The claim of no gastrointestinal risks was not approved for the label when the FDA approved Celebrex and yet, Searle, Pharmacia and Pfizer, have each been cited for stating or implying in promotional materials that Celebrex worked better than other pain relief drugs because it posed no gastrointestinal risks.
In fact, when the FDA approved Celebrex it specifically warned that any promotional activities "that make or imply comparative claims about the frequency of clinically serious GI events compared to NSAIDs or specific NSAIDs will be considered false and/or misleading . . ."
Furthermore, the FDA required the Celebrex label to include the warning that "serious gastrointestinal toxicity can occur at any time, with or without warning symptoms, in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs)."
In 2005, the FDA required the Celebrex label to include a boxed warning stating: "NASIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal."
Claims that portray Celebrex as a superior pain reliever are also false and misleading because the FDA has stated that, "none of the comparative studies with naproxen, ibuprofen, and diclofenac to-date has been designed to demonstrate superiority or a specified degree of similarity in a rigorous way."
One Celebrex TV ad found to be false and misleading promoted the drug for use in treating osteoarthritis or rheumatoid arthritis, and shows a woman playing a guitar with a voice-over saying, "With Celebrex, I will play the long version." The FDA sent Pfizer a "warning" letter on this ad stating:
"While the Guitar TV ad suggests a direct benefit to this patient's wrist/hand/finger joints related to movement and flexibility, it fails to state the actual approved indication (e.g., relief of signs and symptoms of osteoarthritis)."
The FDA also pointed out that this ad failed to include any risk information about Celebrex, thus omitting the major side effects and contraindications, and said the omission of this information implies that there are no risks, which overstates the drug's safety.
The FDA determined that another TV ad was misleading and warranted a warning letter that began with the announcement: "Celebrex presents, arthritis tips."
The ad features a woman dressed as doctor stating: "Arthritis is the most wide-spread crippling disability in the United States today. Arthritis is the predominant cause of activity limitations and is a major determinate of nursing home institutionalization for the elderly."
"One out of every 7 people and 1 in every 3 families is affected by arthritis," the ad states. "If you feel any pain or discomfort in your joints, contact your local doc."
The commercial concludes by saying: "These arthritis tips have been brought to you by Celebrex."
The FDA said that this ad is product-specific, and misleading because it omits important information about the drug's safety and effectiveness and makes unsubstantiated claims. The FDA said the ad promotes Celebrex by name at the beginning and end and that using the term arthritis tips clearly suggests that the drug is an arthritis treatment.
The totality of this presentation, the FDA letter advised, suggests that Celebrex is an effective treatment for preventing or modifying the progression of arthritis, such that crippling disability and nursing home institutionalization may be avoided, when in fact, Celebrex is indicated only for relief of the signs and symptoms of OA and RA and is not indicated for disease modification (i.e., altering the course of the progression of arthritis).
"Moreover," the FDA said, "we are not aware of substantial evidence or substantial clinical experience demonstrating that treatment with Celebrex will prevent crippling effects or disability due to arthritis or prevent nursing home institutionalization of elderly patients with arthritis."
"Therefore," the letter warned, "your Arthritis Tips TV ad greatly overstates the proven benefits of Celebrex."
In fact, when the FDA approved Celebrex it specifically warned that any promotional activities "that make or imply comparative claims about the frequency of clinically serious GI events compared to NSAIDs or specific NSAIDs will be considered false and/or misleading . . ."
Furthermore, the FDA required the Celebrex label to include the warning that "serious gastrointestinal toxicity can occur at any time, with or without warning symptoms, in patients treated with non-steroidal anti-inflammatory drugs (NSAIDs)."
In 2005, the FDA required the Celebrex label to include a boxed warning stating: "NASIDs, including CELEBREX, cause an increased risk of serious gastrointestinal adverse events including bleeding, ulceration, and perforation of the stomach or intestines, which can be fatal."
One Celebrex TV ad found to be false and misleading promoted the drug for use in treating osteoarthritis or rheumatoid arthritis, and shows a woman playing a guitar with a voice-over saying, "With Celebrex, I will play the long version." The FDA sent Pfizer a "warning" letter on this ad stating:
"While the Guitar TV ad suggests a direct benefit to this patient's wrist/hand/finger joints related to movement and flexibility, it fails to state the actual approved indication (e.g., relief of signs and symptoms of osteoarthritis)."
The FDA also pointed out that this ad failed to include any risk information about Celebrex, thus omitting the major side effects and contraindications, and said the omission of this information implies that there are no risks, which overstates the drug's safety.
The FDA determined that another TV ad was misleading and warranted a warning letter that began with the announcement: "Celebrex presents, arthritis tips."
The ad features a woman dressed as doctor stating: "Arthritis is the most wide-spread crippling disability in the United States today. Arthritis is the predominant cause of activity limitations and is a major determinate of nursing home institutionalization for the elderly."
"One out of every 7 people and 1 in every 3 families is affected by arthritis," the ad states. "If you feel any pain or discomfort in your joints, contact your local doc."
The commercial concludes by saying: "These arthritis tips have been brought to you by Celebrex."
The FDA said that this ad is product-specific, and misleading because it omits important information about the drug's safety and effectiveness and makes unsubstantiated claims. The FDA said the ad promotes Celebrex by name at the beginning and end and that using the term arthritis tips clearly suggests that the drug is an arthritis treatment.
The totality of this presentation, the FDA letter advised, suggests that Celebrex is an effective treatment for preventing or modifying the progression of arthritis, such that crippling disability and nursing home institutionalization may be avoided, when in fact, Celebrex is indicated only for relief of the signs and symptoms of OA and RA and is not indicated for disease modification (i.e., altering the course of the progression of arthritis).
"Moreover," the FDA said, "we are not aware of substantial evidence or substantial clinical experience demonstrating that treatment with Celebrex will prevent crippling effects or disability due to arthritis or prevent nursing home institutionalization of elderly patients with arthritis."
"Therefore," the letter warned, "your Arthritis Tips TV ad greatly overstates the proven benefits of Celebrex."
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