-
Measure serum immunoglobulin levels if recurrent infections develop. Consider bronchiectasis or pulmonary fibrosis if patients develop persistent respiratory symptoms.
-
…Patients who are co-infected with hepatitis B and C viruses are at risk of hepatitis B reactivation, and should be monitored and managed according to current clinical guidelines.
-
Patients with active infection with this virus should not be treated with ofatumumab.
-
Establish hepatitis B status before initiating carfilzomib and in patients with unknown hepatitis B virus serology who are already being treated with carfilzomib.…
-
Establish hepatitis B virus status before initiating daratumumab and in patients with unknown hepatitis B virus serology who are already being treated with daratumumab.…
-
…Establish hepatitis B virus status before initiating ibrutinib. Consider prophylaxis for patients who are at an increased risk of opportunistic infections.…
-
Before starting treatment with pomalidomide, establish hepatitis B virus status in all patients.…
-
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.
-
In April 2016, letters were sent regarding canagliflozin (Invokana▼, Vokanamet▼), BCR-ABL tyrosine kinase inhibitors, pomalidomide (Imnovid▼), and retigabine (Trobalt)
-
Recent clinical trials have shown increased mortality when bendamustine (Levact) was used in combination treatments outside its approved indications. Be aware that the risk of opportunistic infections for all patients receiv…
-
Letters were sent about ibrutinib, daclizumab, aflibercept, valproate medicines, and arsenic trioxide.
-
…Do not use daclizumab in patients with pre-existing hepatic disease or hepatic impairment.…
-
Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
-
We are aware of reports of serious liver injuries and deaths in patients with primary biliary cholangitis with pre-existing moderate or severe liver impairment who were not adequately dose-adjusted. Follow dose reduction and…
-
…Discontinue or interrupt cladribine if significant hepatic injury is confirmed.
-
Medicines or herbal remedies that induce CYP3A4 enzymes reduce blood levels of levonorgestrel, which may reduce emergency contraceptive efficacy.
-
Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
-
Cases of serious liver injury with elevated transaminases and bilirubin have been reported during treatment with Kaftrio–Kalydeco combination therapy. In all patients, measure alanine aminotransferase (ALT), aspartate aminot…
-
Letters were sent about Myocrisin (sodium aurothiomalate), Cerliponase alfa (Brineura▼), Darzalex▼(daratumumab), retinoids▼, and febuxostat (Adenuric). A recall alert was issued for medicines that were taken out of the regul…
-
Patients who take telbivudine and pegylated interferon are at increased risk of peripheral neuropathy and should stop taking both medicines if symptoms occur.
-
A summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.
-
Healthcare professionals should monitor the use and safety of antiretroviral drugs for the treatment of HIV as they are advanced.
-
The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
-
Healthcare professionals prescribing nitrofurantoin should be alert to the risks of pulmonary and hepatic adverse drug reactions and advise patients to be vigilant for the signs and symptoms in need of further investigation.…
-
Liver function should be tested before and during treatment with temozolomide.
-
Liver function tests should be carried out at treatment initiation, during treatment, and also when the dose is increased.
-
Routine monitoring of liver function now recommended.
-
INR should be monitored closely during treatment of chronic hepatitis C with direct-acting antivirals in patients also receiving vitamin K antagonists (eg, warfarin), because of possible changes in liver function during treatment.…
-
Monitor glucose levels closely in patients with diabetes during direct-acting antiviral therapy for hepatitis C, particularly within the first 3 months of treatment, and modify diabetes medication or doses when necessary.…
-
Test liver function before and during treatment and tell patients to avoid sunlight exposure.
-
Suspension of the licences (marketing authorisations) for Octagam (intravenous human normal immunoglobulin 5% and 10%) lifted.
-
…Discontinue fingolimod if significant hepatic injury or herpes meningoencephalitis is confirmed.…
-
Serious liver injury has been reported during treatment with pirfenidone in the first year after initiation, including 2 cases with a fatal outcome. Measure alanine aminotransferase (ALT), aspartate aminotransferase (AST), a…
-
While an urgent EU-wide review of new information on liver safety is under way, promptly review patients on treatment. Only initiate daclizumab in restricted groups of patients with limited treatment options and keep all pat…
-
Patients who use products that contain maltose, xylose, or galactose should use glucose-specific monitors.
-
Reminder on risk of serious and fatal toxicity in overdose.
-
While an urgent EU safety review evaluates reports of serious cardiovascular events and immune-mediated reactions, including autoimmune hepatitis, the use of alemtuzumab (Lemtrada) has been restricted and strengthened requirements have been introduced to monitor vital signs and liver function…
-
Sitaxentan (Thelin▼) withdrawn due to hepatotoxicity.
-
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.
-
Topical oral salicylate gels are no longer indicated for people younger than 16 years for pain associated with infant teething, orthodontic devices, cold sores, or mouth ulcers.
-
New monitoring instructions to detect these side effects as soon as possible.
-
Prescribers should be vigilant for possible thrombotic adverse reactions.
-
A review of the benefits and risks of alemtuzumab (including fatal reactions) in the treatment of multiple sclerosis has now concluded and recommended a revised indication, additional contraindications, and strengthened moni…
-
Avoid concomitant use of amiodarone with simeprevir (Olysio▼) and sofosbuvir (Sovaldi▼) combination therapy, unless other antiarrhythmics cannot be given.
-
Avoid concomitant use of amiodarone with ledipasvir-sofosbuvir (Harvoni▼), and amiodarone with sofosbuvir (Sovaldi▼) and daclatasvir (Daklinza▼), unless other antiarrhythmics cannot be given.
-
-
Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) levels should be measured before starting treatment with tocilizumab and monitored every 4–8 weeks for the first 6 months of treatment followed by every 12 …
-
Patients receiving apomorphine and domperidone require an assessment of cardiac risk factors and ECG monitoring to reduce the risk of serious arrhythmia related to QT-prolongation.
-
A summary of letters and drug alerts recently sent to healthcare professionals.
-
If bilirubin and/or creatinine test results are inconsistent with clinical observations, request re-testing using another method to determine the validity of the result.