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

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

[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].

Cox AR. Assessing, managing and reporting adverse drug reactions may better equip us to minimise medicines-related harm. Pharmacy in Practice 2008;18(2):57-61

A PDF version is here, courtesy of Medicom. (Note this version contains a correction referred to in the following edition of Pharmacy in Practice.

Duphaston/Duphaston HRT (dydrogesterone) is to be withdrawn from the market from March 2008 for commercial reasons.

Duphaston was licensed for use in several indications, including threatened or recurrent miscarriage, dysfunctional uterine bleeding, and hormone replacement therapy.

A Public Assessment Report available for download below reviews evidence for the efficacy of progesterone and dydrogesterone in the maintenance of pregnancy in women with threatened miscarriage or recurrent miscarriage.

For several decades, progesterone and progestogens (such as dydrogesterone) have been used to maintain early pregnancy.

The public assessment report is here [PDF].

The concern about lumiracoxib’s▼ potential for rare but serious, even fatal liver reactions must feature in prescribing decisions about the drug, along with the increased risk of thrombotic events seen with all coxibs (note that all coxibs are now contraindicated for people with established ischaemic heart disease, cerebrovascular disease and peripheral artery disease, and individual risk assessment is appropriate for patients with risk factors for cardiovascular events)

There are at least 28 case reports of QT prolongation and TdP, some with fatal outcome in the context of off-label intravenous haloperidol. Healthcare professionals should consider this new risk information when making individual treatment decisions for their patients.

More at the FDA.

Following consultation with the MHRA and other European regulators, the manufacturer of the osteoarthritis drug lumiracoxib (Prexige), is writing to health professionals to inform them of new restrictions on the prescribing of lumiracoxib. Concern was raised worldwide after rare reports of serious liver reactions; mostly relating to daily doses that are higher than licensed in the EU.

The new measures include regular liver monitoring for patients taking lumiracoxib. In addition, lumiracoxib should not be used in patients with current liver disease or those thought to be at possible risk because of their previous history or other medicines.

The balance of risks and benefits of lumiracoxib in the treatment of osteoarthritis will be further evaluated by European Regulatory Authorities in September. Any updated advice will be issued following that evaluation.

Read on…

On 16 June 2007 the Japanese Ministry of Health Labour and Welfare announced that by 31 May 2007 it had received 1377 reports of adverse reactions since 2001, when marketing of oseltamivir started in Japan.

Of these, 567 were serious neuropsychiatric cases, 211 showing abnormal behaviour. The number of deaths reported was 71. These are not only “adverse events” but also “adverse reactions” to oseltamivir because many doctors classed and reported them as probably related or that causality could not be ruled out.

The letter is correct to note that spontaneous reports to regulatory authorities are not adverse events (any event that occurs after the use of a drug with no assessment of causality), since the suspicion of the doctor that the drug was the cause of the event makes them adverse reactions (events that are suspected to be causally-related to the use of a drug). However, it is also important to note that such suspicions are not clear evidence of causality. It is over-simplistic to accept the decision of a doctor to report to a spontaneous reporting system as evidence of causality. Firstly, spontaneous reporting schemes specifically ask for doctors to report possible reactions, not those they have clear causality for. Secondly, the assessment of causality is highly variable between clinicians, especially if the judgement is based on non-expert opinions without the use of a standard algorithm. For this reason, the more cautious interpretation of Dr Simon R J Maxwell may well be the more sensible approach:

Before 2007, there had already been more than 100 reports of neuropsychiatric events (including delirium, convulsions, and encephalitis) with oseltamivir in children, almost entirely from Japan, which has the highest usage of oseltamivir worldwide. However, these disturbing events had to be seen in the context of the millions of prescriptions worldwide and the fact that abnormal behaviour could also be due to flu or disease related complications. Indeed, a Food and Drug Administration (FDA) review of clinical trial and postmarketing data concluded that these events were not clearly drug related but might be related to higher rates of flu related encephalitis in Japan. Since last November, the FDA has required that doctors be warned that patients should be closely monitored for signs of abnormal behaviour throughout the treatment period and the European Medicine Evaluation Agency (EMEA) took similar steps in February.

The controversy about oseltamivir is a further reminder that, although common adverse effects of a drug may emerge in prelicensing studies, the detection of rarer and potentially more serious events has to await exposure of large numbers of patients. In the UK, oseltamivir is a “black triangle” drug, so it remains under more intensive surveillance. Doctors and other healthcare professionals should report all minor as well as serious adverse events via the yellow card scheme.

It is also notable that the Japan Institute of Pharmacovigilance is non-profit making organisation that argues against the use of flu vaccine and anti-pyretics, as well as publishing articles suggesting that “High cholesterol level makes a long life“. Things you may wish to bear in mind when assessing their views on drug safety.