Drug Advisories
CMAJ is committed to publishing advisories and warnings of
serious adverse drug reactions from Health Canada (HC) and the US Food and
Drug Administration (FDA) as soon as they are available. In addition, we
regularly create practical, readable summaries of the important
information contained in some advisory and warning letters. For more
information about drug reactions reported in Canada, see the Health
Canada Web site.
2010 | 2009 | 2008 | 2007 | 2006 | 2005
| 2004 | 2003
| Advisory |
From |
Date posted |
| Transdermal fentanyl warnings |
FDA |
December 21, 2007 |
| Medication to relieve sleepiness modafinil (Alertec): Serious skin reactions, psychiatric symptoms and cardiac condition alerts |
HC |
December 21, 2007 |
| Carbamazepine severe skin reactions and specific HLA types |
FDA |
December 12, 2007 |
| Radio Frequency Ablation Device deaths |
FDA |
December 12, 2007 |
| MMR vaccine lot recalls |
HC |
December 12, 2007 |
| Omeprazole and esomeprazole: Cardiac safety update |
FDA |
December 12, 2007 |
| Breast implant information from Health Canada |
HC |
December 12, 2007 |
| Bedwetting treatment: Severe hyponatremia, seizures and death |
FDA |
December 5, 2007 |
| Rosiglitazone (Avandia) US warnings |
FDA |
November 22, 2007 |
| Smoking cessation drug varenicline (Chantix, Champix)): suicidal thoughts |
FDA |
November 22, 2007 |
| Heart attack risk and rosiglitazone (Avandia) |
FDA |
November 16, 2007 |
| Deaths on B-lactam antibiotic cefepime |
FDA |
November 16, 2007 |
| PDE-5 inhibitors Viagra, Levitra and Cialis and hearing loss: Info sheet for MDs |
FDA |
November 16, 2007 |
| Welsh Allyn Automatic External Defibrillators Recall |
FDA |
November 8, 2007 |
| Restrictions on rosiglitazone (Avandia, Avandamet, Avandaryl) |
HC |
November 8, 2007 |
| Mycophenolate mofetil (CellCept): pregnancy loss, congenital malformations |
FDA |
October 30, 2007 |
| Blood conservation agent aprotinin (Trasylol): increased risk of death |
FDA |
October 26, 2007 |
| Sleep disorder treatment modafinil (Provigil): Stevens Johnson syndrome |
FDA |
October 24, 2007 |
| Baxter infusion pump failures |
HC |
October 24, 2007 |
| Cochlear implant, meningitis risk update |
FDA |
October 18, 2007 |
| OTC cough and cold products and kids |
HC |
October 18, 2007 |
| Echocardiogram Bubble study agents: Cardiopulmonary adverse events |
FDA |
October 18, 2007 |
| Cox-2 inhibitor Lumiracoxib (Prexige) withdrawm from Canadian market |
HC |
October 5, 2007 |
| Lead contamination of Calabash Chalk |
HC |
October 5, 2007 |
| Bisphosphanates and atrial fibrillation |
FDA |
October 5, 2007 |
| Gadolinium-based contrast agents in MRI: warnings |
FDA |
October 5, 2007 |
| Haloperidol (Haldol): Injectable warnings |
FDA |
September 24, 2007 |
| Telithromycin (Ketek): Indications removed |
HC |
September 14, 2007 |
| Oral fentanyl adverse effects |
FDA |
September 14, 2007 |
| Paradigm
MiniMed Insulin Infusion Pumps: over-delivery of insulin near MRI
machines |
HC |
August 20, 2007 |
| Rituximab
(Rituxan): fatal Progressive Multifocal Leukoencephalopathy (PML)
when used for the lupus and vasculitis |
HC |
August 20, 2007 |
| Codeine
and risk to breastfeeding infants |
FDA |
August 20, 2007 |
| Thiazolidinediones
Diabetes Drugs and CHF risks |
FDA |
August 17, 2007 |
| Parkinson's
treatment pergolide (permax) taken off Canadian market |
HC |
August 17, 2007 |
| Entecavir
