Τέρμα οι κοξίμπες;

[bromptonista]

Ας ανοίξουμε και ένα σοβαρό θέμα... φαίνεται ότι η υποψία ότι οι αναστολείς COX-2 βλάπτουν το καρδιαγγειακό έχει γίνει πλέον βεβαιότητα, μετά την απόσυρση του Vioxx από την αμερικανική και την παγκόσμια αγορά.

Η απόσυρση του φαρμάκου όμως έχει προκαλέσει μια χιονοστιβάδα από ερωτήματα στην παγκόσιμα ιατρική κοινότητα, όπως αυτή εκφράζεται μέσα από άρθρα στο Lancet και το New England Journal of Medicine, σχετικά με το φαρμακευτικό μάρκετινγκ και τις επιπτώσεις στη δημόσια υγεία... τελικά οι "νταβατζήδες" δεν είναι μόνο ελληνικό φαινόμενο...

Σημείωση: τα σχετικά φάρμακα κυκλοφορούν με τα ίδια ονόματα στην ελληνική αγορά: Vioxx, Celebrex, Bextra.

[Τα σχετικά άρθρα από το Medscape]

Sept. 30, 2004 — Merck & Co., Inc., announced today a voluntary withdrawal of rofecoxib (Vioxx) from the U.S. and worldwide market due to safety concerns of an increased risk of cardiovascular events, according to an alert from MedWatch, the U.S. Food and Drug Administration (FDA) safety information and adverse event reporting program.

Rofecoxib is a cyclooxygenase 2–selective, nonsteroidal anti-inflammatory drug (NSAID) that was approved by FDA in May 1999 for the relief of the signs and symptoms of osteoarthritis, for the management of acute pain in adults, and for the treatment of menstrual symptoms, and was later approved for the relief of the signs and symptoms of rheumatoid arthritis in adults and children.

On Sept. 27, the data safety monitoring board for an ongoing long-term study of rofecoxib (APPROVe) recommended that the study be stopped early for safety reasons. The study showed an increased risk of cardiovascular events, including heart attack and stroke, in patients receiving rofecoxib compared with placebo, particularly those who had been taking the drug for longer than 18 months. Based on this new safety information, Merck and FDA officials met the next day, and during that meeting, the FDA was informed that Merck was voluntarily withdrawing rofecoxib from the market.

"Merck did the right thing by promptly reporting these findings to FDA and voluntarily withdrawing the product from the market," Acting FDA Commissioner Dr. Lester M. Crawford says in an FDA news release. "Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo."

According to an FDA public health advisory, patients who are currently taking rofecoxib should contact their physician for guidance regarding discontinuation and alternative therapies.

Dr. Crawford added that the FDA will closely monitor other drugs in this class for similar adverse effects. "All of the NSAID have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."

For more information, healthcare professionals are advised to contact Merck at 1-888-368-4699 or at http://www.merck.com, or the FDA's Drug Information Office at 1-301-827-4573 or 1-888-463-6332 or go to the FDA's Web site at: http://www.fda.gov/cder/drug/infopage/vioxx/default.htm.

Reviewed by Gary D. Vogin, MD

NEW YORK (Reuters Health) Oct 06 - The US Food and Drug Administration did not fulfill its responsibilities when it allowed Merck to continue to market its cyclooxygenase-2 inhibitor rofecoxib (Vioxx), despite mounting evidence that it posed a cardiovascular risk, according to two editorials that will appear in the October 21st issue of The New England Journal of Medicine.

One editorialist, Dr. Eric J. Topol, even supports a full Congressional review into this issue.

Dr. Topol, chairman of cardiovascular medicine at the Cleveland Clinic in Ohio, points out that the FDA Arthritis Advisory Committee met in 2001 to discuss the risk associated with rofecoxib, with data showing a "clear-cut excess number of myocardial infarctions."

Since then, there have been multiple epidemiologic studies underscoring that risk. (see Reuters Health reports, August 21, 2001, October 4, 2002, March 10, 2004, August 25, 2004).

But Merck did not withdraw rofecoxib from the market until September 30th, after more than 80 million patients had been exposed to the drug, Dr. Topol notes, in what represents the largest prescription-drug withdrawal in history.

