Summary
Consumer advocate Dr. Sydney Wolfe, while agreeing with the FDA's decision to order pharmaceutical manufacturer Pfizer to remove their product Bextra from the market, worries that the FDA has left the job half done. "The FDA is ultimately doing more harm than good," according to Dr. Wolfe, because Celebrex (also manufactured by Pfizer) has been allowed to remain on the market, despite some experts say are significant risks of damage to the heart.
The FDA has asked Pfizer to add a "black box" warning to Celebrex, warning doctors and consumers of possible complications associated with the drug. Dr. David Graham, a scientist working for the FDA, has said that the FDA should have banned Celebrex in high dosages.
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Washington - A prominent consumer advocate and an outspoken FDA scientist welcomed the suspension of Pfizer's painkiller Bextra, but said some or all doses of its related drug, Celebrex, also should be suspended from the market.
On Thursday Pfizer said it would stop selling Bextra at the request of United States and European regulators.
The US Food and Drug Administration also asked the company to add a so-called "black box" warning to the label of its painkiller Celebrex, stating health risks from the drug.
FDA officials said they asked Pfizer to stop selling Bextra, a Cox-2 pain medicine similar to Celebrex and Merck & Company's withdrawn Vioxx, because of cardiovascular risks and the possibility of a sometimes fatal skin reaction.
Public Citizen's Health Research Group Director Dr Sidney Wolfe said, while he welcomed Bextra's suspension, the heart risks for Celebrex also warranted its removal.
"The black box warning will lead people to think Celebrex is no more dangerous" than other pain drugs, including naproxen, Wolfe said.
"The FDA is ultimately doing more harm than good."
FDA veteran scientist David Graham, who called for the removal of Bextra along with four other drugs last year, said he was disappointed that the FDA did not ban high doses of Celebrex.
Graham added the agency "took far too long" to act.
Pfizer has vigorously defended the safety of Celebrex in the past and said on Thursday that it would work with the
FDA on the new label.
Worries about the safety of painkillers have grown since September when Merck pulled Vioxx off the market after a study showed an increased risk of heart attack and stroke.
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About the author: Mike Adams is a consumer health advocate and award-winning journalist with a passion for teaching people how to improve their health He has authored more than 1,800 articles and dozens of reports, guides and interviews on natural health topics, and he has created several downloadable courses on survival and preparedness, including his widely-downloaded course on personal safety and self-defense. Adams is an honest, independent journalist and accepts no money or commissions on the third-party products he writes about or the companies he promotes. In 2010, Adams created TV.NaturalNews.com, a natural living video sharing site featuring thousands of user videos on foods, fitness, green living and more. He also launched an online retailer of environmentally-friendly products (BetterLifeGoods.com) and uses a portion of its profits to help fund non-profit endeavors. He's also a noted pioneer in the email marketing software industry, having been the first to launch an HTML email newsletter technology that has grown to become a standard in the industry. Adams volunteers his time to serve as the executive director of the Consumer Wellness Center, a 501(c)3 non-profit organization, and regularly pursues cycling, nature photography, Capoeira and Pilates.
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Wednesday, May 18, 2005
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