Since Celebrex was launched in January, federal regulators have received 95 reports of errors by doctors and pharmacists in dispensing Celebrex problems blamed on health professionals confusing the painkiller with similarly named drugs.
None of the cases involve serious injury or death. But the two companies that jointly sell Celebrex, Monsanto Co. and Pfizer Inc., have recently started trying to clear up the confusion with an educational campaign aimed at doctors and pharmacists.
"This is an accident waiting to happen," said Hedy Cohen, vice president of nursing at the Institute for Safe Medication Practices, a Huntington Valley, Pa., nonprofit group that tracks medication errors. "It's a matter of time until a person that is already sick gets the wrong drug and the chance for a serious injury can occur."
This spring, Celebrex became the fastest-selling new drug ever, with about 9.3 prescriptions written so far. It is on track to have more than $1 billion in sales this year, and upwards of $4 billion by 2002, analysts say.
Of the 95 medication mixups reported to the Food and Drug Administration, only 22 cases involved a patient actually taking the wrong drug. With the rest, someone caught the error in time.
At the urging of the FDA, Monsanto and Pfizer have paid for advertisements in major medical journals to make sure doctors and pharmacists understand the difference between the sound-alike drugs and the need to verify they are giving out the right pill. The companies' marketing representatives are reinforcing the message during visits to doctors.
If the problem does not improve, the FDA could make the companies change the drug's name, which analysts say could threaten sales. Monsanto has already changed the drug's name once, from Celebra, after federal regulators said it sounded too much like other medications.
"We are still concerned about the problem," said Jerry Phillips, an FDA official who assesses the risk of drugs that already have reached the market. "This is a significant number of errors."
Medical experts say reports to the FDA generally represent a small proportion of the errors that occur because the reporting system is voluntary. But Monsanto officials said more mixups occur with Celebrex because the drug is so popular, and they stressed the number of actual medication errors is a very small percentage of the prescriptions written.
Celexa is made by Forest Laboratories, and Cerebyx by Warner-Lambert.
Monsanto spokeswoman Sally Benjamin Young would not reveal how much the company is spending on the education campaign, which started last month.
The companies are advising pharmacists to ask patients about the drug they are receiving to avoid any errors. The mixups largely occur because pharmacist cannot read the doctor's handwriting, pharmacists say.
Written by Phil Galewitz