Drug Advisories

CMAJ is committed to publishing advisories and warnings of serious adverse drug reactions from Health Canada 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.

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ADVISORY FROM DATE POSTED
ADHD drug atomoxetine (Strattera): potential for severe liver injury FDA Dec 22, 2004
Increased cardiovascular events for patients taking naproxen in Alzheimer's trial FDA Dec 21, 2004
Familial Adenomatous Polyposis celecoxib trial halted due to excess cardiovascular events HC Dec 21, 2004
Pamidronate (Aredia) and/or zoledronic acid (zometa) and osteonecrosis of the jaw HC Dec 21, 2004
FDA recall of CARDIAC REader System: false negative TnT and myoglobin results FDA Dec 16, 2004
Valdecoxib (Bextra) not to be used in patients undergoing CABG CMAJ summary FDA Dec 14, 2004
Valdecoxib (Bextra) and cardiovascular risk and serious skin reactions CMAJ summary HC Dec 14, 2004
New hemoglobin targets for cancer patients using Epoetic (procrit) FDA Dec 10, 2004
Lorazepam pills containing GLYBURIDE HC Dec 08, 2004
FDA recall of Tosoh Bioscience AIA-600 II Enzyme Immunoassay Analyzer, software version 3.02 FDA Dec 08, 2004
Inappropriate use of Bicillin C-R to treat syphilis FDA Dec 06, 2004
Risk of rhabdomyolysis (muscle breakdown) for patients taking Crestor HC Nov 26, 2004
Depo-Provera and bone density loss CMAJ summary FDA Nov 26, 2004
FDA Recall of Access CardioSystems Automated External Defibrillators -failure to deliver shock FDA Nov 26, 2004
Recall unused Advanced Bionics implantable cochlear stimulators HC Nov 11, 2004
Safety Information on the LTV Series Ventilators FDA Nov 10, 2004
Rheumatoid arthritis drugs Humira (adalimumab) and anakinra: serious reactions FDA Nov 10, 2004
Recall of Oral-B CrossAction Power and PowerMAX toothbrushes and refills FDA Nov 2, 2004
Cardiac valve problems and pergolide (Permax) HC Oct 27, 2004
Eprex and vascular thrombotic events HC Oct 26, 2004
Potassium supplement recall HC Oct 26, 2004
Risk of serious infection from ultrasound medical gels CMAJ summary  HC Oct 26, 2004
TNFa-blocking agents, including Remicade, increased cases of lymphoma in trials FDA Oct 13, 2004
Rituxan (rituximab): Hepatitis B virus (HBV) reactivation with fulminant hepatitis, hepatic failure, and death in patients with hematologic malignancies FDA Oct 13, 2004
Vioxx (rofecoxib) withdrawal from market regarding possible cardiovascular adverse events CMAJ summary HC Oct 06, 2004
Levoxyl (levothyroxine): reports of choking and gagging on tablets stuck in throat FDA Oct 06, 2004
Zometa (zoledronic acid) Injection: osteonecrosis of the jaw FDA Oct 01, 2004
Recall of LTV series of ventilators, models 1000, 950, 900 and 800: battery failure FDA Oct 01, 2004
Voluntary withdrawal of Vioxx (rofecoxib) CMAJ summary FDA Oct 01, 2004
LAMICTAL (lamotrigine) levels decreased on oral contraceptives HC Sept 29, 2004
FDA recall of infusion pump Medtronic Model 8870 software application cards FDA Sept 27, 2004
Cracking Protonix I.V. for Injection vials FDA Sept 27, 2004
Nellcor CapnoProbe Sublingual Sensors Recall FDA Sept 27, 2004
Class I recall of the Minerva Patient Lift (models ML-20 and ML-30) FDA Sept 2, 2004
Health Canada Advises Consumers to Return Euro-K and Riva-K Potassium Chloride Products Health Canada Sept 3, 2004
Important Safety Information on Euro-K and Riva-K Sustained Release Potassium Supplements Health Canada Sept 2, 2004
