Safety Information
Drug Safety Update Vol 2 Issue 4 (November 2008)
Drug safety advice
Varenicline: adverse psychiatric reactions, including depression
Tigecycline: new formulation affects compatibility
Yellow Card scheme update
Reporting by community pharmacists is encouraged for OTCs
Hot topic - Ezetimibe and possible increased risk of cancer: results of SEAS study
Stop Press - Rimonabant: European suspension of marketing authorisation
Stop Press -
Inhaled anticholinergics: recent published data for risk of death or stroke
Stop Press -
Paracetamol use in infancy: no strong evidence for asthma link
Other information from the MHRA
Patient Information Leaflet of the month: Telfast
‘My medicine’: new section on MHRA website
Device bulletin: use of in vitro diagnostic devices with other medical equipment
Herbal medicines: packaging shows MHRA approval
Copies of this bulletin are available for Download
Etoricoxib (Arcoxia)
02 October 2008
Updated and strengthened safety recommendations:
- Do not use in patients with high blood pressure persistently elevated above 140/90 mm/Hg and which is not adequately controlled
- All patients who start treatment should have blood pressure monitored within 2 weeks of starting and periodically thereafter
Information from the manufacturer is available for Download
Drug Safety Update Vol 2 Issue 3 (October 2008)
Drug safety advice
Ergot-derived dopamine agonists: risk of fibrotic reactions in chronic endocrine uses
Use of antibiotics in premature labour: latest information
Yellow Card scheme update
When to report an adverse drug reaction
Hot topic - Pseudoephedrine and ephedrine nasal decongestants: risk of illicit use
Stop Press - Theophylline: narrow therapeutic index and potential for misuse
Other information from the MHRA
Central Alerting System: access to urgent safety guidance
Patient Information Leaflet of the month: Livial (tibolone)
Unlicensed medicines: latest imports
Consultation: dispensing opticians and access to prescription medicines
Copies of this bulletin are available for Download
Cabergoline (Cabaser and Dostinex)
15 September 2008
Information from the manufacturer is available for Download
Rimonabant (Acomplia)
05 September 2008
Suspension of marketing authorisation because of concerns about psychiatric side-effects:
- Do not issue, renew, or dispense any prescriptions for rimonabant
Information from the manufacturer is available for Download
Drug Safety Update Vol 2 Issue 2 (September 2008)
Drug safety advice
Fentanyl patches: serious and fatal overdose from dosing errors, accidental exposure, and inappropriate use
Yellow Card scheme update - Please report suspected adverse reactions to vaccines
Hot topic - Introduction of human papillomavirus immunisation in the UK
Stop Press - Viracept: update on carcinogen contamination (ethyl mesylate)
Stop Press -
Natalizumab (Tysabri): progressive multifocal leukoencephalopathy
Stop Press -
Monthly round-up of letters to healthcare professionals
Stop Press -
Intrathecal drug pumps: missing propellant
Stop Press -
Caffeine for apnoea of prematurity: correction
Stop Press -
Recall of reagent for paracetamol levels
Other information from the MHRA
Patient Information Leaflet of the month: Prostasan (saw palmetto)
Azithromycin reclassification: pharmacy availability to treat chlamydia
Copies of this bulletin are available for Download
Natalizumab ( Tysabri)
15 August 2008
Progressive multifocal leukoencephalopathy
Information from the manufacturer is available for Download
Pergolide (Celanace)
21 July 2008 to 08 August 2008
Fibrotic reactions, including cardiovalvulopathy, associated with chronic use
Information from the manufacturer is available for Download
Lenalidomide ( Revlemid)
05 August 2008
Preclinical data for teratogenicity
Information from the manufacturer is available for Download
Drug Safety Update Vol 2 Issue 1 (August 2008)
Drug safety advice
Antiepileptics: risk of suicidal thoughts and behaviour
Recombinant human erythropoetins: new recommendations for treatment of anaemia in cancers
Yellow Card Scheme Update - Serious versus severe reactions
Hot topic - Lenolidamide or thalidomide for multiple myeloma
Stop Press - Molifloxacin - restricted use
Accusol 35 solutions - precipitate formation during haemofiltration
Carffeine for apnoea od prematurity - check dose regimen before use
Intrathecal drug pumps - disrupted drug delivery
