Intuniv materials get FDA warning

Share this article:
Patient materials for Shire's ADHD drug Intuniv presented unsubstantiated effectiveness and superiority claims and downplayed important risk info, said the FDA's Division of Drug Marketing, Advertising and Communication.

In a June 22 untitled letter, DDMAC asked Shire to stop giving out an Intuniv “patient starter kit.” The agency said materials “use large and colorful headers to highlight benefits of Intuniv therapy, including a prominent and compelling image of a child in a large monster suit, while the risk information appears in small font and in single-spaced paragraph format, and in many cases only appears at the end of each piece.”
Share this article:
close

Next Article in Features

Email Newsletters

More in Features

Antidote: On Cystic Fibrosis treatments

Antidote: On Cystic Fibrosis treatments

Recent treatments in CF, including the inhaled antibiotic Tobramycin, have increased lifespan well into adulthood.

The $3 generic and the $1,000 pill: pharma outsiders just don't get it

The $3 generic and the $1,000 pill: pharma ...

What do you call the people who treat medical breakthroughs as if they were bank heists? Malicious? Uninformed? Not with it?

Leadership Exchange Uncut : The Agency-Client Relationship

Leadership Exchange Uncut : The Agency-Client Relationship

Click the above link to access MM&M's first Leadership Exchange Uncut e-book, "The Agency-Client Relationship"