Following Merck’s decision on September 30, 2004 to withdraw Vioxx (Rofecoxib), Renata has voluntarily suspended sales of Fexib effective October 1, 2004. In addition, pharmacies in Bangladesh have been requested to return any unsold quantities of Fexib to Renata distribution centres or to any member of the field force.

The decision by Merck came after a 3-year study demonstrated that Vioxx 25 milligram dose increased the risk of heart attack and strokes beginning 18 months of treatment in patients taking Vioxx compared to those taking placebo. The study was initially commissioned to investigate whether Vioxx at 25 mg dose prevents recurrence of potentially cancer causing polyps in the colon and rectum. [Source: www.vioxx.com/rofecoxib/vioxx/consumer/index.jsp ]

Medical experts in the USA have advised patients to stop taking Vioxx and consult their doctor about alternatives. However, they have also stated patients should not panic because the risk of a Rofecoxib induced heart attack is relatively low. [Source: Yahoo News. September 30, 2004]

Vioxx is one of the key drugs for Merck with estimated sales of US $2.5bn. Shares in Merck plummeted by more than 25% following the announcement. Analysts say that the worldwide withdrawal of Vioxx could reduce 2004 earnings by 50-60 cents a share, wiping an estimated US $750m from fourth quarter sales. [Source: The Financial Times. September 30, 2004]

In contrast, the withdrawal of Fexib will have a very modest effect on the financial performance of Renata. Up until August 2004, Fexib constituted a mere 0.5% of total pharmaceutical sales.

Rofecoxib belongs to the Cox-2 Inhibitor class of drugs. The safety profile of Cox-2 Inhibitors is likely to come under scrutiny worldwide. However, Pfizer was quick to defend Celecoxib -- another Cox-2 Inhibitor. Joe Feczco, Pfizer’s President for worldwide development said, “Pfizer is confident in the long-term cardiovascular safety of Celebrex (Celecoxib).” He added that a recent US FDA study of 1.4 million patients demonstrated no increased cardiac risk for those taking Celecoxib. [Source: Cardiovascular News]