason. It felt like my brain was all tangled and it was really hurting me, and had been for years. So I talked with my doctor, and she put me on 200mg seroquel. Since then I can think clearly and feel happy, I love it. You start at 25mg and work up to higher doses. Watch out though, if you try to start at 200mg it can knock you out for 24hrs, or at least it knocked me out. I have suffered insomnia for many years and have tried numerous drugs on this list. Most of which failed to provide any relief. After just one dose of Seroquel XR, I slept a full 8 hours, and even took a nap during the day. My mood has changed, and I feel so much healthier now that I am able to get good, sound, NORMAL sleep. Two thumbs up for Seroquel XR. I highly recommend you discuss this drug with your physician if you are having CHRONIC trouble sleeping, NOT casual sleeping problems. It has changed my life. I hope this helps some other insomniacs out there who have been suffering for years, the way I had been. BEST OF LUCK to all of you.

Important Safety Information for SEROQUEL XR

Elderly patients with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) treated with this type of medicine are at an increased risk of death, compared to placebo (sugar pill). SEROQUEL XR is not approved for treating these patients. Antidepressants have increased the risk of suicidal thoughts and actions in some children, teenagers, and young adults. Patients of all ages starting treatment should be watched closely for worsening of depression, suicidal thoughts or actions, unusual changes in behavior, agitation, and irritability. Patients, families, and caregivers should pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. Report any change in these symptoms immediately to the doctor. SEROQUEL XR is not approved for patients under the age of 18 years. Stop SEROQUEL XR and call your doctor right away if you have some or all of the following symptoms: high fever; excessive sweating; stiff muscles; confusion; changes in pulse, heart rate, and blood pressure. These may be symptoms of neuroleptic malignant syndrome (NMS), a rare and very serious condition that can lead to death. High blood sugar and diabetes have been reported with SEROQUEL XR and medicines like it. If you have diabetes or risk factors such as obesity or a family history of diabetes, your doctor should check your blood sugar before you start taking SEROQUEL XR and also during therapy. If you develop symptoms of high blood sugar or diabetes, such as excessive thirst or hunger, increased urination, or weakness, contact your doctor. Complications from diabetes can be serious and even life threatening. Increases in triglycerides and in LDL (bad) cholesterol and decreases in HDL (good) cholesterol have been reported with SEROQUEL XR. Your doctor should check your cholesterol levels before you start SEROQUEL XR and during therapy. Weight gain has been reported with SEROQUEL XR. Your doctor should check your weight regularly. Tell your doctor about any movements you cannot control in your face, tongue, or other body parts, as they may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking SEROQUEL XR. TD may also start after you stop taking SEROQUEL XR. Other risks include feeling dizzy or lightheaded upon standing, decreases in white blood cells (which can be fatal), or trouble swallowing. Tell your doctor if you experience any of these. Before starting treatment, tell your doctor about all prescription and nonprescription medicines you are taking. Also tell your doctor if you have or have had low white blood cell count, seizures, abnormal thyroid tests, high prolactin levels, heart or liver problems, or cataracts. An eye exam for cataracts is recommended at the beginning of treatment and every 6 months thereafter. Since drowsiness has been reported with SEROQUEL XR, you should not participate in activities such as driving or operating machinery until you know that you can do so safely. Avoid becoming overheated or dehydrated while taking SEROQUEL XR. Do not drink alcohol while taking SEROQUEL XR. Tell your doctor if you are pregnant or intend to become pregnant. Avoid breast-feeding while taking SEROQUEL XR. The most common side effects are drowsiness, dry mouth, constipation, dizziness, increased appetite, upset stomach, weight gain, fatigue, disturbance in speech and language, and stuffy nose. Do not stop taking SEROQUEL XR without talking to your doctor. Stopping SEROQUEL XR suddenly may cause side effects. This is not a complete summary of safety information. Please discuss the full Prescribing Information with your health care provider.

