Pfizer Suspends Sales of Bextra Amid Broader Efforts by FDA To Address Safety Concerns With Pain Medications
Pfizer on Thursday suspended U.S. sales of the COX-2 inhibitor Bextra at the request of FDA, which took "sweeping action to address the health risks of widely used painkillers, calling" on manufacturers" to include "sterner warnings" on their labels, the Wall Street Journal reports (Wilde Mathews/Hensley, Wall Street Journal, 4/8). Pfizer also suspended sales of Bextra in Canada and the European Union (Appleby et al., USA Today, 4/8).
In February, an FDA advisory committee recommended that Bextra remain on the market but include strong warnings about the potential risk for cardiovascular events linked with the medication. Steven Galson, acting director of the FDA Center for Drug Evaluation and Research, said that Bextra did not pose more safety risks than other COX-2 inhibitors (Kaufman, Washington Post, 4/8).
However, FDA asked Pfizer to suspend sales of Bextra because of increased risk for a "serious and potentially life-threatening" allergic skin reaction. Galson said that Bextra offered "no added advantage" over other COX-2 inhibitors but had the "special risk" of the skin reaction (Wall Street Journal, 4/8).
FDA scientist David Graham, who cited Bextra as one of five medications on the market about which he had safety concerns, said that the agency was aware of the increased risk for skin reaction for two years but only required the addition of a warning to the medication label in December 2004 (Appleby et al., USA Today, 4/8).
Pfizer officials in a statement said that the company "respectfully disagrees" with FDA conclusions about Bextra but will work with the agency to return the medication to the market (Bell/Kohn, Baltimore Sun, 4/8). In addition, Pfizer officials said that the company will conduct additional studies on risk for cardiovascular events linked with Bextra (Neergaard, AP/Las Vegas Sun, 4/7).
FDA officials on Thursday announced that the agency will require stronger warnings on other COX-2 inhibitors and over-the-counter nonsteroidal anti-inflammatory drugs, such as ibuprofen and naproxen, to inform patients about the increased risk for cardiovascular events and gastrointestinal bleeding. Prescription medications will have to include "black box" warnings on their labels, and OTC treatments will have to include similar warnings (Rubin, USA Today, 4/8).
According to the Philadelphia Inquirer, almost 50 medications or combination treatments currently on the market are classified as NSAIDs. John Jenkins, an official in the FDA Office of New Drugs, said, "We plan to develop our proposed text for the new labeling in the next few weeks, and will request that each sponsor adopt that text" (Ginsburg/FitzGerald, Philadelphia Inquirer, 4/8).
Galson said that FDA expects "companies to voluntarily run promotions ... that acknowledge these risks" (Higgins, Washington Times, 4/8). He added, "Let me emphasize now, this announcement is unlikely to be the last word you'll hear on these drugs. Clinical investigations continue. And in our new spirit of keeping the public informed earlier of emerging drug safety issues ... we may be providing further modifications as new information comes to light" (Alonso-Zaldivar/Gellene, Los Angeles Times, 4/8).
Pfizer, which on Wednesday announced plans to reduce costs by $4 billion annually and restated 2005 earnings estimates, might have to make additional cost reductions to return to double-digit earnings growth by 2006, according to William Blair analyst Winton Gibbons. Bextra had $1.3 billion in sales in 2004, and Pfizer officials said on Wednesday that they expected the sales of Bextra and Celebrex, a second COX-2 inhibitor manufactured by the company, to rebound.
However, some industry analysts said that the medications likely would not reach previous sales levels because of safety concerns. Steven Hill, a health care and portfolio analyst at First Investors, said, "It was already a declining story."
Robert Hazlett, a pharmaceutical industry analyst at SunTrust Robinson Humphrey, called the suspension of sales of Bextra a "kind of a minor victory" for Celebrex, the only COX-2 inhibitor currently on the market (Appleby et al., USA Today, 4/8).
Jamie Rubin, a pharmaceutical analyst with Morgan Stanley, called the suspension of sales of Bextra a "minor setback" for Pfizer, adding, "The company has clearly already been positioning Celebrex as the lead horse in its COX-2 franchise" (Washington Times, 4/8). Celebrex had $3.3 billion in sales last year (Tansey, San Francisco Chronicle, 4/8).
According to USA Today, Pfizer also "finds itself the focus of a growing, multifront legal threat similar to the one faced by Merck" after the company withdrew the COX-2 inhibitor Vioxx from the market in September 2004.
Investors have filed a series of securities lawsuits that allege Pfizer made misleading and false statements about the safety of Bextra and Celebrex. In addition, Pfizer faces several consumer and product liability lawsuits that allege the company misled patients who purchased Bextra and caused serious health problems among those who took the medication. Daniel Becnel, an attorney whose office has filed many of the Vioxx lawsuits, said that he would ask the federal Judicial Panel on Multidistrict Litigation to consolidate Bextra and Celebrex lawsuits with a single federal judge.
