Dr Reddy's in spot with US health regulator again

Hauled for not highlighting risk associated with injectable generic

Dr Reddy's Laboratories has run into trouble with the US health authorities again, this time for not highlighting important risk information on a promotional website for injectable generic fondaprinux sodium, a drug that it launched in the US market recently.

This is second instance of the company running into trouble with the US health authorities. The failure to provide adequate warning about the risk of using the USP for injections was raised by the Department of Health and Human Services, under the US FDA.

Last year, the US health regulator imposed an import ban on products made at Dr Reddy's Laboratories' Mexican plant for violation of current good manufacturing practices.

According to James S Dvorsky, Regulatory Review Officer, Division of Professional Promotion, Office of Prescription Drug Promotion, a promotional website for the drug downplayed the serious risks associated with fondaparinux sodium by failing to prominently display the boxed warning for this drug.

The drug is indicated for the treatment of deep vein thrombosis in patients undergoing hip fracture/replacement surgery, knee replacement surgery or abdominal surgery.

"... While this risk is conveyed as part the patient video and text at the very bottom of the website, the overall effect of this presentation undermines the communication of the boxed warning regarding the risk of spinal/epidural hematomas and potential paralysis, misleadingly suggesting that the drug is much safer than has been demonstrated by substantial evidence," the US regulator said.
    
Dr Reddy's has a licence from Australian pharmaceutical firm Alchemia Ltd to make and sell this drug. In addition, it has a separate agreement with Alchemia for Europe, where a launch is expected after 2012, which is royalty-based.
    
OPDP requested Dr Reddy's to immediately halt the dissemination of violative promotional materials for fondaparinux sodium such as the promotional website.
    
"The violations discussed in this letter do not necessarily constitute an exhaustive list. It is your responsibility to ensure that your promotional materials for fondaparinux sodium comply with each applicable requirement of the FD&C Act and FDA implementing regulations," the regulatory official further said.
    
The authority directed the company to submit its reply to the finding on or before January 12. However, it is not clear whether the company has furnished its response to the USFDA as DRL officials were not available for comment.
    
The open healthcare professional (HCP) product information website for the drug
(https://bsmedia.business-standard.comwww.Reddyfondaparinux.Com/index.Html) did not open despite repeated attempts.

According to market reports, US sales of the branded version of the drug, Arixtra, sold by GlaxoSmithKline, amount to $340 million a year.