Generic Seroquel in the United States

Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA) announced today that it has commenced commercial launch of Quetiapine Fumarate Tablets, the Company's generic version of AstraZeneca's schizophrenia treatment, Seroquel® Tablets. The brand product had annual sales of approximately $4.6 billion in the United States, based on IMS sales data. About Teva Teva Pharmaceutical Industries Ltd. (NASDAQ: TEVA) is a leading global pharmaceutical company, committed to increasing access to high-quality healthcare by developing, producing and marketing affordable generic drugs as well as innovative and specialty pharmaceuticals and active pharmaceutical ingredients. Headquartered in Israel, Teva is the world's largest generic drug maker, with a global product portfolio of more than 1,300 molecules and a direct presence in about 60 countries. Teva's branded businesses focus on CNS, oncology, pain, respiratory and women's health therapeutic areas as well as biologics. Teva currently employs approximately 46,000 people around the world and reached $18.3 billion in net revenues in 2011. Teva's Safe Harbor Statement under the U.S. Private Securities Litigation Reform Act of 1995: This release contains forward-looking statements, which express the current beliefs and expectations of management. Such statements are based on management's current beliefs and expectations and involve a number of known and unknown risks and uncertainties that could cause our future results, performance or achievements to differ significantly from the results, performance or achievements expressed or implied by such forward-looking statements. Important factors that could cause or contribute to such differences include risks relating to: our ability to develop and commercialize additional pharmaceutical products, competition from the introduction of competing generic equivalents and the impact of increased governmental pricing pressures, the effects of competition on revenues of our innovative products, especially Copaxone® (including competition from innovative orally-administered alternatives, as well as from potential generic equivalents), potential liability for revenues of generic products prior to a final resolution of outstanding patent litigation, including that relating to the generic version of Protonix®, the extent to which we may obtain U.S. market exclusivity for certain of our new generic products, the extent to which any manufacturing or quality control problems damage our reputation for high quality production and require costly remediation, our ability to identify, consummate and successfully integrate acquisitions (including the acquisition of Cephalon), our ability to achieve expected results through our innovative R&D efforts, dependence on the effectiveness of our patents and other protections for innovative products, intense competition in our specialty pharmaceutical businesses, uncertainties surrounding the legislative and regulatory pathway for the registration and approval of biotechnology-based products, our potential exposure to product liability claims to the extent not covered by insurance, any failures to comply with the complex Medicare and Medicaid reporting and payment obligations, our exposure to currency fluctuations and restrictions as well as credit risks, the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement, adverse effects of political or economical instability, major hostilities or acts of terrorism on our significant worldwide operations, increased government scrutiny in both the U.S. and Europe of our agreements with brand companies, interruptions in our supply chain or problems with our information technology systems that adversely affect our complex manufacturing processes, the impact of continuing consolidation of our distributors and customers, the difficulty of complying with U.S. Food and Drug Administration, European Medicines Agency and other regulatory authority requirements, potentially significant impairments of intangible assets and goodwill, potential increases in tax liabilities resulting from challenges to our intercompany arrangements, the termination or expiration of governmental programs or tax benefits, any failure to retain key personnel or to attract additional executive and managerial talent, environmental risks and other factors that are discussed in our Annual Report on Form 20F for the year ended December 31, 2010 and in our other filings with the U.S. Securities and Exchange Commission.

