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From: Alpharma

January 8, 2004

Pharmacists:

We would like to inform you that we have received a number of complaints, mostly from patients, that Purepac's Lorazepam Tablets have crumbled during storage. Our investigation has shown that this may be caused by the use of a well-closed container when dispensing this product. It is important that our Lorazepam Tablets be dispensed in a tight, light-resistant container as required by the U.S. Pharmacopeia (USP) and as stated in our product labeling. The reason for this requirement is that well-closed containers are more permeable to moisture than tight containers, and as a result, the tablets may break or crumble when exposed to high humidity. For your reference, specifications for multiple-unit dispensing containers can be found in USP 26, Section<671>.

If you have any questions or require further information, please contact our Medical Affairs Department at 1-800-432-8534.

Sincerely,

Robert Sanzen

Sr. Vice President, Sales and Marketing

As a demonstration of our ongoing commitment to excellence in customer service, Apotex Corp. is pleased to announce that Capital Returns has been selected as our return goods processing agent. Effective July 1, 2004 all Apotex Corp. returns for expired and short-dated product should be sent to Capital Returns, Inc at the following address:

Capital Returns, Inc. CapOne Return Program 4066 North Port Washington Road Milwaukee, WI 53212 Phone: 800-950-5479

All returns will be processed in accordance with updated Apotex Corp's Return Goods Policy, Our updated policy can be found here. Please review the policy in detail and update your records accordingly as changes have been made.

Capital Return's Customer Service Team is available for any questions that you may have on how to return the product. In ordeer to avoid any delays in the processing of your returns, please make sure to include the following information with your return: your complete company name and address, your wholesaler name and address (if applicable), debit memo number and current DEA number and expiration date.

Should you have any questions regarding the status of a return, please call Capital Returns, Inc at 800-950-5479.

Thank you for your valued business.

Source: Apotex Corp

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Fibromyalgia

by: T.S. Gaginella, Ph.D., R.Ph. RPhLink V. P. of Clinical Pharmacy Services

March, 2003

Muscle aches, pains, stiffness and being tired all the time are just part of a stressful lifestyle or of getting older, right? - Wrong! Unfortunately for the over 6 million people who suffer with fibromyalgia this scene is played over and over again, day after day. Fibromyalgia is not a disease in medical terms because its cause is unknown. It is best classified as a syndrome- a collection of sings and symptoms; principally chronic fatigue, widespread muscle soreness,a and pain. Doctors all too often tell patients with symptoms of fibromyalgia that "it's all in your head." New research may be on the brink of reversing this attitude.

Emerging scientific evidence is providing a foundation to help us understand the basis for at least some of the symptoms associated with this syndrome. For example, a recent medical report showed that persons with fibromyalgia have a greater quantity of substance P, a mediator of pain, in their nervous system. These results support the idea that fibromyalgia is not some sort of psychiatric disorder, but that it may involve a fundamental defect in the perception of or the body's response to pain.

The symptom complex we know as fibromyalgia was first reported in the medical literature in the early 1800's. It was previously known as "muscular rheumatism," "fibrocystits," and "neurasthenia." It most often afflicts young to middle-aged women, but men and children are also susceptible to this devastating disorder.

No one knows what causes fibromyalgia. Possibly a viral or bacterial infection, trauma or heredity. However, the abnormalities seem to be primarily associated with changes in brain and nervous system function. In addition to noticing multiple areas of soreness or pain on the body, individuals with fibromyalgia lack energy and are easily fatigued. Attending to what would be normal activities for most people, such as taking a short walk, going to a desk job, grocery shopping or preparing a meal are often exhausting for someone with fibromyalgia. Other common problems are difficulty in remembering things, dizziness, incoordination, hearing loss, and tingling in the arms and legs. Insomnia and depression are frequently associated with fibromyalgia. In many patients there is an increase in the sensitivity of the bladder to pain and irritation. Irritable bowel syndrome ( intestinal cramps with or without diarrhea) also often accompanies fibromyalgia.

Persons with fibromyalgia can easily get frustrated and exasperated; unfortunately physicians are often unsympathetic. In these days of HMOs and Managed Care it is especially difficult for patients to find a doctor who will take the time to properly care for them. Those afflicted are therefore beginning to take more personal responsibility for maximizing their health and controlling their symptoms. Support groups have sprung up throughout the country and are gaining members steadily.

Current treatment for fibromyalgia is mostly by trial and error, using synthetic pharmaceuticals. These drugs - sedatives for sleep, antidepressants, anti-inflammatory drugs and opiate analgesics for pain - have side effects including dry mouth, difficult urination, blurred vision, mental confusion, "hangover" and even addiction. The word is out that certain herbs and nutritional supplements relieve many of the symptoms of fibromyalgia. It is advisable to use nutritional and herbal combinations only after consultation with a pharmacist or another professional knowledgeable in natural medicine. Because of the need to fight fatigue during the day and to deal with the insomnia at night, a two-part regimen makes good sense - a daytime formula to increase one's energy and sense of well-being; plus a nighttime formula to promote sleep. Both of these formulas should contain ingredients to reduce pain and muscle spasms.

Education about fibromyalgia, diligence in maintaining appropriate physical therapy and a well-designed regimen of nutritional supplements, provide hope for relief from fibromyalgia.

