Janessen-Cilag has discontinued Gynol II®, a spermicidal jelly containing nonoxinol '9'.
Ortho-creme contains the same active ingredient but it is a cream base rather than a jelly. The tube size is also slightly smaller at 70g compared to 81g in Gynol II.
Action: Ortho-creme may be a suitable alternative for patients who are currently using Gynol II with good effect.
Inhaled Insulin (Exubera)® is already receiving media attention despite the product not being launched yet.
It is likely that a great many patients will be disappointed when the product is launched because there are several contraindications and monitoring issues associated with this novel product.
Inhaled Insulin is a short acting insulin for the treatment of Type I and Type II diabetes however it is not recommended for use in the following patients:
- Current smokers
- Any who has smoked in the last 6 months
- Patients with poorly controlled, unstable or severe asthma
- Patients with severe COPD
- Patients with Heart Failure and compromised lung function
- Patients under the age of 18
Any patient who is initiated on inhaled insulin should also undergo a baseline assessment of lung function using spirometry to assess FEV1. This test should be repeated at 6 months in all patients and periodically thereafter depending upon the decline in lung function. Patients whose lung function is confirmed as having declined by 20% or more should have treatment stopped.
This insulin is also a short acting insulin and many patients will still need to inject an intermediate or long acting insulin. This removes the main advantage for needle phobic patients if injections will still be necessary.
Action: Inhaled insulin will be suitable for a relatively small number of patients given the contraindications and also comes with some intensive monitoring requirements. Uptake should be initiated and initially managed in a secondary care setting.
Diabetes Care has published a paper comparing immediate release (IR) metformin to a once-daily extended-release product (Glumetza)®.
The study recruited patients with Type II Diabetes with elevated HbA1c and fasting plasma glucose (FPG). Approximately 50% of the patients were treatment naive, 25% had been on metformin monotherapy, 15% on sulphonylurea monotherapy and 10% on a combination of metformin and sulphonylurea. Patients were randomised to one of four treatment options as follows:
- Metformin SR 1500mg once daily
- Metformin SR 1500mg twice daily
- Metformin SR 2000mg once daily
- Metformin IR 1500mg twice daily
Comparable reductions were seen in HbA1c and FPG in all groups and the rate of adverse gastrointestinal events was also similar in all groups. There was more nausea reported in the IR metformin group however discontinuation rates were not statistically different between the groups.
The product used in this study is not available in the UK however there is a sustained release version of metformin (Glucophage SR)® that also failed to demonstrate superior tolerability in a randomised controlled trial. As reported earlier, the Scottish Medicines Consortium rejected Glucophage SR for use on the NHS in Scotland.
Action: IR Metformin remains the first line treatment choice in patients with Type II Diabetes. SR Metformin fails to offer any advantages over IR Metformin.
The manufacturer of Linezilid (Zyvox)® has written to clinicians to inform them of an update to the Summary of Product Characteristics to include an additional safety warning.
The new warning has been made in response to post marketing surveillance data collected that linked use of the drug to peripheral neuropathy and optic nerve neuropathy potentially leading to loss of vision. These effects primarily occurred in patients using the drug for longer than maximum recommended duration of 28 days.
This drug is mainly used in hospital settings however some areas have explored the possibility of providing this drug under a shared care arrangements with clinicians in primary care. Linezolid already requires weekly monitoring of full blood count.
Action: In light of this new safety warning linezolid appears to be unsuitable for shared care. Clinicians are reminded that the recommended treatment duration is 10-14 days with a maximum duration of 28 days.
The Prescription Pricing Authority has published information regarding the changes to Controlled Drug legislation.
The Safer Management of Controlled Drugs section of the website contains information for prescribers, community pharmacists, primary care trusts and patients. It highlights many of the practical changes that will occur following the changes in legislation.
Action: This information is a useful summary of the new roles and responsibilities to ensure readiness for the changes.