SEROQUEL XR is Now Available to Treat Bipolar Depression

AstraZeneca today launched its once-daily SEROQUEL XR(R) (quetiapine fumarate) Extended-Release Tablets for the acute treatment of the depressive episodes associated with bipolar disorder and the manic and mixed episodes associated with bipolar I disorder, as well as the maintenance treatment of bipolar I disorder as adjunctive therapy to lithium or divalproex. SEROQUEL XR is also now available in two new tablet strengths, 50-mg and 150-mg.(1) Once-daily SEROQUEL XR is the only medication FDA-approved for the treatment of acute depressive, manic, and mixed episodes of bipolar disorder.(2) "Bipolar depression is a serious and debilitating illness with few approved treatment options," said Dr. Trisha Suppes, Professor of Psychiatry and Behavioral Sciences, Medical Center and VA Palo Alto Health Care System. "People with bipolar disorder are known to struggle more frequently with the depressive rather than the manic symptoms. SEROQUEL XR has been shown to be effective as a monotherapy in treating bipolar depressive symptoms, such as sadness, loss of interest, and feelings of worthlessness." Approximately 8 million American adults may be affected by bipolar disorder, also known as manic-depressive illness, a serious psychiatric condition characterized by recurring episodes of depression and mania.(3,4) For many patients with bipolar disorder, the depressive symptoms are more disruptive than the manic symptoms.(5) "When symptomatic, people with bipolar disorder experience depressive symptoms more than three times longer than manic symptoms, and this may interfere with daily activities," said Dr. Arthur Lazarus, Senior Director, Clinical Development for AstraZeneca. "The approval of SEROQUEL XR for the treatment of bipolar disorder provides patients with the only medication that has been proven to treat the acute depressive, manic, and mixed episodes of bipolar disorder." Today's announcement follows the October 2008 FDA approval of SEROQUEL XR for these indications in bipolar disorder. SEROQUEL XR is now available in 50-mg, 150-mg, 200-mg, 300-mg, and 400-mg tablet strengths. SEROQUEL XR is also approved for the acute and maintenance treatment of schizophrenia.(1) For the full prescribing information, go to www.SEROQUELXR.com. Approximately 8 million American adults may be affected by bipolar disorder, a serious psychiatric condition also known as manic depressive illness.(3,4) Bipolar disorder consists of recurring episodes of mania and depression.(6) Bipolar I disorder is characterized by one or more manic or mixed episodes, often with one or more episodes of major depression, whereas bipolar II disorder is distinguished by one or more major depressive episodes accompanied by at least one hypomanic episode.(6) Patients with bipolar I disorder experience depressive symptoms approximately three times longer than manic symptoms.(7) Similarly, patients with bipolar II disorder spend almost forty times longer in the depressed state than in hypomania.(8) Up to 50 percent of patients with bipolar disorder attempt suicide, and approximately 15 to 20 percent complete suicide.(9) Bipolar disorder is often misdiagnosed as major depressive disorder. This misdiagnosis can lead to unfocused treatment that may exacerbate the disease. In fact, many patients face ten years or more before a correct diagnosis is made.(10) Prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression.(1,11) Bipolar disorder is typically managed through a treatment strategy with several phases - including acute and maintenance phases. In the acute phase, the aim is to improve the acute symptoms of the patient; the maintenance treatment phase aims to reduce the risk of recurrence of future episodes.(12) SEROQUEL XR is indicated for the treatment of acute depressive episodes associated with bipolar disorder, acute manic or mixed episodes associated with bipolar I disorder as monotherapy and as an adjunct to lithium or divalproex; maintenance treatment of bipolar I disorder as adjunct therapy to lithium or divalproex, and acute and maintenance treatment of schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment and the appropriate dose. Hyperglycemia, in some cases extreme and associated with ketoacidosis, hyperosmolar coma, or death, has been reported in patients treated with atypical antipsychotics, including quetiapine. The relationship of atypical use and glucose abnormalities is complicated