admin May 12th, 2010
The MHRA have published Drug Safety Update May 2010. Subjects include:
- SSRIs and SNRIs: risk of persistent pulmonary hypertension in the newborn
- Antidepressants: risk of fractures
- Carbapenems: concomitant use with valproic acid not recommended
- Oral tacrolimus products: measures to reduce the risk of medication errors
- Simvastatin: increased risk of myopathy at high dose (80 mg)
- Panitumumab (Vectibix): serious hypersensitivity reactions
admin April 28th, 2010
Recently in the UK, tamulosin has been given OTC status. Lucy Titcomb and Jacqueline Jones of the UK Ophthalmic Pharmacy Group have an interesting letter published in The Pharmaceutical Journal about the incidence of Floppy Iris Syndrome associated with tamulosin.
Although mention of IFIS during cataract surgery is made in the special warnings and precautions for use in the summary of product characteristics (SPC) for Flomax Relief MR, and is referred to in the patient information leaflet as a very rare side effect affecting less than 1 in 10,000 people, this is far from what is seen in clinical practice.
Since the syndrome was first reported, there have been many publications confirming the association between IFIS and tamsulosin treatment. In a review of this association published in 2009, Leibovici et al3 report the occurrence of IFIS in patients exposed to tamsulosin to be between 57 and 100 per cent compared with 0 to 5 per cent in those not exposed to the drug.
The age group of men suffering from BPH and that of those undergoing cataract surgery are similar and therefore we would expect a substantial number of patients treated with tamsulosin to present for cataract surgery. Pharmacists recommending over-the-counter tamsulosin to men who present with symptoms of BPH need to emphasise the importance of avoiding starting tamsulosin where cataract surgery is likely to be scheduled in the near future.
Whether bought OTC or obtained on prescription, it is vital that ophthalmologists are made aware that a patient is taking or has taken tamsulosin so that cataract surgery can be assigned to a surgeon experienced in dealing with IFIS as the syndrome has been reported after as short a period as two days of taking tamsulosin
admin April 8th, 2010
The YCCWM now has a twitter feed @yccwm.
admin April 8th, 2010
The MHRA have published Drug Safety Update: Volume 3, Issue 9, April 2010 which includes this month:
- Yasmin: update on risk of venous thromboembolism
- Clopidogrel and proton pump inhibitors: interaction – updated advice
- Intravenous zoledronic acid: adverse effects on renal function
- Parenteral amphotericin B: fatal overdose risk due to confusion between lipid-based and non-lipid-based formulations
- Rifadin infusion (rifampicin): new solvent formulation and changes to compatible diluents
- Becaplermin (Regranex) for diabetic ulcers: contraindicated in patients with any known current cancer
- MHRA conference for doctors in training
- Patient information leaflet of the month: Methotrexate Tablets
admin March 11th, 2010
The MHRA have published the March issue of Drug Safety Update, including:
- 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.
admin February 15th, 2010
A member of our staff has written an editorial on the story of MMR vaccine and autism for The Pharmaceutical Journal.
admin February 15th, 2010
Drug Safety Update has been issued, including the following 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.
- 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.
admin January 22nd, 2010
Sibutramine has been withdrawn.
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]
admin January 13th, 2010
The MHRA have published a new Drug Safety Update (January 2010 [PDF]), which includes information on phenytoin:
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.
admin November 30th, 2009
The Yellow Card Centre West Midlands has issued re:Action number 38:
HPV vaccination
Varenicline and self-harm
Uncomfortable ulcers: Nicorandil-induced genital ulcers.
[PDF]
