Archived - Important safety information on pms-Sodium Phosphates Oral Solution with kidney impairment and nephrocalcinosis - Pharmascience Inc.

Public Communication - Health Canada Endorsed Important Safety Information on
Phosphates solution (oral sodium phosphates)

December, 2005

Subject: Safety Information on Phosphates solution (oral sodium phosphates) and kidney impairment

Montreal, Quebec (December, 2005), Pharmascience Inc. following discussion with Health Canada, would like to inform you of important new safety information concerning Phosphates solution (oral sodium phosphates).

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 240ml (8oz) glasses of clear fluids in accordance with the specific regimen outlined by your doctor.

Pharmascience Inc. has sent a letter to health care professionals informing them of this new safety information. A copy of this letter can be found at www.pharmascience.com or on the Health Canada website. Following consultation with Health Canada the prescribing information for the product will also be revised.

For media inquiries, please contact Gilda Abdulezer at 1-800-363-8805 ext: 5055

Pharmascience Inc
6111 Royalmount
Montreal, Quebec
H4P 2T4
Tel: 1-888-550-6060
Fax: (514) 342-7764
e-mail: azurek@pharmascience.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