Drug safety advice
Tacrolimus: new oral liquid (Modigraf); formulations not interchangeable without careful therapeutic monitoring.
Yellow Card Scheme update
Problem with postal delivery of Yellow Cards.
Swine flu portal update
Suspected adverse reactions to flu antivirals and vaccines confirm recognised safety profile. Hot topics - Orlistat safety update.
Hot topics - Nicotine replacement therapy and harm reduction.
Stop press - Sibutramine: suspension of EU licenses recommended as evidence indicates risks outweigh benefits.
Stop press - Off-label intraocular use of recombinant tissue plasminogen activator: risk of intraocular lens opacification.
Stop press - Please report suspected adverse reactions associated with intra-articular use of local anaesthetics.
Other information from the MHRA
Patient Information Leaflet of the month: amoxicillin.

Copies of this bulletin are available for Download

---

21 January 2010

Sibutramine

Suspension of marketing authorisation as risks outweigh benefits

Information is available for Download

---

Drug Safety Update Vol 3 Issue 6 (January 2010)

Drug safety advice
Phenytoin: risk of Stevens-Johnson syndrome associated with HLA-B*1502 allele in patients of Thai or Han Chinese ethnic origin
Gadolinium-containing contrast agents: new advice to minimise the risk of nephrogenic systemic fibrosis
Hot topic - Methylphenidate: new patient information

Copies of this bulletin are available for Download

---

Drug Safety Update Vol 3 Issue 5 (December 2009)

Drug safety advice
Ciclosporin: must be prescribed and dispensed by brand name
Finasteride: potential risk of male breast cancer
Yellow Card Scheme update
Reporting of suspected adverse reactions to flu antivirals and flu vaccines
How to complete a Yellow Card
End-of-year quiz
Test your drug-safety knowledge
Stop press - Etravirine: reports of severe hypersensitivity reactions
Stop press - Rituximab: progressive multifocal leukoencephalopathy in a patient without prior treatment for rheumatoid arthritis
Stop press - Warfarin: product information to be amended to give clearer, up-to-date advice Drug alert: Recall of Gaviscon Advance Peppermint Flavour, Boots Heartburn Relief Peppermint Flavour, Peptac Peppermint Liquid, and Peptac Liquid Aniseed Flavour
Other information from the MHRA
Patient Information Leaflet of the month: Arthrotec
Quiz answers
How did you score?

Copies of this bulletin are available for Download

 

---

07 November 2009

Rituximab (MabThera)

A third case of progressive multifocal leukoencephalopathy in patients with rheumatoid arthritis receiving MabThera

Information is available for Download

---

Drug Safety Update Vol 3 Issue 4 (November 2009)

Drug safety advice
Bisphosphonates: osteonecrosis of the jaw
Vigabatrin for infantile spasms: risk of movement disorders and MRI abnormalities
Colchicine: reminder on risk of serious and fatal toxicity in overdose
Orciprenaline sulphate (Alupent): withdrawal due to unfavourable benefit-risk profile
Yellow Card Scheme update
MHRA Swine Flu ADR Portal now extended to include reporting of suspected reactions to swine influenza vaccines
Hot topic - Medical and non-medical prescribing: mixing medicines in clinical practice
Hot topic - Statins: updated product information on adverse reactions in patient leaflets
Stop press - Oseltamivir (Tamiflu): update to Patient Information Leaflet
Other information from the MHRA
Patient Information Leaflet of the month: Zocor Heart-Pro
Introduction of the Traditional Herbal Registration Certification Mark

Copies of this bulletin are available for Download

---

18 October 2009

Intelence (etravirine)

Cases of toxic epidermal necrolysis and drug rash with eosinophilia and systemic symptoms (DRESS).

Information is available for Download

---

Drug Safety Update Vol 3 Issue 3 (October 2009)

Drug safety advice
Ceftriaxone: incompatibility with calcium-containing solutions—updated advice
High-dose cyproterone acetate: potential risk of (multiple) meningiomas
Yellow Card Scheme update
Human papillomavirus (HPV) immunisation programme—first year safety review
Hot topics - Smoking and smoking cessation: clinically significant interactions with commonly used medicines
Hot topics - Aspirin: not licensed for primary prevention of thrombotic vascular disease
Stop press - Varenicline and suicidal behaviour: cohort study provides some reassurance Other information from the MHRA
Patient Information Leaflet of the month: medicines used in tuberculosis

Copies of this bulletin are available for Download

---

Drug Safety Update Vol 3 Issue 2 (September 2009)

Yellow Card Scheme update
How to complete an online Yellow Card
Hot topic - Insulin glargine (Lantus): studies of possible cancer link
Hot topic - Pseudoephedrine and ephedrine: update on measures to reduce risk of illicit use
Hot topic - Over-the-counter painkillers containing codeine or dihydrocodeine
Stop press - Clopidogrel and proton pump inhibitors: interaction—clarification
Stop press - Other information from the MHRA
Patient information leaflets of the month: Hyalgan

