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From: Janssen

March 11, 2004

                                                 urgent notificaion

Dear DURAGESIC Patient:

As a patient who uses DURAGESIC (fentanyl Transdermal system) CII patches, there is important new information about the patch that you need to know.

The problem...                                                                                                                                                                                                     You may have heard recent news reports that a specific lot of DURAGESIC 75mcg/hr patches were recalled by Janssen Pharmaceutical Products, L.P.The reason for this recall was that a small percentage of patches in this lot had a potential leak along one edge of the patch, which could allow some of the medication inside the patch to leak out.

This problem has been seen, rarely, in other lots of Duragesic, and Jenseen has taken immediate steps to correct it. However, you should be alert to the rare possibility of receiving a patch with a leak. You should follow the updated DURAGESIC handling and applicatio instructions, which are described below.

The DURAGESIC patch contains a strong narcotic medication in the form of a gel. When used normally, the medication inside the patch is slowly delivered into the skin through the adhesive side of the patch. If the medication leaks from the patch, patients can get either too much or too little medication. If medication gets in a patient's mouth or eyes, he or she may be exposed to too much medication. This overexposure may cause nausea, sedation, drowsiness, or potentially life-threatening complications. If the medication leaks out of the patch, there may not be enough to provide adequate pain control and the patient may experience withdrawal symptoms. These include sweating, sleeplessness, and abdominal discomfort.

All new patients            What you should do...

If you should ever come in contact with the gel by mistake, you should know what to do to be safe

If you observe moisture or gel in the pouch containing a DURAGESIC patch, do not use it and call your pharmacist or physician for instructions.

Remember: do not touch the gel.

If you do have uninteded contact with the gel, either because you touched the sticky side of the patch or because of a leak or tear in the patch, immediately wash the affected area with large amounts of water only.

if you still have concerns once you have thoroughly washed the affected area, speak with your pharmacist or physician for further instructions.

For more information about safely applying and using DURAGESIC, speak with your doctor, pharmaxist, or visit www.duragesic.com, where you can find important safety information, illustrations showing how to apply the patch, and answers to frequently asked questions.

If you have any questions or concerns about using the DURAGESIC patch, please call the Janssen Contact Center at 1-800-JANSSEN (1-800-526-7736).

Sincerely,

November, 2002

From: Aventis Pharmaceuticals

Nasacort Nasal Inhaler, a leading metered-dose aerosol corticosteroid, is still available for seasonal and perennial allergic rhinitis patients

If the aerosol corticosteroid prescribed by a physician is no longer available to you, consider substituting it with Nasacort Nasal Inhaler.

Nasacort is:

The only leading intranasal corticosteroid still available as a metered-dose aerosol as well as an aqueous spray
Indicated for the treatment of seasonal and perennial allergic rhinitis in adults and children ages 6 and older
Fast and effective, decreasing symptoms of allergic rhinitis in as soon as 12 hours

For additional information on Nasacort Nasal Inhaler, please visit www.nasacort.com. It's soon to be the only leading intranasal corticosteroid prescription you will be able to fill in aerosol formulation.

Sincerely, The Nasacort Team

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January, 2003

From: Wyeth Consumer Healthcare

Five Good Reasons to Recommend Centrum Daily

Many people do not get enough of the vitamins and minerals they need from diet alone
A recent report in a leading medical journal recognizes the link between vitamins and the reduced risk of chronic diseases, and recommends that all adults take one multivitamin daily
Centrum® is a complete multivitamin/mineral supplement, and provides important antioxidants including lycopene and lutein
Centrum® incorporates the latest advances in nutrition. With Centrum®, people can be sure they're always getting the most up-to-date nutritional support
In order to keep up with the latest scientific research, the makers of Centrum® have reduced the Vitamin A content of Centrum® and Centrum Silver® to 3500 IUs per tablet

Why Lycopene?

Lycopene is an antioxidant found in tomatoes and tomato-based products.

Emerging science suggests that lycopene is one of the ingredients found in tomatoes that may play a role in helping to reduce the risk of heart disease.

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February 2003 Amnesteem From: Bertek Pharmaceuticals

IMPORTANT AMNESTEEM (ISOTRETINOIN) DISPENSING INFORMATION FOR ALL PHARMACISTS

A few weeks ago, an Amnesteem shelf hanger was sent to your via Pharm/alert. This document has been revised and should be replaced with the enclosed shelf hanger.

The bullet point, "MUST have been written within past 7 days (female patients only)" has been revised.

The revision deletes the phrase "(female patients only)."

Prescriptions for both males and females must have been written within the past 7 days.

As a reminder:

The qualification date on the yellow sticker is for female patients only and refers to the date of the confirmatory negative pregnancy test. Prescriptions for female patients must be filled within 7 days of the qualification date written on the yellow sticker.

Prescriptions for male patients do not require a qualification date on the yellow sticker, and must be filled within 7 days of the date the prescription was written. The qualification date for the male patient is the date on the prescription.

Please replace the previous shelf hanger with the enclosed revised version dated January 2003.

Sincerely,

James H. Sherry, MD, PhD Vice President, Clinical Research

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From: Ortho McNeil Re: Topamax 12-2003

Important Drug Warning

The Prescribing information for Topamax (topiramate/topiramate capsules) Tablets/Sprinkle Capsules has been revised to include a warning that TOPAMAX causes hypercloremic, non-anion gap metabolic acidosis (decreased serum bicarbonate). TOPAMAX is approved and marketed for the adjunctive treatment of partial-onset seizures, generalized tonic-clonic seizures associated with the Lennox-Gastaut syndrome in adults and children two years of age and older.

