Privacy Statement
ASTRAZENECA PRIVACY STATEMENT
LAST UPDATED: July 08, 2008
- Introduction
- Collection of Information
- Security
- Cookies
- Advertising
- Minors
- Tell A Friend
- Links
- Contact Us
Introduction
AstraZeneca respects that the privacy of your personal information is important to you. We have developed this privacy statement to let you know how the Information (as defined below) that we collect about you will be maintained and used. We may change this statement from time to time so we ask that you revisit this privacy statement to be sure that you are familiar with our current policies because the revised policy will apply to you. In the event we make any changes to this privacy statement we will post the revised policy on this web site together with the date on which we made the most recent changes.
If you are a physician or other health care professional, this statement only applies to Information collected online through this web site, other AstraZeneca web sites, or where we specifically say that this policy shall apply.
Collection of Information
AstraZeneca may collect personally identifiable information about you, such as name, address, telephone number, e-mail address, date of birth, or other similar information ("Information") when you voluntarily submit it to us or when you give permission to others to share such Information with us. Your Information may be used to fulfill your request for information, to send you health-related materials, to develop products, services and programs that you may find useful, to provide access to your account information, or to contact you. If you do provide Information to us, you agree that we may contact you through a variety of methods including postal mail, e-mail and telephone. From time to time we may also request that you provide us with additional demographic, or other health information through responses to questions or surveys, or through use of search functions or other forms of feedback that we may use to serve you better. Except as specifically provided in this privacy statement, AstraZeneca will not transfer, sell or rent Information to anyone without your consent. We may share your information with other AstraZeneca companies worldwide or with our co-promotion partners. We may occasionally transfer or share your Information with third parties who perform certain services on our behalf. Such third parties have agreed that they will only use the Information on behalf of AstraZeneca. All Information that we transfer or share will be used and disclosed in a manner consistent with the terms of this privacy statement.
You can visit much of our web site without providing us with Information. However, some areas of the web site may require that you register in order to access specific content, features, interactive tools, or services or participate in a particular activity, such as subscribing to a newsletter or joining a program. You may always choose not to provide the requested Information but you may then not be able to participate in the particular activity.
Through our web sites, AstraZeneca also collects non-personally identifiable information relating to such matters as: the total number of visits to our web sites, the number of visitors to each page of our web sites, the Internet Protocol (IP) addresses of our visitors, and the time spent on our web sites. We use this information to understand how our visitors use our web sites so we can improve the customer experience. We may also use your IP address to help diagnose problems with our servers, and for purposes of system administration. From time to time we may also share non-personally identifiable information with others.
We gather aggregate data about visitors to our web sites for purposes of product development and improvement of our web sites, and also for market analysis. We may provide information from our web sites in aggregate form without personally identifiable information to third parties. Any third party that receives aggregated data must agree not to attempt to re-identify the persons to whom it belongs.
If you contact us to report on your experience, or the experiences of your patient, with the use of our products, we may contact you for follow up information. We may also use the information you provide to submit reports of side effects to government agencies such as the U.S. Food and Drug Administration, or as otherwise required by law or governmental audit.
AstraZeneca reserves the right to share your Information in order to respond to authorized information requests of government authorities, the courts, law enforcement agencies or where required by law, or for corporate audits or to respond to complaints or security threats. Further, in the event we determine for business reasons to reorganize, sell or transfer a product or all or a part of our business, we may share your Information with third parties involved in such transactions, such as actual or prospective purchasers, and other business partners, in which case we will obtain written assurances that the Information will be appropriately protected.
Security
AstraZeneca uses reasonable technical and administrative safeguards to protect Information from unauthorized access, use, loss or destruction. Any Information you provide to us is held on a secured web server (a computer that stores web documents, allowing users to access web pages using web client software) operated by AstraZeneca (or by an agent of AstraZeneca performing services on our behalf). Please be advised that although we have tried to create a secured and reliable site for you, the confidentiality of any Information, or communication or material transmitted over the Internet cannot be guaranteed. We urge you to exercise caution when conveying personally identifiable information over the Internet. When disclosing any personally identifiable information, you should remain mindful that such information might be accessible by the public and, consequently, may be collected and used by others without your consent. You should also recognize that your use of the Internet and this site is solely at your own risk.
