Browse Conditions Browse Medicines

Keep Me Informed - Patient safety updates added since April 2019

Since April 2019 Keep Me Informed have detailed over 30 patient safety warnings. Most of these relate to specific side effects that have been identified by manufacturers and resulted in amendments to the product information including the patient leaflet. Other safety information relates to interactions and contraindications (situations where a medicine should not be prescribed or prescribed with caution).

By notifying patients, carers and healthcare professionals of these side effects we hope to ensure that the information is targeted to people who have specific interest. This direct service is not available through any other source. In addition to the detailed changes made by the manufacturer we also aim to ensure that:
  • complex medical terms are explained in plain English
  • symptoms of side effects and interaction are described
An important situation we highlight is in the warnings to pregnant or breastfeeding women. Four of the warnings published are specifically about this topic.

For a list of the details please see the full article.

Feature
An adverse drug reaction is an unexpected or dangerous reaction to a drug. They impact:
  • Patient Safety
  • Quality of life
  • Adherence
  • Use of resources
  • Cost to the healthcare system
  • Cost of illness to patients
  • Medication effectiveness

Reporting of side effects is a major safety contribution by healthcare profession and patients. Reports enable the regulatory agencies to establish what information should be made available to improve safety.

The following patient safety warnings have been published on Keep Me Informed since April 2019. Click on the Medicine entry to go to the article.


Patient safety warnings
Conditions Medicine
Ingredient/Brand name
Warning
Actinic keratoses 5-aminolevulinic acid, brand name Ameluz Hypersensitivity, an uncommon adverse event, also occurs before illumination
Acute myeloid leukaemia decitabine, brand name Dacogen Hyperglycaemia added as a “very common” adverse effect
Allergy cetirizine, brand name Zirtek Caution should be exercised when prescribing cetirizine to lactating women
Anti-inflammatory medicine etanercept, brand name Benepali▼ Lichenoid skin reactions have been added as a rare adverse event
Anti-inflammatory medicine certolizumab pegol, brand name Cimzia Lichenoid skin reactions have been added as a rare adverse event
Anti-inflammatory medicine etanercept, brand name Enbrel Lichenoid skin reactions have been added as a rare adverse event
Antiphospholipid syndrome Direct oral anticoagulant therapies
rivaroxaban, brand name Xarelto▼
apixaban, brand name Eliquis
edoxaban, brand name Lixiana▼
Increase in the risk of recurrent thrombotic events
Bone cancer denosumab, brand name Xgeva Lichenoid skin reactions have been added as a rare adverse event
Carcinoid syndrome telotristat ethyl, brand name Xermelo▼ Faecaloma has been added as an uncommon adverse effect
Colon cancer
Colorectal cancer
gastric cancer
breast cancer
capecitabine, brand name Xeloda Tablets should be swallowed whole and should not be crushed or cut
Gastric cancer
colorectal cancer
non-small cell Lung cancer
ramucirumab, brand name Cyramza▼ Adverse drug reactions of haemangioma and thrombotic microangiopathy added
HIV infection lopinavir and ritonavir, brand name Kaletra Use of Kaletra with another medicine, lomitapide (brand name Lojuxta) is contraindicated (not recommended)
HIV infection cobicistat, brand name Tybost Darunavir and cobicistat should not to be initiated during pregnancy
HIV infection emtricitabine, elvitegravir, cobicistat and tenofovir alafenamide fumarate - brand name Genvoya▼ Do not to initiate this product during pregnancy
HIV infection emtricitabine, elvitegravir, cobicistat and tenofovir alafenamide fumarate - brand name Stribild Do not to initiate this product during pregnancy
HIV infection darunavir, brand name Prezista Use with ritonavir or cobicistat is contraindicated
Lung cancer, mesothelioma pemetrexed, brand name Alimta Added side effects of infectious and non-infectious skin disorders of the:
dermis - the layer under the top layer of skin
hypodermis - the layer below the dermis used mainly to store fat
subcutaneous tissue
Macular oedema
Uveitis
dexamethasone, brand name Ozurdex Blurred vision or other visual disturbances may indicate cataract, glaucoma or rare diseases such as central serous chorioretinopathy.
Melanoma
Non-small cell lung cancer
Renal cell carcinoma, a kidney cancer
Hodgkin lymphoma
Squamous cell cancer of the head and neck
Urothelial cancer, a cancer of the bladder and urinary tract
nivolumab, brand name Opdivo▼ Hypoparathyroidism added as a common adverse effect (low levels of parathyroid hormone)
Melanoma
Non-small cell lung cancer
dabrafenib, brand name Tafinlar Severe cutaneous (skin) adverse reactions (SCARs), including:
  • Stevens‑Johnson syndrome, and
  • Drug reaction with eosinophilia and systemic symptoms (DRESS)
Multiple myeloma carfilzomib, brand name Kyprolis▼ Cytomegalovirus infection has been added as an uncommon adverse effect.
Multiple sclerosis
alemtuzumab, brand name Lemtrada EMA review under way following reports of immune mediated conditions and problems with the heart and blood vessels
Myelodysplastic disorders
Chronic myelomonocytic leukaemia
Acute myeloid leukaemia
azacitidine, brand name Vidaza Pericarditis has been added as an uncommon adverse event.
Neutropenia lipegfilgrastim, brand name Lonquex▼ Nausea added as a “very common” gastrointestinal, adverse effect
Premature luteinising hormone (LH) surges ganirelix, brand name Orgalutran 'Hypersensitivity reactions’ clarified to include events such as:
  • anaphylaxis (including anaphylactic shock)
  • angioedema
  • urticaria
Rheumatoid arthritis tofacitinib, brand name Xeljanz▼ Do not exceed recommended dose. Blood clots shown in lungs at high doses.
Soft tissue infection
Pneumonia
ceftaroline fosamil, brand name Zinforo Eosinophilia has been added as an adverse drug reaction with a frequency from not known to rare
Systemic lupus erythematosus (SLE) belimumab, brand name Benlysta▼ Increased risk of: depression, suicidal ideation or behaviour or self-injury
Type 2 diabetes sodium-glucose co-transporter 2 (SGLT2) inhibitors.
canagliflozin
- Invokana and Vokanamet
dapagliflozin - Forxiga, Qtern, Edistride, Ebymect and Xigduo
empagliflozin - Jardiance, Glyxambi▼ and Synjardy
ertugliflozin - Steglatro▼, Segluromet▼ and Steglujan
New warning relates to 6 reports of Fournier’s gangrene (necrotising fasciitis of the genitalia or perineum).
Type 2 diabetes ertugliflozin, brand name Steglatro▼ Patients at high risk of lower limb amputations and should ensure preventative foot care management and maintain adequate hydration (fluids)
Type 2 diabetes liraglutide, brand name Victoza Patients should check their blood glucose levels so that their doctor can adjust the dose of sulfonylurea medicines and insulin if being taken
For more information about these safety warnings please go to the individual condition or product entries.

Reporting of suspected adverse reactions

Reporting suspected adverse reactions (side effects) after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals or patients are asked to report any suspected adverse reactions via the Yellow Card Scheme at yellowcard.mhra.gov.uk or search for MHRA Yellow Card in the Google Play or Apple App Store.


Disclaimer: This site is designed to offer information for general educational purposes only. The health information furnished on this site and the interactive responses are not intended to be professional advice and are not intended to replace personal consultation with a qualified physician, pharmacist, or other healthcare professional. We cannot provide individual medical advice. You must always seek the advice of a professional for questions related to a disease, disease symptoms, and appropriate therapeutic treatments.