Copies of this bulletin are available for Download

---

Drug Safety Update Vol 3 Issue 1 (August 2009)

Hot topic - Safety information on oseltamivir (Tamiflu) and zanamivir (Relenza) for pandemic swine influenza A/H1N1
Hot topic - Herbal products: safety update
Hot topic - Monitoring the impact of regulatory action taken by the MHRA
Stop press - Rotigotine patches: lifting of prescribing restrictions
Stop press - Infant medicine feeder: recall due to overdose risk
Other information from the MHRA
Patient Information Leaflet of the month: Symbicort

Copies of this bulletin are available for Download

---

Drug Safety Update Vol 2 Issue 12 (July 2009)

Drug safety advice
Clopidogrel and proton pump inhibitors: interaction
Abacavir: risk of myocardial infarction - update from epidemiological studies
Yellow Card scheme update
You can report side effects and adverse drug interactions on a Yellow Card
Hot topic - Use of long-acting β-agonists in chronic obstructive pulmonary disease
Stop press - Mycophenolate mofetil: pure red cell aplasia
Stop press - Hydroxycut range of food supplements: risk of liver damage
Stop press - Priadel Liquid: potential for dosing errors
Stop press - Clarification: ACE inhibitors and angiotensin II receptor antagonists - use during breastfeeding
Other information from the MHRA
Patient Information Leaflet of the month: sulfasalazine
Consultation: proposals to strengthen and rationalise EU pharmacovigilance

Copies of this bulletin are available for Download

---

6 July 2009

ADR Reporting to Tamiflu, Relenza and future Swine flu H1N1 vaccines

Letter to healthcare professionals about a new online system for reporting suspected adverse drug reactions (ADRs) to Tamiflu, Relenza and future Swine flu H1N1 vaccines.

Information is available for Download

---

6 July 2009

Clopidogrel and Proton Pump Inhibitors

Information and frequently asked questions regarding interactions between the use of clopidogrel and proton pump inhibitors (PPIs).

Information is available for Download

---

Drug Safety Update Vol 2 Issue 11 (June 2009)

Drug safety advice
Antipsychotics: risk of venous thromboembolic events
Chloral hydrate (Welldorm) and Triclofos: not first-line options for insomnia
Oral salicylate gels: not for use in those younger than age 16 years
Topical ketoprofen: reminder on risk of photosensitivity reactions
Yellow Card scheme update
The Black Triangle Scheme
Hot topic - Counterfeit medicines: patient guidance for distribution via pharmacies
Stop press - Clopidogrel and proton pump inhibitors: possible interaction
Stop press - Erlotinib: new safety information
Stop press - Counterfeit insulin pen Novofine needles: vigilance needed for lot number 08J02S
Stop press - Prescription of blood lancet devices: hepatitis risk from incorrect use
Other information from the MHRA
Patient Information Leaflets of the month: Skelid for Paget’s disease
Medical devices: practice guidance

Copies of this bulletin are available for Download

---

Erlotinib (Tarceva)

26 May 2009

New safety information about the following risks: gastrointestinal perforation; bullous and exfoliative skin disorders; and ocular disorders.

Information from the manufacturer is available for Download

---

Drug Safety Update Vol 2 Issue 10 (May 2009)

Drug safety advice
Aliskiren: risk of angioedema and renal dysfunction
ACE inhibitors and angiotensin II receptor antagonists: recommendations on use during breastfeeding
Non-steroidal antiinflammatory drugs: reminder of renal failure and impairment
Yellow Card Scheme update
Patient Reporting
Hot topic - Orlistat key safety information to support pharmacy availability
Stop Press - New advice on oral salicylate gels for those younger than age 16 years
Stop Press - Fortadol: risk of derious liver damage
Other information from the MHRA
Patient Information Leaflet of the month: Caverject
MHRA-NICE London study day for doctors in training

Copies of this bulletin are available for Download

---

Drug Safety Update Vol 2 Issue 9 (April 2009)

Drug safety advice
Antiepileptics: adverse effects on bone
Methylthioninium chloride (methylene blue): update on CNS toxicity with serotonergic drugs
Yellow Card Scheme update
Human papillomavirus immunisation programme - safety update
Hot topic - Off-label or unlicensed use of medicines: prescribers’ responsibilities
Hot topic - Over-the-counter cough and cold medicines for children
Other information from the MHRA
Patient Information Leaflet of the month: Proctofoam HC
MHRA-NICE London study day for doctors in training
New MHRA webpage resource for pharmacists