by the possibility of increased risk of diabetes in the schizophrenic population and the increasing incidence of diabetes in the general population. However, epidemiological studies suggest an increased risk of treatment-emergent, hyperglycemia-related adverse reactions in patients treated with atypical antipsychotics. Patients starting treatment with atypical antipsychotics who have or are at risk for diabetes should undergo fasting blood glucose testing at the beginning of and periodically during treatment. Patients who develop symptoms of hyperglycemia should also undergo fasting blood glucose testing. In long-term clinical trials of quetiapine, hyperglycemia (fasting glucose greater than or equal to 126 mg/dL) was observed in 10.7% of patients receiving quetiapine (mean exposure 213 days) vs. 4.6% in patients receiving placebo (mean exposure 152 days). Clinically significant increases in cholesterol (4%-16% for quetiapine vs. 2%-7% for placebo) and triglycerides (8%-23% for quetiapine vs. 6%-16% for placebo) have been observed in clinical trials. The proportion of patients in clinical trials meeting a weight gain criterion of greater than or equal to 7% of body weight was 5%-23% for quetiapine vs. 0%-7% for placebo. A potentially fatal symptom complex, sometimes referred to as Neuroleptic Malignant Syndrome (NMS), has been reported in association with administration of antipsychotic drugs, including quetiapine. Rare cases of NMS have been reported with quetiapine. Clinical manifestations of NMS are hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia). Additional signs may include elevated creatine phosphokinase, myoglobinuria (rhabdomyolysis), and acute renal failure. The management of NMS should include immediate discontinuation of antipsychotic drugs. Leukopenia, neutropenia, and agranulocytosis (including fatal cases), have been reported temporally related to atypical antipsychotics, including quetiapine. Patients with a pre-existing low white blood cell (WBC) count or a history of drug induced leukopenia/neutropenia should have their complete blood count monitored frequently during the first few months of therapy. In these patients, SEROQUEL XR should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with neutropenia should be carefully monitored, and SEROQUEL XR should be discontinued in any patient if the absolute neutrophil count is < 1000/cubic mm. Tardive dyskinesia (TD), a potentially irreversible syndrome of involuntary dyskinetic movements, may develop in patients treated with antipsychotic drugs. The risk of developing TD and the likelihood that it will become irreversible are believed to increase as the duration of treatment and total cumulative dose of antipsychotic drugs administered to the patient increase. TD may remit, partially or completely, if antipsychotic treatment is withdrawn. Quetiapine should be prescribed in a manner that is most likely to minimize the occurrence of TD. Warnings and Precautions also include the risk of orthostatic hypotension, cataracts, seizures, hyperprolactinemia, and possibility of suicide attempts. Examination of the lens by methods adequate to detect cataract formation, such as slit lamp exam or other appropriately sensitive methods, is recommended at initiation of treatment or shortly thereafter, and at 6-month intervals during chronic treatment. The possibility of a suicide attempt is inherent in schizophrenia, and close supervision of high risk patients should accompany drug therapy. The most commonly reported adverse reactions associated with the use of SEROQUEL XR vs. placebo in clinical trials for schizophrenia and bipolar disorder were somnolence (25%-52% vs. 10%-13%), dry mouth (12%-37% vs. 1%-7%), constipation (6-10% vs. 3-6%), dyspepsia (5-7% vs. 1-4%), dizziness (10-13% vs. 4-11%), orthostatic hypotension (7% vs. 5%), weight gain (7% vs. 1%), increased appetite (12% vs. 6%), fatigue (6-7% vs. 2-4%), dysarthria (5% vs. 0%), and nasal congestion (5% vs. 1%). SEROQUEL XR. AstraZeneca is engaged in the research, development, manufacturing and marketing of meaningful prescription medicines and in the supply of healthcare services. AstraZeneca is one of the world's leading pharmaceutical companies with global healthcare sales of $ 31.6 billion and is a leader in gastrointestinal, cardiovascular, neuroscience, respiratory, oncology and infectious disease medicines. In the United States, AstraZeneca is a $13.5 billion dollar healthcare business.