Data on hyperchloremic, non-anion gap metabolic acidosis are derived from placebo-controlled trials and post-marketing experience in over 2.5 million patients. In clinical trials, the rate of occurrence of a persistently decreased serum bicarbonate ranges from 23-67% for patients treated with topiramate and 1-10% for placebo. The incidence of markedly low serum bicarbonate in clinical trials ranges from 3-11% for topiramate and 1 to <1% for placebo.

Generally, decreases in serum bicarbonate occur soon after initiation of topiramate, although they can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate, with an average decrease of 4mEQ/L at daily doses of 400 mg in adults and approximately 6 mg/kg/day in pediatric patients. Rarely, patients can experience decrements to values below 10 mEq/L.

Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate.

Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such s fatigue and anorexia, or more sever sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as rickets in pediatric patients) and/or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated.

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face of persistent acidosis, alkali treatment should be considered.

The following has been added to TOPAMAX prescribing information.

Under WARNINGS

Metabolic Acidosis

Hyperchloremic, non-anion gap, metabolic acidosis (i.e., decreased serum bicarbonate below the normal reference range in the absence of chronic respiratory alkalosis) is associated with topiramate treatment. This metabolic acidosis is caused by renal bicarbonate loss due to the inhibitory effect of topiramate on carbonic anhydrase. Such electrolyte imbalance has been observed with the use of topiramate in placebo-controlled clinical trials and in the post-marketing period. Generally, topiramate-induced metabolic acidosis occurs early in the treatment although cases can occur at any time during treatment. Bicarbonate decrements are usually mild-moderate (average decrease of 4mEq/L at daily doses of 400 mg in adults and at approximately 6 mg/kg/day in pediatric patients); rarely, patients can experience severe decrements to values below 10mEq/L. Conditions or therapies that predispose to acidosis (such as renal disease, severe respiratory disorders, status epilepticus, diarrhea, surgery, ketogenic diet, or drugs) may be additive to the bicarbonate lowering effects of topiramate.

In adults, the incidence of persistent treatment-emergent decreases in serum bicarbonate (levels of <20 mEq/L at two consecutive visits or at the final visit) in controlled clinical trials for adjunctive treatment of epilepsy was 32% for 400 mg/day, and !% for placebo. Metabolic acidosis has been observed at doses as low as 50 mg/day. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5 mEq/L decrease from pretreatment) in these trials was 3% for 400 mg/day, and 0% for placebo. Serum bicarbonate levels have not been systematically evaluated at daily doses greater than 400 mg/day.

In pediatric patients (<16 years of age), the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adjunctive treatment of Lennox-Gastaut Syndrome or refractory partial onset seizures was 67% for TOPAMAX (at approximately 6 mg/kg/day), and 10% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value <17mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for TOPAMAX and 0% for placebo. Cases of moderately severe metabolic acidosis have been reported in patients as young as 5 months old, especially at daily doses above 5 mg/kg/day.

Although not approved for the prophylaxis of migraine, the incidence of persistent treatment-emergent decreases in serum bicarbonate in placebo-controlled trials for adults for prophylaxis of migraine was 44% for 200 mg/day, 39% for 100 mg/day, 23% for 50 mg/day, and 7% for placebo. The incidence of a markedly abnormally low serum bicarbonate (i.e., absolute value<17 mEq/L and >5mEq/L decrease from pretreatment) in these trials was 11% for 200 mg/day, 9% for 100 mg/day, 2% for 50 mg/day, and 1% for placebo.

Some manifestations of acute or chronic metabolic acidosis may include hyperventilation, nonspecific symptoms such as fatigue and anorexia, or more severe sequelae including cardiac arrhythmias or stupor. Chronic, untreated metabolic acidosis may increase the risk for nephrolithiasis or nephrocalcinosis, and may also result in osteomalacia (referred to as Rickets in pediatric patients) and / or osteoporosis with an increased risk for fractures. Chronic metabolic acidosis in pediatric patients may also reduce growth rates. A reduction in growth rates may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone related sequelae has not been systematically investigated.

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended. If metabolic acidosis develops and persists, consideration should be given to reducing the dose or discontinuing topiramate (using dose tapering). If the decision is made to continue patients on topiramate in the face or persistent acidosis, alkali treatment should be considered.

Under Precautions:

Laboratory Tests

Measurement of baseline and periodic serum bicarbonate during topiramate treatment is recommended ( see WARNINGS).

Pediatric Use:

Safety and effectiveness in patients below the age of 2 years have not been established. Topiramate is associated with metabolic acidosis. Chronic untreated metabolic acidosis in pediatric patients may cause osteomalacia (rickets) and may reduce growth rates. A reduction in growth rate may eventually decrease the maximal height achieved. The effect of topiramate on growth and bone-related sequelae has not been systematically investigated (see Warnings).

Under OVERDOSE:

Topiramate overdose has resulted in severe metabolic acidosis (see WARNINGS).

You can further our understanding of adverse events by reporting all cases to Ortho-McNeil at the contact numbers listed below or to the FDA MedWatch Program by phone (1-800 FDA 1088), by fax (1-800-FDA-0178, by mail (using postage paid form to MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787) or via www.accessdata.fda.gov/scripts//medwatch/.

A copy of the full Prescribing Information is enclosed for your reference. If you have any questions regarding TOPOMAX tablets and TOPOMAX Sprinkle Caplets, please feel free to call Ortho-McNeil Medical Affairs Division at 1-800-682-6532

Sincerely,

Joseph Hulihan, MD

Group Director, CNS Research

^{Ortho-McNeil
Pharmaceutical}^{,
Inc. 1000 Route 202, PO Box 300 Raritan, NJ
08869-0602 908-218-6000 Telephone}

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