Medicines Information

The Medicines and Healthcare products Regulatory Agency (MHRA) issue regular Drug Safety Updates with advice for medicines users.

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.

For more information please follow the link: https://assets.publishing.service.gov.uk/media/626182c48fa8f523b51299e6/Pregabalin-PSL-April_2022_V2.pdf

Carbimazole: increased risk of congenital malformation if taken in pregnancy

April 2019 – Carbimazole is associated with an increased risk of congenital malformations when used during pregnancy, particularly in the first trimester of pregnancy and at high doses (15 mg or more of carbimazole daily).

Patients who take carbimazole and are planning to become pregnant, or who become pregnant during treatment should make an appointment with a clinician.

Patients currently taking carbimazole should ensure appropriate contraception is in place.

For more information, please follow the link: https://www.medicinesinpregnancy.org/leaflets-a-z/carbimazole/

Modafinil (Provigil): increased risk of congenital malformations if used during pregnancy

November 2020: Modafinil potentially increases the risk of congenital malformations when used in pregnancy.

Modafinil should not be used during pregnancy and women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil.

Patients currently taking modafinil should make an appointment to discuss treatment if they are pregnant or planning to become pregnant, or to discuss appropriate contraception.

For more information, please follow the link: https://www.medicinesinpregnancy.org/search-results/?q=modafinil

Valproate uses during pregnancy – risk of birth defects

March 2018, updated January 2024 – Valproate (Epilim, Depakote and other generic brands) is associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy.

Since 2018 any use of valproate in patients of childbearing potential must be within the terms of the Pregnancy Prevention Programme. This is designed to make sure patients are fully aware of the risks and the need to avoid becoming pregnant.

Patients currently taking valproates should make an appointment to discuss treatment if they are pregnant or planning to become pregnant, or to discuss appropriate contraception.

For more information, please follow this link: https://www.medicinesinpregnancy.org/search-results/?q=valproate

Topiramate (Topamax) – contraindicated in pregnancy

Updated June 2024 – Topiramate may cause an increased risk of birth defects if taken in pregnancy.

Topiramate is now contraindicated in pregnancy and should only be prescribed if appropriate contraception is always maintained.

Harms included a higher risk of congenital malformation, low birth weight and a potential increased risk of intellectual disability, autism and attention deficit hyperactivity disorder in children of mothers taking topiramate during pregnancy.

Patients currently taking topiramate should make an appointment to discuss treatment if they are pregnant or planning to become pregnant, or to discuss appropriate contraception.

For more information follow this link: https://www.medicinesinpregnancy.org/search-results/?q=topiramate

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

NHS Emergency Steroid card

September 2020 – Recently issued National guidance promotes a patient-held Steroid Emergency Card to help healthcare staff identify patients with adrenal insufficiency and provide information on emergency treatment.

This means that there are now 2 types of steroid alert card a patient may be required to carry:

A steroid treatment card (blue card)
This carries a series of instructions for the patient and informs healthcare professionals to whom the patient shows the card. The card should be carried when a patient is taking ORAL steroids. Patients taking oral corticosteroids for periods of more than three weeks should receive a steroid treatment card, or those receiving more than four short oral courses per year.
A steroid emergency card
Is a prompt to help healthcare staff to identify appropriate patients and gives information on the emergency treatment to start if they are acutely ill, or experience trauma, surgery or other major stressors.
The steroid emergency card should be given to all patients with primary adrenal insufficiency and those who are steroid dependent (on a long-term oral steroid).

Cards are available through community pharmacies or the card can be downloaded from the Society for Endocrinology adrenal crisis webpage.

Further information about the steroid emergency card is available [EXTERNAL PDF LINK]

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 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

Symptoms 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.

Individual information about these medicines can be found on www.nhs.uk

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.

Further information at: https://www.gov.uk/drug-safety-update/hydrochlorothiazide-risk-of-non-melanoma-skin-cancer-particularly-in-long-term-use