Dexamethasone 500microgram tablets recalled
31st August 2009
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have issued a class 2 drug alert recalling the following batches of dexamethasone 500microgram tablets due to concerns with the results of stability tests.
Dexamethasone 500microgram (Essential Generics livery, Chemidex pharma)
batch numbers 9334 and 9336, first distributed on 2009-03-05 and 2009-06-12 respectively.
All unused stock of the above batches should be quarantined and returned for credit. For stock return enquiries contact Movianto Customer Care (01234 248632).
For medical information enquiries contact Chemidex Pharma (01784 477167).
We understand dexamethasone 500microgram tablets can be imported via Durbin PLC (020 8869 6555).
Update [2009-09-08]
Dexamethasone tablets 500microgram (PMS, Canada) can be obtained via Durbin PLC (020 8869 6555), 100tablets = £16.82 (based on exchange rate) + VAT + delivery charge (£5.95 + VAT per order), although currently awaiting stock delivery.
NB the product licence holder does not provide a certificate of analysis/conformity.
EMEA approves fentanyl citrate nasal spray
31st August 2009
The European Medicines Agency (EMEA) has granted a marketing authorisation for fentanyl citrate (Instanyl) nasal spray solution for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. Nycomed plans to launch the product later this year.
The product details for the lowest strength preparation 500microgram/mL (50microgram/dose), can be downloaded from the link below.
MHRA information on herbal products
24th August 2009
The latest UK Medicines and Healthcare products Regulatory Agency (MHRA) drug safety update contains information on herbal products and Traditional Herbal Registration (THR). A product with a THR number will have been assessed by the MHRA for safety, quality and patient information. The permitted minor indications are based on traditional use and not proven efficacy. The SPCs and PiLs for these products are contained within the public assessment reports for each THR product and can be found on the MHRA website (see below).
MHRA August 2009 drug safety update
MHRA list of THR products (public assessment reports)
MHRA herbal products website information for consumers
DH consultation on regulation of alternative medicine practitioners
24th August 2009
A joint consultation has been launched from the UK Department of Health (DH) seeking views on whether, and if so how, to regulate acupuncturists, herbal medicine practitioners and traditional Chinese medicine (TCM) practitioners. The closing date is 2nd November 2009. The consultation document and on-line response system can be accessed from the link below.
Interaction between PPIs and clopidogrel
24th August 2009
The UK Medicines and Healthcare products Regulatory Agency (MHRA) have highlighted a clinically significant interaction between Proton Pump Inhibitors (PPIs) and clopidogrel.
Several studies have found that the use of PPIs lowered the clinical effectiveness of clopidogrel in preventing the recurrence of atherothrombotic events in patients who have previously had a serious heart condition.
Clopidogrel can cause GI side effects and is therefore frequently prescribed together with a PPI.
Current advice to healthcare professionals is:
• review the need for PPI therapy in patients who are also taking clopidogrel at the next appointment. Use of these medicines together should be avoided unless considered essential
• check whether patients who are taking clopidogrel are using over-the-counter PPI omeprazole and consider whether another gastrointestinal therapy would be more suitable
• PPIs should be prescribed in line with their licensed indications where possible.
Further information can be obtained from the MHRA website link below.
NICE supplementary advice for end of life treatments
24th August 2009
The supplementary advice to be given to the UK National Institute for Clinical Excellence (NICE) appraisal committees when they are appraising treatments which may extend life, at the end of life, is now available from the NICE website (see below). This follows the consultation in December 2008. The consultation responses and summary to responses are also available.
RPSGB calls for equality in CD prescribing for pharmacists
24th August 2009
The UK Royal Pharmaceutical Society of Great Britain (RPSGB) has called for equality between nurses and pharmacists in the prescribing of controlled drugs (CD). Independent nurse prescribers are allowed to prescribe CDs in certain conditions. Currently pharmacist independent prescribers cannott prescribe CDs, even when the medicine in question is a CD which they can sell as ingredients in over the counter medicines.
FDA takes action against unapproved topical ibuprofen products
24th August 2009
The US Food and Drug Administration (FDA) has informed consumers and healthcare professionals of its intent to take action against eight companies that market unlawful over-the-counter (OTC) topical drug products containing ibuprofen.
The names of the products and manufacturers that received warning letters are:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Creme (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Creme (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)
There are currently no approved applications for topical ibuprofen products in the US.
FDA approves buccal fentanyl with REMS plan
6th August 2009
The US Food and Drug Administration (FDA) has approved a fentanyl buccal soluble film preparation (Onsolis) for breakthrough pain in cancer, in patients who already use opioid pain medication around the clock and are considered opioid tolerant. The preparation delivers the drug via an absorbable film that adheres to the inside of the cheek. The absorption profile is substantially different to other transmucosal fentanyl products and doses are not equivalent.
Onsolis was approved with a Risk Evaluation and Mitigation Strategy (REMS) plan
and will only be available through a restricted distribution program called the FOCUS program. Under this program, only registered prescribers, pharmacies and patients will be able to prescribe, dispense, and receive Onsolis. The program will provide training and educational materials to prescribers and pharmacy personnel, and a counselling call will be placed to patients prior to dispensing to ensure they have been adequately educated about the appropriate use of the drug. Prescription orders will be filled only by participating pharmacies that send the product directly to the patients' homes.
For further details see the FDA website question and answer document link below.
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