Archived - Important safety information on Fleet® Phospho-Soda® (sodium phosphates oral solution) with kidney impairment and nephrocalcinosis - Johnson & Johnson - MERCK Consumer Pharmaceuticals

December, 2005

Subject: Safety information on Fleet^® Phospho-Soda^® (Sodium Phosphates Oral Solution) and kidney impairment

Guelph, Ontario (December 2005) - Johnson & Johnson - MERCK Consumer Pharmaceuticals, following discussions with Health Canada, would like to inform you of important new safety information concerning Fleet^® Phospho-soda^® (sodium phosphates oral solution).

Sodium phosphates oral solution is commonly used to cleanse the bowel prior to surgery, prior to colonoscopy and other medical examinations of the bowel. The product is also used at a lower dose as a laxative for relief of occasional constipation. There have been very rare reports of patients who experienced a reduction in kidney function, both temporarily and permanently, due to formation of calcium deposits in their kidneys subsequent to the use of sodium phosphates for bowel cleansing. In a few of these cases patients experienced kidney failure. As a result of this new safety information we would like to highlight the following:

• Use sodium phosphates to cleanse the bowel only under the direction of a doctor and only as directed by your doctor.
• Drink plenty of clear fluids (as directed by a doctor) when using sodium phosphates to cleanse the bowel.
• Do not exceed the recommended dose when using sodium phosphates as an occasional laxative.

In order to prevent dehydration, drinking a sufficient quantity of clear fluids is particularly important when using sodium phosphates for cleansing the bowel. It also helps ensure your bowel is thoroughly clean for an effective procedure. Your doctor or pharmacist can provide appropriate guidance in this regard. This should involve six or more 240 mL (8 oz) glasses of clear fluids in accordance with the specific regimen outlined by your doctor.

Johnson & Johnson - MERCK has sent a letter to health care professionals informing them of this new safety information. A copy of this letter can be found at http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/index-eng.php. Following consultation with Health Canada the prescribing information for the product will also be revised.

For media inquiries, please contact Lan Lai-Minh at (519) 826-6226 ext 5215.

The management of health product related adverse reactions depends upon health care professionals and consumers reporting them. Any cases of serious and/or unexpected adverse reactions in patients taking sodium phosphates should be reported to Johnson & Johnson - MERCK or Health Canada at the following addresses:

Johnson & Johnson - MERCK Consumer Pharmaceuticals

890 Woodlawn Road West

Guelph, Ontario

N1K 1A5

Telephone: 1-888-730-4636

Fax: (519) 826-6205

e-mail: fleet@mcneilcanada.com

Any suspected adverse reaction can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

Health Canada

Address Locator: 0701C

Ottawa, Ontario, K1A 0K9

Tel: (613) 957-0337 or Fax: (613) 957-0335

To report an Adverse Reaction, consumers and health professionals may call toll free:

Tel: 866 234-2345

Fax: 866 678-6789

cadrmp@hc-sc.gc.ca

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:

Marketed Health Products Directorate

email: MHPD_DPSC@hc-sc.gc.ca

Tel.: (613) 954-6522

Fax.: (613) 952-7738