DRUG CHANGE!!!

Issued by:
Pfizer Inc.

235 East 42nd Street

New York, NY 10017-5755

212-573-2323


The purpose of this communication is to inform healthcare professionals about a change in the prescribing information for Zoloft ® (sertraline hydrochloride) tablets and oral concentrate. This change, made at the request of the Food and Drug Administration, articulates a pimozide/sertraline interaction and arises from the results of the study entitled, “Phase 1 Open Study Designed to Determine the Potential Interaction of Sertraline With Cisapride or Pimozide in Healthy Male and Female Subjects.”

Based upon these study results, the CONTRAINDICATIONS and PRECAUTIONS sections of the Zoloft prescribing information have been revised as follows (underlined text indicates new text):

CONTRAINDICATIONS
Concomitant use in patients taking monoamine oxidase inhibitors (MAOIs) is contraindicated (see WARNINGS). Concomitant use in patients taking pimozide is contraindicated (see PRECAUTIONS).

PRECAUTIONS—Drug Interactions—CNS Active Drugs
In a study comparing the disposition of intravenously administered diazepam before and after 21 days of dosing with either ZOLOFT (50 to 200 mg/day escalating dose) or placebo, there was a 32% decrease relative to baseline in diazepam clearance for the ZOLOFT group compared to a 19% decrease relative to baseline for the placebo group (p<0.03). There was a 23% increase in Tmax for desmethyldiazepam in the ZOLOFT group compared to a 20% decrease in the placebo group (p<0.03). The clinical significance of these changes is unknown.

In a placebo-controlled trial in normal volunteers, the administration of two doses of ZOLOFT did not significantly alter steady-state lithium levels or the renal clearance of lithium.

Nonetheless, at this time, it is recommended that plasma lithium levels be monitored following initiation of ZOLOFT therapy with appropriate adjustments to the lithium dose.

In a controlled study of a single dose (2 mg) of pimozide, 200 mg sertraline (q.d.) co-administration to steady state was associated with a mean increase in pimozide AUC and Cmax of about 40%, but was not associated with any changes in EKG. Since the highest recommended pimozide dose (10 mg) has not been evaluated in combination with sertraline, the effect on QT interval and PK parameters at doses higher than 2 mg at this time are not known. While the mechanism of this interaction is unknown, due to the narrow therapeutic index of pimozide and due to the interaction noted at a low dose of pimozide, concomitant administration of ZOLOFT and pimozide should be contraindicated (see CONTRAINDICATIONS).

The risk of using ZOLOFT in combination with other CNS active drugs has not been systematically evaluated. Consequently, caution is advised if the concomitant administration of ZOLOFT and such drugs is required.

There is limited controlled experience regarding the optimal timing of switching from other drugs effective in the treatment of major depressive disorder, obsessive-compulsive disorder, panic disorder, posttraumatic stress disorder, and premenstrual dysphoric disorder to ZOLOFT. Care and prudent medical judgment should be exercised when switching, particularly from long-acting agents. The duration of an appropriate washout period which should intervene before switching from one selective serotonin reuptake inhibitor (SSRI) to another has not been established.



Zoloft was launched in 1992 for the treatment of major depressive disorder. It is also approved for the treatment of panic disorder, obsessive-compulsive disorder (OCD), posttraumatic stress disorder (PTSD), and premenstrual dysphoric disorder (PMDD). It has been shown to be safe in the long-term treatment of pediatric OCD. Zoloft is the only SSRI approved for the long-term treatment of PTSD. Over the past decade, Zoloft has been used for more than 10.2 billion patient days of therapy worldwide.*

We trust this information is useful in providing guidance on the appropriate use of sertraline concomitantly with pimozide.

Sincerely,

Cathryn M. Clary, MD

Senior Medical Director

Medical and Scientific Affairs

Pfizer Inc.


*IMS America Global Sales Audits. Dec. 1990-June 2002.

