June 2002

From: AdvancePCS

Novartis Pharmaceuticals Corporation has issued a letter to notify health care professionals of the association of myocarditis with Clozaril® (clozpine) therapy.  Clozaril is used for the management of severely ill schizophrenic patients who fail to respond adequately to standard drug treatment for schizophrenia.

The U.S. Food and Drug Administration and Novartis Pharmaceuticals Corporation have strengthened the Boxed Warning and Warnings sections of the product labeling for Clozaril as follows: (1) The previously existing Boxed Warning has been relocated to the beginning of the product labeling and revised to advise health care providers of the association of myocarditis with clozapine therapy; (2) A subsection titled "Myocardits" has been added to the Warnings section to provide data and clozapine treatment guidelines related to this issue.

The following summarizes the information added to the product labeling:

• Analyses of postmarketing safety databases suggest that clozapine is associated with an increased risk of fatal myocarditis, especially during, but not limited to, the first month of therapy.

• The possibility of myocarditis should be considered in patients receiving Clozaril who present with unexplained fatigue, dyspnea, tachypnea, fever, chest pain, palpitations, other signs or symptoms of heart failure, or electrocardiographic findings such as a ST-T wave abnormalities or arhythmias.  Tachycardia, which has been associated with Clozaril treatment, is a reliable predictor of myocarditis.

• Prompt discontinuation of Clozaril treatment is warranted upon suspicion of myocarditis.  Patients with clozapine-related myocarditis should not be rechallenged with Clozaril.

AdvancePCS has communicated this information the physicians identified as having patients who recently filled a prescription for Clozaril.

If you encounter a patient obtaining a prescription for Clozaril, or one that presents the signs or symptoms above, please inform him or her of the revised warnings, and recommend that he or she discuss with the prescribing physician.

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January, 2003

From: Abbott Pharmaceuticals

Please find enclosed some important information regarding Biaxin® XL (clarithromycin extended-release tablets) and its patient benefits - greater tolerability than Biaxin (clarithromycin) tablets and convenient QD dosing.  Biaxin XL prescriptions are written for the Biaxin XL Pac, a convenient 7-day patient pack.

Biaxin XL is widely prescribed by the physician community, with approximately 59% of all new Biaxin/Biaxin XL tablet prescriptions being written for the extended release formulation - Biaxin XL.  Furthermore, nearly 27% of Biaxin XL prescriptions are written for the Biaxin XL Pac, a convenient 7-day patient pack.

Biaxin XL extended release tablets provide patients with greater tolerability vs. Biaxin tablets, the original formulation of Biaxin.  In fact, in clinical trials, patients experienced 67% fewer discontinuations due to GI events or abnormal taste within Biaxin XL than Biaxin.

An improvement over Biaxin tablets, Biaxin XL offers patients convenient QD dosing and a short course of therapy.  Biaxin XL should be prescribed 2 x 500 mg QD for 7 days for the treatment of community-acquired pneumonia and acute bacterial exacerbations of chronic bronchitis and for 14 days for the treatment of acute maxillary sinusitis.

To order Biaxin XL, please order from your usual source or call Abbott customer service at 1-800-255-5162.

Biaxin XL Indications

BIAXIN XL is indicated for mild to moderate infections in adults for the treatment of; acute bacterial exacerbation of chronic bronchitis (ABECB) due to H influenzae, H parainfluenzae, M catarrhalis, or S pneumoniae; community-acquired pneumonia due to H influenzae, H parainfluenzae, M catarrhalis, S pneumonia, C pneumoniae (TWAR), or M pneumoniae and for acute maxillary sinusitis (AMS) due to H influenzae, M catarrhalis, or S pneumoniae.

The efficacy and safety of BIAXIN XL in treating other infections for which other formulations of BIAXIN are approved have not been established.

Common Adverse Events

The most frequently reported adverse events in adults taking BIAXIN XL were diarrhea (6%), abnormal taste (7%), and nausea (3%).  Overall gastrointestinal adverse events were reported by a similar proportion of patients taking either BIAXIN XL or BIAXIN tablets; however patients taking Biaxin XL tablets reported significantly less severe gastrointestinal symptoms compared to patients taking BIAXIN tablets.  In addition, patients taking BIAXIN XL had significantly fewer discontinuations for drug-related gastrointestinal adverse events or abnormal taste compared to BIAXIN tablets.

Other Safety Considerations

Clarithromycin is contraindicated in patients taking cisapride, pimozide, astemizole, or terfenadine due to the potential for cardiac arrhythmias when taken in combination; and in patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic.

Clarithromycin may elevate digoxin serum concentrations.  Serum digoxin concentrations should be carefully monitored while digoxin and clarithromycin are taken concomitantly.

Clarithromycin should not be used in pregnant women except in circumstances for which no alternative therapy is appropriate.

We hope you find these materials to be educational and useful.  If you have any questions regarding Biaxin XL, please call (800) 633-9110.

Please see enclosed full prescribing information.

Sincerely,

Tip Parker, R.Ph.                                                                                                                                Sr. Manager, Trade Relations and National Accounts