Arthritis: Strongest possible warning on 'safe' drugs

The days may be numbered for a new family of arthritis drugs that is causing serious fungal infection and tuberculosis (TB) in the patient, sometimes resulting in death.

The American drug regulator, the Food and Drug Administration (FDA), is calling on manufacturers of the TNF-blocking drugs to toughen the warning on the drug’s labelling.  The FDA had already called for a ‘black box’ warning – which alerts doctors to the fact that a drug is potentially dangerous – before its latest announcement.

TNF-blockers were heralded as the safer option for arthritis sufferers than the COX-2 family, which included Vioxx, the subject of the largest class action suit in history after it was found to be responsible for at least 60,000 deaths.

But the TNF-blockers have their own problems.  The FDA has been inundated by reports that the drugs cause serious fungal infections, sometimes resulting in death.  In many cases, doctors have been slow to react, possibly not realizing that the drug was to blame, and the patient has died from the infection.  In one outbreak involving 21 patients, 12 died.

(Source: Journal of the American Medical Association, 2008; 300: 1639).