Once upon a time there were arthritis drugs known as NSAIDs (non-steroidal anti-inflammatory drugs), but they caused gastrointestinal problems, such as ulcers. So researchers at your friendly, neighbourhood pharmaceutical company came up with a new breed of NSAID known as COX-2 (cyclooxygenase-2) inhibitors, which were meant to be far kinder to the stomach.
Now, every drug has side-effects, and the COX-2 inhibitors are no different. Their side-effects are . . . gastrointestinal problems, such as ulcers.
Recognising that nobody’s perfect, the pharmaceutical industry and the drug regulators decided to press on with the COX-2 inhibitors, and several are now on the market.
The latest to win its spurs was Bextra (valdecoxib), approved in America by the Food and Drug Administration in 2001, and last summer in Europe by the EMEA.
Unfortunately, the FDA has discovered that Bextra doesn’t just cause gastrointestinal problems, such as ulcers – it also causes life-threatening skin reactions, including toxic epidermal necrolysis, as well as anaphylactic reactions and angiodema. Patients in the US who suddenly start developing a rash are now being told to stop treatment immediately. These reactions, which resulted in several people needing hospital treatment, only came to light once the drug had been approved in the US – around March 2002, in fact.
Interestingly, the recently created EMEA didn’t meet to discuss the drug until last July, five months after people were being rushed to hospital in America.
On approving the drug, the agency was told that Bextra’s side-effects included dry mouth, hypertension, insomnia, anaemia, and so on (regular readers of this column can probably complete the list). But there was no mention that it could cause life-threatening skin reactions. So, is the EMEA now going to issue a warning to doctors in Britain? We watch the space with great interest.