Over the Counter by Dr. Gaginella

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From: Reliant Pharmaceuticals                                                 03/27/04

Important News For Pharmacies---From Reliant Pharmaceuticals

Reliant Pharmaceuticals is now the sole owner and marketer of the RYTHMOL(propafenone HCI) brand family of products in the United States

Reliant Pharmaceuticals is also pleased to announce the availability of RYTHMOL SR (propafenone HCI) extended release capsules BID (every 12 hours)--a new, more convenient formulation of RYTHMOL (propafenone HCI) for patients with atrial fibrillation(AFib). RYTHMOL SR is indicated to prolong the time of recurrence of symptomatic AFib in patients without structural heart disease.

        In clinical trials, RYTHOMOL SR significantly delayed the time to first recurrence of symptomatic AFib, with increased efficacy at each dose.

         Three convenient BID (every 12 hours) dosing options are available:225, 325, or 425 mg capsules. Physicians must titrate for individual patient needs and tolerance. Treatment initiation with new RYTHMOL SR does not require hospitalization and may result in cost savings to the patient. No loading dose is required, and there is no need for ongoing hepatic toxicity monitoring in patients with normal hepatic function.

          Therapy should be initiated with RYTHMOL SR 225 MG bid (every 12 hours). If addition therapeutic effect is needed, dosage may be increased at 5-day intervals9minimum). The switch from RYTHMOL TID to BID dosing does not follow a 1 mg:1 mg conversion rule. For example, patients taking 150 mg propafenone TID (450 mg/day) would be switched to RYTHMOL SR 325mg BID (650 mg/day). Pleade see Pharmacokinetics and Metabolism section of full Prescribing Information.

To ensure maximum knowledge of RYTHMOL SR, Reliant Pharmaceuticals is currently rolling out multifaceted programs, including:

Nationwide detailing by a dedicated cardiovascular specialty sales force

Professional education programs designed to reinforce product information

A comprehensive promotional campaign

Because we expect this marketing effort to create a surge in demand for RYTHMOL SR, we are encouraging pharmacists to contact their wholesalers in order to ensure that ample supplies are available for prescription fulfillment. To assist you in ordering RYTHMOL SR, we have enclosed a fact sheet with product/packaging specifications and ordering/pricing information.

           Reliant Pharmaceuticals is committed to maintaining a position partnership with our customers and we promise to prvide you with the best possible service and support. If you would like additional information about RYTHMOL SR and/or our company, please feel free to contact our Customer Service Department at 1-800-475-2140.

Sincerely,

Andrew H. Isaacs

RYTHMOL Family Brand Manager        Reliant Pharmaceuticals

Please see Boxed Warning on reverse side of this letter and enclosed Prescribing Information

Indication

RYTHMOL SR (propafenone HCI) extented release capsules are indicated to prolong the time to recurrence of symptomatic atrial fibrillation in patients without structural heart disease.

The use of RYTHMOL SR in patients with permanent atrial fibrillation or in patients exclusively with atrial flutter or PSVT has not been evaluated. RYTHMOL SR should not be used to control ventricular rate during atrial fibrillation.

The effect of RYTHMOL SR on mortality has not been determined ( see black box WARNINGS).

Important Safety Information                                                                                                                                              WARNINGS                                                                                                                                                                       Mortality:                                                                                                                                                                         In the National Heart, Lung and Blood Institue's Cardiac Arrhythmia Suppression Trial (CAST), a long-term, umlti-center, randomized, double-blind study in patients with asymptomatic non-life-threatening ventricular arrhythmias who had a myocardial infarction more that six days but less than two years previously, an increased rate of death or reversed cardiac arrest rate (7.7%; 56/730) was seen in patients treated with encainide or flecainide (class 1C antiarrhythmics) compared with that seen in patients assigned to placebo (3.0%; 22/725). The average duration of treatment with encainide or flecainide in this study was ten months.

The applicability of the CAST results to other populations (e.g. those without recent myocardial infarction) or other antiarrhythmic drugs is uncertain, but at present it is prudent to consider any 1C antiarrhythmic to have a significant rist in patients with structural heart disease. Given the lack of any evidence that these drugs improve survival, antiarrghthmic agents should generally be avoided in patients with non-life-threatening ventricular arrhythmias, even if the patients are experienceing unpleasant, but not life-threatening, symptoms or signs.

The most commonly reported adverse events in the trial included dizziness, chest pain, palpitations, taste disturbance, dyspnea, nausea, constipation, anxiety, fatigue, upper respiratior tract infection, influenza, first degree heart block and vomiting.

References: 1. RYTHMOL SR Prescribing Information, Reliant Pharmaceuticals. 2. Pritchet ED, Page RL, Carlson M, Undesser K. Fava G, for the Tythmol Atrial Fibrillation Trial (RAFT) Investigators, Efficacy and safety of sustained-rease propafenone SR) for patients with atrial fibrillation. Am J. Carfiol, 2009-92-946.3. Meinerftz T. Lip GYH, Lombardi Fet al. on behalf of the ERAFT Investigators Efficacy and safety of propafenone sustained release in the prophylaxis of sympthomatic paroxysmal atrial fibrillation (The European Rythmol/Rytmonrm Atrial Fibrillation Trial [ERAFT] Study) Am J Cardiol 2002;90:1300-1306.

Reliant Pharmaceuticals january 2004   RYTH-2001

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