Galderma Labs distributed a bogus product label for its Tri-Luma Cream that falsely claimed the drug was for long-term use and failed to note that it can cause birth defects if used by pregnant women, the FDA said. Tri-Luma, for hyperpigmenation, is approved only for short-term use and can cause these risks, the FDA said:
... embryo-fetal death, altered fetal growth, congenital malformations, and potential neurologic deficits.The FDA's warning letter to Galderma insists the company desist from distributing product with the wrong labelling and to submit a plan to the agency by Aug. 31 that includes corrective publicity for patients who may have seen the faulty information.
While it is common for drug companies to make mistakes in their advertising or to push the envelope a little in describing efficacy or playing down risks, Galderma seems to have gone several steps further. Distributing a bogus PI with the actual medicine looks like an act of madness.
The FDA also described "visual aids" (presumably sales materials) that urged use of Tri-Luma with chemical skin peels, even though that combination of drugs could actually make hyperpigmentation worse. The company's claim was:
Tri-Luma Cream May enhance results with glycolic acid peels.The FDA said:
These claims and presentations misleadingly suggest that Tri-Luma is safe and effective for use in combination with glycolic acid peels. However, Tri-Luma is not approved for use with other agents and treatment methods.
... Other potential consequences of this unapproved use include increasing the skin's sensitivity to UV light, thereby increasing the risk of sun damage and subsequent worsening of melasma, and increasing post-inflammatory hyperpigmentation in patients with darker skin types,The FDA told the company it was "extremely concerned" about the unapproved PI and the "numerous alarming differences between the FDA-approved PI (dated January 18, 2002) and the unapproved PI that is being disseminated by Galderma."
The letter was faxed to Galderma CEO Francois Fournier (pictured) Aug. 18; at the time of writing the Galderma web site contained no public statement addressing the issue.