Seroquel aimed at reducing possible dispensing confusion with Serzone

AstraZeneca announced that it is changing the appearance of container labeling and packaging for Seroquel (quetiapine fumarate), which is indicated for the treatment of schizophrenia in adults. It's part of an effort to reduce the potential for medication dispensing errors with Serzone (nefazodone hydrochloride), an antidepressant manufactured by Bristol-Myers Squibb Company. AstraZeneca said it is continuing to work closely with the FDA to design an educational program to address the issue. The multi-faceted educational campaign about the new labeling and packaging, as well as how to prevent future medication errors was launched on May 20, when AstraZeneca also sent out a "Dear Healthcare Professional" letter informing physicians and pharmacists of the potential for medication dispensing errors with Serzone. [You can find the letter at www.fda.gov/medwatch] Instances of prescribing errors have involved either Serzone being substituted for Seroquel, or vice-versa. Medication dispensing errors are often a result of miscommunication, such as poor handwriting on prescription forms, and confusion between drugs with similar names. Astrazeneca said that it is important to note that the FDA concerns do not pertain to the safety, efficacy or tolerability of Seroquel, a first-line atypical antipsychotic, when properly prescribed and dispensed. Seroquel is one of many prescription drugs that have recently received attention with regard to medication dispensing errors. "AstraZeneca is cooperating fully with the FDA to ensure a number of actions are taken to address future medication errors involving Seroquel and Serzone," said James Pusey, MD, vice president, CNS, Pain and Infection therapy area. "Schizophrenia is a serious disease and an interruption in treatment can lead to negative consequences for the patients. AstraZeneca is a responsible company and our most important priority is to ensure that our products are being administered appropriately and safely." In order to more clearly differentiate Seroquel from Serzone on pharmacy shelves, AstraZeneca is creating new package labels emphasizing the "QUEL" in a new font and color, and is changing the bottle cap from white to blue. This should be available shortly. The company will also be communicating with the National Mental Health Association (NMHA) and the National Alliance for the Mentally Ill (NAMI), to make them aware of the issue. The educational awareness campaign will also include: Ads in professional journals describing the issue of medication errors and providing a visual of the revised packaging Patient information wallet card Shelf tags Self-inking Seroquel prescription stamps for distribution to physicians. Professionals and patients can also visit www.seroquel.com for more information, or they can contact AstraZeneca at 800-236-9933. The labeling for Seroquel (quetiapine fumarate) Tablets includes a warning relative to a condition known as tardive dyskinesia (which is often associated with long-term use of antipsychotic agents), and a rare condition known as neuroleptic malignant syndrome (NMS symptoms include muscle rigidity, fever, and irregular pulse). Labeled precautions include orthostatic hypotension and the possible risk of cataract development. As with other antipsychotics, therapy with Seroquel should be used cautiously in patients with a history of seizures or with conditions that can potentially lower the seizure threshold.

