EU Bans Cough Syrup Chemical over Severe Allergies, DDA yet to Take Action

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EU Bans Cough Syrup Chemical over Severe Allergies, DDA yet to Take Action

December 5: The European Union's drug regulator has warned that cough medicines containing the chemical pholcodine should be banned due to the risk of potentially deadly allergic reactions in people under general anaesthetic.

According to AFP, the European Medicines Agency (EMA) recommended that treatments containing pholcodine, which is used in adults and children to treat dry coughs, should be withdrawn from sale.

"Use of pholcodine in the 12 months before general anaesthesia... is a risk factor for developing an anaphylactic reaction to muscle relaxants in the anaesthetic,” AFP quoted the Amsterdam-based watchdog as saying.

Anaphylactic shock is a "sudden, severe and life-threatening allergic reaction", it added.

Medicines with the chemical were "being withdrawn from the EU market and will therefore no longer be available by prescription or over the counter".

AFP added that opioid-based pholcodine has been used as a cough medicine since the 1950s.

In April 2020 at the height of the Covid-19 pandemic, when dry cough was one of the main symptoms of the disease, French authorities had recommended against the use of syrups with pholcodine.

The EMA in January had recommended updating packaging to warn of the risk of allergies, based on new data.

The EMA’s warning comes just a week after the Department of Drug Administration (DDA) of Nepal issued a similar warning against the use and sale of pediatric drugs having chemical compounds such as Ethylene Glycol and Diethylene Glycol.   

According to the DDA, the World Health Organization (WHO)'s report has also noted that the use of medicines having Ethylene Glycol and Diethylene Glycol in different countries, including Zambia and Indonesia, has had serious effect on their kidneys of children and also caused death in some cases.   

The DDA in a statement issued on November 28 made it clear that the medicines such as Promethazine Oral Solution, Kofexmalin Baby Cough Syrup, My Cough Baby Cough Syrup and Magrip and Cold Syrup produced by Haryana-based Miden Pharmaceuticals Limited containing such hazardous substance have not been registered in Nepal.   

The department has also instructed the drug manufacturing companies to ensure that they do not mix-up such harmful chemical elements in the drugs manufactured and sold in Nepal.

However, the DDA is yet to ban pholcodine in Nepal.

According to the DDA, the Government of Nepal has banned the production, sale, distribution, storage, transportation and import/export of a combination of narcotic drugs except the combination containing pholcodine and codeine and their sales as cough sedatives.


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