Metronidazole for Clostridium difficile associated diarrhoea - use oral formulation
Patient Information Leaflet of the Month - AmBisome
Copies of this bulletin are available for Download
Accusol 35 solution
22 July 2008
Precipitate formation : caution in use is needed
Information from the manufacturer is available for Download
Adalimumab (Humira)
16 July 2008
Reports of hepatosplenic T-cell lymphoma
Information from the manufacturer is available for Download
Rimonabant (Accomplia)
14 July 2008
Psychiatric disorders, particularly depression
Information from the manufacturer is avilable for Download
Bevacizumab (Avastin)
14 July 2008
Avastin is not approved for use in combination with sunitinib for any indication
Information from the manufacturer is available for Download
Deferasirox (Exjade)
10 July 2008
Liver failure and need for monitoring; GI haemorrhage and ulceration; and renal tubulopathy
Information from the manufacturer is available for Download
Drug Safety Update Vol 1 Issue 12 (July 2008)
Drug safety advice
Varenicline: suicidal thoughts and behaviour
Bisphosphonates: atrial fibrillation
Yellow Card scheme update - Black triangle: symbol for intensively monitored drugs or vaccines
Hot topic - Inhaled products that contain corticosteroids
Stop Press - Rotigotine patches: new prescribing and storage requirements
Stop Press - Enoxaparin (Clexane) contamination: latest information
Stop Press - Ergot-derived dopamine agonists: new warnings and contraindications
Stop Press - Etoricoxib: new prescribing guidelines
Stop Press - Recombinant human erythropoietins: new warning for use in patients with cancer
Patient Information Leaflet of the Month - Aldactone
New section on MHRA website for ophthalmologists and cardiologists
Copies of this bulletin are available for Download
Drug Safety Update Vol 1 Issue 11 (June 2008)
Natalizumab (Tysabri): safety overview—progressive multifocal leukoencephalopathy, hypersensitivity, and hepatotoxicity
Nicorandil: gastrointestinal ulceration
Promotion of the Scheme in community pharmacies
Hot topic - Ezetimibe: new data from the ENHANCE trial
Stop Press - Herbal products marketed for erectile dysfunction
Patient Information Leaflet of the Month: Epipen
Safe use of medical lasers and other optical radiation devices
Oxygen cylinders and regulators: top tips leaflet
MHRA challenges and priorities: response to public consultation
Copies of this bulletin are available for Download
Natalizumab (Tysabri)
19 May 2008
Reports of serious liver injury
Information from the manufacturer are available for Download
Drug Safety Update Vol 1 Issue 10 (May 2008)
Rimonabant (Acomplia): depression; psychiatric adverse reactions
Exenatide (Byetta): risk of acute pancreatitis
Yellow Card scheme update - Has this reaction been reported before? Finding out about suspected adverse drug reactions reported to the MHRA
Hot topic - Monitoring the safety of antiretroviral drugs
Stop Press - Abacavir and didanosine: results of D:A:D study
Stop Press - Enoxaparin (Clexane) contamination: advice for healthcare professionals
Other information from the MHRA Intrathecal drug pumps
Patient Information Leaflet of the month: Vicks Sinex Soother Nasal Spray
Pregnancy testing: top tips leaflet
Copies of this bulletin are available for Download
Drug Safety Update Vol 1 Issue 9 (April 2008)
Hormonal contraceptives: cervical cancer - latest evidence
Combined hormonal contraceptives: venous thromboembolism - update
Cyproterone acetate with ethinylestradiol (co-cyprindiol): recommended duration of use
Carbamazepine: genetic testing in some Asian populations
Hot Press - New addition to the Yellow Card scheme - the online reporting form
Stop Press - Updated advice - Over-the-counter cough and cold medicines for children
Stop Press - Combined oral contraceptives: prevention of ovarian cancer
Stop Press - Antidepressants: suicidal thoughts and behaviour - summary report
Stop Press - Clove oil: life-threatening reactions on overdose
Patient Information Leaflet of the month
Regulation of unlicensed medicines: informal consultation
Copies of this bulletin are available for Download
Drug Safety Update Vol 1 Issue 8 (March 2008)
Ketoconazole: restricted indications
Tazocin: new formulation
Telbivudine:risk of peripheral neuropathy with pegylated interferon
Modafanil: serious skin reactions, hypersensitivity and psychiatric symptoms
Yellow Card Centres - important contribution to drug safety
