Pharmacy Technicians on the Road to Regulation Focus on ...

health canada advisories & notices
April 9, 2010
April 9, 2010
March 31, 2010
March 25, 2010
March 25, 2010
March 23, 2010
March 22, 2010
March 20, 2010
March 15, 2010
March 11, 2010
March 8, 2010
March 1, 2010
February 16, 2010
February 11, 2010
February 9, 2010
Health Canada, in consultation with GlaxoSmithKline, has revised the provisional expiry date of the adjuvanted H1N1 vaccine (Arepanrix).
This revision is not safety–related but is due to a decline in strength of the H1N1 antigen in specific lots.
Further to the recent regulatory recommendations in the United States and European Union to not approve Zeftera due to concerns
regarding the conduct of clinical trials, Janssen-Ortho Inc., in collaboration with Health Canada, decided to issue a Notice to Hospitals
regarding the discontinuation of sale of Zeftera (ceftobiprole medocaril) on April 16th, 2010.
Health Canada is warning Canadians that an unauthorized health product, “West Pharm Therma Lean Fat Burner Energizer” was found on
the Canadian market. West Pharm Therma Lean Fat Burner Energizer contains Ephedrine and caffeine, which combined together, may cause
serious and possibly fatal adverse effects. Canadians suffering from heart conditions, high blood pressure and diabetes are among those
particularly at risk. The product was distributed across Canada via the internet by Nutrition First (www.nutritionfirst.ca), a company located
in Nova Scotia.
Health Canada is warning Canadians that an unauthorized health product, “Herbal Diet Natural” has been found on the Canadian market
and contains an undeclared pharmaceutical ingredient similar to the prescription drug sibutramine. Sibutramine may pose serious health
risks, particularly to people with heart problems.
WinRho SDF (Rho(D) Immune Globulin (Human)) Association with Intravascular Hemolysis in the Treatment of Immune Thrombocytopenic
Purpura (ITP)- Important New Prescribing Information - Cangene Corporation. Resulting from the analysis of reports of intravascular
hemolysis, changes to the prescribing information for WinRho SDF for the treatment of immune thrombocytopenic purpura (ITP) have been
made. These changes include new contraindications and conditions of use.
Health Canada is advising consumers that Ratiopharm Inc., of Mirabel, Quebec, has voluntarily recalled all units from two lots (Lot HF26
and Lot HF27) of the prescription drug Ratio-Prednisolone Ophthalmic Solution (DIN 00700401) in 1.0% strength because some bottles may
contain particles that could lead to increased eye irritation.
Health Canada is informing health care professionals and Canadians of changes to the labelling information for the prescription antibiotic
Avelox (moxifloxacin). The updated labelling incorporates important safety information related to the rare risk of severe liver injury.
LifeScan has initiated a voluntary recall of specific lots of OneTouch SureStep Test Strips because they may provide false low test results
when blood glucose is greater than 22.2 mmol/L. Customers are asked to contact LifeScan immediately to find out if their test strips are
affected.
Health Canada would like to remind the thousands of Canadians who rely on medical devices or systems with internal clocks to check these
devices to ensure they switch from Standard Time to Daylight Savings Time on Sunday, March 14, 2010 at 2:00 a.m.
There are new changes to the Dose Conversion Guidelines - Janssen-Ortho Inc., Cobalt Pharmaceuticals Inc., Teva Canada Limited, Ranbaxy
Pharmaceuticals Canada Inc., ratiopharm inc., Sandoz Canada Inc. and Pharmascience Inc. The morphine dose conversion ratio (parenteral
versus oral) is now of 1:3. The conversion doses of IV/IM morphine to Fentanyl Transdermal Systems (patch strengths of 75, 87 and 100 mcg/
hour) were revised to “not applicable” to reflect the insufficiency of data available for guidance.
Health Canada is warning Canadians that an unapproved health product, “Power-Max” contains sildenafil, a prescription medication was
found on the Canadian market in Ontario. Sildenafil may pose serious health risks, particularly to people with heart problems.
Health Canada is advising consumers not to use the following foreign health products due to concerns about possible adverse reactions: 2H
& 2D, Products distributed by Atlas Operations Inc., Products distributed by Bodybuilding.com, STRO Emperor Capsules and Tian Yang Xu
Huo Oral Ulcer Capsule.
Accutane has been associated with cases of severe skin reactions (e.g. toxic epidermal necrolysis, Stevens-Johnson syndrome and erythema
multiforme).
Dana Douglas Inc. has initiated a voluntary recall of certain neXus I, II and III rollators which may break during use resulting in the user
falling and suffering serious injury including bruising, broken bones or death.
Health Canada is advising consumers that the unauthorized product “Complete 7-Day Cleanse” is being recalled because it contains a
number of active ingredients with a combined effect that may pose serious health risks.
For complete information & electronic mailing of the Health Canada Advisories/Warnings/Notices subscribe online at:
http://www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html
MedEffect e-Notice is the new name which replaces Health Canada’s Health_Prod_Info mailing list.
The content of the e-notices you receive will remain the same and are now part of MedEffect, a new Health Canada Web site dedicated to adverse
reaction information. MedEffect can be visited at www.hc-sc.gc.ca/dhp-mps/medeff/index_e.html
Health Canada Notices are also linked under “Notices” on the OCP website: www.ocpinfo.com
pharmacyconnection • May/June 2010
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