CELEBREX

Celebrex & Vioxx

A panel of experts with the FDA recently made recommendations regarding Celebrex and Vioxx, two expensive drugs used to treat individuals with arthritis. The drugs that are known as selective COX-2 inhibitors are marketed as powerful and strong, although studies have not proven them to be any more effective than older non-steroidal, anti-inflammatory drugs called NSAIDs. The ruling of the FDA focused on the supposed ability of the COX-2 inhibitors to reduce pain without the gastrointestinal risks associated with older NSAIDs.

Celebrex’s manufacturer, Pharmacia, submitted results from a study comparing its drug with ibuprofen and diclofenac, two other NSAIDs. The FDA determined that the company had not presented a significant safety advantage of their drug compared to other NSAIDs. Consequently, the panel refused Pharmacia’s request to remove the gastrointestinal risk warning, “serious stomach problems, such as bleeding, can occur without warning” that all NSAIDs must include on their packaging and in all of their advertisements. This is in spite of the fact that these drugs can cause ulcers.

Many study participants also took low aspirin doses in order to minimize their risk of a heart attack. This canceled any benefits regarding protecting the stomach that Celebrex claims to offer. Most of the individuals targeted by Celebrex are older and more likely to be taking aspirin. The FDA also issued Pharmacia a fourth warning letter claiming that their marketing of Celebrex is “false, lacking in balance.” The company minimized the potentially serious risk posed to individuals who use Celebrex in combination with blood-thinning drugs such as aspiring.

The FDA panel was not as hard on the manufacturer of Vioxx, Merck. The company submitted a study that revealed a lower rate of stomach ulcers than the drug, naproxen. However, there wasn’t a large enough drop to convince the FDA panel to remove the bleeding risks warning from the labels on Vioxx. The FDA panel did agree to describe these results on the drug’s label at the request of Merck. The panel stated that patients and doctors must be warned that the risk of a heart attack or cardiovascular problems are twice as high for people who take Vioxx compared to naproxen. A month’s supply of glucosamine costs approximately $10 to $20, whereas the same supply of Celebrex or Vioxx will cost between $72 and $85.

Several clinical trials have revealed that glucosamine is effective to relieve pain for individuals suffering from osteoarthritis. This popular dietary supplement is available over the counter and has also proven to be safer than NSAIDs such as acetaminophen, ibuprofen and aspirin. Approximately 15,000 people die every year and 70,000 are hospitalized after suffering gastrointestinal bleeding caused by NSAIDs.

Glucosamine has also been proven to slow the progression of osteoarthritis in recent clinical trials. One trial included 212 individuals who suffered from mild to moderate osteoarthritis of the knee. Some participants were given a daily dose of 1,500 mg of glucosamine, whereas others were given a placebo for a period of three years. X-rays were taken of all the participants’ knees before and after the trial. Individuals who were given the placebo revealed a progressive joint-space narrowing, but the people who took glucosamine did not.

The placebo group showed slightly worse symptoms; however, the group that took glucosamine revealed a significant reduction of disability and pain during the three years. Neither group experienced any major complications. This trial was very important because it lasted three years, unlike the regular two-month period of most clinical trials for prescriptions drugs awaiting FDA approval. Glucosamine did not require pre-approval safety and efficacy testing normally required of prescription drugs because it is classified as a dietary supplement.