Celebrex Causes Concern

Name Confusion Plagues Celebrex / Celebrex Tied To 10 Deaths; GI Bleeding

This aritcle is a part of the Arthritis Archives.

Dateline: April 21, 1999

Its approval was highly anticipated, the sales soared, and now Celebrex is causing concern.

Name Confusion Plagues Celebrex

Since Celebrex (generic name celecoxib) made its debut in January 1999, there have been 53 reports of errors due to name confusion. The name brand Celebrex is being mixed up with that of two other drugs, Cerebyx and Celexa.

• Celebrex (celecoxib) is the new COX-2 selective inhibitor used for the treatment of arthritis.
• Cerebyx (fosphenytoin) is an intravenous drug used to treat epilepsy
• Celexa (citalopram) is a medication used to treat depression and symptoms of fibromyalgia.

The similarity among the names has caused confusion and mistakes, but no serious injuries or fatalities...yet. In 10 of the 53 reported cases, the patient actually received the wrong drug. In 19 of the cases, the wrong drug was prescribed but the error was caught before the patient was dispensed the wrong drug. In the remaining 24 cases, doctors and pharmacists reported the name "Celebrex" to be confusing.

The reported number of errors is the most the Food and Drug Administration (FDA) has ever received for any drug that has only been available to consumers for 4 months. The FDA's Office of Postmarketing Drug Risk Assessment is reportedly in contact with the manufacturers of Celebrex in an attempt to solve the problem. Under consideration is another name change for Celebrex along with a campaign to educate:

• consumers
• physicians
• pharmacists

The name already has been changed once, from Celebra to Celebrex, prior to approval for marketing.

Doctors have written about 2.5 million prescriptions for Celebrex since it became available. The number of reported errors may seem relatively small compared to the number of prescriptions written, but 95% of medication errors are never reported since such reporting is voluntary.

Some health care systems are attempting to find their own solutions to the problem by:

• requesting that doctors fill out prescriptions completely
• listing generic and trade names of drugs
• writing clearly
• including the ailment which is being treated

Patients also have a responsibility to:

• learn about the drugs they are being prescribed
• recognize possible errors
• asking questions of doctors and pharmacists when in doubt

Awareness and education by the patient can help deter serious mistakes caused by uncertainty. This situation is another example of the importance of becoming a partner in our own health care.

Celebrex Tied To 10 Deaths, 11 Cases GI Hemorrhage

News media spread a report yesterday which originated in The Wall Street Journal regarding Celebrex and a link between:

• 10 deaths which occurred during its first three months on the market.
• 11 cases of gastrointestinal hemorrhage which were also sited.

Reportedly the information was obtained by the Wall Street Journal from the FDA under the Freedom of Information Act.

• 5 of the 10 people who died had gastrointestinal bleeding or ulcers.
• 2 of the deaths were connected to heart attacks, one to drug interaction, and one to kidney disorder.
• No cause was given for one of the people.

Comments which were attributed to spokespersons from the FDA and from Monsanto's Searle implied that more research needs to be done before conclusions can be accurately drawn about the safety of Celebrex. Ten cases is considered insignificant for interpretation. More information about the histories of the ten people must be considered before their deaths can be tied directly to their use of Celebrex. Of the ten deaths, it was reported that 8 had prior histories of heart, liver, or gastrointestinal problems. It should be remembered that if a death is reported for a person taking a particular drug, the drug itself is not necessarily the cause of the death. Other factors may be contributory.

More Information

_{Sources: Prescription Errors With Popular New Painkiller Blamed On Confusion Over Name, Intelihealth, 4/15/99; Sound-Alike Drugs Confuse Doctors, St. Louis Post-Dispatch, 4/18/99; Celebrex Linked To 10 Deaths, APOnline, 4/20/99; Paper: Celebrex Linked to 10 Deaths, Intelihealth, 4/20/99; Celebrex Linked To 10 Deaths, Reuters, 4/20/99; FDA Unworried By Deaths Linked To Super-Aspirin, abcnews.com/Reuters, 4/20/99
First published: 04/21/1999}