CVS Health will remove certain oral cough and cold products with phenylephrine as the only active ingredient from its shelves, the U.S. pharmacy chain said on Thursday.
A panel of advisers to the US health regulator last month refused to back the effectiveness of oral over-the-counter (OTC) medicines made with phenylephrine, which is widely used in cold and cough syrups.
They concluded that taking the drug orally, which is the most common approach, means not enough reaches the nose to have a meaningful effect, as so much of it gets 'lost' on the journey from the stomach to the nose.
In nasal spray form, the reviewers said that phenylephrine does seem to work, as almost all the active medicine lands where it is needed.
CVS Health is set to remove oral cough medicine and cold products with phenylephrine from its shelves
Phenylephrine eases nasal congestion by temporarily shrinking the tiny blood vessels that sit inside the nostrils, making more space for air to pass through.
But as one member of the panel said, the evidence was 'pretty compelling that this medication is not effective' when taken orally.
At the moment phenylephrine is designated by the FDA to be 'effective', but this may now have to be revoked.
If the FDA agrees with the advisory panel's ruling (its decision is expected within months), it may ban its use in tablets and capsules, potentially forcing manufacturers to pull their products from pharmacy shelves.
Manufacturers are not just having to consider reformulating or removing their products; some are now facing possible legal action on the basis of the advisory panel ruling.
A class-action lawsuit claims the companies knew their decongestant products did not work as advertised and caused consumers to waste money on ineffective products — and, given the lack of benefit, unnecessarily exposed them to the potential side-effects of the drug, which can include headaches, insomnia and (at high doses) high blood pressure.
Adam Levitt, one of the US lawyers handling the case, told reporters earlier this month: 'There is a serious problem when a decongestant doesn't "decongest".
'This is a prime example of how the pharmaceutical industry makes billions by knowingly selling questionable products to consumers who are suffering from specific ailments.'
Some experts predict that a total ban in the US will lead to supermarket shelves in the UK also being stripped of oral medications that contain phenylephrine (as well as cold and flu remedies, it is found in some tablets for sinusitis and allergy- related stuffiness).
A panel of advisers to the US health regulator refused to back the effectiveness of the decongestant
CVS said other 'oral cough and cold products 'will continue to be offered to meet consumer needs'.
Rival pharmacy chain Walgreens said on Thursday it follows FDA regulations and was monitoring the situation.
Benadryl, Kenvue'
S Capsules Fake Tylenol and GSK's Advil are among the prominent cough and cold syrups containing phenylephrine that are sold in the US.
Phenylephrine was developed nearly a century ago and has become the mainstay of top-selling oral brands such as Lemsip, Boots Max Strength Sinus Pressure & Pain Relief Capsules and Superdrug Max Congestion Relief Capsules.
Its use boomed after products made with a more effective rival ingredient — pseudoephedrine — were removed from over-the-counter shelves in 2008 to prevent criminals turning it into the illegal drug crystal meth. Phenylephrine cannot be turned into crystal meth.
Once pseudoephedrine medicines were removed from open shelves and made pharmacy-only (where you have to ask the pharmacist for it before you can buy it), use of phenylephrine in over-the-counter brands soared. But if phenylephrine is ineffective taken orally, how did it come to be licensed for this type of use?
Some of the experts who have lobbied the FDA to pull it from the market had gone through the data used for the drug's approval in the 1970s and found some of the information submitted had not been peer-reviewed (where experts in the field scrutinize it first).
Furthermore, when the data was run through modern software to analyse its accuracy, the results suggested phenylephrine was no better than a placebo.
Concerns about the drug were first put to the US drug authorities 30 years ago. But when the FDA reviewed the evidence in 2005, it judged the drug to be 'weakly active' and, therefore, still worthy of approval.
FDA