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UK to Pull Pseudoephedrine

The move could force pharmaceutical companies into a reformulation drive to produce alternative over the counter (OTC) cold and flu products// that do not contain the restricted ingredients.

The MHRA has issued a public consultation letter seeking opinion on the proposed restrictions, which would see the nasal decongestants converted to prescription-only and a reduction in pack size by the end of 2007.

The move comes in response to the growing illicit use of OTC ephedrine- and pseudoephedrine-based drugs for the production of the Class A controlled drug, methylamphetamine.

The agency highlights the fact that alternative active ingredients can be used in cough/cold remedies, noting that "many manufacturers of pseudoephedrine/ephedrine containing products already have phenylephrine containing products authorised and many are currently available with similar indications."

However, experience in the US, where sales of pseudoephedrine were restricted last year, has shown some difficulties in making a straight swap from pseudoephedrine to phenylephrine, with some companies even dropping development of such products as unfeasible.

Phenylephrine has some distinct disadvantages compared to pseudoephedrine, which have hampered the growth of a market that was anticipated to expand rapidly in the US in the face of the new legislation.

Phenylephrine does not last as long in the body as pseudoephedrine, which can make it a less attractive option for consumers, and some parties have questioned its efficacy altogether.

Only last month, US firm SCOLR dropped its phenylephrine development plans, claiming that the treatment "did not justify continued internal development."

SCOLR vice president and chief technology officer, Stephen Turner, told In-PharmaTechnologist at the time that "phenylephrine-based reformulations have not yielded a successful, cost-effective alternative to extended-rel
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1. Canadian Court Rules Grocery Shops can Sell Cold Medications Containing Pseudoephedrine
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