The UAE’s Ministry of Health will not add a warning label to a pharmaceutical drug that may increase the risk of cancer. The refusal follows a ruling by US authorities that the drug should carry a ‘black box’ warning — the strongest carried by medicines in the US.
Elidel, a cream applied to skin to treat the disease eczema, may pose a cancer risk when absorbed into the body, according to a recent study by The Food and Drug Administration (FDA). In the US, the drug, produced by Novartis, is available on prescription across the UAE from private healthcare clinics and a number of hospitals.
However, Novartis and the UAE Ministry of Health have ruled out removing the cream from the country’s medical centres.
“Following discussions with the UAE Ministry of Health, we wish to make it clear that there has been no decision by the ministry to withdraw the product, amend its labelling, or otherwise affect the availability of the treatment within the UAE,” said Novartis Middle East in a statement.
This rebuttal comes on the back of an FDA public health commission report, which last week advised healthcare professionals to prescribe Elidel only as direct-ed and only after other eczema treatments have failed to work. In addition, the FDA has added a ‘black box’ warning to the health professional label for the product and is developing a medication guide for patients.
In a statement, the FDA said animal studies had shown a potential link with cancer. FDA data also included a small number of reports of cancers in children and adults treated with Elidel. It is estimated that millions of people in the Middle East and North Africa currently suffer from eczema.
Although the FDA’s actions represent bad move for Novartis, the news has been described by competitor AvVaa World Health Care Products as a “watershed event”. AvVaa markets the only non-toxic, all-natural over-the-counter eczema treatment.
The FDA’s ruling is another blow for the region’s pharmaceutical industry, which currently has a tarnished image following a high-profile case last year involving a painkiller that was only removed from the Middle East’s shelves at the last minute.
Vioxx, which regulators believe may have resulted in the deaths of up to 27,000 users and given tens of thousands of others heart disease was not pulled even after a study showed the drug doubled the risk of cardiac arrest.
Manufacturers, Merck, kept the drug on the market, despite compelling evidence that it was harmful. Finally, in the face of irrefutable evidence the company voluntarily withdrew Vioxx from the shelves last September.
Novartis' advice is that a thin layer of Elidel should be applied to affected skin twice daily. If there is no noticeable improvement within six weeks, or if exacerbation occurs, then treatment with Elidel should be discontinued and another therapeutic option considered.For all the latest business news from the UAE and Gulf countries, follow us on Twitter and Linkedin, like us on Facebook and subscribe to our YouTube page, which is updated daily.
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