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Osteonecrosis of the external auditory canal has been reported very rarely (fewer than 1 in 10 000 patients) with bisphosphonates, mainly in association with long-term therapy (2 years or longer).
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Patient reminder cards about the risk of osteonecrosis of the jaw are being introduced; denosumab 120 mg is now contraindicated in patients with unhealed lesions from dental or oral surgery.
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EU review confirms that the cardiovascular risk of high-dose ibuprofen (≥2400mg/day) is similar to COX 2 inhibitors and diclofenac.
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Last month, letters were sent regarding ketoprofen gel, fingolimod (Gilenyaâ–¼) and efavirenz (Sustiva).
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The new module helps clinicians understand how to identify, manage and avoid side effects when using corticosteroids.
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If you suspect exfoliative dermatitis caused by an adverse drug reaction to ustekinumab, stop treatment.
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Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
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Oral diclofenac is associated with a small increased risk of cardiovascular side effects and is therefore no longer available over the counter.
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Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
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From October 2014 Dexamethasone 4 mg/ml injection (Organon Laboratories Limited) will be replaced by Dexamethasone 3.8 mg/ml solution for injection (Aspen Pharma Trading Limited).
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Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
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Restricted indication and new monitoring requirements.
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Screening for hepatitis B virus is now recommended in all patients (not only those at risk of this infection) before starting treatment for all indications.
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New recommendations after a Europe-wide review of cardiovascular safety.
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Rare cases of atypical femoral fracture with long-term use.
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The non-identical nature of biological medicines and vaccines means it is very important that safety surveillance is carried out on a brand/product-specific basis.
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Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
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Fatal cases of severe symptomatic hypocalcaemia, and risk of hypocalcaemia at any time during treatment.
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Febuxostat must be stopped immediately if hypersensitivity occurs and must not be re-started in patients who have ever developed a hypersensitivity reaction to febuxostat.
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Atypical femoral fractures reported rarely with bisphosphonate therapy, mainly in patients receiving long-term treatment for osteoporosis.
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A case of progressive multifocal leukoencephalopathy (PML) with a fatal outcome was reported in a patient with rheumatoid arthritis who had not previously received treatment with methotrexate or a TNF antagonist.
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Reminder on risk of serious and fatal toxicity in overdose.
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All patients with cancer should have a dental check-up before bisphosphonate treatment.
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A reminder for those who use topical ketoprofen to avoid direct sunlight, ultraviolet rays, sunbeds or sunlamps.
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You should take caution when you use NSAIDs in patients with renal impairment or are at risk.
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Spontaneous reporting on the Yellow Card portal has provided important information in the identification of PML associated with some drugs.
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Do not prescribe etoricoxib to patients whose blood pressure is persistently above 140/90 mmHg and inadequately controlled.
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Clinical trial results suggest an increased risk of atrial fibrillation for zoledronic acid (Aclastaâ–¼), pamidronic acid, and possibly for alendronic acid, although the balance-risk remains favourable for bisphosphonates.
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Marketing authorisations for carisoprodol are to be suspended after a European review concluded that the risks of treatment outweigh the benefits.
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Patients should use the lowest effective dose, and the shortest duration of treatment necessary to control symptoms.
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To avoid the risk of air embolism, these products should not be infused under pressure.
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Systemic piroxicam should be initiated only by specialists as a second-line treatment for arthritis, with patients who currently take piroxicam reassessed at a routine appointment.
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Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.