Copies of this bulletin are available for Download

---

Drug Safety Update Vol 2 Issue 8 (March 2009)

Drug safety advice
Methylphenidate: updated guidance on safe and effective use in ADHD
Atomoxetine: risk of psychotic or manic symptoms
Antipsychotics: use in elderly patients with dementia
Exenatide (Byetta): risk of severe pancreatitis and renal failure
Bisphosphonates: atypical stress fractures
Yellow Card scheme update
Adverse drug reactions in focus: progressive multifocal luekoencephalopathy
Hot topic - Public perception of herbal medicines
Stop Press - Efalizumab (Raptiva): recommendation to suspend marketing authorisation
Stop Press - Patient-controlled analgesia extension sets: risk of inadequate pain relief
Stop Press - Effects of MRI on implantable drug pumps
Stop Press - Oral bowel cleansing solutions: risk of harm
Other information from the MHRA
Patient Information Leaflets of the month: smoking-cessation aids
Consultation: changes to legislation and working during an influenza pandemic

Copies of this bulletin are available for Download

---

Efalizumab (Raptiva)

20 February 2009

Recommendation to suspend marketing authorisation as risks outweigh benefits

Information from the manufacturer is available for Download

---

Bevacizumab (Avastin)

09 February 2009

Reports of severe eye inflammation and sterile endophthalmitis after off-label intravitreal use in Canada

Information from the manufacturer is available for Download

---

Toremefine (Farmeston)

02 February 2009

Risk of QT prolongation

Information from the manufacturer is available for Download
See also Drug Safety Update February 2009, p 7

---

Drug Safety Update Vol 2 Issue 7 (February 2009)

Drug safety advice
Tibolone (Livial): Increased risk of breast cancer recurrence
Non-steroidal anti-inflammatory drugs: cardiovascular risk
Yellow Card scheme update
Reporting guidance
Stop Press - Toremifene (Fareston): risk of QT prolongation
Stop Press - Methylphenidate: new guidance for use in treatment of ADHD
Stop Press - Latest safety information online
Stop Press - Correction: Temsirolimus—severe hypersensitivity reactions during infusion
Other information from the MHRA
Patient Information Leaflet of the month: Actonel-Once-a-Week
Consultation: measures to strengthen the medicines’ supply chain

Copies of this bulletin are available for Download

---

Temsirolimus (Torisel)

05 January 2009

Hypersensitivity/infusion reactions (including some life-threatening and rare fatal reactions) have been associated with the administration of temsirolimus (Torisel)

See also Drug Safety Update January 2009, p3

Information from the manufacturer is available for Download

---

Drug Safety Update Vol 2 Issue 6 (January 2009)

Drug safety advice
Piperacillin/tazobactam: compatibility of generics differs from brand leader (Tazocin)
Temsirolimus: severe hypersensitivity reactions during infusion
Tacrolimus (Advagraf and Prograf): risk of serious medication errors
Yellow Card scheme update
You can report side-effects from unlicensed medicines on a Yellow Card
Hot topic - Second birthday for European regulation of children’s medicines
Other information from the MHRA
Patient Information Leaflet of the month: Tanatril
Consultation: reclassification of Flomax to pharmacy (P) availability without prescription

Copies of this bulletin are available for Download

---

Tacrolimus (Advagraf and Prograf)

01 January 2009

Errors in prescribing, dispensing, and administration leading to serious adverse drug reactions.

Information from the manufacturer is available for Download

---

Drug Safety Update Vol 2 Issue 5 (December 2008)

Drug safety advice
Nitrous oxide: neurological and haematological toxic effects, especially with prolonged use
Rituximab and efalizumab: progressive multifocal leukoencephalopathy
Yellow Card scheme update
Highlights of 2008
End of year quiz
Test your drug safety knowledge
Stop Press - Conventional (typical) antipsychotics: increased mortality in dementia
Stop Press - Prograf and Advagraf (tacrolimus): serious medication errors
Stop Press - Norfloxacin: restricted use in urinary infections
Stop Press - Hedrin: keep treated hair away from sources of fire
Stop Press - Melanotan: an unlicensed medicine, the risks of which are unknown
Stop Press - Tigecycline reformulation affects compatibility: correction
Other information from the MHRA
Patient Information Leaflets of the month: sertraline, molipaxin, and amisulpiride

Copies of this bulletin are available for Download

---

Rituximab (Mabthera)

07 November 2008

Association with progressive multifocal leukoencephalopathy

Information from the manufacturer is available for Download

---

Efaluzimab (Raptiva)

03 November 2008

Association with progressive multifocal leukoencephalopathy

Information from the manufacturer is available for Download

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

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

 

 

Yellow Card Centre Wales
Cardiff University | Department of Pharmacology | Therapeutics and Toxicology | Heath Park | Cardiff | CF14 4XN