FDA CITES EXHIBIT BOOTH PANELS FOR LACKING RISK INFORMATION
Mallinckrodt must stop using exhibit booth panels that lack any information about risks associated with taking its drugs, an FDA warning letter said.
Two drugs, MD-Gastroview and OptiMARK, are misbranded because the panels promote their efficacy but "completely omit" any risk information, said a warning letter sent Oct. 13 and posted to the FDA's website Oct. 24. Booth panels neglected to report any adverse experiences, precautions or warnings for taking either of the drugs, the agency said.
The only allusion to risks was a statement that said, "See representative in booth for full prescribing information," in small letters in the lower left-hand corners of the panels, according to the letter. Additionally, the booth panel for OptiMARK endorsed the product's "excellent safety profile." The FDA called the panel misleading and said the inclusion of the phrase implied the product was safer than studies have shown it is.
The letter directed Mallinckrodt to stop distributing any "violative promotional materials" for the two drugs.
MD-Gastroview is used for contrast enhancement in gastrointestinal scans, and OptiMARK for liver scans and magnetic resonance imaging scans. FDA-approved labeling for both drugs includes multiple warnings and precautions, including one on the possibility of patients going into a shock-like state.
Mallinckrodt has received complaints from the FDA about its exhibit booth panels before, the warning letter noted. The agency's Division of Drug Marketing, Advertising and Communications sent letters to the company earlier this year and in 2004, citing violations nearly identical to those in the Oct. 13 letter, but for different products.
Mallinckrodt intends to fully comply with the FDA and will change the panels according to the agency's guidance, said JoAnna Schooler, a representative for the company.
The warning letter can be seen at www.fda.gov/foi/warning_letters/g6057d.pdf (http://www.fda.gov/foi/warning_letters/g6057d.pdf).