Drug Injury Watch

Accutane Recall Due To Safety Issues Or Declining Sales Or Lawsuit Losses Or Some Combination Of These Factors?

(Posted by Tom Lamb at DrugInjuryWatch.com)[1]_____________________________________________________________________

Update:  Accutane Retrial Verdict: Roche Ordered to Pay $25 Million to Accutane User[2]

By David Voreacos and John Martin

Feb. 16 (Bloomberg) — Roche Holding AG, the Swiss drugmaker, must pay $25.16 million in damages to a former user of its Accutane drug who blamed the acne medicine for his inflammatory bowel disease, a New Jersey jury ruled.

Andrew McCarrell, 38, won the verdict today at a retrial in Atlantic City, New Jersey. An appeals court ordered the new trial after overturning a $2.62 million award he won in May 2007. McCarrell, a computer technician from Birmingham, Alabama, testified he got sick after taking the drug for acne in 1995. He needed five surgeries, including one to remove his colon….



On June 26, 2009 we learned from a Blooomberg news report, “Roche Pulls Accutane Off Market After Jury Verdicts”[3], that Accutane will no longer be available to American patients:

Roche Holding AG, the world’s biggest maker of cancer drugs, is pulling its Accutane acne medicine from the U.S. market after juries awarded at least $33 million in damages to users who blamed the drug for bowel disease.

Roche notified the U.S. Food and Drug Administration today that it was withdrawing Accutane after a “reevaluation” of its product lines showed it faced serious challenges from generic competitors, company officials said in a statement.

“In addition, Roche has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” according to the statement.

About 13 million people have taken Accutane since it went on the market in 1982. The medication was Roche’s second-biggest selling drug before the patent expired in 2002 and rivals started selling generic versions. Roche’s prescription market share of the drug is now below 5 percent, the company said.

From the above information, the apparent reasons for this June 2009 Accutane recall are loss of market share and mounting personal injury lawsuits. 

This brought to mind the Tequin recall by Bristol-Myers Squibb (BMS) in April 2006. 

Here is an article from September 2009 regarding what the FDA had to say about how and (really) why BMS decided to remove its unsafe antibiotic Tequin from the U.S. market — “FDA: Tequin Was Withdrawn From U.S. Market “For Reasons Of Safety Or Effectiveness” Recall That Bristol-Myers Had Said Decline In Sales Was Reason For Its Decision To Stop Selling Tequin[4] (emphasis added):

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