Hot topic - nasal decongestants that contain pseudoephedrine or ephedrine: update on sales restrictions
Stop Press - Boots Medisure Domicillary Dosage System (DDS): risk of incorrect dose
Stop Press - Recent letters to healthcare professionals
Injectable medicines for cosmetic procedures:supply and administration
Earler access to medicines
Patient Information Leaflet of the month
Copies of this bulletin are available for Download
Drug Safety Update Vol 1 Issue 7 (February 2008)
Statins; class effects identified
Varenicline: safety update
Carisoprodol and meprobamate: risks outweigh benefits
Yellow Card scheme update - reporting by patients and public
Hot topic - biosimilar products
Stop Press - Duphaston/Duphaston HRT: withdrawal of Marketing Authorisation
Stop Press - Herbal safety news: OSAS found to contain steroids
Stop Press - Rosiglitazone: new contraindications and warnings
Patient Information Leaflet of the month
Please report suspected counterfeit medicines
Midwife prescribing: public consultation
Copies of this bulletin are available for Download
Modafanil (Provigil)
20 February 2008
Serious skin rash and psychiatric symptoms
Information from the manufacturer is available for Download
Mycophenylate mofetil (CellCept)
18 February 2008
Reports of progressive multifocal leukoenecephalopathy
Information from Roche is available for Download
Telbivudine (Sebivo)
15 February 2008
Risk of peripheral neuropathy
Information from Novartis is available for Download
Alemtuzumab (MabCampath)
11 February 2008
Six infection related deaths in clinical trial of fludarabine and rituximab treatment followed by alemtuzumab for remission consolidation in patients with previously untreated symptomatic B-cell chronic lymphocytic leukaemia
Information from Bayer Schering Pharma is available for Download
Moxifloxacin (Avelox)
11 February 2008
Serious hepatic reactions and bullous skin reactions
Information from the manufacturers is available for Download
Ketoconazole (Nizoral)
01 February 2008
Restricted indications sue to risk of hepatotoxicity
Information from the manufacturers is available for Download
Drug Safety Update Vol 1 Issue 6 (January 2008)
Statins: interactions, and updated advice for atorvastatin
Methylthioninium chloride (methylene blue): CNS toxicity with serotonergic drugs
Desmomelt (desmopressin): call for Yellow Card reporting
Bivalirubin: risk associated with incorrect dose
What happens to your Yellow Card
Hot topic - Long-acting beta2 agonists for asthma: review
Stop Press - Carisoprodol: recommendation to suspend Marketing Authorisations
Stop Press - Parrafin-based treatments: risk of fire hazard
Stop Press - Oral anticancer medicines: risk of incorrect dosing
Patient Information Leaflet of the month
Copies of this bulletin are available for Download
Drug Safety Update Vol 1 Issue 5 (December 2007)
Recombinant human erythropoietins
Rosiglitazone and pioglitazone
Dosulepin
ACE inhibitors and angiotensin II receptor antagonists
Short-acting beta agonists
Electronic reporting
Hot topics - Varenicline: possible effects on driving; psychiatric illness
Hot topics - NSAIDs and coxibs: balancing of cardiovascular and gastrointestinal risks
Drug Safety Update Quiz
Stop Press - Aprotinin: suspension of Marketing Authorisations
Stop Press - Lumiracoxib: suspension of Marketing Authorisations
Stop Press - Strontium ranelate: risk of severe allergic reactions
Stop Press - Talc for pleurodesis: risk of adverse effects
Stop Press - Recent letters to healthcare professionals
Other information from MHRA
Quiz answers
Copies of this bulletin are available for Download
Aprotinin (Trasylol) Licence has been suspended
November 29 2007
The MHRA have suspended the licence due to concerns about safety. The suspension is expected to last at least 3 months, during which a European-wide review will decide whether licences can be reinstated. In the meantime aprotinin will still be available, but its use is unlicensed.
Information from the MHRA site is available for Download
Strontium ranelate (Protelos)
November 22 2007
Healthcare professionals should be alert to the risk of severe allergic reactions, including drug rash and eosinophilia systemic symptoms
Information from the MHRA site is available for Download
Lumiracoxib (Prexige) Licence has been suspended
November 19 2007
The MHRA have suspended the licence for lumiracixib due to the safety concerns about possible liver damage for patients.
