Rofecoxib is an anti-inflammatory medication that blocks certain compounds used to transmit pain signals to the brain. The drug was initially released in 1999, and in 2004, the manufacturer voluntarily withdrew it from the market in the United States. Regulators in other regions of the world undertook reviews to determine if they should continue allowing its sale. A second generation drug that is closely related, etoricoxib, was released in Europe but not the United States. In regions where this drug is available, patients should discuss the risks and benefits carefully with their doctors.
Known by brand names like Vioxx®, this drug acts on pain and inflammation in patients with osteoarthritis, pain conditions, and dysmenorrhea. The recommended dosage depends on the patient and the condition. Doctors typically start low and work up to higher doses to find the threshold where the medication is effective and the patient experiences a minimum of side effects.
Like other non-steroidal anti-inflammatory drugs, rofecoxib can cause gastrointestinal irritation, although it is less hard on the stomach lining than some other medications in this class. The drug can also cause clotting problems, particularly in patients who take blood thinners, and may lead to rashes and other reactions in some patients. The kidneys and liver, both responsible for processing rofecoxib, can also react badly to the medication.
The manufacturer removed the drug from the market in response to several studies showing an increased risk of stroke and cardiovascular disease in patients on the medication. These patients experienced adverse effects at a rate much higher than that of the general population, and the use of rofecoxib appeared to be the cause. Ongoing drug monitoring programs are designed for situations like this, so doctors can report adverse side effects to a central database for manufacturers to review and determine if the drug is safe.
Removal of the drug from the market required careful review of clinical evidence. Some practitioners criticized the company for failing to act quickly enough to pull the drug from the market when it became apparent that it was causing serious side effects. The manufacturer had to balance the need for patient safety with concerns about reputation, as recalling a drug can seriously impact sales. A third party audit revealed that the administration acted appropriately in the rofecoxib recall. If a doctor feels this medication is necessary for a patient, she will go over the risks and benefits carefully and review the patient's medical history for contraindications like a history of clotting problems.