Health Product InfoWatch - March 2017 - Page 3

New health product safety information

The following topics have been selected to raise awareness and, in some cases, to stimulate reporting of similar adverse reactions.

Product monograph and medical device instructions for use updates

The following safety labelling updates, which were recently made to the Canadian product monograph or medical device instructions for use, have been selected for your awareness. A complete list of safety labelling updates for brand name pharmaceutical drugs is available on Health Canada's Web site.

Cophylac Drops (normethadone and p-hydroxyephedrine)

Cophylac Drops should not be used in children under 6 years of age due to a risk of serious harm, including misuse, overdose, and adverse reactions. The pediatric age restriction has been included in the Indications and Clinical Use, Warnings and Precautions, and Dosage and Administration sections of the Canadian prescribing information for Cophylac Drops. Health Canada is working with the manufacturer to update the Cophylac Drops packaging labels in order to reflect the revised pediatric dosage recommendations.

Key messages for healthcare professionals:Footnote 1

  • The use of Cophylac Drops is not recommended in patients under 6 years of age.
  • For children between 6 to 14 years of age, the recommended dosage is 5 to 10 drops twice daily.

Essure Permanent Birth Control System

The instructions for use for Essure Permanent Birth Control System have been updated, including the insertion of a Boxed Warning. The warning highlights the potential for various adverse events (perforation, improper device location, persistent pain, hypersensitivity reactions) that may lead to surgical removal of the device. The warning also stresses the need to use alternative contraception until an Essure Confirmation Test is performed three months after implantation to verify correct location and retention of the insert.

A Patient-Doctor Discussion Checklist has been added to the Canadian Patient Information Brochure for Essure. This checklist, to be reviewed and signed by both the patient and physician prior to device placement, outlines various risks associated with Essure (pregnancy risks, risks around the time of device insertion, long-term risks) as well as the availability of other birth control options.

Key messages for healthcare professionals:Footnote 2

  • An Essure Confirmation Test should be performed three months after insert placement to evaluate insert retention and location. The patient must use alternative contraception until an Essure Confirmation Test demonstrates satisfactory results.
  • There have been reports of perforation of the uterus and/or fallopian tubes, inserts located in the intra-abdominal or pelvic cavity, persistent pain, and allergy or hypersensitivity reactions in some patients. Some of these reported events resulted in insert removal that required abdominal surgery.
  • As with any procedure, hysteroscopic placement of Essure inserts into the fallopian tubes is NOT without risks. Essure placement is an elective procedure, and the patient must be well counseled and understand the risk/benefit relationship. The patient should read the Patient Information Brochure. Allow the patient adequate time after reviewing and considering this information before deciding whether to have the Essure procedure. The Patient-Doctor Discussion Checklist should be reviewed with the patient, and all of the patient's questions answered.

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