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Will Celebrex shake off tainted image?
  • By Marian Chu
  • Published 2018.06.27 16:24
  • Updated 2018.06.27 16:24
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A Korean expert supported the U.S. Food and Drug Administration’s decision that a prescription painkiller, previously mired with cardiovascular safety concerns, was as safe as two similar drugs, ibuprofen and naproxen.

Hong Seung-jae, a professor at the rheumatology department of Kyung Hee University Medical Center, commented on the recent FDA panel’s vote regarding the cardiovascular safety of Celebrex (ingredient: celecoxib) and how it would impact the Korean market, during a Pfizer conference in Seoul Tuesday.

Celebrex, developed by Pfizer, treats pain from arthritis and other conditions.

The COX-2 (cyclooxygenase-2) inhibitor that blocks an enzyme involved in inflammation has had a troubled history, particularly due to similar drugs called Vioxx and Bextra, which were pulled from the market in 2004 in 2005 due to safety issues.

Vioxx, which initially touted fewer stomach complications, became the center of controversy and was finally withdrawn from the market after data linked it to heart attacks and strokes. Bextra then came under fire and was subsequently pulled from the market.

Celebrex was able to withstand the heat but the FDA ordered Pfizer to carry out a study to prove its safety, according to National Public Radio. The 2016 PRECISION study conducted on around 24,000 people led the FDA panel to a 15-5 safety vote, saying that Celebrex is no more harmful regarding strokes and heart attacks than ibuprofen and naproxen.

Hong Seung-jae, a professor at the rheumatology department of Kyung Hee University Medical Center, discusses the cardiovascular safety issues of Celebrex at a press conference hosted by Pfizer Korea in downtown Seoul, Tuesday.

Professor Hong addressed the issue of cardiovascular safety of Celebrex, the FDA panel’s decision, and its impact on the Korean market.

Question: How do you expect the recent FDA panel decision and safety data to impact the Korean market?

A. In Korea, the elderly population is rising and patients with osteoarthritis are increasing exponentially. Rheumatologists like myself are seeing a lot of patients. Physicians from orthopedics are also doing more surgeries for patients for pain maintenance. Elderly patients are also taking more aspirin. And cardiovascular safety concerns are continuing.

Against these patient and disease trends, both gastric and cardiovascular safety will become essential factors for consideration when selecting an NSAID (nonsteroidal anti-inflammatory drug). In this regard, Celebrex will be one of the top priorities.

Q. Can you address the cardiovascular risk of Celebrex and the recent cardiovascular safety vote of the COX-2 inhibitors based on the 2016 PRECISION study?

A. Cardiovascular risk of NSAIDs is an incredibly important issue. Approving the drug after Vioxx was pulled from the market in September 2004 put it in hot water. When I attended the American College of Rheumatology in October 2004, the whole session was canceled and everyone focused on the Vioxx problem. The discussion panel was fielded by the FDA, Pfizer, and MSD but all questions were aimed at the FDA that approved the drug, not the developers.

Much concern was levied against how much the agency examined issues related to drug efficacy and safety. After that, all NSAIDs required extensive data regarding not only gastric safety but also cardiovascular risk safety.

Since then, there have been many meta-analyses. The FDA also does not approve NSAIDs anymore. There have been no new NSAIDs approved by the FDA – the problem of cardiovascular safety has been this big of an issue.

Currently, textbooks outline that naproxen is safe in terms of cardiovascular safety. Votes on naproxen cardiovascular safety have been ongoing, with one result in 2015 showing that it is not safe.

The most recent FDA committee on April 2018 voted on the safety, or the cardiovascular side effects by comparing Celebrex with the most commonly used drugs of naproxen and ibuprofen. In result, all three drugs were found to be safe regarding cardiovascular safety.

The second result was the drug interactions with aspirin. When selecting NSAIDs for patients who must take aspirin, Ibuprofen was known until now as the drug that halves the effect of aspirin. However, the vote showed that naproxen also had safety risks in terms of drug interaction.

On the other hand, Celebrex has no safety concerns regarding the drug interaction risks, resulting in no discussion regarding the matter.

NSAIDs all have similar efficacy – this is acknowledged because it’s been proven. NSAIDs, therefore, are compared in terms of safety. The PRECISION study secured the cardiovascular safety of Celebrex and that it has no problems regarding the drug interactions with aspirin.

yjc@docdocdoc.co.kr

<© Korea Biomedical Review, All rights reserved.>

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