"We are dealing with an enormous pubic health issue," he writes. "Even a fraction of a percent excess in the rate of serious cardiovascular events would translate into thousands of affected people."

Is this cardiovascular risk a class effect? asks Dr. Garret A. FitzGerald of the University of Pennsylvania in Philadelphia.

All three of the approved COX-2 inhibitors depress prostaglandin I-2 formation, which can be expected to "elevate blood pressure, accelerate atherogenesis, and predispose patients receiving coxibs to an exaggerated thrombotic response to the rupture of an atherosclerotic plaque," Dr. FitzGerald writes.

Until more data are available, COX-2 inhibitors may still be a rational choice for patients with low cardiovascular risk and a history of serious gastrointestinal events, he suggests.

However, "it would also seem prudent to avoid coxibs in patients who have cardiovascular disease or who are at risk for it."

Both Dr. Topol and Dr. FitzGerald condemn the FDA for its policy of "watchful waiting," and failure to request a clinical trial specifically assessing the cardiovascular risk of COX-2 inhibitors.

"The best anti-inflammatory medicine for patients with arthritis, if they are at risk for heart disease, is Naprosyn," because of its cardioprotective effects, Dr. Topol told Reuters Health. Medications containing ibuprofen are also reasonable substitutes for rofecoxib.

It is premature to recommend that patients currently prescribed Celebrex or valdecoxib be switched to another drug, he said. "It could be a class effect, but with Vioxx, the signal [for cardiovascular risk] has always been much worse."

The good news, he added, is that "in a day or two" of discontinuing rofecoxib, the cardiovascular effects should wane.

N Engl J Med 2004;351:1707-1711.

LONDON (Reuters) Oct 07 - Drug regulators should tighten licensing rules for new medicines to stop products like Merck & Co Inc's arthritis pill Vioxx from reaching the market, a top medical journal said on Thursday.

Vioxx, which generated sales of $2.55 billion in 2003, was recalled worldwide last week after a clinical study found it increased the risk of heart attacks and stroke.

"The Vioxx story is one of blindly aggressive marketing by Merck mixed with repeated episodes of complacency by drug regulators," the Lancet said in an editorial. "Drug regulators must now reassess the safety and efficacy thresholds required for licensing of a new pharmaceutical product."

Merck denies it acted irresponsibly in the marketing of Vioxx and says it decided to voluntarily withdraw Vioxx from the market worldwide after it received the negative clinical trial findings.

The U.S. Food and Drug Administration, which approved Vioxx in Merck's home market, has also been criticised by some analysts and doctors for not requiring stronger warnings or more studies of the medicine.

But agency officials say they acted appropriately by ordering Merck to add information in 2002 about a study in 2000 that showed an elevated cardiovascular risk for Vioxx patients.

Vioxx Withdrawal Prompts Reevaluation of COX-2 Inhibitor Safety

Laurie Barclay, MD

Oct. 8, 2004 — In the wake of Merck's voluntary, worldwide withdrawal of rofecoxib (Vioxx) on Sept. 30, concerns are surfacing over whether the adverse cardiovascular risk documented with rofecoxib may be a class effect extending to the other cyclooxygenase-2 (COX-2) inhibitors. The U.S. Food and Drug Administration (FDA) issued a public health advisory to inform patients about the withdrawal of rofecoxib, and Acting Commissioner Lester M. Crawford announced the FDA's intention to closely monitor other COX-2 inhibitors for similar adverse events.

"Although the risk that an individual patient would have a heart attack or stroke related to Vioxx is very small, the study that was halted suggests that, overall, patients taking the drug chronically face twice the risk of a heart attack compared to patients receiving a placebo," Dr. Crawford said in a news release. "All of the [nonsteroidal anti-inflammatory drugs (NSAIDs)] have risks when taken chronically, especially of gastrointestinal bleeding, but also liver and kidney toxicity. They should only be used continuously under the supervision of a physician."

Mounting Data

Three-year data from the Adenomatous Polyp Prevention on VIOXX (APPROVe) study, a multicenter, prospective, randomized, double-blind trial, documented an increased relative risk for confirmed cardiovascular events, including myocardial infarction and stroke, for rofecoxib compared with placebo.

