Claris Law Legal Blogging Community

Editor: Andy Childers & Brandon Smith
Profession: SJS Attorneys

Category: Toxic Epidermal Necrolysis

Sanofi Aventis, one of the largest drug manufacturers in the world, is now considering another label change to its ever controversial drug Ketek. Ketek is an antibiotic that is commonly prescribed to help the body fight off infection caused by bacteria and has recently drawn criticism for its documented link to severe liver damage in its consumers. After learning of a Canadian woman who suffered a severe allergic reaction to Ketek called toxic epidermal necrolysis, Sanofi Aventis is now considering a change on its label that would warn potential consumers and physicians of other side effects such as SJS and TEN that causes hundreds of deaths each year.

Ketek is only suspected in the woman's case. She also had a history of allergic reactions to penicillin as well as to the drug class to which Ketek belongs.

But drug maker Sanofi Aventis is discussing with Health Canada whether to strengthen the existing warning about allergic reactions to include the potential for "skin events."

Such an addition to Ketek's prescribing label would unquestionably be a great thing for Sanofi Aventis to do in order to spare the lives of others who may take the medication. The more a patient and his/her doctor knows about a drug the more informed they can be in deciding whether that particular drug is right them and their situation. Other than reduced sales for the drug Ketek, there is no other real down side to further educating consumers about the drugs known side effects. That fact alone should be enough to motivate Sanofi Aventis to change the label to warn about SJS/TEN but we shall see if they decide to do the right thing. In many instances like this, the drug manufacturer routinely puts profits over people and refuses to further inform consumers of potential dangers for the fear of future lost sales and profits. Lets hope Sanofi Aventis chooses to make the labeling change given the grave consequences that can and will likely result if they do not.