• Natalizumab (Tysabri): risk of progressive multifocal leukoencephalopathy increases after two years of therapy.
• Fluoxetine: possible small risk of congenital cardiac defects, similar to that with paroxetine.
• Sirolimus: different immunoassays for therapeutic drug monitoring—risk of incorrect dose adjustment.
• Drug Safety Update gains NHS Evidence accreditation.
• MHRA conference for doctors in training.
• Patient Information Leaflet of the month: Human Varicella-Zoster Immunoglobulin vaccine.

• 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.
• Orlistat safety update.
• Nicotine replacement therapy and harm reduction.
• Sibutramine: suspension of EU licenses recommended as evidence indicates risks outweigh benefits.
• Off-label intraocular use of recombinant tissue plasminogen activator: risk of intraocular lens opacification.
• Please report suspected adverse reactions associated with intra-articular use of local anaesthetics.

The European-wide review of the anti-obesity drug sibutramine (Reductil) has concluded and an opinion reached recommending the suspension of the licence for the medicine across Europe.

Evidence suggests that there is an increased risk of non-fatal heart attacks and strokes with this medicine that outweighs the benefits of weight loss, which is modest and may not be sustained in the long term after stopping treatment.

Prescribers are advised not to issue any new prescriptions for Reductil and to review the treatment of patients taking the drug.

Pharmacists are asked to cease dispensing the medicine. People who are currently taking Reductil are advised to make a routine appointment with their doctor to discuss alternative measures to lose weight. There are no health implications if people wish to stop treatment before seeing their doctor.

The EMEA document [PDF] and Questions and Answers [PDF]

HLA-B*1502 may be associated with an increased risk of developing SJS in individuals of Thai or Han Chinese ethnic origin when treated with phenytoin. If these patients are known to be HLA-B*1502-positive, phenytoin should be avoided when alternative therapy can be given. Use of phenytoin should only be considered if the benefits are thought to outweigh the risks

• In the Caucasian and Japanese population, the frequency of HLA-B*1502 is extremely low, and thus it is not possible at present to conclude on risk association. Adequate information about risk association in other patients of other ethnic origin is currently not available

as well as, gadolinium-containing contrast agents, and methylphenidate in children.

HPV vaccination
Varenicline and self-harm
Uncomfortable ulcers: Nicorandil-induced genital ulcers.

[PDF]

Report here: http://www.yellowcard.gov.uk

• 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
• Smoking and smoking cessation: clinically significant interactions with commonly used medicines
• Aspirin: not licensed for primary prevention of thrombotic vascular disease
• Varenicline and suicidal behaviour: cohort study provides some reassurance

Varenicline: evaluation of the utility of spontaneous consumer reports of suspected adverse effects filed on internet sites [PDF]

Here is a poster we are presenting at the International Society of Pharmacovigilance conference this week.

Angioedema associated with angiotensin-II receptor blockers: a DoTS classification
and analysis [PDF].