In APPROVe, which was designed to evaluate the efficacy of rofecoxib, 25 mg, in preventing recurrence of colorectal polyps in 2,600 patients with a history of colorectal adenomas, the increased cardiovascular risk began after 18 months of treatment with rofecoxib and persisted. At three years, cumulative incidence of cardiovascular events was 7.5 per 1,000 patients receiving placebo compared with 15 per 1,000 patients receiving rofecoxib.

"Although we believe it would have been possible to continue to market Vioxx with labeling that would incorporate these new data, given the availability of alternative therapies and the questions raised by the data, we concluded that a voluntary withdrawal is the responsible course to take," said Raymond V. Gilmartin, chairman, president, and chief executive officer of Merck.

The FDA approved rofecoxib in 1999 for pain and inflammation caused by osteoarthritis, for acute pain in adults, and for menstrual pain, and later approved it for symptoms of rheumatoid arthritis in adults and children. Compared with nonselective NSAIDs that block both COX-1 and COX-2, the purported advantage of rofecoxib and other COX-2 selective inhibitors was lower risk of gastrointestinal ulcers and bleeding, because the COX-1 enzyme helps protect the stomach lining from acid.

In June 2000, the Vioxx Gastrointestinal Outcomes Research (VIGOR) safety study showed an increased risk of serious cardiovascular events. Myocardial infarction was five times higher with rofecoxib (0.5%) than with naproxen (0.1%), and risks of stroke, venous thrombosis, and hypertension were also significantly increased. Although Merck argued that this difference might reflect a cardioprotective effect of naproxen, epidemiologic studies to test that hypothesis have proved inconclusive.

Based on VIGOR and other controlled trials, the FDA changed rofecoxib labeling in April 2002 to include information about increased cardiovascular risk. Safety labels notwithstanding, rofecoxib became one of the most widely used drugs ever to be withdrawn from the market. Two million people worldwide were taking rofecoxib at the time of the withdrawal, resulting in $2.5 billion in rofecoxib sales last year, and about 80 million people have taken the drug since it was first marketed.

But now that rofecoxib is withdrawn, will use of other COX-2 inhibitors increase, given combined sales of rofecoxib, celecoxib (Celebrex), and valdecoxib (Bextra) — the two other approved COX-2 inhibitors, both Pfizer products — exceeding $6 billion worldwide last year? Or will storms brewing over rofecoxib cast doubt on the whole class, including drugs still in the pipeline, such as Merck's etoricoxib (Arcoxia) and lumiracoxib (Prexige) from Novartis?

"There is really a trend that all COX-2 inhibitors may have increased risk of cardiovascular diseases following long-term use in chronic arthritis patients, based on some meta-analyses," Li-Chia Chen, PhD, from the School of Pharmacy and Pharmaceutical Sciences at the University of Manchester, U.K., told Medscape. "However, the long-term use evidence hasn't been finalized." She added that the U.K.'s National Institute for Clinical Excellence will review the evidence next week, and that the guidelines for using COX-2 inhibitors in chronic arthritis will soon be updated.

Potential Mechanisms for Cardiovascular Risk

Mechanistically speaking, there are reasons why inhibiting COX-1 and COX-2 might affect cardiovascular risk. Because COX-1 helps promote thrombosis and COX-2 helps inhibit it, blocking COX-2 but not COX-1 could theoretically increase the risk of myocardial infarction and other thrombotic events. On the other hand, inflammation has also been implicated in cardiovascular events, so controlling inflammation via COX-2 inhibition could conceivably be protective.

In a perspective released early by the New England Journal of Medicine, Garret A. FitzGerald, MD, a professor and chair of pharmacology at the University of Pennsylvania School of Medicine in Philadelphia, suggests that depression of prostaglandin I2 formation by coxibs might be expected to elevate blood pressure, accelerate atherogenesis, and increase the thrombotic response to rupture of an atherosclerotic plaque. In patients at higher cardiovascular risk, coxibs would be more likely to predispose to a clinical event early in the course of treatment.

