The manufacturer of orlistat (Xenical®) has written to healthcare professionals advising that there is a stock shortage of this product.
The shortage is due to manufacturing issues and the manufacturer has now exhausted supplies in their distribution centres. There are likely to be some supplies currently in the wholesaler chain and on pharmacy shelves. The letter does not give an explicit indication when supplies will resume but the manufacturer states it "will issue further communications over the next few weeks".
Action: Clinicians should be aware of this expected shortage. Alternative treatment options are limited so it may be prudent to limit new initiations and to advise existing patient to try alternative outlets when caching prescriptions.
Update: The Pharmaceutical Services Negotiating Committee have reported on this same issue but have noted that generic alternatives are available. This may limit any impact of this shortage.
Update 2: As of 21 March 2012, the Pharmaceutical Services Negotiating Committee have added an update to their site advising that Xenical® is expected to be out of stock for several months.
Update 3: As of 31 July 2012, the manufacturer of orlistat announced that corrective actions are now being taken to manufacture and re-supply to the market as quickly as possible. A further update will be made at the end of August although this will not necessarily mean supplies return at that time.
Update 4: On the 31st of August the manufacturer of orlistat stated that "Stocks of Xenical will be available at wholesalers AAH Pharmaceuticals and Alliance Healthcare Ltd by Wednesday 5th September 2012." So, supplies should be here soon but bear in mind it will take a little while longer for the stock to move from wholesalers to individual pharmacies and that back orders may result in continued supply problems until the supply situation stabilises again.
The British Journal of Clinical Pharmacology has published the results of a study that aimed to assess the relationship between use of selective serotonin reuptake inhibitors (SSRIs) and injurious falls in nursing home residents with dementia. A press release has also been issued which has raised awareness in the general media (BBC).
This paper reviewed daily drug use and daily falls as recorded in 248 nursing home residents for a two year period starting January 2006. The average age of the study group was 82. This daily data collection results in a 85,074 person-day dataset. 152 residents sustained 683 falls, with 38 individuals falling on one occasion and 114 individuals falling more than once. The fall incidence was 2.9 falls per person per year.
SSRIs were used on a total of 11,105 person-days of the analysis period. A significant association was found between the risk of an injurious fall and increasing age, antidepressant use and antipsychotic use.
Dose-response relationships were also assessed by correcting drug dosage to a proportional "daily defined dose". Daily defined dose is a measure of drug consumption produced by the World Health Organization. Data models for a typical 85 year old female resident showed that, compared with non-use of an SSRI, a 0.25 proportional dose increased the risk of an injurious fall by 31%. A 0.5 proportional dose increased risk by 73% and 1.0 proportional use increased the risk by 198%. This risk increased even further with concomitant use of other sedatives or hypnotics.
The authors note that the study may be limited due to the data coming from a single nursing home establishment and that there were no users of fluoxetine or escitalopram during the study period.
The authors conclude that, "even at low doses, SSRIs are associated with increased risk of an injurious fall in nursing home residents with dementia".
Action: Clinicians should be aware of this new research linking SSRIs with falls. It may be prudent to consider the risk of falls and use the lowest effective dose of SSRIs when treating depression in elderly patients with dementia.
The Scottish Medicines Consortium (SMC) has issued its monthly advice on new medicines.
Exenatide once weekly (Bydureon®) has been accepted for restricted use in the treatment of type 2 diabetes mellitus in combination specified oral hypoglycaemic agents when adequate glycaemic control is not achieved despite being on maximally tolerated doses of these oral therapies. The restriction places this treatment as third line treatment option.
Fentanyl single dose nasal spray (Instanyl) has been accepted for restricted use for the management of breakthrough pain in adults already receiving maintenance opioid therapy for chronic cancer pain. The restriction allows use in patients who are unsuitable for other short-acting oral opioids (e.g. oral morphine) as an alternative to other buccal and sublingual fentanyl preparations.
Linagliptin (Trajenta®) has been accepted for restricted use in the treatment of adults with type 2 diabetes mellitus to improve glycaemic control. The restriction allows use in combination therapy with metformin when diet and exercise plus metformin alone does not provide adequate glycaemic control in patients for whom the addition of a sulphonylurea is inappropriate.
Ranolazine (Ranexa®) has been rejected for use as an add-on therapy for the symptomatic treatment of patients with stable angina pectoris who are inadequately controlled or intolerant to first-line anti-anginal therapies. The clinical and economic case was insufficiently robust to gain acceptance.
Action: Clinicians should be aware of the recommendations of the SMC. Routine use of rejected and restricted medicines should be avoided.
The Medicines and Healthcare products Regulatory Agency (MHRA) has published Drug Safety Update for January 2012 (PDF).
This issue contains drug safety information regarding clinically important increases in blood pressure and/or heart rate caused by atomoxetine (Strattera®). A recent review of clinical trial data found that in general the increases in blood pressure and heart rate were as expected (< 5 mmHg and < 10 bpm) but in between 6% and 12% of patients the increases were much higher (≥ 15–20 mmHg) or heart rate (≥ 20 bpm). Clinicians are reminded that atomoxetine is contraindicated in severe cardiovascular or cerebrovascular disorders and that pre-treatment screening and regular monitoring of cardiovascular status is recommended.
This section also advises clinicians that statins may be associated with an increased risk of hyperglycaemia and diabetes. The risk appears to be greatest in patients who are already at an increased risk of developing diabetes based on raised fasting blood glucose levels. Other risk factors include hypertension, elevated triglycerides and raised body mass index. Overall, the benefits of statins strongly outweigh any risks, even in this population subgroup.
The stop press section reminds clinicians that chlorhexidine is known to induce hypersensitivity, including generalised allergic reactions and anaphylactic shock. Although this effect is very rare, chlorhexidine is widely used in antiseptic products including some that can be purchased.
Action: Clinicians will find this publication to be a useful review of current issues in drug safety.
Prodigy has been updated in January 2012 for the following clinical areas:
Action: Clinicians who see patients with any of these conditions may find the new and updated information useful when reviewing current clinical practice.