Urgent medicine recall in South Africa

28 August 2016 - 02:01 By Megan Power

Scores of patients with urinary problems are unknowingly taking blood pressure-lowering tablets following a dangerous pill swap blunder. The potentially life-threatening labelling error led this week to the recall of at least 60 000 bottles of the generic drug‚ distributed mainly in the Western Cape.A pharmacist there raised the alarm last month after discovering that a container of Mylan Oxybutynin 5mg 100’s tablets — used to treat urinary incontinence and urgency — actually contained Mylan Indapamide 2.5mg 30’s. Indapmide is given to patients suffering from hypertension.The mix-up at Mylan's packaging plant in Germiston means patients who are not hypertensive are taking pills that drop their blood pressure. Not only could the wrong medication lead to them urinating more‚ rather than less‚ it could also lead to nausea and dizziness. In patients with low blood pressure already‚ the consequences could be far more severe.The recall‚ launched by Mylan SA in consultation with the Medicines Control Control (MCC)‚ has been classified Class 1‚ Type A - the highest recall the authority can impose.Class I is for defective‚ dangerous or potentially life-threatening medicines that predictably or probably could result into serious health risks or even death.Type A means the recall must reach all suppliers of medicines‚ including wholesalers‚ private and state hospital services‚ retail outlets‚ doctors‚ nurses‚ pharmacists — as well as patients — through a recall letter and media alert.The only public notice so far has been an inconspicuously place advert in a Cape Town newspaper on Monday.It was run with no heading at all‚ much less the mandatory “urgent medicine recall” header required by the MCC. It gave no hint of the urgency of the issue‚ nor did it order consumers to immediately stop taking the drug. It was scant on detail‚ including how many units are involved and which regions in SA are affected.When contacted earlier this week‚ Mylan’s Johannesburg-based company pharmacist‚ Leanne Wentworth‚ initially could not explain why a non-compliant recall notice had been published or supply any other details. She said Mylan was busy preparing proper recall notices and promised a day later to respond to emailed questions. By Friday morning‚ Mylan hadn’t responded. Neither had it placed any further recall notices to alert consumers.The MCC’s registrar‚ Joey Gouws‚ agreed that Monday’s advert was inadequate and not in keeping with MCC guidelines.“I have noticed that none of the headings as per the guideline was included in the final text published by Mylan‚” said Gouws. “I am in agreement that the text will be lost in the newspaper amongst all the other articles‚ with the primary intention of warning the public against the administering of the wrong medication not being met.”The MCC has given the company until Monday to issue a compliant consumer notice or the authority will issue one itself.Mylan‚ a US generics giant‚ is no stranger to controversy. In addition to several global recalls of various drugs‚ including injected cancer meds‚ in the last few years‚ the company is currently at the centre of a price hike furore in the US.Pressure has been put on Mylan to reduce the exorbitant price of its EpiPens‚ which are used to treat life-threatening allergy attacks. The cost of the pens has risen steadily since 2007‚ from around $100 for a pack to two to $600.The price rise has attracted widespread media coverage and led to intense scrutiny of Mylan in the US‚ with several public officials‚ including presidential hopeful Hillary Clinton and Senator Bernie Sanders calling on Mylan to lower the price.On Thursday‚ the company bowed to the pressure‚ announcing it would expand its coupon and patient assistance programmes to help patients facing higher out-of-pocket costs. It said it would immediately offer more financial assistance with co-payments for patients with insurance and expand the number of uninsured patients eligible for free EpiPens.Mylan has also faced issues with its manufacturing plants in India‚ with the US’s Food and Drug Administration citing them for a variety of lapses‚ which investigators said could lead to product contamination.The recalled batch of Mylan Oxybutynin is 1600361‚ with expiry date 01/2018. The container should be returned to the retailer for a full refund. Affected consumers should consult their healthcare providers. For more information‚ patients can contact Mylan pharmacist Leanne Wentworth on 011 4511300/071 2812503 or email medinfosa@mylan.comE-mail: consumer@sundaytimes.co.zaFollow Megan on Twitter: @Power_Report- TMG Digital..

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