Alderley Park, UK – AstraZeneca has announced that it has submitted an application to the U.S. Food and Drug Administration (FDA) for quetiapine (Seroquel) to be granted a licence for the treatment of acute mania associated with bipolar disorder (manic-depressive illness).

The application to the FDA follows the completion of a comprehensive clinical trial programme in bipolar disorder undertaken by AstraZeneca. The trials examined the efficacy and tolerability of quetiapine in the treatment of acute mania on two levels: as monotherapy (i.e to be prescribed on its own) and as adjunctive therapy with standard mood stabilising medication. These clinical trials have delivered strong and positive results in both the monotherapy and adjunctive therapy studies, which confirm quetiapine to be an ideal first line therapy for the treatment of acute mania associated with bipolar disorder.

"Quetiapine is destined to be an important treatment option for patients suffering from bipolar disorder" commented Dr. Gary Sachs from Harvard Medical School, Boston, and lead investigator on the studies. "Treatment compliance in bipolar disorder is particularly critical since patients may lead full and productive lives when stable while a relapse in symptoms can cause real difficulties. The ability of quetiapine to improve the symptoms of the disease while keeping side effects to a minimum, may improve quality of life and ultimately lead to greater compliance with medication, offering real benefits for patients and their families."

The trial programme consisted of four studies involving almost 1000 patients in 28 countries. The results from one of the adjunctive therapy studies were presented earlier this year at the 3rd European Stanley Foundation Conference in Bipolar Disorder, in Germany1. The results from this trial showed that quetiapine, in combination with standard mood stabilising medication (lithium or divalproex), is significantly more effective at treating the acute mania associated with bipolar disorder than mood stabilisers alone. Importantly, the results also showed that quetiapine in combination with mood stabilisers is well tolerated – a major consideration in the treatment of this disorder. The results from the remaining monotherapy studies will be presented at major psychiatry conferences in 2003.

"We are very pleased with the results of the trial programme and are extremely optimistic about the future for Seroquel. Seroquel is a truly unique compound and its profile is ideal for the treatment of bipolar disorder" commented Geoff Birkett, Global Vice President, CNS, Pain and Infection. "Success in the market is driven by the impact on patients and our vision to introduce therapies that truly change patients' lives for the better. With its expanded indication range, Seroquel will continue to help patients and is the cornerstone of our rapidly growing CNS business."

Seroquel (quetiapine) is manufactured by AstraZeneca and is currently approved in over 75 markets. Seroquel combines broad-based efficacy in the treatment of positive, negative, cognitive and affective symptoms of schizophrenia, while offering excellent tolerability. Seroquel is associated with an incidence of EPS and prolactin elevation no different to placebo across the full dosage range, a favourable weight profile, and no clinically important effects on QT interval. To date, over 4 million people have been treated with Seroquel worldwide.

AstraZeneca is a major international healthcare business engaged in the research, development, manufacture and marketing of prescription pharmaceuticals and the supply of healthcare services. It is one of the top five pharmaceutical companies in the world with healthcare sales of over $16.4 billion and leading positions in sales of gastrointestinal, oncology, anaesthesia (including pain management), cardiovascular, central nervous system (CNS) and respiratory products. In CNS, AstraZeneca is dedicated to providing medicines that offer the potential to change patients' lives. The company already markets Seroquel, one of the fastest growing global antipsychotics with proven efficacy and a very favourable side effect profile; and Zomig, a reliable migraine therapy and a leader in the triptan market. AstraZeneca's R&D pipeline also includes leading approaches for the treatment of depression and anxiety, overactive bladder, dementia and stroke.

We are currently negociating with a hosting web site in order to obtain free web hosting from them. This will be the second attempt that we do to become a real domain in stead of being hosted by Tripod as a subdomain.

The Teens For Teens president, Paolo Velasco, is currently in negociation, updates will be informed to you through this newsletter.

Dutch-speaking President 'T4T Nederland'. We are still looking for someone who is willing to become the president of the Dutch T4T section. Your job would involve the management and coordination of the newly created web site in Dutch. We need young people with a lot of imagination who want to set up a good Dutch support system for other teens.

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