(Baraclude) not recommended alone for HIV/hepatitis B virus (HBV)
co-infected patients |
FDA |
August 17, 2007 |
| Specific
gene variants determine warfarin (coumadin) response |
FDA |
August 17, 2007 |
| lumiracoxib
(Prexige): serious liver adverse events |
HC |
August 16, 2007 |
| Proton
pump inhibitors: FDA warns of possible cardiac adverse events |
FDA |
August 13, 2007 |
| Omeprazole,
Losec, Nexium: Increased cardiac event rates in patients taking the
drugs as compared to antireflux surgery |
HC |
August 13, 2007 |
| Proton
pump inhibitors: FDA warns of possible cardiac adverse events |
FDA |
August 10, 2007 |
| Omeprazole,
Losec, Nexium: Increased cardiac event rates in patients taking the
drugs as compared to antireflux surgery |
HC |
August 10, 2007 |
| FDA
warns of red rice/medication interaction |
FDA |
August 10, 2007 |
| Baxter
IV Pump recall: Corrected information |
HC |
August 10, 2007 |
| Baxter
pump recall |
FDA |
July 30, 2007 |
| Ceftriaxone
(Rocephin): Calcium interaction and avoid in neonates |
FDA |
July 11, 2007 |
| Supplements
containing methyl-1-testosterone or methyldienolone: infertility and
liver failure concerns |
HC |
July 11, 2007 |
| Liquid
Form of Colistimethate and The Death of A Cystic Fibrosis
Patient |
FDA |
June 29, 2007 |
| RotaTeq
rotavirus vaccine: Kawasaki's disease |
FDA |
June 20, 2007 |
| US
propofol warning |
FDA |
June
20, 2007 |
| Over
the counter sleep aids laced with benzodiazepine |
HC |
June 15, 2007 |
| Salbutamol
IV/IM to slow labour: Myocardial ischemia |
HC |
June 15, 2007 |
| bevacizumab
(Avastin) and tracheo-esophageal fistula |
HC |
June 13, 2007 |
| COMPLETE
All-In-One Contact Lens Care Solution: Warning |
HC |
June
6, 2007 |
| rosiglitazone
maleate (Avandia): Cardiovascular concerns |
HC |
June 6, 2007 |
| Bone
Cements in Vertebroplasty and Kyphoplasty Procedures:
Complications |
HC |
May 31, 2007 |
| Rosiglitazone
(Avandia): MI, cardiovascular death in diabetics |
HC |
May
31, 2007 |
| Acanthamoeba
Keratitis in contact lens wearers who used Complete
MoisturePlus |
FDA |
May 30, 2007 |
| Acute
renal failure after gadolinium-based contrast for MRI |
FDA |
May 24, 2007 |
| rosiglitazone
(Avandia) Differing Rates Of Ischemic Cardiovascular Events in
ongoing trial |
FDA |
May
23, 2007 |
| Chronic
iron overload drug deferasorix (Exjade): acute renal failure |
FDA |
May 23, 2007 |
| Diabetic
test strips: OneTouch Ultra Test Strips may have damaged
package |
HC |
May 23, 2007 |
| Myozyme
(alglucosidase alfa) black particles on reconstitution of
drug |
HC |
May 18, 2007 |
| Gefitinib
(Iressa): No survival benefit in SCC of the Head and Neck
patients |
HC |
May 16, 2007 |
| ICDs
safety update |
HC |
May 10, 2007 |
| Diabetes
treatment pioglitazone (Actos) and increased fracture risk CMAJ Summary |
HC |
May 9, 2007 |
| FDA
issues suicide warnings for young adults using
antidepressants |
FDA |
May 3, 2007 |
| darbepoietin
alfa (Aranesp) or epoetin alfa (Eprex) and hemoglobin >120:
cardiovascular events and thromboses, tumour progression |
HC |
April 23, 2007 |
| DDU-100
Series Automatic External Defibrillators: Problems and corrective
actions |
HC |
April 18, 2007 |
| Natural
health product weight loss aids: warnings |
HC |
April 18, 2007 |
| Antispasticity
agent tizanidine hydrochloride (Zanaflex): CYP1A2
interactions |
FDA |
April 11, 2007 |
| Bone
Cement for Vertebroplasty and Kyphoplasty Procedures: Safety
