Pharmacovigilance Working Party Recommendations

Risedronate and the risk of oesophageal cancer


Levodopa, dopamine agonist and COMT inhibitor products and risk of impulse control disorders (ICDs)


Risk of allopurinol-induced serious cutaneous adverse reactions – association in patients who are carriers of the HLA-B*5801 allele


Tramadol: risk of convulsion, serotonin syndrome, suicide and posology in the elderly and in patients with renal or hepatic impairment


Inconsistency in product information of prazepam-containing medicinal products regarding contra-indication in glaucoma


Association of oxcarbazepine with risk of hypersensitivity adverse drug reactions potentially associated with HLA-A*3101 allele


Risk of carbamazepine-induced cutaneous reactions – association with HLA-A*3101 allele in European and Japanese patients and update of recommendation on testing for HLA-B*1502 allele in some Asian populations


Paracetamol, solution for infusion (MRP Perfalgan (FR) and generic products) and risk of accidental overdosing of neonates and infants (due to medication errors following confusion between mg and ml) and underweight adults


Fluoroquinolones and risk of QT-interval prolongation


Selective serotonin reuptake inhibitors (SSRIs) (fluvoxamine, citalopram, escitalopram, fluoxetine and sertraline, paroxetine) and possible risk of male infertility due to sperm impairment


Class effect of Gonadotropin-releasing hormone agonists (buserelin, goserelin, histrelin, leuprorelin, nafarelin, triptorelin) on depression


Prescription-only proton pump inhibitors (omeprazole, esomeprazole/naproxen, omeprazole/ketoprofen, esomeprazole, lansoprazole, pantoprazole, rabeprazole) and risk of fractures of the hip, wrist and spine


Class effects of proton-pump inhibitors (dexlansoprazole, esomeprazole, lansoprazole, omeprazole, rabeprazole, pantoprazole) on magnesium blood levels in long-term users


Antiepileptics and possible risk of bone disorder


Ketoprofen and Ketorolac and Risk of gastrointestinal toxicity


Escitalopram and risk of QT prolongation


Oral Methotrexate – Review on potential fatal overdose due to medication errors


HMG-CoA Reductase Inhibitors and safety the risk of new onset diabetes/impaired glucose metabolism


Rosuvastatin (Crestor) and risk of gynaecomastia


Topiramate – and risk of congenital malformations


Tibolone (Livial) and risk of venous thromboembolism (VTE) and other risks


Effect of Strattera (atomoxetine) on blood pressure and heart rate from review of MAH clinical trial database


Domperidone and risk of QTc prolongation, serious ventricular arrhythmias and sudden cardiac death


Key elements for SmPC and PL regarding Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN) for 14 “high risk” substances (for systemic use)


Powder formulations of Plantago ovata seeds and allergic reactions after prolonged occupational exposure


Antipsychotics (conventional and atypical) and use during the third trimester of pregnancy and risk of abnormal muscle movements and/or withdrawal symptoms in newborns


Citalopram and the risk of QT prolongation


Paracetamol use at therapeutic doses in severe hepatic impairment or severe haemolytic anaemia


ACE-inhibitors and hydrochlorothiazide and their use in pregnancy and lactation


Beta-blocking agents for ophthalmic use and systemic adverse drug reactions after ophthalmic administration


Insulin products and risk of cardiac failure with concomitant use of pioglitazone


Risk of psychiatric adverse drug reactions to inhaled and intranasal corticosteroids and risk of non-psychiatric systemic adverse drugs reactions to intranasal corticosteroids


Long-Acting Beta Agonists (LABAs) - Increased risk of exacerbation of asthma symptoms


Tamoxifen and the risk of variability in clinical response due to CYP2D6 genetic variants or when given with CYP2D6 inhibitors


Alendronate and the risk of oesophageal cancer


Camphor containing ointments and risk of unintented oral ingestion


Rosuvastatin and higher incidence of diabetes mellitus and gluscose metabolism disorders in healthy individuals without hyperlipidaemia


Isotretinoin and the risk of erythema multiforme


SSRIs and TCAs and the risk of bone fractures


SSRIs, venlafaxine and mirtazapine and the risk of Persistent Pulmonary Hypertension in Neonates (PPHN)


Fluoxetine and the risk of Congenital Malformations


Propylthiouracil and the risk of serious liver injury


Valproic Acid and the risk of interaction with carbapenems


Cyproterone acetate and the risk of meningiomas


Association of HMG-CoA Reductase Inhibitors with safety concerns: sleep disturbances; memory loss; micturition disorders; sexual disturbance; depression; interstitial pneumopathy


Phenytoin-related SJS in association with HLA-B*1502 allele in individuals of Thai or Han Chinese origin


Apomorphine containing products and risk of QT interval prolongation


Short-acting beta agonists and risk of myocardial ischemia


Conventional (Typical) Antipsychotics and increased mortality in elderly people with dementia


Antipsychotics and risk of venous thromboembolism (VTE)


Vigabatrin and MRI abnormalities and movement disorders


Ceftriaxone and the risk of precipitation when given with calcium


Alendronic acid and the risk of stress fractures of the proximal femoral shaft


Additional hypotensive effects following co-administration of non-selective alpha-blockers and phosphodiesterase-5-inhibitors


Hydrochlorothiazide and use during pregnancy


Angiotensin Converting Enzyme (ACE) inhibitors and Angiotensin II Receptor Antagonists (AIIRAs): Use during pregnancy & lactation


Bisphosphonates and Atrial fibrillation


Ibuprofen and low dose aspirin interaction


Antiepileptics and suicidal behaviour


Carbamazepine related Stevens Johnson Syndrome and association with HLA-B*1502


Antidepressants and suicidal thoughts and behaviour