"The evidence for hazard from Vioxx is much stronger than for other members of the class, [but] there is a clear mechanistic explanation for what we saw in APPROVe and it would apply across the class," Dr. FitzGerald told Medscape. "Although the studies to date have been designed in a way that minimizes the likelihood of detecting a cardivascular signal, there have been suggestions consistent with that possibllity with all members of the class. The outcome of APPROVe shifts the burden of responsibility to those who claim that the results with Vioxx were due to some off target COX-2 independent effect."

In a rabbit model (Proc Nat Acad Sci., Aug. 29, 2000), damage after temporary coronary artery ligation was increased by treatment with celecoxib, which completely blocked the cardioprotective effects of the COX-2 enzyme. The authors concluded that the COX-2 enzyme is a "cardioprotective protein," suggesting that COX-2 inhibitors may neutralize these protective effects.

Safety of Celecoxib

Although the Celecoxib Long Term Arthritis Safety Study (CLASS) trial did not show a significantly increased rate of myocardial infarction with celecoxib compared with the nonspecific NSAIDs ibuprofen or diclofenac, the incidence of adverse events related to cardiac ischemia was higher with celecoxib, especially in patients not taking aspirin. In that group, the rate of myocardial infarction was 0.2% with celecoxib and 0.1% with the other two drugs. For all patients, there was a higher incidence of atrial fibrillation in the celecoxib group than in patients taking ibuprofen or diclofenac, which was more pronounced in the group not taking aspirin.

"There was some increase in cardiovascular events sufficient to trigger some worried comments by the FDA physician who reviewed the [CLASS] data," Sidney M. Wolfe, MD, director of Public Citizen's Health Research Group, told Medscape.

Dr. FitzGerald pointed out that the original report of the CLASS trial suggested a more favorable gastrointestinal adverse effect profile for celecoxib than for the other NSAIDs with no increase in cardiovascular risk. However, this report contained only six months of data from a one-year study, and the full data showed no difference between celecoxib and the traditional NSAIDs on predefined gastrointestinal end points.

In a statement on Oct. 1, Pfizer concluded that based on long-term clinical trials in more than 6,000 patients, celecoxib did not increase the risk of myocardial infarction or stroke in patients with arthritis and pain, even at higher-than-recommended doses.

Pfizer vice president Mitch Gandelman went on to suggest that the company would investigate whether celecoxib might reduce cardiovascular risk, according to a New York Times story on Oct. 4. In support of this hypothesis, he mentioned two small-scale university studies but acknowledged that the evidence was "scant and inconclusive." As of press time, Mr. Gandelman and Pfizer representatives had not returned Medscape's calls requesting comments.

Safety of Valdecoxib

Pfizer's drug valdecoxib (Bextra) is also "under a cloud because another FDA physician reviewing the data on that drug concluded there may be an increased cardiovascular risk," said Dr. Wolfe, who is also an adjunct professor of internal medicine at Case Western Reserve University in Cleveland, Ohio. "I think it is very likely that the effect of increasing cardiovascular risk is a class effect."

According to agency files obtained in a lawsuit by Public Citizen, an unredacted review by the FDA Medical Officer recommended nonapproval for valdecoxib for acute pain, citing the Coronary Artery Bypass Graft (CABG) Surgery study 035. Even though the entire study population received prophylactic low-dose aspirin, this trial showed an excess of serious cardiovascular thromboembolic adverse events including death in association with the use of valdecoxib, 40 mg twice daily, when added to ad lib parenteral narcotic analgesia. In other databases, including formal safety Trials 47 and 62, valdecoxib at doses higher than 20 mg per day was associated with a greater incidence of edema and hypertension than were ibuprofen, naproxen, and diclofenac.

Safety of Lumiracoxib

In the Therapeutic Arthritis Research and Gastrointestinal Event Trial (TARGET) comparing lumiracoxib with naproxen or ibuprofen, serious gastrointestinal events were significantly lower in the lumiracoxib group, but only in patients not taking aspirin. Although the trial lacked power to detect a difference in the rates of cardiovascular events in nonaspirin users, there was a nonsignificant increase in the lumiracoxib group (0.26 vs 0.18 per 100 patient-years; hazard ratio, 1.47).

