Recombinant DNA products predominated among the most frequently reported suspect brand name drugs. The tumor necrosis factor (TNF) blockers Enbrel (etanercept; Immunex Corp, Seattle, Washington; approved November 1998), Humira (adalimumab; Abbott Laboratories, Abbott Park, Illinois; approved December 2002), and Remicade (infliximab; Centocor Ortho Biotech Inc, Horsham, Pennsylvania; approved November 1999) were first, third, and fourth most frequently reported suspect drugs, respectively. Because these drugs suppress the immune system, they carry the risk of opportunistic infections. In 2005 the FDA required the manufacturers of all TNF blockers to add a warning about lymphomas, followed by a safety alert issued in September 2008 and strengthened warnings about the risk of invasive fungal infections on the product label for these and another TNF blocker, Cimzia (certolizumab pegol; UCB, Brussels, Belgium). The reporting curves for Enbrel, Humira, and Vioxx (rofecoxib; Merck & Co Inc, Whitehouse Station, New Jersey) are bimodal (Figure). All begin with a typical Weber effect reporting curve, where the reports increased over the first 2 years of follow-up and then began to go down, until the safety alerts spurred a second larger peak. Remicade was the subject of a safety alert in 2001 regarding increased mortality among patients with congestive heart failure and saw only a slight dip in reporting 5 years after approval.