The UK's medicines regulator has issued an urgent recall for a batch of Tamoxifen tablets after the pills failed crucial dissolution tests, raising concerns they may not work properly in patients' bodies.
The Medicines and Healthcare Products Regulatory Agency (MHRA) issued the alert for batch HZ10030 of Tamoxifen 20mg tablets, manufactured by Wockhardt UK Limited, after discovering the medication may not dissolve effectively into the bloodstream.
The affected batch consists of 30-pack tablets with an expiry date of April 30, 2027. The MHRA confirmed it has not received any complaints or reports of harm from patients who have taken the recalled medication.
Dissolution tests are standard procedures conducted by regulators and manufacturers to verify how quickly a medication's active ingredient releases into the body. These tests help predict the drug's performance once consumed.
Tamoxifen is a vital medication for approximately 550,000 British breast cancer survivors
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The effectiveness of oral medications depends on proper dissolution in the gastrointestinal tract before absorption into the bloodstream.
When tablets fail these tests, it can indicate potential problems with how the drug will work in patients.
Wockhardt UK Limited initiated the recall as a precautionary measure after identifying the dissolution failure during routine stability testing. The affected batch was first distributed on August 22, 2024.
Tamoxifen is a vital medication for approximately 550,000 British breast cancer survivors, capable of reducing their risk of disease recurrence by up to 45 per cent.
The drug works by blocking oestrogen activity in the body, preventing it from reaching cancer cells and slowing or stopping tumour growth.
Originally developed as a contraceptive in 1962, Tamoxifen transformed breast cancer treatment in the 1980s when trials demonstrated its effectiveness post-surgery.
The National Institute for Health and Care Excellence now recommends it for roughly 80 per cent of breast cancer patients.
In 2013, it became the first drug prescribed to prevent cancer, offered to women with strong family histories of the disease.
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The drug is capable of reducing their risk of disease recurrence by up to 45%
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The MHRA has instructed healthcare professionals to immediately stop supplying the affected batch and quarantine all remaining stock for return to suppliers.
Pharmacists and dispensing GPs have been notified through NHS regional teams.
Patients are advised to continue taking their medication as prescribed, with the recall being managed at the pharmacy and wholesaler levels as a precautionary measure. Anyone experiencing adverse reactions should seek medical attention promptly.
The MHRA encourages reporting of any suspected adverse reactions through its Yellow Card scheme, established in the 1960s to monitor drug safety.
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