PhVWP 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

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

Antidepressants and suicidal thoughts and behaviour