The conundrum over COX-2 inhibitors may have a chilling effect on drugs awaiting approval, which is justified if increased cardiovascular risk is a class effect, but unfortunate if the risk is exclusive to rofecoxib. The FDA and other regulatory agencies might ask for greater quantities and longer duration of safety data before approval.

Although lumiracoxib is already approved in the U.K., the FDA rejected Novartis's application last year, requesting more efficacy data. In a trial of 18,000 patients, lumiracoxib reduced the risk of gastrointestinal adverse effects without increasing the risk of myocardial infarction compared with ibuprofen and naproxen. However, in a commentary in the Aug. 21 issue of The Lancet, Eric J. Topol, MD, from the Cleveland Clinic Foundation in Ohio, noted that the trial excluded many people with coronary artery disease and demonstrated potential problems with liver toxicity.

Risk-Benefit Data

After analyzing benefit-to-risk ratio, some experts have concluded that even a small increase in cardiovascular risk for the coxibs may not justify their use, given limited evidence of greater efficacy or lower gastrointestinal toxicity than other NSAIDs. In a recent cost-effectiveness analysis by Rachel Elliott, BPharm, MRPharmS, PhD, nonselective NSAIDs plus proton-pump inhibitors or misoprostol were more cost-effective than COX-2 inhibitors for preventing severe gastrointestinal bleeding, according to Dr. Chen.

"One has to wonder, what is the point of taking [coxibs], if they don't have any advantage in terms of gastrointestinal toxicity over the older NSAIDs," Dr. Wolfe said. "They are no more effective than the older NSAIDs. Unlike the older NSAIDs, there is some concern about increased cardiovascular risk."

Dr. Chen and colleagues conducted a systematic review (J Clin Pharm Ther., June 2004;29[3]:215-229) of the analgesic efficacy and tolerability of COX-2 inhibitors for postoperative pain control in 18 randomized controlled trials enrolling a total of 2,783 patients. Relief of orthopaedic pain was no different with rofecoxib 50 mg or naproxen 550 mg. Although the adverse effects of single-dose COX-2 inhibitors were generally mild and less than nonselective NSAIDs, there was no significant difference. Overall, the investigators concluded that the analgesic efficacy and tolerability of single-dose COX-2 inhibitors were better than for opioid-containing analgesics and similar to nonselective NSAIDs, but they recommended further studies to examine the efficacy and tolerability of COX-2 inhibitors.

"Since the launch of COX-2 inhibitors, debates over their benefits (ie, decreasing severe gastrointestinal adverse events) and therapeutic roles is still going on. The trade-off between their risk and benefit is still not clear," Dr. Chen said. "The 'class effect' of cardiovascular diseases is one of the concerns with other COX-2 inhibitors.... We need more head-to-head comparisons, long-term follow-up, and patient-centered resources use data to answer these questions."

According to Dr. Wolfe, the COX-2 enzyme has important functions throughout the body, including bone healing, repair of tendon rupture, circulation to the heart, and other protective and restorative roles, especially in emergency situations.

"The body needs to be able to produce [the COX-2 enzyme] and use it as part of the healing process," Dr. Wolfe said. "By inhibiting it as the COX-2 inhibitors do, more so than the older NSAIDs, you're asking for trouble.... I think the safe way to go is really not to use any of the drugs in this class, even the ones left after Vioxx is coming off the market."

In response to physicians who argue that the coxibs may be more effective in a subgroup of patients refractory to other drugs, Dr. Wolfe counters that trials and clinical experience with older NSAIDs may not have adequately tested a range of doses that might be equivalent in terms of pain relief to doses that are being used for the coxibs.

"I don't think there's really any evidence at all from the standpoint of effectiveness in pain relief in treating rheumatoid arthritis or osteoarthritis that these COX-2 inhibitors are working on people who have never responded to the other [NSAIDs]," Dr. Wolfe said. His group is considering whether the evidence suggests that the FDA should issue a box warning for other coxibs, or even remove them from the market.

