Detailed Overview: MHRA New Drug Risks (2024)

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Detailed Overview: MHRA New Drug Risks (2024)

20:47

The Medicines and Healthcare Products Regulatory Agency (MHRA) prioritises drug safety by issuing updates on emerging risks. Here’s a breakdown of some key new risks from 2024:

1️⃣ Fluoroquinolone Antibiotics: Restricted Use

Fluoroquinolones (e.g., ciprofloxacin, levofloxacin), widely prescribed for bacterial infections, are now recommended only when no other antibiotics are appropriate. The MHRA reviewed reports of serious adverse reactions, including:

Tendonitis and tendon rupture
Long-term nerve damage (peripheral neuropathy)
Aortic aneurysm and aortic dissection

These severe side effects are particularly concerning for the elderly, patients with renal impairment, and those using corticosteroids(

GOV.UK

GovDelivery

The MHRA advises extra caution in these high-risk groups and stricter adherence to the use guidelines.

2️⃣ Topiramate (Topamax): Pregnancy Risk

Topiramate, commonly used for epilepsy and migraines, has been flagged by the MHRA for its risks in pregnancy. New safety measures emphasize that Topiramate should not be prescribed to women of childbearing potential unless they are part of a Pregnancy Prevention Programme. The risks to the unborn child include:

Congenital malformations such as cleft palate
Low birth weight
Increased risk of neurodevelopmental disorders like autism and ADHD in children exposed to Topiramate during pregnancy(
GovDelivery

The Pharmaceutical Journal

This update aligns with ongoing efforts to reduce risks associated with teratogenic drugs (drugs that can cause fetal abnormalities).

3️⃣ Valproate: Updated Guidance for Male Patients

Previously known for its severe risks during pregnancy, Valproate (used for epilepsy and bipolar disorder) now has added warnings for male patients. MHRA highlighted recent findings indicating that men taking valproate could also impact future pregnancies, with children at risk of neurodevelopmental disorders. The recommendations for men include using effective contraception during treatment(

The Pharmaceutical Journal

This guidance underscores valproate’s high teratogenic potential, expanding concerns from pregnant women to men of reproductive age.

4️⃣ Topiramate and Valproate Combination: Increased Risk

The combination of Topiramate and Valproate, often used for refractory epilepsy, was also highlighted for its synergistic risk factors. When used together, these drugs pose a heightened risk of fetal harm and neurodevelopmental issues. Healthcare providers are advised to reconsider this combination therapy, especially for women of reproductive age(

The Pharmaceutical Journal

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