Cookies
The use of cookies is now standard, and you will find them used by most major web sites. A cookie is a text file stored on a user's computer hard drive containing information about the user. Cookies are used for a variety of purposes, including to help you log into parts of our web sites, to enable us to track the interests of our users to enhance their experience on this site, for market research purposes, and to deliver content specific to a user's interests. We will place a cookie in the web browser (e.g., Internet Explorer) file of your computer when you visit our site; we or an independent advertising company or other contractor whom we engage may also from time to time deliver a uniquely-numbered cookie to your web browser through an e-mail if you have opted-in to receive e-mail from AstraZeneca. You may delete or decline the cookie using the tools in your web browser, and you may still use our site; however, some parts of our site may not work properly for you.
Advertising
We sometimes use independent advertising companies to provide ads on our behalf across the Internet ("advertising company"). These advertising companies also help us analyze our advertising campaigns and the general usage patterns of visitors to our web sites. This is primarily accomplished through the use of cookies, and Internet tags (such as action tags, web beacons, pixel tags, clear GIF (Graphics Interchange Format) images and invisible GIFs). Such companies may place these tags on our web sites or on other web sites. Used in conjunction with cookies, Internet tags are programmed by the advertising company to collect certain non-personally identifiable information about visitors to our web site and other web sites. This information may be used to provide ads about goods and services of potential interest to you, or to improve your web site experience. The advertising company does not know the names, addresses, e-mail addresses or telephone numbers of web site visitors, and does not link online actions to an identifiable person. The advertising company reports the non-identifiable data that it collects on our behalf back to us without identifying specific web site visits (other than to our own Web sites). We use this information to improve our web sites and our advertising. In order to deliver more relevant content or advertising, from time to time we may link the information we receive to our customers' Information. If we do link such data, it is treated under this policy as Information as described above under Collection of Information. If you would like more information about this practice, or if you want to prevent an independent advertising company from sending and reading cookies or action tags on your computer, you can visit the advertising company's web site and opt out.
Minors
We do not knowingly collect directly any personal information from anyone under the age of 13, nor do we knowingly market our web sites to anyone under the age of 13.
Tell-A-Friend
On some AstraZeneca sites, you can choose to use a "tell-a-friend" or referral function on our website to let someone else know about an AstraZeneca web site or product. In such a case we will ask for your friend's name and email address, as well as Information about you. The information that you may provide for a friend will be used to send an email on your behalf and will not be collected or stored by AstraZeneca for any additional purpose.
Links
As a convenience to you, AstraZeneca may provide links from this web site to other web sites maintained by independent third parties. This privacy statement applies solely to the information collected on this web site. We are not responsible for the privacy practices of such other sites. We encourage you to be aware when you leave this site and to read the privacy policies of any web site that you may visit.
Contact Us
We welcome your questions and comments regarding this privacy statement and the use of your Information. You may also contact us to update or correct the Information you have provided to us or to opt out of services that you may have previously signed up for. If you have any questions about this privacy statement or about our use of Information, or if you would like to request any changes be made to your Information, please contact the Information Center at AstraZeneca at 800-236-9933.
Indications
SEROQUEL XR is indicated in adults for (1) adjunctive therapy to antidepressants in major depressive disorder; (2) acute depressive episodes in bipolar disorder; (3) acute manic or mixed episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; (4) maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex; and (5) schizophrenia. SEROQUEL is indicated in adults for the treatment of (1) acute depressive episodes in bipolar disorder; (2) acute manic episodes in bipolar I disorder, as either monotherapy or adjunct therapy to lithium or divalproex; (3) maintenance treatment of bipolar I disorder as an adjunct to lithium or divalproex, and (4) schizophrenia. Patients should be periodically reassessed to determine the need for treatment and the appropriate dose.
Important Safety Information About SEROQUEL XR and SEROQUEL
INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS: Elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk (1.6 to 1.7 times) of death, compared to placebo (4.5% vs 2.6%, respectively). SEROQUEL XR and SEROQUEL are not approved for the treatment of patients with dementia-related psychosis. (See Prescribing Information for complete Boxed Warnings.)
SUICIDALITY AND ANTIDEPRESSANT DRUGS: Antidepressants increased the risk of suicidal thinking and behavior in children, adolescents, and young adults in short-term studies of major depressive disorder and other psychiatric disorders. Patients of all ages started on therapy should be observed closely for clinical worsening, suicidality, or unusual changes in behavior, especially during the initial few months of drug therapy or when changing dose. Families and caregivers should be advised of the need for close observation and communication with the prescriber.
SEROQUEL XR is not approved for use in patients under the age of 18 years. SEROQUEL is not approved for use in patients under the age of 10 years. (See Prescribing Information for complete Boxed Warnings.)
Neuroleptic Malignant Syndrome (NMS): A potentially fatal symptom complex, sometimes referred to as 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. Management should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy, intensive symptomatic treatment, and medical monitoring, and treatment of any concomitant serious medical problems.