Since the withdrawal of rofecoxib, class action lawsuits have emerged in Canada and in the U.S., and both Merck and the FDA have been criticized for their handling of the situation. In an early-release perspective in the New England Journal of Medicine, Dr. Topol suggests that the debacle could have been prevented had many early warning signs been heeded, and that neither Merck nor the FDA fulfilled their responsibilities to the public.

Based on all the available data on rofecoxib and celecoxib available as of Aug. 22, 2001, Dr. Topol and colleagues concluded that there was a clear-cut excess number of myocardial infarctions associated with rofecoxib, and an increase with celecoxib not meeting statistical significance, mandating a trial specifically to assess cardiovascular risk and benefit of these agents in patients with established coronary artery disease.

Long-term Issues

Whether the damage from rofecoxib to the COX-2 class is over is still unclear. Dr. FitzGerald advocates long-term follow-up of patients in the APPROVe study to ascertain long-term risk.

"Many effects may wear off very quickly, but if the drug induced hardening of the arteries, that would take longer to dissipate," Dr. FitzGerald said. "The best people to advise us now are the FDA. They are an unbiased source and they have access to more information than any investigator or any individual company. The question is whether they should offer a warning to patients at high cardiovascular risk concerning all members of the class until we have more information and whether they can give us guidance on duration of therapy in other patients."

Dr. Topol calls for a full congressional review of the rofecoxib situation, claiming that Merck valued sales over safety, and that the FDA's passive position of waiting for data to accrue was not acceptable. Merck issued a response calling Dr. Topol's commentary "flawed in many important respects" and detailing the history of Merck's interaction with the FDA over rofecoxib.

After the VIGOR study, Dr. Wolfe suggested that the FDA could have forced Merck to at minimum put a box warning on rofecoxib and recommend that it should be used as a last-choice drug. "My guess is that if the FDA had forced the company to do that, the drug would not have been used anywhere near as much, and even though it ultimately came off the market last week, the number of people damaged would have been reduced enormously," he said.

Editor's Note: Dr. FitzGerald reports having received consulting fees from NiCox and Merck and research support from Merck.

N Engl J Med. Published online Oct. 6, 2004.

Reviewed by Gary D. Vogin, MD

[GoLdIe]

Τα celebrex (celecoxib) ειναι αυτο που επαιρνα πριν 3 βδομαδες...

[bromptonista]

[Και η άμεση απάντηση του ΕΟΦ:]

ΕΛΛΗΝΙΚΗ ΔΗΜΟΚΡΑΤΙΑ

Εθνικός Οργανισμός Φαρμάκων

1.10.2004

Απόσυρση από την κυκλοφορία φαρμακευτικών προϊόντων με Ροφεκοξίμπη (VIOXX και PEROXX)

Ο ΕΟΦ έλαβε γνώση της απόφασης της Εταιρείας Merck & Co να αποσύρει οικειοθελώς από την κυκλοφορία το φάρμακο ροφεκοξίμπη. H απόσυρση είναι άμεση, γίνεται σε παγκόσμια κλίμακα και αφορά σε όλα τα σκευάσματα και δοσολογίες της ροφεκοξίμπης καθώς και σε όλες τις κλινικές δοκιμές όπου χορηγείται το συγκεκριμένο φάρμακο.

Το φάρμακο ροφεκοξίμπη (VIOXX και PEROXX) είναι αναλγητικό αντιφλεγμονώδες, για την αντιμετώπιση συμπτωμάτων οστεοαρθρίτιδας και ρευματοειδούς αρθρίτιδας.

Η Εταιρεία Merck & Co έλαβε την απόφαση αυτή μετά λεπτομερή ανάλυση ευρημάτων των τριών τελευταίων ετών από τη Κλινική Μελέτη APPROVe. Στη μελέτη αυτή παρατηρήθηκε αυξημένος κίνδυνος σοβαρών θρομβωτικών καρδιαγγειακών επεισοδίων, όπως έμφραγμα του μυοκαρδίου και αγγειακό εγκεφαλικό επεισόδιο στους ασθενείς που ελάμβαναν VIOXX σε σχέση με εκείνους οι οποίοι έπαιρναν εικονικό φάρμακο. Η διαφορά αυτή στον αυξημένο σχετικό κίνδυνο ήταν σαφής μετά από τουλάχιστον 18 μήνες συνεχούς αγωγής με 25 mg VIOXX .

