The Medicines and Healthcare products Regulatory Agency (MHRA) regulates medicines, medical devices and blood components for transfusion in the UK
The MHRA issue regular Drug Safety Updates advising on the latest advice for medicines users. Some of the recent updates include:
Pregabalin (Lyrica): findings of safety study on risks during pregnancy
April 2022 – A new study has suggested Pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy unless clearly necessary.
Patients who are planning a pregnancy or who become pregnant during treatment should make an appointment to discuss their health condition and any medicines they are taking
More information can be found HERE
Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervision
March 2022 – Amiodarone is used to treat certain types of abnormal heart rhythm, including atrial fibrillation and tachyarrhythmias (heart beats unevenly or too fast). Treatment should be initiated under hospital or specialist supervision and in accordance with clinical guidance.
Amiodarone is associated with serious adverse effects in several organ systems including the eyes, gastrointestinal tract, nerves, skin, thyroid, lungs, heart, and liver. Amiodarone has a long plasma half-life of around 50 days, meaning that any adverse effects may persist for a month (or more) after treatment has stopped. Patients must be monitored closely during treatment
Advice for patients and carers:
Always read the patient information leaflet provided with your medicines and follow the advice on other medicines to avoid and what to do if you have a side effect.
Your doctor may perform tests of your blood, lungs, heartbeat, and eyes before and during treatment – it’s important to have these tests because they can identify if there’s a problem. During treatment blood tests are advised every 6 months.
Stop taking amiodarone and see a doctor or go to a hospital straight away if you experience any of the following during treatment or in the period after stopping amiodarone:
New or worsening shortness of breath or coughing that will not go away
Yellowing of the skin or eyes (jaundice), feeling tired or sick, loss of appetite, stomach pain, or high temperature
Weakness, weight loss or weight gain, heat or cold intolerance, hair thinning, sweating, changes in menstrual periods, swelling of the neck (goitre), nervousness, irritability, restlessness, or decreased concentration
Your heartbeat becomes even more uneven or erratic, or becomes very slow
Any loss of eyesight
SGLT2 inhibitors: Serious side effects
February 2019 – SGLT-2 inhibitors are medicines that lower blood sugar by increasing the amount of glucose excreted in the urine. SGLT-2 Inhibitors are used in diabetes and also have benefits in kidney disease heart failure.
They include:
empagliflozin (Jardiance®)
canagliflozin (lnvokana®)
dapagliflozin (Forxiga®)
ertugliflozin (Steglatro®).
If you take one of these medications you should be aware of the potential side effects as, if they are not identified early, they can serious problems. As with all medication please read any information that accompanies the medication carefully. Please ask your Pharmacist, diabetic nurse or GP if you have any questions. The major side effects include:
Diabetic ketoacidosis
Sympoms include: Nausea, vomiting, fast breathing, abdominal pains, unusual drowsiness, or fever.
Fournier’s gangrene
An extremely rare side effect affecting about 1.6 out of 100,000 people
Symptoms include: Severe pain, tenderness, redness, or swelling in the genital or groin area accompanied by fever or malaise.
If you have any of these symptoms, please contact a medical professional, such as a doctor or nurse immediately, even if your blood sugars are near normal.
If your GP practice is closed, please call the NHS 111 service, by dialling 111, for more advice. Tell them that you are worried about one of the conditions above.
Stop this medication until you have further medical advice.
Full updates can be found HERE
Hydrochlorothiazide: risk of non-melanoma skin cancer, particularly in long-term use
November 2018 – Studies have shown a dose-dependent increased risk of non-melanoma skin cancer with exposure to increasing cumulative doses of Hydrochlorothiazide (contained in some combination products used for high blood pressure). Patients taking Hydrochlorothiazide should:
- Regularly check for and report any new or changed skin lesions or moles
- Limit their exposure to sunlight and UV rays and use adequate protection when exposed to sunlight and UV rays to minimise the risk of skin cancer
- Make an appointment to discuss alternative options to the use of hydrochlorothiazide if you would like to and particularly if you have had a previous skin cancer.