Geodon (ziprasidone) associated with increased risk of hyperglycemia and diabetes FDA Sept 1, 2004
Remicade (infliximab) associated with leukopenia, neutropenia, pancytopenia, and systemic vasculitis FDA Aug 24, 2004
Low molecular weight heparin enoxaparin sodium (lovenox) requires dosage adjustment in severe renal impairment FDA Aug 17, 2004
Chemotherapeutic bevacizumab (Avastin) associated with increased risk of serious arterial thromboembolic events FDA Aug 17, 2004
US Tracheostomy Tube and Cannula recall FDA Aug 10, 2004
Potential adverse effects of SSRIs and other anti-depressants on newborns Health Canada Aug 10, 2004
Possible Association of RITUXAN (rituximab) with Hepatitis B Reactivation Health Canada Aug 3, 2004
Patients not to use Aristolochic Acid derivatives over concerns of cancer, kidney failure CMAJ summary Health Canada July 28, 2004
Patients to not use sesa hair supplement capsules due to unacceptable levels of lead Health Canada July 28, 2004
Recall of the Hepatitis B and C tests: Roche COBAS TaqMan and TaqMan 48 Analyzer FDA July 27, 2004
FDA recall of Boston Scientific Express2TM coronary stents FDA July 27, 2004
FDA Recall of Troponin Test kits -VITROS Troponin I Reagent Pack FDA July 27, 2004
FDA recall of two lots of Taxus eluting coronary stents FDA July 15, 2004
FDA recall of Arjo Alenti Lift hygiene chair FDA July 15, 2004
FDA recall of VISULINK 532/U medical device FDA July 15, 2004
Potential trazodone interactions Health Canada July 13, 2004
Rheumatoid Arthritis treatment leflunomide (Arava) and interstitial lung disease Health Canada June 29, 2004
CIDEX OPA instrument sterilization solution: contraindicated for reprocessing of urological instruments used on patients with a history of bladder cancer Health Canada June 29, 2004
Pharmacists must ensure that patients on different clozapine brands, have updated registries Health Canada June 29, 2004
Concerns that neonates exposed to SSRIs, SNRIs in 3rd trimester may develop Serotonin-syndrome-like symptoms at birth FDA June 29, 2004
Rosuvastatin (Crestor) and rhabdomyolysis CMAJ summary Health Canada June 24, 2004
Recall of Penicillin allergy test: PRE-PEN (benzylpenicilloyl polylysine injection) Health Canada June 22, 2004
Risk factors for crestor (rosuvastatin) associated myopathy CMAJ summary FDA June 15, 2004
Recall of the Tecan Clinical Workstation (TCW) used in the detection of gonorrhea and chlamydia FDA June 15, 2004
Hemodialysis treatment and potential for patient to patient cross contamination Health Canada June 15, 2004
Recall of Proglycem hypoglycemic treatments Health Canada June 8, 2004
Potential for self harm/suicide in users of SSRIs and newer antidepressants- Luvox (fluvoxamine maleate) Health Canada June 3, 2004
Potential for self harm/suicide in users of SSRIs and newer antidepressants- Paxil (paroxetine) Health Canada June 3, 2004
Potential for self harm/suicide in users of SSRIs and newer antidepressants- Zoloft sertraline hydrochloride) Health Canada June 3, 2004
Potential for self harm/suicide in users of SSRIs and newer antidepressants- Remeron RD & Remeron (mirtazapine) Health Canada June 3, 2004
Potential for self harm/suicide in users of SSRIs and newer antidepressants- Prozac (fluoxetine hydrochloride) Health Canada June 3, 2004
Potential for self harm/suicide in users of SSRIs and newer antidepressants- Effexor / Effexor XR (venlafaxine) Health Canada June 3, 2004