information |
HC |
April 11, 2007 |
| CPAP
Mask Recall |
HC |
April 11, 2007 |
| telithromycin
(Ketek): No longer indicated for Acute bacterial sinusitis and acute
bacterial exacerbations of chronic bronchitis |
FDA |
April 11, 2007 |
| Intussusception
following administration of Rotavirus, Live, Oral, Pentavalent
vaccine (RotaTeq) |
FDA |
April 11, 2007 |
| Omalizumab
(Xolair)- serious allergic reactions and anaphylaxis |
FDA |
April 11, 2007 |
| FDA
ADHD Prescription Guides for safe prescribing |
FDA |
April 11, 2007 |
| Mycophenolate
mofetil (CellCept) trial terminated: acute rejection in heart
transplant patients |
FDA |
April 11, 2007 |
| Herbal
sleep supplement Sleepees contains a habit-forming drug |
HC |
April 11, 2007 |
| Entecavir
(Baraclude)- Risk of developing HIV resistance |
FDA |
April 11, 2007 |
| Pioglitazone
(Actos) and fracture concern CMAJ Summary |
FDA |
April 11, 2007 |
| Vitamin
mineral supplement EMPowerplus: adverse reactions |
HC |
April 11, 2007 |
| Pinel
Waist Restraint: Risk of positional asphyxiation |
HC |
April 11, 2007 |
| Confirm
Clearly Smart Pregnancy Test and Refills: false-positives |
HC |
April 11, 2007 |
| Worldwide
Recall of Automated External Defibrillators: Lifeline and ReviveR
AEDs |
FDA |
April 11, 2007 |
| darbepoetin
alfa (Aranesp),epoetin alfa (Epogen, Procrit): Safety
concerns |
FDA |
April 11, 2007 |
| Actimmune
trial for idiopathic pulmonary fibrosis (IPF) halted: lack of
effect |
FDA |
April 11, 2007 |
| Gadodiamide
(Omniscan) and Nephrogenic Systemic Fibrosis/Nephrogenic Fibrosing
Dermopathy (NSF/NFD) |
HC |
April 11, 2007 |
| US
warning: sedative-hypnotic drug product label changes |
FDA |
April 11, 2007 |
| Linezolid
(Zyvox): Infection safety concerns |
FDA |
April 11, 2007 |
| Patient
restraints: Warnings |
HC |
April 11, 2007 |
| Pediatric
antinauseant (trimethobenzamide hydrochloride) Tigan: Withdrawal in
US for lack of effectiveness |
FDA |
April 11, 2007 |
| Deferasirox
(Exjade): acute renal failure and cytopenias |
HC |
April 4, 2007 |
| Antibiotic
telithromycin (Ketek): exacerbation of myasthenia gravis,
hepatotoxicity, visual disturbances, and loss of
consciousness |
FDA |
April 4, 2007 |
| Influenza
treatment oseltamivir (Tamiflu): Suicidality in Japanese
teens |
HC |
April 4, 2007 |
| Aprotinin
(Trasylol): hypersensitivity reactions and renal dysfunction |
HC |
April 4, 2007 |
| Permax
withdrawn: valvulopathy concerns |
HC |
April 4, 2007 |
| Tegaserod
(Zelnorm) withdrawn: cardiovascular concerns |
HC |
April 4, 2007 |
| Darbepoetin
alfa(Aranesp) drug ineffective in reducing RBC transfusions or
fatigue in cancer patients |
FDA |
February 7, 2007 |
| Health
Canada warns against use of several foreign erectile dysfunction
products |
HC |
February 7, 2007 |
| ranibizumab
(Lucentis)- Preliminary SAILOR study results suggest increased CVA
risk |
FDA |
February 7, 2007 |
| Topical
anaesthetic drugs: US warning |
FDA |
February 7, 2007 |
| Death
and illness when heparin stopped prior to drotrecogin alfa
(Xigris)for severe sepsis |
HC |
January 10, 2007 |
| Kidney
failure after contrast MRI |
FDA |
January 10, 2007 |
| Oseltamivir
(Tamiflu): self-injury and delirium in patients with
Influenza |
FDA |
January 10, 2007 |
| Warnings
regarding several foreign natural health products |
HC |
January 10, 2007 |
| pioglitazone
(Actos) and fracture concern |
FDA |
January 10,
2007 |
|
