Celebrex and Aleve enter FDA's crosshairs

NEW YORK: Just months after the Vioxx recall, two more painkillers have to answer questions about whether they raise the risk of heart problems.

NEW YORK: Just months after the Vioxx recall, two more painkillers have to answer questions about whether they raise the risk of heart problems.

Within a three-day period, the Food and Drug Administration (FDA) announced that two separate studies of Pfizer's Celebrex and Bayer's Aleve had been halted after researchers saw an increased incidence of cardiovascular events compared to a placebo.

Pfizer, which recently selected Ogilvy as AOR for its arthritis drugs, stressed that the results contradict past research.

"Pfizer is taking immediate steps to fully understand the results and rapidly communicate new information to regulators, physicians, and patients around the world," chairman and CEO Hank McKinnell explained in a statement.

The FDA has asked Pfizer to voluntarily suspend promotion of Celebrex. The drug company didn't return calls for comment.

Bayer is also stressing to the media that past research on its over-the-counter painkiller contradicts the new findings.

"Bayer healthcare is strongly committed to public safety and is obviously concerned about the report," said PR director William O'Donnell, reading a prepared statement. "We will consider the data in the context of the 30-year history of safe use of [Aleve] as a pain reliever."

O'Donnell declined to answer questions about the company's other PR efforts, and noted that the statement had not been posted on the newswires.

The FDA has also taken a hit in the headlines over whether it can adequately monitor drugs post-approval. A spokeswoman there did not respond to a request for comment.

Nancy Turett, president and global director of Edelman's health practice, said the crises are likely to create greater public familiarity with the companies and their executives.

"They've done quite a good job of disclosing information when they have it," she said.

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