In February, Pfizer officials in an annual report acknowledged that the company faces a number of government investigations and lawsuits related to Bextra and Celebrex and said that potential judgments or settlements "could have a material adverse effect" on operations (McCoy, USA Today, 4/8).
The actions by FDA on Thursday indicate "the beleaguered agency has decided to take a tougher approach to the problem of health risks that surface" after medications have reached the market, the Los Angeles Times reports. The suspension of sales of Bextra also reduces the likelihood that Vioxx will return to the market, according to the Los Angeles Times. FDA said that Merck must submit a new application for Vioxx and that an agency advisory committee must consider the request (Los Angeles Times, 4/8).
According to the Wall Street Journal, the suspension of sales of Bextra "could presage a higher bar for approval of new products and a more public and confrontational process when problems emerge" with medications currently on the market (Wall Street Journal, 4/8).
Curt Furberg, a member of the FDA advisory committee that met in February who opposed the recommendation to allow Bextra to remain on the market, said that stronger warning labels on COX-2 inhibitors and NSAIDs could prompt pharmaceutical companies to conduct studies on their products to prove they have lower safety risks than rival medications. However, others experts said that pharmaceutical companies likely would not conduct such studies (San Francisco Chronicle, 4/8).
According to Galson, "FDA is providing the public information based on the latest available scientific data to guide the careful and appropriate use of these drugs aimed at maximizing their potential benefits and minimizing their risks" (Kerr, Long Island Newsday, 4/8).
Lennie Duensing of the American Academy of Pain Management said that the FDA actions on Thursday "caught doctors and pharmacists completely off guard. We're trying to get a grip on it" (Seabrook et al., Atlanta Journal-Constitution, 4/8).
Elizabeth Tindall, president of the American College of Rheumatology, said, "Patients will just be terrified, and they'll stop everything, and we're going to have to try to pick up the pieces" (Henderson, Boston Globe, 4/8).
Thalia Segal, a pain specialist at New York University, said, "We used to just put people on these drugs for life and not think about it, but we can no longer commit them to lifelong therapy with impunity. We have to use these medications judiciously and follow people more closely. We have to rely on a much more individualized approach" (O'Connor, New York Times, 4/8).
Jeannine Kenney, senior policy analyst at Consumers Union, said, "Removal of a dangerous drug from the market is a good thing, but it leads to the larger question -- why were these unsafe drugs being sold in the first place?" (Baer, Baltimore Sun, 4/8).
Alastair Wood, a professor at Vanderbilt University and chair of the FDA advisory committee that met in February, said that the agency is "now into dealing with this more seriously, using their bully pulpit more aggressively" (Wall Street Journal, 4/8).
Furberg said, "I did not expect them to have the guts to do it. I feel vindicated" (Rubin, USA Today, 4/8).
Sen. Chuck Grassley (R-Iowa) said in a statement on Thursday, "It will be good news if today's action ... is a turning point and indicates a more independent FDA. Otherwise, today's action may raise more questions than it gives answers for patients and their doctors" (Appleby et al., USA Today, 4/8).
Several broadcast programs reported on the suspension of sales of Bextra.
- CBS' "Evening News": The program includes discussion on the suspension (Attkisson, "Evening News," CBS, 4/7). The complete segment is available online in RealPlayer.
- CNN's "News From CNN": The program includes discussion on the suspension (Cohen, "News From CNN," CNN, 4/7). The complete transcript is available online.
- CNN's "Wolf Blitzer Reports": The program includes comments from Galson; Dr. Michel Dubois, director of the New York University Pain Management Center and professor of clinical anesthesiology at the NYU School of Medicine; physicians; and patients (Chernoff, "Wolf Blitzer Reports," CNN, 4/7). The complete transcript is available online.
NBR: The segment includes comments from Anthony Butler, a pharmaceutical industry analyst with Lehman Brothers (Gharib, NBR, 4/7). The complete transcript is available online.
- NPR's "All Things Considered": The program includes comments from Galson and Wood (Silberner, "All Things Considered," NPR, 4/7). The complete segment is available online in RealPlayer.
- NPR's "Day to Day": The program includes discussion on the suspension (Chadwick/Vigeland, "Day to Day," NPR, 4/7). The complete segment is available online in RealPlayer.
- NPR's "Morning Edition": The segment includes comments from Galson, Wood and Dr. Steven Nissen of the Cleveland Clinic (Knox, "Morning Edition," NPR, 4/8). The complete segment is available online in RealPlayer.
- PBS' "NewsHour with Jim Lehrer": The segment includes discussion of the suspension (Dentzer, "NewsHour with Jim Lehrer," PBS, 4/7). The complete transcript is available online. The complete segment is available online in RealPlayer.