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BioMarin receives warning letter for downplaying Orapred risks on website

Pharma Compliance Alert, October 18, 2006

FDA says the website for BioMarin's asthma drug Orapred down plays the drugs risks and implies the drug is approved for a broader range of conditions than its approved indication, according to an Oct. 11 warning letter.

FDA argues that www.orapredsmallpackage.com fails to provide appropriate information on the risks associated with the use of Orapred. Although there is a link to the full prescribing information on the second page of the product website, this link "does not mitigate the misleading omission of risk information" on the pages of the site that contains various efficacy claims for the drug, FDA says.

The only risk information about Orapred on the product website is the statement "As with all glucocorticoids, Orapred is contraindicated in persons with systemic fungal infections. Please see full prescribing information for a complete listing of adverse events such as dermatological and gastrointestinal disturbances."

FDA says that this statement does not convey important warnings, precautions, and adverse reactions associated with Orapred.

FDA argues that by stating product claims without noting important limitations of the drug, the website "implies that Orapred is useful in a broader range of conditions or patients than has been demonstrated by substantial evidence."

Orapred is FDA-approved for the control of severe or incapacitating allergic conditions intractable to adequate trials of conventional treatment in adult and pediatric populations with asthma or asthma caused by respiratory disorders.

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