Drugmaker Pfizer Inc. is in talks with regulators over a likely change to arthritis drug Bextra’s label to warn doctors about the risk of a potentially deadly skin reaction, the company said in a regulatory filing.
Pfizer also said in the filing it is under investigation by New York and Connecticut in connection with potentially improper promotion of drugs for uses other than those approved by U.S. regulators, and has initiated an internal probe relating to its sales operations in Croatia.A Pfizer spokesman declined to comment on the investigation or its talks with the U.S. Food and Drug Administration over Bextra. In May, Pfizer agreed to pay $430 million to resolve criminal charges and civil liabilities stemming from the illegal promotion of epilepsy drug Neurontin.BEXTRA AT RISKPrudential Securities analyst Tim Anderson said the warning on Bextra, which is in the same class of drugs as Pfizer’s Celebrex and Merck & Co.’s withdrawn arthritis drug Vioxx, suggests the commercial future of Bextra is at risk.Pfizer said it is talking to regulators about carrying a “black box” warning that it might result in a rare, but sometimes fatal skin disorder called Stevens-Johnson syndrome.A black-box warning is the strongest warning the United States can put on prescription drugs.”Any black box warning does not bode well for the product,” said Cathay Financial analyst Sena Lund. However, he said since the Vioxx recall and concerns over cardiovascular risks of drugs on the class, “the FDA, physicians and patients have already been on high alert.”Launched in 2001, Bextra had sales last year of $687 million.STATE PROBESIn the New York investigation, Pfizer said it has received a letter from Attorney General Eliot Spitzer’s office requesting documents and information on clinical trials of certain drugs for uses other than those approved by the FDA. Pfizer said the probe involved the possible promotion of products for unapproved uses.Pfizer said it received a letter from the Connecticut attorney general’s office requesting similar materials concerning its antidepressant Zoloft.Connecticut Attorney General Richard Blumenthal in a statement said he was seeking details on how Pfizer marketed Zoloft to children. The state also is seeking clinical trial data on the drug’s safety and effectiveness.Last month, the FDA ordered Pfizer and other antidepressant makers to put tough warnings on the drugs to alert doctors, parents and patients that the drugs increase risks of suicidal behavior among children and teens.Only Eli Lilly and Co.’s Prozac is approved by the FDA for treating depression in children.Pfizer spokesman Paul Fitzhenry said both investigations were new, but declined to specify which drugs the New York attorney general was investigating. A spokesman for Spitzer’s office declined to comment.Lund said he had too few details about the investigations to assess the situation, but added, “It’s always risky.” He maintained his “outperform” rating on Pfizer.Pfizer also said it has voluntarily provided the Department of Justice and the Securities and Exchange Commission with information regarding an internal probe of certain potentially improper payments made in connection with foreign sales activities in Croatia.Pfizer’s shares fell 38 cents, or 1.3 percent, to $28.41 on the New York Stock Exchange on Monday. (Source: Reuters, Nov 2004)