Potential for self harm/suicide in users of SSRIs and newer antidepressants- Celexa (citalopram hydrobromide) Health Canada June 3, 2004
Patients warned to not use over-the-counter weight loss product Thermonex Health Canada June 1, 2004
FDA recall of Quick-set Plus insulin infusion pumps FDA May 25, 2004
Trazodone (desyrel): potential for drug interactions with CYP3A4 inhibitors ketoconazole, ritonavir, and indinavir FDA May 18, 2004
Muromonab-CD3 (Orthoclone OKT*3) transplant antirejection drug:cerebral edema, lymphomas Health Canada May 18, 2004
Diarrhea and Ischemic Colitis in Patients Using tegaserod hydrogen maleate (ZELNORM) Health Canada May 11, 2004
Zelnorm (tagserod maleate) and diarrhea and ischemic colitis CMAJ summary FDA May 4, 2004
Inadequate sterilization of acetabular reamer Health Canada April 27, 2004
Recall of Medtronic implantable cardioverter defibrillators (ICDs) FDA April 22, 2004
Asthma drug zafirlukast (Accolate) and serious hepatic adverse events CMAJ summary Health Canada April 20, 2004
Concerns about infusion pumps Health Canada April 20, 2004
Olanzapine (Zyprexa): increased incidence of cerebrovascular events in dementia trials CMAJ summary Health Canada April 13, 2004
FDA fentanyl patch (duragesic) recall FDA April 13, 2004
Clozapine (Clozaril) and increased risk of hyperglycemia and diabetes FDA April 13, 2004
Atypical antipsychotic aripiprazole (Abilify) and hyperglycemia and diabetes FDA April 13, 2004
Recall of Human Rabies Vaccine IMOVAX (Aventis Pasteur) FDA April 6, 2004
Absorbable hemostatic agents during surgery: ways to reduce paralysis and neural deficits FDA April 6, 2004
Incorrect lot number listed for Vitek antibiotic susceptibility test cards FDA April 6, 2004
FDA recalls some bacterial susceptibility testing cards FDA Mar 30, 2004
FDA warns of worsening of suicidality in some patients taking antidepressants FDA Mar 24, 2004
Olanzepine (Zyprexa) and Hyperglycemia CMAJ summary FDA Mar 23, 2004
Olazepine (Zyprexa) and Strokes in the Elderly CMAJ summary Health Canada Mar 23, 2004
Piperacillin/tazobactam association with false positive results on an Aspergillus Assay Health Canada Mar 16, 2004
Failure of Faaborg battery operated patient lifts: Recall due to serious injuries, death FDA Mar 16, 2004
Fetanyl transdermal patches (Duragesic) Recall in US for manufacturing defect FDA Feb 24, 2004
HIV drug Neviramine (Viramune) and hepatic toxicity, rash CMAJ summary Industry Feb 19, 2004
Pergolide (Permax): Sudden onset of sleep in Parkinsonian patients CMAJ summary Health Canada Feb 19, 2004
Counterfeit Contraceptive patches FDA Feb 10, 2004
Severe life-threatening reactions to nevirapine (Viramune) CMAJ summary FDA Feb 3, 2004
Fluticasone propionate (Flonase/Flovent/Advair) and ritonavir (Norvir/Kaletra) interaction Health Canada Feb 3, 2004
Oseltamivir (Tamiflu) unsafe in infants under 1 year old CMAJ summary FDA Jan 27, 2004
Epoetin alpha (Eprex): Do not give it subcutaneously Health Canada Jan 20, 2004
Smoke/fire in anesthesia machines using sevoflurane (SEVORANE AF) and desiccated carbon dioxide (CO2) absorbent Health Canada Jan 13, 2004
False results with the HBsAg ELISA System 3 Confirmatory Test FDA Jan 13, 2004
Serious liver injury with use of pyrazinamide (Tebrazid) and rifampin for latent TB Health Canada Jan 13, 2004
Oseltamivir (Tamiflu) not to be used in children less than 1 year CMAJ summary FDA Jan 7, 2004
Strangulation of infants by IV tubing and monitor leads Health Canada Jan 6, 2004