European regulators tag 100-plus drugs with 'black triangle'

The European Medicines Agency has rolled out its list of drugs that soon will bear the "black triangle." The labeling logo is designed to encourage doctors and patients to report side effects, as part of a new effort to more closely monitor drug safety. The list of 100-plus products includes all new drugs and biologics approved since January 2011.

Under new pharmacovigilance legislation in Europe, drugmakers will be required to add the inverted black triangle to these drugs' labels. EMA says currently marketed products must bear the triangle by year's end, while drugs approved after September 1 have to roll out with the new labeling.

The list includes big-name introductions of the past couple of years, including Novartis' ($NVS) multiple sclerosis pill Gilenya, Pfizer's ($PFE) cancer treatment Xalkori, Roche's ($RHHBY) melanoma drug Zelboraf, Merck's ($MRK) hepatitis C treatment Victrelis, Amgen's ($AMGN) bone drug Xgeva, Sanofi's ($SNY) colon cancer treatment Zaltrap, Johnson & Johnson's ($JNJ) prostate treatment Zytiga and Bristol-Myers Squibb's ($BMY) melanoma drug Yervoy.

In addition to drugs that are "new active substances" and new biologics, those brought to market under a conditional approval also must wear the black triangle.Among those are Amgen's cancer fighter Vectibix, first approved by the EMA in 2007; GlaxoSmithKline's ($GSK) breast cancer drug Tyverb/Tykerb, which won EMA approval in 2008; and Johnson & Johnson's HIV drug Intelence, also approved in 2008. Drugs authorized "under exceptional circumstances" are also included.

The EMA program follows a study released last year, which showed that one-fourth of drugs approved in Canada over 16 years were later tagged with serious safety warnings or pulled from the market for safety reasons. An accompanying Archives of Internal Medicine editorial advocated special labeling for new drugs during their first three years on the market.

- get the EMA announcement
- see the list of drugs affected