US to Assess if Cold Drugs do Ease Nasal Congestion
The US government is set to seek the advice of an expert panel in order to establish the efficiency of new versions of over-the-counter cold treatments such as Sudafed. The principal point of enquiry will be whether such drugs actually do ease nasal congestion.
The discussions follow a petition drafted by University of Florida researchers, in which they urged the government to assess the ingredients used in new formulations of these drugs. The petition was based on its assertion that very limited information exists to back claims that they can be effective, and that they are without risk when taken by children.
Drug firms recently began to use phenylephrine in cold drugs, after a law was introduced stating that pseudoephedrine - the traditional ingredient - be restricted to prescription drugs. Among the firms that developed new versions of existing medicines were Wyeth Pharmaceuticals, Procter and Gamble and Johnson & Johnson.
According to some, when phenylephrine is administered at a 10 milligram dose, its ability to relieve congestion barely exceeds that of placebos. Consequently, it has been recommended that phenylephrine is increased to a 25mg dose when taken by adults, and that it is avoided entirely by children.
The Consumer Healthcare Products Association, however, has supplied the US Food and Drug Administration with data relating to seven trials that it says highlights the performance of phenylephrine. According to agency spokeswoman, Elizabeth Funderburk: "Phenylephrine has been relieving peoples congestion for decades, and we believe this meta-analysis reaffirms that."
She added: "It refutes the contention that phenylephrine in its 10-milligram dose does not provide effective nasal decongestion."
Last week, the US FDA's advisory panel recommended that cough/cold medicines should not be given to children under six. While the FDA is not bound to follow its panel's advice, historically, it has tended to do so.
Source - Pharmaceutical International's US Correspondent
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