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Pfizer, J&J and the Test That Could End Cough Medicines for Kids

By Jim Edwards

Updated on: July 6, 2011 / 9:31 AM EDT / MoneyWatch

Pfizer (PFE), Johnson & Johnson (JNJ) and a group of other companies are processing the results from a joint study of cough and cold medicines as they await word from a Canadian court on whether they must face a class-action lawsuit alleging the non-prescription drugs don't work in children under age 6. Both the case and the trial results could spell doom for the companies' child medicine franchises.

The trial of the cough suppressant dextromethorphan, which is found in Pfizer's Robitussin and J&J's Tylenol Cough & Cold, was suspended in June for seasonal reasons, according to a note on the ClinicalTrials.gov web site.

The FDA banned use of over-the-counter cough and cold meds in infants under 2 back in 2007. But it rejected a ban on the drugs in the under-sixes in 2008. It's still studying the issue in kids aged 2 through 12.

The Canadian suit, however, argues that drug companies have known since 1989 that the medicines are ineffective in children and more dangerous for them. That year, Health and Welfare Canada -- the northern equivalent of the FDA -- received a report stating that cough/cold medicines should only be given to children under 5 via the supervision of a doctor (meaning they would have to be prescribed, which defeats the whole point of retail shelf medicines).
The door may be closing on cough/cold medicines for children:

In December 2010, the FDA moved to ban dozens of unapproved cough/cold products that had been "grandfathered in" under the FDA's arcane rules regarding drugs that were already on the market before the agency was founded in the early part of the 20th Century.
A November 2010 study in the journal Pediatrics found that emergency room visits by under-2s declined by half after the FDA banned cough/cold medicine use in infants.
In 2009, a Canadian court ruled that the class-action case should not be dismissed.
In 2008, Health Canada banned the drugs in kids under 6.
In 2007, another Pediatrics study found that honey worked better than dextromethorphan for children.

The plaintiffs filed for class certification for their lawsuit in April, a lawyer involved in the case told BNET; a ruling is expected later this year.

Meanwhile, Pfizer, Novartis (NVS) Procter & Gamble (PG) and Boehringer Ingelheim ended their trial of dextromethorphan in kids aged 6 to 11. The first three of those companies are also defendants in the class action suit. The trial is a weak one -- it pits dextro against a placebo, rather than honey -- but if it does not show a statistically significant benefit for the drug, or if too many safety signals arise in its data, the companies will come under pressure from the FDA (and trial lawyers) to withdraw their products for pediatric use.

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Image by Flickr user anjanettew, CC.