Medicines Information

Important Drug Safety Updates from MHRA

The Medicines and Healthcare products Regulatory Agency (MHRA) regularly issues Drug Safety Updates to provide essential advice for medicine users. Below is a summary of recent key updates:

Pregnancy-Related Risks

Several medications carry significant risks if used during pregnancy, emphasizing the importance of effective contraception and timely discussions with a healthcare professional.

• Pregabalin (Lyrica)
  • Update: April 2022
  • Key Risk: A new study suggests a slightly increased risk of major congenital malformations if used in the first trimester of pregnancy. The risk is considered low, with an absolute risk slightly elevated (3-4%) compared to the expected background risk (2-3%).

 

• • • Patient Advice:
      • Continue to use effective contraception during treatment.
      • Avoid use in pregnancy unless clearly necessary.
      • If you are planning a pregnancy or become pregnant, make an appointment to discuss your health condition and medicines with your clinician.
    • More Information: https://assets.publishing.service.gov.uk/media/626182c48fa8f523b51299e6/Pregabalin-PSL-April_2022_V2.pdf

 

• Carbimazole
  • Update: April 2019
  • Key Risk: Associated with an increased risk of congenital malformations when used during pregnancy, particularly in the first trimester and at high doses (15 mg or more daily).
  • Patient Advice:
    • Ensure appropriate contraception is in place.
    • If you are planning to become pregnant or become pregnant during treatment, make an appointment with a clinician.
  • More Information: https://www.medicinesinpregnancy.org/leaflets-a-z/carbimazole/

 

• Modafinil (Provigil)
  • Update: November 2020
  • Key Risk: Potentially increases the risk of congenital malformations when used in pregnancy, with a reported 15% likelihood of birth defects compared to 3% in the general population.
  • Patient Advice:
    • Should not be used during pregnancy.
    • Women of childbearing potential must use effective contraception during treatment and for 2 months after stopping modafinil. Modafinil may reduce the effectiveness of steroidal contraceptives, requiring alternative or additional methods.
    • If you are pregnant, planning to become pregnant, or need to discuss appropriate contraception, make an appointment to discuss treatment.
  • More Information: https://www.medicinesinpregnancy.org/search-results/?q=modafinil

 

• Valproate (Epilim, Depakote and other generic brands)
  • Update: March 2018, updated January 2024
  • Key Risk: Associated with a significant risk of birth defects and developmental disorders in children born to women who take valproate during pregnancy. The risk includes an 11% risk of birth defects and a 30-40% risk of neuro-developmental disabilities.
  • Patient Advice:
    • Since 2018, any use of valproate in patients of childbearing potential must be within the terms of the Pregnancy Prevention Programme.
    • If you are pregnant, planning to become pregnant, or need to discuss appropriate contraception, make an appointment to discuss treatment.
  • More Information: https://www.medicinesinpregnancy.org/search-results/?q=valproate

 

• Topiramate (Topamax)
  • Update: Updated June 2024
  • Key Risk: Contraindicated in pregnancy due to an increased risk of birth defects, low birth weight, and a potential increased risk of intellectual disability, autism, and attention deficit hyperactivity disorder (ADHD) in children.
  • Patient Advice:
    • Topiramate is now contraindicated in pregnancy.
    • It should only be prescribed if appropriate contraception is always maintained, as part of a Pregnancy Prevention Programme.
    • If you are pregnant, planning to become pregnant, or need to discuss appropriate contraception, make an appointment to discuss treatment.
  • More Information: https://www.medicinesinpregnancy.org/search-results/?q=topiramate

Other Important Drug Safety Updates

• Amiodarone (Cordarone X): Risks and Monitoring
  • Update: March 2022
  • Key Concerns: Amiodarone is used for abnormal heart rhythms but is associated with serious adverse effects in several organ systems (eyes, gastrointestinal tract, nerves, skin, thyroid, lungs, heart, and liver). It has a long plasma half-life of around 50 days, meaning side effects can persist for a month or more after stopping treatment.

 

• • Patient Advice:
    • Treatment should be initiated under hospital or specialist supervision.
    • Always read the patient information leaflet.
    • Your doctor may perform tests of your blood, lungs, heartbeat, and eyes before and during treatment; it’s important to have these tests. Blood tests are advised every 6 months during treatment.

• • • Stop taking amiodarone and see a doctor or go to a hospital straight away if you experience any of the following during treatment or after stopping:
      • New or worsening shortness of breath or persistent coughing.
      • 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 (signs of thyroid issues).
      • Your heartbeat becomes even more uneven or erratic, or becomes very slow.
      • Any loss of eyesight.

 

• NHS Emergency Steroid Card
  • Update: September 2020
  • Purpose: National guidance promotes patient-held Steroid Emergency Cards to help healthcare staff identify patients with adrenal insufficiency and provide information on emergency treatment.
  • Two types of cards:
    1. Steroid Treatment Card (blue card): Carries instructions for the patient and informs healthcare professionals. Should be carried by patients taking ORAL steroids for more than three weeks or more than four short oral courses per year.
    2. Steroid Emergency Card: A prompt for healthcare staff to identify patients and provide emergency treatment if they are acutely ill, experience trauma, surgery, or other major stressors. It should be given to all patients with primary adrenal insufficiency and those who are steroid dependent (on long-term oral steroids).
  • How to Obtain: Cards are available through community pharmacies, from your GP at your next routine review, from hospital teams at your next appointment, or can be downloaded from the Society for Endocrinology adrenal crisis webpage.
  • More Information:
    • https://www.endocrinology.org/adrenal-crisis
    • https://www.england.nhs.uk/wp-content/uploads/2020/08/NPSA-Emergency-Steroid-Card-FINAL-2.3.pdf

 

• SGLT2 inhibitors: Serious Side Effects
  • Update: February 2019
  • Medications Included: empagliflozin (Jardiance®), canagliflozin (Invokana®), dapagliflozin (Forxiga®), ertugliflozin (Steglatro®). These medicines lower blood sugar and benefit kidney disease and heart failure.
  • Key Side Effects (if not identified early, can be serious):
    1. Diabetic Ketoacidosis (DKA): Symptoms include nausea, vomiting, fast breathing, abdominal pains, unusual drowsiness, or fever.
    2. Fournier’s Gangrene: An extremely rare side effect (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.
  • Patient Advice:
    • Read all accompanying medication information.
    • Ask your pharmacist, diabetic nurse, or GP if you have questions.
    • Contact a medical professional immediately (doctor or nurse) if you have any of the above symptoms, even if your blood sugars are near normal.
    • If your GP practice is closed, call NHS 111 for advice, mentioning your concern about these conditions.
    • Stop this medication until you have further medical advice.
  • More Information: www.nhs.uk

 

• Hydrochlorothiazide: Risk of Non-Melanoma Skin Cancer
  • Update: November 2018
  • Key Risk: 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 for high blood pressure), particularly with long-term use. The known photosensitising activity of hydrochlorothiazide is a suggested mechanism.
  • Patient Advice:
    • Regularly check for and report any new or changed skin lesions or moles.
    • Limit your exposure to sunlight and UV rays and use adequate protection.
    • Make an appointment to discuss alternative options if you would like to, especially if you have had a previous skin cancer.
  • More Information: https://www.gov.uk/drug-safety-update/hydrochlorothiazide-risk-of-non-melanoma-skin-cancer-particularly-in-long-term-use