Vioxx is a non-steroid anti-inflammatory drug (NSAID) that was hailed a miracle drug in May 1999 when it was approved by the FDA (Food and Drugs Administration) for the treatment of osteoarthritis, menstrual cramps, and adult pain management. The reason for the enthusiasm shown by the medical world when this drug was approved was due to the keys difference between the drug and the previously used NSAIDs. Voixx, along with Celebrex, was one of a new breed of NSAIDs known as Cox-2 Inhibitors. This is because the drug selectively inhibited only the Cox-2 enzyme produced by the body, whereas other NSAIDs also prohibited the Cox-1 enzyme, which was responsible for protecting the stomach lining and therefore often resulted in severe gastric problems.
However, following studies performed recently, it has been discovered that Vioxx is associated with a far more worrying side effect than stomach problems. This drug has been linked to dramatically increased cases of stroke and heart disease, and on 30 th September 2004 was withdrawn from the market by its manufacturing company, the drug giant, Merck.
Merck's decision to recall voixx from the market was an independent one and not influenced by the FDA. However, although the FDA is still looking into the results of the studies carried out, the agency has agreed that the drug does appear to pose a danger to patients, and will be assisting Merck with the withdrawal of the drug from the US market. The FDA also issued a public health warning on the same day that Vioxx was withdrawn.
Following Merck's decision to withdraw Vioxx from the market, those that are currently taking this prescribed drug are advised to visit their physicians as soon as possible to discuss an alternative medication. Officials are also keen to reassure patients that, although the risks of stroke and heart disease are increased in comparison to other NSAIDs, the risk to each individual is still not a big risk.
Merck's decision to withdraw Vioxx from the market came after information produced from a trial known as the APPROVe [ Adenomatous Polyp Prevention on VIOXX] trial. This trial entailed comparing Vioxx to a placebo to see if the drug was effective in preventing colon polyps recurrences. However, after eighteen months of continuous treatment with Vioxx during the trial, it was discovered that these patients were at increased risk of stroke and heart attacks, hence the trial was cut short.
An earlier study, conducted by Merck, was known as VIGOR. The aim of this study was to find out more about gastrointestinal effects of Voixx on users. However, although this study also showed evidence of increased heart trouble and stroke, Merck claimed that the findings were not significant enough the recall the drug at that time.
Merck's voluntary recall of Vioxx means that this drug will no longer be available at pharmacies. Patients that have been prescribed this drug will no longer be able to get a presc rip tion for it, and those with existing presc rip tion will not be able to get the medication from the pharmacy. Instead, these patients are strongly advised to visit their GPs in order to discuss an alternative treatment. Those with unused portions of the drug can return them to Merck and will be issued with a refund.