Η ροφεκοξίμπη είναι φάρμακο που ανήκει στην κατηγορία των μη στεροειδών αντιφλεγμονωδών και ειδικότερα των εκλεκτικών αναστολέων του ενζύμου κυκλο-οξυγενάση 2 (CΟΧ-2).

Τα νέα δεδομένα αφορούν ειδικά στη ροφεκοξίμπη και όχι επί του παρόντος σε άλλα φάρμακα που ανήκουν στην ίδια κατηγορία (κοξίμπες).

Ο ΕΟΦ συνιστά σε όλους τους ασθενείς που βρίσκονται σε θεραπευτική αγωγή με το συγκεκριμένο φάρμακο να διακόψουν τη λήψη του και να ζητήσουν το ταχύτερο ιατρική συμβουλή σχετικά με εναλλακτικές φαρμακευτικές επιλογές.

ΑΠΟ ΤΗ ΔΙΟΙΚΗΣΗ

[bromptonista]

Τα celebrex (celecoxib) ειναι αυτο που επαιρνα πριν 3 βδομαδες... 

←

Εσύ δεν κινδυνεύεις

Είσαι γυναίκα πριν την εμμηνόπαυση...

[Azrai]

Μπορειτε να διαβασετε σχετικο αρθρο και στην πορτα της εδρας της φαρμακολογιας (με τα απαραιτητα αλαζονικα σχολια για το οτι ο ΙΣΤ ειχε πει οτι δεν χορηγουμε τα φαρμακα αυτα κτλ κτλ... δεν λεω, μπορει πραγματι να το ειχε πει, αλλα εμενα εξακολουθει να μου φαινεται αλαζονας, εγωκεντρικος και ψωναρα....)

[Nievsky]

Να πούμε και 2 λογάκια για τη χρήση ΜΣΑΦ σε μυοσκελετικά προβλήματα.

Σε οστεοαρθρίτιδα οι οδηγίες της αμερικάνικης ρευματολογικής εταιρείας είναι ότι δεν χορηγούμε ΜΣΑΦ,εκτός σε περιπτώσεις βαριάς οστεαρθρίτιδας ή με σημεία φλεγμονής(=ερυθρότης,πόνος,διόγκωση,όχι απλώς διαταραχή της αρχιτεκτονικής της περιοχής),γιατί στην οστεοραθρίτιδα δεν υπάρχει φλεγμονή και έτσι διαδοχικές έρευνες έχουν δείξει ότι δεν πλεονεκτούν από το απλό Depon.

Σε οσφυαλγίες πάλι δεν έχουν ένδειξη τα ΜΣΑΦ γιατί κατά 95% είναι εκφυλιστικές(οστεοαρθρίτις-δεν υπάρχει φλεγμονή!) ή μηχανικές(κήλες δίσκων-δεν υπάρχει φλεγμονή!).Εάν πει πάλι κάποιος ότι καταστέλλει και μικρή φλεγμονή που υπάρχει να θυμίσω ότι η ρευματοειδής αρθρίτις αντιμετωπίζεται με 2 δισκία ασπιρίνης την ημέρα.Είναι λοιπόν κάτι πραπάνω από προφανές ότι η ευρεία χρήση ΜΣΑΦ που συμβαίνει δεν έχει καμιά θέση στην ιατρική.Αν μη τι άλλο το τελευταίο αυτό κρούσμα καταδεικνύει ότι οι γιατροί κάνουν κάτι λάθος με το να μην βάζουν το μυαλό τους να σκέφτεται και να εμπιστεύονται τυφλά τις εταιρείες ή τις μόδες.

Υ.Γ.Ακόμα χειρότερα οι κοξίμπες καταστέλλουν τη φλεγμονή με τη COX-2 δράση,αλλά παρ'ολ'αυτά δίδονται σε οστεοαρθρίτιδα κατά κόρον.Αυτό σημαίνει ότι κάποιοι γιατροί δεν έκαναν τη δουλεία τους καλά.