If you’ve ever heard about Stevens-Johnson Syndrome (SJS) or toxic epidermal necrolysis (TEN) – two related forms of rare disorder that can cause you to shed your skin following an allergic reaction – you may think that the medications triggering such extreme allergic reactions are limited to prescription drugs. But that is not the case.
Just last month, pharmaceutical and healthcare giant Johnson & Johnson (J&J) acknowledged that their over-the-counter ibuprofen product, Motrin, can trigger that allergic reaction. According to CBS Business Network, a recent California case uncovered that J&J has known about this possible side effect since the 1980s. Despite this known danger, Motrin packaging does not list the possibility on any of its warning labels.
Under the California appellate court ruling, J&J may soon have to add a warning on all Motrin packages sold in the U.S. that cautions consumers specifically about the possibility of SJS and TEN. This specific warning is not currently required by the U.S. Food and Drug Administration (FDA), although the bottle does have disclaimers about severe allergic reactions, so it has not been added to Motrin bottles sold in the U.S.; however, such a warning does exist for those sold in Germany.
In court, J&J noted that they have complied with all FDA requirements. But the court believes that this may no longer be enough, stating that “a central premise of federal drug regulation [fusion_builder_container hundred_percent=”yes” overflow=”visible”][fusion_builder_row][fusion_builder_column type=”1_1″ background_position=”left top” background_color=”” border_size=”” border_color=”” border_style=”solid” spacing=”yes” background_image=”” background_repeat=”no-repeat” padding=”” margin_top=”0px” margin_bottom=”0px” class=”” id=”” animation_type=”” animation_speed=”0.3″ animation_direction=”left” hide_on_mobile=”no” center_content=”no” min_height=”none”][is] that the manufacturer bears responsibility for the content of its label at all times. It is charged both with crafting an adequate label and with ensuring that its warnings remain adequate as long as the drug is on the market.”
According to CBS Business Network, the idea that ultimate responsibility for proper drug safety warnings lies with the manufacturer, rather than the FDA, is a relatively new one. The U.S. Supreme Court decision in Wyeth v. Levine in 2009 acknowledged that FDA regulations are the minimum standards for pharmaceutical companies and those making and selling drugs may be responsible for applying higher standards if apparent health risks exist.
California’s application of this decision against J&J could mean that not only will J&J start warning consumers about the possibility of SJS (or even death from TEN), but other drug manufacturers may start including more than just the FDA warnings on their products.
Source: Why J&J Didn’t Warn U.S. Consumers That Motrin Can Make Your Skin Fall Off