Risky in Alzheimer’s: Zyprexa, Risperdal, Seroquel

The anti-psychotic drugs Zyprexa (olanzapine), Risperdal (risperidone) and Seroquel (quetiapine) do not offer people with Alzheimer’s disease significant relief from symptoms of delusion and aggression, according to a new study. Moreover, the drugs carry risks of sudden death and other side effects that may offset any benefit within this patient population. The Clinical Antipsychotic Trials of Intervention Effectiveness–Alzheimer’s Disease (CATIE-AD) trial was the first major study of its kind to include people with Alzheimer’s living outside a nursing home. Results were reported in The New England Journal of Medicine (NEJM) and summarized by the Associated Press (AP) on October 12. Among the approximately 4.5 million Americans diagnosed with Alzheimer’s disease, approximately 75% will develop aggressive behavior, delusions or hallucinations, according to the AP report, and consequently may try to harm their caregivers or themselves – often prompting a move to a nursing home. About 25% of people in nursing homes are on drugs such as Zyprexa, Risperdal or Seroquel, according to the AP, and roughly an equal number of people with Alzheimer’s living at home have also taken them – despite very limited evidence of benefit. Unfortunately, no alternative drugs currently exist, and better medications will not be approved for some years. The 42-site, placebo-controlled study by Lon S Schneider, MD, and colleagues involved 421 people with Alzheimer’s disease and psychosis who were living at home (or with a relative or in an assisted-living situation) and required a high level of care. All participants received either olanzapine (mean 5.5 mg daily), quetiapine (mean 56.5 mg daily), risperidone (mean 1.0 mg daily) or placebo. All of the active drugs are newer-generation anti-psychotics developed to treat schizophrenia. However, they may be prescribed off-label by doctors for other indications, and all carry warnings that they raise the risk of death for elderly people with dementia-related psychotic symptoms and are not approved for use in these patients. Researchers followed participants for 36 weeks – a longer time-period than in prior studies – and doses were adjusted as needed. Results showed symptom improvement in about 30% of participants receiving active drugs, and in about 21% of participants on placebo. Some participants switched treatments during the study’s second phase (results of which are scheduled for release in spring 2007). Although the rate of death was higher in the group taking active medication (5 versus 2 deaths), the researchers noted that this difference may purely have been due to chance, and they did not report the causes of death. The study’s lead investigator, Dr Schneider, director of the Alzheimer’s Disease Center of California and a University of Southern California professor, noted that doctors should try using the anti-psychotic drugs on patients as needed, but recommended that they be closely monitored for both improvement and side effects: “Patients are put on these kinds of medications and not particularly monitored and treated for indefinite periods of time,” Schneider reportedly said. “That just maximizes risk.” He added that, while people with Alzheimer’s in nursing homes need symptom relief more because they generally have worse behavior problems, their health tends to be more fragile and they are therefore more vulnerable to developing side effects. In an editorial appearing in the same issue of the NEJM, Dr Jason Karlawish of the University of Pennsylvania’s Alzheimer’s Disease Center wrote that Zyprexa, Risperdal and Seroquel offered benefits to some people with Alzheimer’s, with few or no side effects. However, he noted that the study suggest that Zyprexa and Risperdal are equally effective and superior to placebo and Seroquel in treating behavioral problems related to Alzheimer’s, “but this benefit was limited to a subgroup of patients who either tolerated or did not have side effects such as parkinsonism and sedation… “These results …suggest that these drugs have a limited, but at times necessary, role in the care of patients with Alzheimer’s disease.”

Indications for SEROQUEL XR

SEROQUEL XR is a once-daily tablet approved in adults for (1) add-on treatment to an antidepressant for patients with major depressive disorder (MDD) who did not have an adequate response to antidepressant therapy; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar disorder alone or with lithium or divalproex; (4) long-term treatment of bipolar disorder with lithium or divalproex; and (5) schizophrenia. Click here to see the Prescribing Information for SEROQUEL XR, including Boxed WARNINGS. Click here to see the Medication Guide for SEROQUEL XR. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088. The information on this Web site should not take the place of talking with your doctor or health care professional. If you have any questions about your condition, or if you would like more information about SEROQUEL XR, talk to your doctor or pharmacist. Only you and your health care professional can decide if SEROQUEL XR is right for you. Patient photos are intended to be representative of typical patients with bipolar disorder and are not of actual patients. SEROQUEL XR is a registered trademark of the AstraZeneca group of companies. Some things to consider about SEROQUEL XR for bipolar depression SEROQUEL XR is FDA approved to specifically treat the depressive moods of bipolar disorder (known as bipolar depression) In a clinical trial, people who took SEROQUEL XR experienced an improvement in bipolar depression SEROQUEL XR can help treat the symptoms of bipolar depression SEROQUEL XR is proven to effectively work alone to treat three of the episodes of bipolar disorder—mania (highs), mixed (highs and lows), and depression (lows) —for the short term SEROQUEL XR is also approved for long-term maintenance treatment of bipolar disorder when added to lithium or divalproex SEROQUEL XR is convenient. For many with bipolar depression, SEROQUEL XR is one pill, once a day SEROQUEL XR has potential side effects—learn more about side effects Qualified patients may be able to start saving on their SEROQUEL XR prescriptions. If you are eligible, you could get monthly savings on out-of-pocket costs over $25.* Be sure to read the eligibility requirements