Up until 1999, patients with osteoarthritis and various other ailments were prescribed standard non-steroid anti-inflammatory drugs (NSAIDs), which were able to relieve inflammation and pain, but often resulted in a range of uncomfortable side effects, most notably gastric problems. However, in 1999 two new drugs were approved, and these drugs were called Vioxx and Celebrex. Known as Cox-2 Inhibitors (because they inhibited the Cox-2 enzyme in the body as opposed to NSAIDs, which inhibit both Cox-1 and Cox-2 enzymes), these drugs were welcomed and hailed as miracle drugs. However, after five years of successfully manufacturing the drug Vioxx - and after making an estimated $8 billion in profits over these five years - the drug giant Merck has withdrawn Vioxx from the market.
The withdrawal came following research that indicated that patients on Vioxx were at dramatically increased risk of heart attack and stroke. There is now scandal and controversy following a series of claims that Merck knew about these risks four years ago, and that they should have withdrawn the drug immediately but in fact simply covered up the potential dangers.
The purpose of Voixx was to relieve the signs and symptoms of osteoarthritis, menstrual discomfort, and other types of adult pain. This is a non-steroid anti-inflammatory drug that works in a different way to standard NSAIDs. The Cox-1 enzyme produced by the body has an important function, which is to protect the stomach lining. Standard NSAIDs work by inhibiting both Cox-1 and Cox-2 enzymes, hence the associated side effect of gastric problems. Vioxx works differently in that it inhibits only the Cox-2 enzymes, which means that it does not cause the same gastric issues as the other NSAIDs.
Vioxx is a prescription only medication, and is also known as rofecoxib. This is the drug's generic or chemical name, as opposed to the name Vioxx, which is a given name used to market the drug. The drug, until its recent withdrawal, was used to treat adults only, as investigations into its use with those under eighteen had not yet been investigated.
Approval for the drug was granted in May 1999 but the Food and Drugs Administration (FDA). A press release announcing the approval stated:
"Vioxx was evaluated for the treatment of the signs and symptoms of OA in placebo- and active-controlled clinical trials of six to 86 weeks that included approximately 3,900 patients. The effectiveness of Vioxx 12.5 mg and 25 mg once a day was shown to be comparable to prescription-strength non- steroidal, anti-inflammatory drugs (NSAIDs) ibuprofen 800 mg three times a day and diclofenac 50 mg three times a day for treatment of the signs and symptoms of OA"
A further section of the release entitled 'selected cautionary information' stated:
"The most common side effects reported in clinical trials with Vioxx were upper-respiratory infection, diarrhea and nausea. People who have had an allergic reaction to Vioxx, aspirin or other traditional NSAIDs should not take Vioxx.
Although Vioxx has a low potential for stomach ulcers, serious GI ulcers can occur without warning symptoms. Physicians and patients should remain alert for signs and symptoms of GI bleeding. Vioxx should not be taken by women in late pregnancy. Safety and effectiveness in children have not been evaluated."
No mention of possible heart risks was made, despite the claims that are now in circulation stating that these side effects were evident in trials at the time of approval, and the manufacturer, Merck, knew about these effects.
