-
Letters were sent about Arsenic Trioxide (Trisenox), Uptravi▼ (selexipag), DepoCyte (cytarabine), Cinryze▼ (C1 esterase inhibitor [human]), and Clexane (enoxaparin sodium).
-
Healthcare professionals should be aware of the potential for delayed onset of angioedema and the distinction between bradykinin- and histamine-mediated cases, as treatment strategies differ significantly and bradykinin-medi…
-
We inform healthcare professionals of new risk minimisation measures for JAK inhibitors used to treat chronic inflammatory disorders, consistent with the measures introduced for tofacitinib (Xeljanz) in 2020 and 2021.…
-
…Cases of interstitial lung disease and pneumonitis have been reported in patients receiving CDK4/6 inhibitors indicated for some breast cancers.…
-
The MHRA has reviewed the evidence for finasteride and dutasteride and the risk of suicidal thoughts and behaviours and has recommended further measures to minimise this risk.
-
Saquinavir at a reduced dose for the first week of treatment
-
Patients should use the lowest effective dose, and the shortest duration of treatment necessary to control symptoms.
-
If Fournier’s gangrene is suspected, stop the SGLT2 inhibitor and start treatment urgently (including antibiotics and surgical debridement). Fournier’s gangrene is a rare but potentially life-threatening infection that requires urgent medical attention.…
-
Test for raised ketones in patients with ketoacidosis symptoms, even if plasma glucose levels are near-normal.
-
SGLT2 inhibitor treatment should be interrupted in patients who are hospitalised for major surgical procedures or acute serious medical illnesses and ketone levels measured, preferably in blood rather than urine.…
-
With the exception of medicines containing zidovudine, stavudine, or didanosine, product information will no longer include warnings on fat redistribution or lactic acidosis.
-
Risk of tuberculosis - screen all patients before starting treatment and monitor them closely.
-
New warnings due to risk of hyperkalaemia, hypotension, and impaired renal function have been agreed following an EU-wide review.
-
In light of feedback, we have clarified our article on concomitant use of these medicines in heart failure.
-
In light of the most recent evidence, the previous advice on the concomitant use of clopidogrel with proton pump inhibitors has now been modified. Use of either omeprazole or esomeprazole with clopidogrel should be discouraged.…
-
Test for raised ketones in patients with acidosis symptoms, even if plasma glucose levels are near-normal.
-
Canagliflozin may increase the risk of lower-limb amputation (mainly toes) in patients with type 2 diabetes. Evidence does not show an increased risk for dapagliflozin and empagliflozin, but the risk may be a class effect. P…
-
Patients should be tested for hepatitis B virus before starting treatment with BCR-ABL tyrosine kinase inhibitors.
-
Possible illicit drug use should be considered when prescribing medicines that have the potential to interact adversely.
-
Patients who present with acute or worsening signs and symptoms of keratitis should be referred promptly to an ophthalmology specialist.
-
Further evidence that the cardiovascular risk with diclofenac is higher than other non-selective NSAIDs and similar to the selective COX-2 inhibitors.
-
…In patients who receive a systemic VEGF pathway inhibitor, reduce as far as possible any modifiable risk factors such as hypertension.
-
A UK and Europe-wide review of available efficacy and safety data confirmed that reboxetine has benefit over placebo in its authorised indication.
-
There have been reports of acute pancreatitis associated with drugs in the dipeptidylpeptidase-4 (DPP-4) inhibitor class of antidiabetic agents (‘gliptins’).
-
Use in women who are planning pregnancy should be avoided unless absolutely necessary, in which case the potential risks and benefits should be discussed
-
The maximum recommended dose for simvastatin in conjunction with amlodipine and diltiazem is now 20 mg/day.
-
Mothers who are breastfeeding should not take ACE inhibitors or angiotensin II receptor antagonists in the first few weeks after delivery.…
-
New contraindications and warnings for combination of aliskiren (Rasilez) with angiotensin-converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs).
-
Tapentadol may increase seizure risk in patients taking other medicines that lower seizure threshold, for example, antidepressants and antipsychotics. Serotonin syndrome has also been reported when tapentadol is used in comb…
-
Key MHRA advice and guidance issued so far on medicines safety and pharmacovigilance, including on reporting to the Yellow Card Scheme.
-
Tofacitinib should not be used in patients older than 65 years of age, people who are current or past smokers, or individuals with other cardiovascular (such as diabetes or coronary artery disease) or malignancy risk factors…
-
Drug interactions involving CYP2D6, genetic variants, and variability in clinical response
-
Use during breastfeeding
-
Healthcare professionals should monitor the use and safety of antiretroviral drugs for the treatment of HIV as they are advanced.
-
Coadministration of a corticosteroid with an HIV-treatment-boosting agent may increase the risk of adrenal suppression due to a pharmacokinetic interaction.
-
Cases of serotonin syndrome have been identified in associated with bupropion, especially in overdose or when bupropion is administered with other drugs with a serotonergic effect.
-
Proton pump inhibitors (PPIs) are associated with very infrequent cases of subacute cutaneous lupus erythematosus (SCLE), a non-scarring dermatosis that can develop in sun-exposed areas.
-
The authorisation holder for dapagliflozin has withdrawn the indication for type 1 diabetes mellitus. The removal of the type 1 diabetes indication is not due to any new safety concerns and the other indications of dapaglifl…
-
There have been reports of rejection of solid organ transplants in patients treated with nivolumab or pembrolizumab. Ipilimumab (Yervoy▼) may also interfere with immunosuppressive therapy, increasing the risk of graft reject…
-
Detailed recommendations for dose restrictions when used with some other drugs as interactions may increase the risk of adverse effects, or reduce the effectiveness of statin treatment.
-
How MHRA monitors the impact of regulatory action taken.
-
New maximum daily dose restrictions (including in elderly patients), contraindications, and warnings.
-
Aceclofenac is now contraindicated in patients with certain established cardiovascular diseases.
-
Avoid use in patients with previous or existing psychiatric symptoms and discontinue treatment if new or worsening psychiatric symptoms occur.
-
Prescribing advice should be followed carefully, particularly recommended upper dose limits due to associated higher gastrointestinal risk than most other NSAIDs in the class.
-
Indication restricted to second-line treatment and contraindicated with some cardiovascular conditions and medicines
Furthermore, cilostazol is now contraindicated in patients with any of the following:
Unstable ang…
-
Caution should be used in patients with known risk factors for venous thromboembolism in addition to the underlying disease. Patients older than 65 years of age are at an increased risk of serious infections and should be tr…
-
Mirabegron is now contraindicated in patients with severe uncontrolled hypertension; advice about regular monitoring is being introduced because of cases of severe hypertension.
-
Healthcare professionals should consider measuring magnesium levels before starting PPI treatment and repeat measurements periodically during prolonged treatment.
-
You should take caution when you use NSAIDs in patients with renal impairment or are at risk.