Hyperglycemia and Diabetes Mellitus: 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. Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. In some cases, hyperglycemia has resolved when the atypical antipsychotic was discontinued; however, some patients required continuation of antidiabetic treatment despite discontinuation of the suspect drug.
Hyperlipidemia: Undesirable alterations in lipids have been observed with quetiapine use. Increases in total cholesterol, LDL-cholesterol and triglycerides, and decreases in HDL-cholesterol have been reported in clinical trials. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of and periodically during treatment.
Weight Gain: Increases in weight have been observed in clinical trials. Patients receiving quetiapine should receive regular monitoring of weight.
In some patients, a worsening of more than one of the metabolic parameters of weight, blood glucose, and lipids was observed in clinical studies. Changes in these parameters should be managed as clinically appropriate.
Tardive Dyskinesia (TD): 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. Although much less commonly, TD can develop after relatively brief treatment periods at low doses or even after treatment discontinuation. 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, and discontinuation should be considered if signs and symptoms of TD occur.
Orthostatic Hypotension: Quetiapine may induce orthostatic hypotension with associated dizziness, tachycardia, and syncope, especially during the initial dose titration period and should be used with caution in patients predisposed to hypotension or with known cardiovascular or cerebrovascular disease.
Leukopenia, Neutropenia, and Agranulocytosis: 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, quetiapine should be discontinued at the first sign of a decline in WBC absent other causative factors. Patients with neutropenia should be carefully monitored, and quetiapine should be discontinued in any patient if the absolute neutrophil count is <1000/mm3.
Cataracts: 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.
QT Prolongation: Postmarketing cases show increases in QT interval in patients who overdosed on quetiapine, in patients with concomitant illness, and in patients taking medicines known to cause electrolyte imbalance or increase the QT interval. Avoid use with drugs that increase the QT interval and in patients with risk factors for prolonged QT interval.
Seizures: Quetiapine should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, eg, Alzheimer’s dementia.
Potential for Cognitive and Motor Impairment: Since quetiapine has the potential to impair judgment, thinking, or motor skills, patients should be cautioned about performing activities requiring mental alertness, such as operating a motor vehicle or operating hazardous machinery, until they are reasonably certain that quetiapine therapy does not affect them adversely.
Body Temperature Regulation: Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotics. Appropriate care is advised for patients who may exercise strenuously, be exposed to extreme heat, receive concomitant medication with anticholinergic activity, or be subject to dehydration.
Dysphagia: Esophageal dysmotility and aspiration have been associated with antipsychotic drug use. Use caution in patients at risk for aspiration pneumonia. Aspiration pneumonia is a common cause of morbidity and mortality in elderly patients, in particular those with advanced Alzheimer's dementia.
Suicide: The possibility of a suicide attempt is inherent in schizophrenia, bipolar disorder, and depression, and close supervision of high risk patients should accompany drug therapy.
Warnings and Precautions Also Include: The risk of hypothyroidism, hyperprolactinemia, transaminase elevations, priapism, and withdrawal.
Common Adverse Reactions: The most commonly observed adverse reactions (incidence ≥ 5% and twice placebo) associated with the use of SEROQUEL XR versus placebo in clinical trials for all indications were somnolence (25%-52% vs 9%-13%), dry mouth (12%-40% vs 1%-8%), constipation (6%-11% vs 3%-6%), dizziness (10%-13% vs 4%-11%), increased appetite (2%-12% vs 0%-6%), dyspepsia (2%-7% vs 1%-4%), weight gain (3%-7% vs 0%-1%), fatigue (3%-14% vs 2%-4%), dysarthria (1%-5% vs 0%), and nasal congestion (2%-5% vs 1%). The most commonly reported adverse reactions associated with the use of SEROQUEL vs placebo in adults in clinical trials for all indications were somnolence (18%-57% vs 8%-15%), dry mouth (9%-44% vs 3%-13%), dizziness (9%-18% vs 5%-7%), constipation (8%-10% vs 3%-5%), asthenia (2%-10% vs 1%-4%), abdominal pain (4%-7% vs 1%-3%), postural hypotension (4%-7% vs 1%-3%), pharyngitis (4%-6% vs 3%), weight gain (4%-6% vs 1%-3%), lethargy (5% vs 2%), ALT increased (5% vs 1%) and dyspepsia (4%-7% vs 1%-4%).
Please see Full Prescribing Information for SEROQUEL XR 
and SEROQUEL , including Boxed Warnings.
This product information is intended for US health care professionals only.
