“Checks have also revealed that only the Accuhaler Seretide is registered with Drug Control Authority (DCA), with the registration number MAL20001532ARZ, while the Accuhaler Ventolin is not registered with the DCA.
“The Accuhaler Seretide sold in Malaysia is manufactured in the United States, while those involved in the recall in the UK market are manufactured in the UK itself,” assured Datuk Dr Noor Hisham, Director-General of Health.
He added that the Accuhaler Seretide available in Malaysia are safe for use and will not affect patient care.
While a small fraction of asthma cases are well-controlled in Malaysia, about 1.8 million asthma cases are still either partly-controlled or totally uncontrolled, according to the MOH in 2016. To control their asthma, patients need to have asthma inhalers by their side.
Dr Noor Hisham further stressed that “the MOH always takes into consideration the quality, safety and effectiveness of pharmaceutical products before they are approved for registration. Quality control of pharmaceutical products registered in the market is also carried out to ensure that the products are completely safe.”
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UK recalls three batches of asthma inhalersThe announcement from MOH comes after the recall of two brands of inhalers – Accuhaler Ventolin and Seretide – in the UK on 21 February, as it was feared that the products could not deliver the potential life-saving medication correctly.
The Medicines and Healthcare products Regulatory Agency (MHRA) in UK issued a patient level drug alert, and recalled two specific affected lots of faulty inhalers manufactured by Glaxo Wellcome UK Limited. Due to manufacturing issues, experts warned that a small number of the devices were not delivering the full number of doses.
According to a spokesman, more than 4,500 Ventolin 200mcg inhalers and 1,400 Seretide 50/250mcg inhalers were affected.
As such, more than 5.4 million asthma sufferers were warned to check if they possessed any of the specific batches of Accuhaler Ventolin inhalers – those used for emergency relief of asthmatic symptoms.
In addition, one lot of Accuhaler Seretide was recalled from hospitals, pharmacies, dispensing practices, wholesalers and retailers in the UK. The Accuhaler Seretide was recalled only at the pharmacy level as it is used for maintenance of preventative treatment of asthma, rather than a treatment for relief.
Even so, only a small proportion of these batches, which were distributed in the UK market, are faulty.
Patients in the UK urged to replace inhalersPatients in the UK were also advised to seek medical advice and return the inhalers to their pharmacists for a replacement – if they find that their symptoms were not relieved as normal after usage.
“It is important [that] people check whether they have an affected inhaler. We want patients and their families to be confident that treatment will be safe and effective when required,” highlighted Bernadette Sinclair Jenkins, MHRA’s Regulatory Assessment Unit Manager of the Inspections, Enforcement and Standards unit.
Hampshire-based GP Dr Andy Whittamore noted that, “there may be a mark or tear in the foil strip of the Accuhaler devices. This tear could mean the inhaler doesn’t give you all the doses your inhaler is meant to.”
Although the dose of the medication is affected, Dr Whittamore commented that “the fault hasn’t affected the medicine itself, so don’t worry – you’ve not been taking anything that could have harmed your health.”
While the “worst that could have happened is you weren’t getting the dose of medicine you need,” Dr Whittamore still urges the patients to “get a new one, because this is the inhaler you need if you have an asthma attack.”
“Asthma attacks are serious and can be life threatening – so be prepared and always keep an effective reliever inhaler with you,” he cautioned. MIMS
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