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MagazineSeptember 1996 (Vol. 7 Issue 6)Feldene

Feldene (generic name: piroxicam) seems to be one of those drugs that people either hate or really loathe

Feldene (generic name: piroxicam) seems to be one of those drugs that people either hate or really loathe. Manufactured by Pfizer, it's a nonsteroidal anti inflammatory drug (NSAID) designed to treat both osteo and rheumatoid arthritis.

It's rarely been out of the news. Most recently it caught the attention of the US Food and Drug Administration (FDA) because Pfizer had failed to report cases of adverse drug reactions to the drug within the statutory 15 days. Pfizer's reports were between 70 and 500 days late.

Ten years ago, The Health Research Group, the American medical watchdog, petitioned the FDA to have Feldene banned for the over 60s. The Group claims the drug has caused serious side effects, and "numerous deaths", especially in older people. People over the age of 60 are more likely than others to suffer stomach and intestinal bleeding, ulcers and perforations, the Group reports.

The Canadian drug regulators, worried about adverse reactions to Feldene, have halved the recommended dose to just 10 mg a day, whereas the British and American authorities have stuck to the 20 mg dosage.

Extensive trials revealed that 30 per cent of users on 20 mg a day suffer some side effect. Gastrointestinal symptoms, such as bleeding, ulcers and perforation, occurred in 20 per cent of these, while others reported dizziness, headaches, vertigo, tinnitus, depression, insomnia, swollen eyes, hair loss, jaundice and rashes.

In all, the American Physicians Desk Reference (PDR) lists around 110 possible side effects. In a note to patients, the PDR states: "Feldene, like other drugs of its class, is not free of side effects", a sentence presumably up for the Jack Benny Pithy Understatement Award. To doctors, it advises counselling to patients of the potential risks.

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