Information from Novartis is available for Download
Mycophenolate mofetil (CellCept)
November 16 2007
Concerns of congenital abnormalities after use in pregnancy
Information from Roche is available for Download
Drug Safety Update Vol 1 Issue 4 (November 2007)
Fibrates: new prescribing advice
Lumiracoxib: hepatotoxicity
Ceftriaxone: incompatability with calcium-containing solutions
Codeine: very rare risk of side-effects in breast fed babies
St John's wort: interactions with all antiepileptics
Hot topics - Illegal herbal remedies that contaon Aristolochia: vigilance needed
Hot topics - Nasal decongestants that contain pseudoephedrine or ephedrine: sales restrictions
Stop Press - Moxifloxacin: hepatotoxicity and serious skin reactions - prescribing update
Stop Press - Coproxamol withdrawal: reminder to prescribers
Stop Press - Ecoflac infusion solutions: risk of air embolism
Copies of this bulletin are available for Download
Drug Safety Update Vol 1 Issue 3 (October 2007)
Piroxicam
Ketoprofen + ketorolac
Inhaled corticosteroids
Pneumovax II
Bisphosphonates
Lorazepam
Hot topics - Botulinum toxin
Hot topics - Rosiglitazone + pioglitazone
Copies of this bulletin are available for Download
Drug Safety Update Vol 1 Issue 2 (September 2007)
Hormone-replacement therapy
Tibolone
Desmopressin nasal spray
Pabrinex
Corticosteroids
Hot topic - Duloxetine
Copies of this bulletin are available for Download
New (interim) restrictions on prescription of lumiracoxib, following concerns over liver safety
August 23 2007
Following consultation with the MHRA and other European regulators, the manufacturer of the osteoarthritis drug lumiracoxib (Prexige), is writing to health professionals to inform them of new restrictions on the prescribing of lumiracoxib. Concern was raised worldwide after rare reports of serious liver reactions; mostly relating to daily doses that are higher than licensed in the EU.
Information from the MHRA site is available for Download
Drug Safety Update Vol 1 Issue 1 (August 2007)
Gadolinium-containing contrast agents and nephrogenic systemic fibrosis
Extraneal and products that contain (or are metabolised to) maltose, xylose, or galactose: false glucose reading
α1-adrenoreceptor antagonists and intraoperative floppy iris syndrome
Cabergoline: risk of cardiovalvulopathy
Linezolid: restriction of indication
Dopamine agonists and pathological gambling, increased libido, and hypersexuality
Antidepressants and risk of suicidal behaviour
Hot topic - Isotretinoin for severe acne
Hot topic - Smoking-cessation aids
Copies of this bulletin are available for Download
Rimonabant (Acomplia)
July 19 2007
New advice concerning the use of rimonabant (Acomplia) for weight loss in patients taking antidepressants or those with major depression.
The European Medicines Agency (EMEA) has recommended that rimonobant (Acomplia), a medicines for the treatment of obesity, must not be used by patients with major depression or those being treated with antidepressants bacause the risk of psychiatric side effects.
Information from the MHRA site is available for Download
Gadolinium - containing contrast agents
June 26 2007
Risk of Nephrotic Systemic Fibrosis - update from Prof Sir Gordon Duff, Chairman of the Commission on Human Medicines
Information from the MHRA site is available for Download
Gadopentetate dimeglumine (Magnevist)
June 25 2007
Risk of nephrotic systemic fibrosis
Information from Bayer Schering Pharma AG is available for Download
Nephrotic Systemic Fibrosis with the gadolinium containing magnetic resonance imaging (MRI) contrast agents - Update
Information from the MHRA site is available for Download
Lenalidomide (Revlimid)
June 19 2007
Lenalidomide is teratogenic and therefore contraindicated in pregnancy; it is also contraindicated in women of childbearing potential unless all conditions of the Pregnancy Prevention Programme are met.
Information from Celgene is available for Download
Rosiglitazone (Avandia)
May 26 2007
MHRA statement on cardiac safety of rosiglitazone (Avandia) is available for Download
Bevacizumab (Avastin)
May 08 2007
Occurrence of tracheoesophageal fistula during study of chemotherapy plus radiography plus Avastin in patients with limited-stage small-cell lung cancer (unapproved indication)
Information from Roche Pharmaceuticals is available for Download
Triamcinolone acetonide (Adcortyl/Kenalog) injections
May 07 2007
Cases of endophthalmitis, eye inflammation, increased intraocular pressure and visual disturbances after unapproved route of intraocular administration
Information from Bristol Myers Squibb Pharmaceuticals is available for Download
Cabergoline (Cabaser)
April 12 2007
Pathological gambling and increased libido are potential class effects of dopamine agonists
Information issued by Pfizer Global is available for Download
Risk of fibrotic cardiac valvuopathy: important information about second-line indication, contraindications, and new monitoring requirements
Information issued by Pfizer Global is available for Download
Pioglitazone containing products (Actos, Compectact, Glustin, Tandemact)
April 11 2007
Risk of fractures in women on long term treatment
Information issued by Takeda UK Ltd is available for Download
Rituximab (Mabthera)
April 02 2007
Reports of progressive multifocal leukoencephalopathy in unapproved indications of systemic lupus erythematosus and vasculitis.
A drug warning issued by Roche Pharmaceuticals is available for Download