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From: GlaxoSmithKline                                         02/04

New FDA-Approved Indication

GlaxoSMithKline is Excited to announce the US Food and Drug Administration's (FDA) approval of Lamictal (lamotrigine) Tablets for the maintenance treatment of adults with bipolar I disorder to delay the time to occurrence of mood episodes (depression, mania, hypomania, mixed episodes) in patients treated for acute mood episodes with standard therapy. Additionally, the FDA has noted that findings for Lamictal were more robust in bipolar depression-one of the most significant medical needs in the treatment of this devastating illness. The effectiveness of Lamictal in the acute treatment of mood episodes has not been established. The effectiveness of Lamictal as maintenance treatment was established in 2 placebo-controlled trials of 18 months' duration. Lamictal is the first FDA-approved therapy since lithium for the long-term maintenance of bipolar I disorder.

The new indication for bipolar I disorder expands the clinical usefulness of lamictal beyond the treatment of epilepsy. Should you or your customers have any questions about Lamictal, or if you would like a free copy of the Lamictal for Bipolar Disorder Informational Booklet for patients, please contact the GlaxoSmithKilne Customer Response Center at 1-888-825-5249. For more information about Lamictal, log on to www.lamictal.com

Lamictal has been available in the US since 1994. It is available in more than 90 countries and has more than 5 million patient exposures worldwide

Lamictal also is indicated as adjunctive therapy for partial seizures in adults and pediatric patients(> 2 years of age); as adjunctive therapy for the generalized seizures of Lennox-Gastraut syndrome (LGS) in adult and pediatric patients (> 2 years of age); and for conversion to monotherapy in adults with partial seizures who are receiving treatment with a single enzyme-inducing antiepileptic drug.

In the treatment of epilepsy, the safety and effectiveness of Lamictal have not been established 1) as initial monotherapy, 2) for conversion to monotherapy from non-enzyme-inducing antiepileptic drugs (eg, valproate), or 3) for simultaneous conversion to monotherapy from 2 or more concomitant AEDs). Safety and effectiveness in patients below the age of 16, other than those with partial seizures and the generalized seizures of LGS, have not been established.

Help Prevent Dispensing Errors

Pharmacists are more aware of the importance of correctly dispensing prescriptions than anyone, and no one is in a better position to help ensure that all patients receive the treatment they need.

Important Dispensing Information

Dispensing errors have occurred involving Lamictal. Your assistance is requested in clearly communicating oral and written prescriptions to help avoid dispensing errors. Please alert patients for whom you are dispensing these medications that they should carefully check the medication they receive and promptly bring any questions or concerns to your attention.

Important Note: Dispensing errors have occurred between Lamictal and other medications, most commonly Lamisil, lamivudine, Ludiomil, labetalol, and Lomotil.  Patients who do not receive Lamictal would be inadequately treated and could experience serious consequences. Conversely, patients erroneously receiving Lamictal, especially high initial doses, would be unnecessarily subjected to serious side effects.

If you become aware of a prescription dispensing error involving Lamictal, please contact GlaxoSmithKline at 1-800-334-4135; the USP Medication Errors Reporting Program at 1-800-233-7767; or the US Food and Drug Administration's MedWatch program at 1-800-FDA-1088.

Important Safety Information

Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of Lamictal, some of which have included Stevens-Johnson syndrome. In clinical trials of bipolar and other mood disorders, incidence of these rashes was 0.08% (0.8/1000) in adult patients receiving Lamictal as initial monotherapy and 0.13% (1.3/1000) in adults on adjunctive therapy for epilepsy. For further safety information on the increased risk of serious rash in pediatric patients with epilepsy, please see full Prescribing information.

In a prospectively followed cohort of 1,983 pediatric patients with epilepsy taking adjunctive Lamictal, there was one rash-related death. In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis (TEN) and/or rash-related death have been reported, but their numbers are too few to permit a precise estimate of the rate.

Lamictal ordinarily should be discontinued at the first sign of rash, unless the rash is clearly not drug-related.

The risk of nonserious rash is increased when the recommended initial dose and/or the rate of dose escalation of Lamictal is exceeded. There are suggestions, yet to be proven, that the risk of severe, potentially life-threatening rash may be increased by 1) coadministration of Lamictal with valproic acid; 2) exceeding the recommended initial dose of Lamictal; or 3) exceeding dose escalation of Lamictal. However, cases have been reported in the absence of these factors. Therefore, it is important that the dosing recommendations be followed closely.

Please consult accompanying complete Prescribing information for Lamictal.


Robert A. Leadbetter, MD

Senior Director, Therapeutic Area of Bipolar Disorder and Schizophrenia

Clinical Development and Medical Affairs



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From: TAP PHARMACEUTICAL PRODUCTS INC.                                                02/23/04


                    - First Combination pack of Its Kind Provides New Option-          

        LAKE FOREST, Ill., November 19, 2003 - TAP Pharmaceutica Products Inc. today announced that the U.S. Food and Drug Administration (FDA) approved PREVACID NapraPAC (lansoprazole delayed-release capsules and naproxen tablets kit), a first of its kind combination package containing two widely used medications in one prescription.  PREVACID NapraPAC contains the nonsteroidal anti-inflammatory drug (NSAID) NAPROSYN (naproxen tablets) and the acid suppressor PREVACID (lansoprazole), the most prescribed* proton-pump inhibitor(PPI) in the U.S., in one convenient package.  PREVACID NapraPAC is indicated for reducing the risk of NSAID-associated gastric ulcers in patients with a history of a documented gastric ulcer that require the use of an NSAID for treatment of the signs and symptoms of rheumatoid arthritis, osteoarthritis and ankylosing spondylitis.  Controlled studies did not extend beyond 12 weeks.

