From:  LILLY

May 2002

Dear Pharmacy Professional,

We would like to bring to your attention a situation involving tampering with Zyprexa® (olanzapine), indicated for the treatment of schizophrenia and acute bipolar mania.  Lilly has been made aware of a small number of tampering incidents in which pharmacists in the United States have found Zyprexa 10 and 15 mg bottles which have had all of the Zyprexa tablets removed and replaced with white tablets marked, "aspirin."  The reports, thus far, have been confined to 60 count 10 mg and 15 mg bottles of Zyprexa.  We have been in contact with the United States Food and Drug Administration and are continuing together additional information through a diligent investigation of this situation.

From what we know at this time, these incidents appear to be isolated and limited in scope and no injuries or adverse effects related to the tampering have been reported to date.

Zyprexa 10 mg tablets are round and white, similar to aspirin; however, they are clearly marked in blue with the word, "Lilly" and the number, "4117" on one side, and no markings on the other side.  Zyprexa 15 mg tablets are oval-shaped and blue and are embossed with the word, "Lilly" and the number, "4415."  If you discover a bottle of Zyprexa that contains white tablets marked "aspirin," or any markings other than "Lilly" and the four-digit Lilly identification number, please notify NNC Group at 1-800-668-4391.

At Lilly, patient safety is our first priority.  We appreciate your assistance in helping us to resolve this matter as quickly as possible.  Lilly and the United States Food and Drug Administration are investigating this matter.  Lilly is taking all possible steps to protect the quality and integrity of its products.  If you have any additional questions, please contact us at 1-800-LILLY-RX.

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September, 2002

From: Abbott Pharmaceuticals

Dear Pharmacist:

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 is readily available in bottles and pacs.

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 with Biaxin XL than Biaxin.

An improvement over Biaxin tablets, Biaxin XL offers patients convenient QD dosing and a short course 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 catarrhales, or S pneumoniae; community-acquired pneumonia due to H influenzae, H parainfluenzae, M catarrhalis, S pneumoniae, 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 know hypersensitivity to clarithromycin or any macrolide antibiotic.

Clarithromycin may elevate digoxin serum concentrations.  Serum digoxin concentrations should be carefully monitored while digoxin and clarithrymycin 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.

Sincerely,

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