March 03, 2009

J&J/Janssen Fined $4.5 Million Over Risperdal Misleading Claims

This just hit the press yesterday: last week, a judge in West Virginia sided with the state's Attorney General over allegations that J&J/Janssen had sent misleading mailings to doctors in the state, ones that made misleading claims about Risperdal and, separately, J&J's pain patch Duragesic.

The court assessed a fine totaling $4.475 million. The Attorney General had sued J&J/Janssen in 2004. I don't know if any other states are suing the company over the same mailings.

The court found:

"'The wording of [the defendants’] November 2003 Risperdal letter was intentionally constructed to modify the FDA’s warning language and mislead healthcare professionals, who rely on this information when prescribing medication for their patients.'"

I've not been able to find a copy of the letter, but it's described thus by one legal website:

"Johnson & Johnson, also known as Janssen Pharmaceutica, has touted Risperdal as having a reduced risk of side effects or adverse health reactions in comparison to other atypical antipsychotics. Although the FDA had approved Janssen’s revision to its warning labels regarding the increased risk of hyperglycemia and diabetes mellitus, it concluded that Janssen’s warning letter dated November 10, 2003 contradicted these revised warnings on the product labeling; the warning letter actually claims that Risperdal is associated with a lower risk of diabetes than other atypical antipsychotics. In fact, the FDA summoned Janssen to provide such evidence to support this claim of decreased incidence of hyperglycemia and diabetes."

Can't any of these atypical makers do anything right?

Posted by Philip Dawdy at March 3, 2009 12:01 AM
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Comments

Do you have any additional information about the FDA's problems with Duragesic?

Posted by: Stiff Man at March 3, 2009 12:08 AM

Risperdal is the worst medication ever. Period.

Posted by: Princess at March 3, 2009 05:37 PM

Thank you for this post, Philip.

Posted by: Emily at March 7, 2009 01:40 PM

I'm a bit confused (been away for several months, thanks to the hell of my OCD, so I'm catching up on some back posts)...Risperdal can raise blood sugar and put me at a higher risk for diabetes (I'm already at risk without it)? My pdoc wanted to prescribe me Abilify, and I told him no, because I was concerned about the risk of raised blood sugar, so he prescribed Risperdal (I get the generic) instead. Are you saying he knew I wouldn't want such a drug, and he put me on one, anyway?

Posted by: Jen at March 12, 2009 03:07 AM
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