FDA advisory panel votes to keep COX-2 drugs on the market
An FDA advisory panel voted last Friday that COX-2 inhibitor drugs, which have recently been tied to increased cardiovascular risks, should remain on the market but be accompanied by strong warnings.Recommendations from the panel are non-binding, but the FDA generally follows its advice. The panel includes members of the FDA arthritis and drug safety and risk management advisory committees. COX-2 inhibitors, which include Merck's Vioxx and Pfizer's Celebrex, are used to relieve arthritis and other types of pain.
The panel said in its recommendations that it thought Vioxx posed a greater risk to consumers than other COX-2 inhibitors and should be restricted, according to the Washington Post. However, it voted to allow Vioxx to return to the market and voted to allow Pfizer to keep Celebrex on the market.
It also recommended banning all direct-to-consumer advertising for the drugs; adding a "black box" warning to all COX-2 inhibitor labels; and requiring doctors to give patients a written warning that the medications increase a patient's risk of heart attack or stroke. The panel also recommended placing new warning labeling for nonsteroidal anti-inflammatory drugs such as ibuprofen.