         It is estimated that 20 million people in the United States have osteorathritis (OA) and 2.1 million adults have rheumatoid arthritis (RA).  NSAIDs are commonly prescribed for the relief of pain and inflammation in these patients.  In fact, NSAIDs are the most prescribed class of medicines in the world.

          "NAPROSYN, like most NSAIDs, is vbery effective at relieving pain associated with arthritis, but it has been recognized as being associated with serious gastrointestinal side effects, like stomach ulcers," said A. Mark Fendrick, M.D., associate professor of Internal Medicine in the School of Medicine at the University of M8ichigan Health System.  "PREVACID NapraPAC represents an easy-to-use option in one prescription for arthritis patients who must take anti-inflammatory agents to relieve their pain, but who also need to reduce the risk of reccurrence of stomach ulcers."

NSAID Toxicity and Ulcer Risk                                                                                                                                                                                        NSAIDs can cause ulcers by interfering with the stomach's ability to protect itself from gastric irritants, such as acid.  Gastric ulcers are round or oval sores where the lining of the stomach has been eaten away by stomach acid and digestive juices.  NSAIDs, such as aspirin and naproxen, can irritate the stomach lining and can cause ulcers.

        In the United States, it is estimated that 14 million people take an NSAID on a daily basis.  Approximately 100,000 patients are hospitalized and between 10,000-20-000 patients die each year from NSAID-related ulcer complications.  The risk of NSAID-induced GI events is increased two- to four-fold in patients with a history of prior ulcer disease or complications.  This is the most significant rist factor for NSAID-induced complications.

PREVACID Shown to Reduce the Risk of Recurrent Gastric Ulcers                                                                                          

A multi-center. dpib;e-blind placebo- and misoprostol-controlled study examined more than 500 patients who required chronic use of NSAIDs and who had a history of a documented gastric ulcer.  Patients were randomized to received 15 mg or 30 mg PREVACID once daily, 200 mcg misoprostol four times a day or placevo for 12 weeks.  Data from this study demonstrated that significantly more patients remained ulcer free with PREVACID compared to placebo.  In fact, after 12 weeks of the study, 80 percent of patients on  PREVACID 15 mg, 82 percent on PREVACID 30 mg, and 93 percent on misoprostol 200 mcg remained ulcer free compared to only 51 percent taking placebo.

        Futhermore, in a dubset analysis of study data from 119 patients, 89 percent of patients taking PREVACID 15 mg plus naproxen, with or without aspirin, remained free of recurrent stomach ulcers after 12 week versus 83 percent of patients taking misoprostol and 33 percent taking placebo plus naproxen.  Conconitant aspirinwas used in 15 percent of patients.

About PRAVACID Napra PAC                                                                                                                   PREVACID NapraPAC is available as a daily dose of one PREVACID 15 mg delayed release capsule and two NAPROSYN tablets of either 375mg or 500 mg.  NAPROSYN is an NSAID with analgesic and antipyretic properties that has been prescribed for over 25 years for relief from pain associated with conditions such as rheumatoid arthritis, osteoarthritis, and ankylosing spondylitis.

       A monthly course of PREVACID NapraPAC is conveniently supplied in weekly blister cards.  The easy-to-use blister card indicates which pills to take on which days, an important convenience for patients.  PREVACID NaPraPAC opens easily, and provides simple and clear directions.  The package also meets the Consumer product Safety Commision's criteria for child-resistance.

        PREVACID NapraPAC is contraindicated in patients with known hypersensitivity to any component of the formulations of lansoprazole or naproxen. 

         Naproxen is also contraindicated in patients in whom aspirin or other NSAIDs/analgesic drugs induce the syndrome of asthma, rhinitis, and nasal polyps.  Both types of reactions have the potential of being fatal.  Other naproxen-containg products should not be used concomitantly.

          Serious GI toxicity such as bleeding, ulceration, and perforation can occur with or without warning symptoms with chronic NSAID therapy.

        In the risk-reduction study of PREVACID for NSAID-associated ulcers, the incidence of diarrhea  was 5% and 3% for the PREVACID  and the placebo groups, respectively.  Symptomatic response to PREVACID does  not preclude the presence of gastric malignancy.

        For further importand information on PREVACID NapraPAC, please see the complete prescribing information, log onto www.prevacid.com/naprapac/pi or call 800-622-2011.

About TAP Pharmaceutical Products Inc.

         TAP Pharmaceutical Products Inc., located in Lake Forest, Ill., is a joint e\venture between Abbott Laboratories, headquartered in Abbott Park, Ill., and Takeda Chemical Industries, Ltd., of Osaka, Japan.  TAP also markets Lupron Depot (leuprolide acetate for depot suspension).                                                              

          For more information on  TAP Pharmaceutical Products Inc. and its products, wisit the company's web site at www.tap.com.


NAPROSYN and NapraPAC are trademakes of Syntex Pharmaceuticals International, Limited.

*IMS HEALTH, National Prescription Audit Plus 7 Weekly, November 2003.



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