Rofecoxib drug data and news

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Merck Announces Preliminary Analyses of Off-Drug Extension of ...  May 11, 2006
APPROVe was designed to evaluate the efficacy of rofecoxib 25 mgin preventing recurrence of colorectal polyps in patients with ahistory of colorectal adenomas. ... - Finanzen.net,

Genetics plays a role in the side effects experienced by people ...  May 5, 2006
The study looked at people taking two popular painkillers, Rofecoxib ( Vioxx ) and Celecoxib ( Celebrex ), known as COX-2 inhibitors. ... - Xagena.it,

How safe is your painkiller?  May 13, 2006
While valdecoxib and rofecoxib have been voluntarily withdrawn from the US market by the manufacturers, mandatory celecoxib labelling is required to contain ... - Hindustan Times,

Mobic linked to higher risk of adverse cardiovascular events than ...  Apr 17, 2006
Taiwan ) assessed the risk of acute myocardial infarction, angina, stroke and transient ischaemic attack ( TIA ) in long-term users of Rofecoxib ( Vioxx ) and ... - Xagena.it,

Cardiovascular outcomes in new users of coxibs and nonsteroidal ...  Apr 29, 2006
Predefined exposure groups included the 3 coxibs available in the US during the study period (celecoxib, rofecoxib, and valdecoxib), as well as oral ... - HeartZine,

Vioxx Study Stings Merck  May 3, 2006
..."A small proportion of patients using rofecoxib for the first time had their first myocardial infarction shortly after ... Rofecoxib is the generic name for Vioxx. ... - TheStreet.com

Heart risks of Vioxx hit early in seniors: study  May 2, 2006
...voluntarily withdrew Vioxx, also called rofecoxib, from the market in September 2004 after a study reported that it doubled the risk of heart attacks and ... - CBC Ottawa,

Canadian Vioxx study challenges Merck  May 3, 2006
..."In this large, population-based study of elderly people we demonstrated that the cardiovascular risks associated with the use of rofecoxib are more acute that ... - CNNMoney.com

Merck & Co: Treading the Biotech Path  May 10, 2006
The company has a few testing years ahead following the fall-out from the Vioxx (rofecoxib) withdrawal in 2004 and a crucial patent expiry to key drug Zocor ... - International News Service,

Breast Cancer Prevention Strategies Explored  May 9, 2006
While COX-2 inhibitors such as rofecoxib and celecoxib have been under fire for increasing the risk for adverse cardiac events, researchers in the oncology ... - Journal of American Medical Association (subscription),

New Vioxx study contradicts key Merck defence  May 2, 2006
We demonstrated that, among elderly users of predominantly low doses of these agents, short-term use of rofecoxib [Vioxx] is not without risk," the study said. ... - MSN Money

Merck’s Worst Nightmare, a Study that Shows Vioxx Heart Attack ...  May 3, 2006
The team found that “among elderly users of predominantly low doses of these agents, short-term use of rofecoxib is not without risk, and that risk of MI ... - Newsinferno.com,

Vioxx Heart Risk Found to Be Early and Persistent  May 3, 2006
MONTREAL, May 3 — Vioxx (rofecoxib) attacks hearts early, not late, and its hazardous effect is sustained for seven days after treatment is stopped ... - MedPage Today,

Use of First- and Second-Generation Cyclooxygenase-2-Selective ...  Apr 19, 2006
...safety of cyclooxygenase (COX)-2-selective nonsteroidal antiinflammatory drugs (NSAIDs) has come under scrutiny after the withdrawal of rofecoxib and halting ... - HeartZine,

Vioxx may trigger heart attacks within days  May 3, 2006
The controversial painkiller Vioxx (rofecoxib) may cause heart attacks within just two weeks of starting the drug treatment, a study of Canadian patients claims ... - Nature.com (subscription),

Vioxx study could undermine Merck legal defense  May 3, 2006
Merck - and indeed the US Food and Drug Administration - have taken the position that patients needed to be taking Vioxx (rofecoxib) for 18 months or more ... - Pharma Times (subscription),

Despite Conflicts, Drug Judges Continue to Vote Yea or Nay  Apr 26, 2006
...that at a 2005 advisory committee meeting to evaluate the risks of the COX-2 inhibitors Bextra (valdecoxib), Celebrex (celecoxib) and Vioxx (rofecoxib) "93% of ... - MedPage Today,

Selective inhibitors of mPGES-1, a new class of anti-inflammatory ...  Apr 17, 2006
Ever since the association of selective inhibitors of COX-2 – Vioxx ( Rofecoxib ), Bextra ( Valdecoxib ), and Celebrex ( Celecoxib ) - with an increased ... - Xagena.it,

Plaintiffs mixed up in suit brought by high volume filer  Apr 27, 2006
...cardiac problems. It is the brand name of rofecoxib, a cox-2 inhibitor and a non-steroidal anti-inflammatory (NSAID). Brooks and ... - St. Clair Record,

Research Misconduct, Retraction, and Cleansing the Medical ...  Apr 17, 2006
Expression of concern: Bombardier, et al. Comparison of upper gastrointestinal toxicity of rofecoxib and naproxen in patients with rheumatoid arthritis. ... - Annals of Internal Medicine

Case 13-2006 — A 50-Year-Old Man with a Painful Bone Mass and ...  Apr 26, 2006
A 10-day course of prednisone and a trial of rofecoxib resulted in no improvement over a period of 6 weeks. Two and a . . . [Full Text of this Article]. - New England Journal of Medicine (subscription),

Why COX-2 Inhibitors Hurt the Heart.  Apr 26, 2006
...this research. Merck manufactured Vioxx (rofecoxib), a COX-2 that was pulled from the market for its cardiovascular side effects. - PharmExec.com,

Newsonline | $32m damages awarded in Texas Vioxx case - 24/04/2006  Apr 24, 2006
A Texas jury awarded the family of Leonel Garza $32 million - which will be reduced under state capping laws - after finding that Vioxx (rofecoxib) caused the ... - Pharma Times (subscription),

Pfizer profits soar despite slipping revenues  Apr 20, 2006
...for the recovery in the product, which has been affected by the fall-out related to the withdrawal of Merck & Co's rival product Vioxx (rofecoxib) in 2004 ... - Pharma Times (subscription),

FDA 'needs more power to force Phase IV testing  Apr 26, 2006
...chairman Joe Barton, amid allegations that the FDA is tardy in removing potentially unsafe drugs, such as Merck & Co's painkiller Vioxx (rofecoxib), from the ... - Pharma Times (subscription),

ACE inhibitors: Reports suggest that NSAIDs may diminish the antihypertensive effect of Angiotensin Converting Enzyme (ACE) inhibitors. In patients with mild to moderate hypertension, administration of 25 mg daily of VIOXX with the ACE inhibitor benazepril, 10 to 40 mg for 4 weeks, was associated with an average increase in mean arterial pressure of about 3 mm Hg compared to ACE inhibitor alone. This interaction should be given consideration in patients taking VIOXX concomitantly with ACE inhibitors.

Aspirin

Concomitant administration of low-dose aspirin with VIOXX may result in an increased rate of GI ulceration or other complications, compared to use of VIOXX alone. In a 12-week endoscopy study conducted in OA patients there was no difference in the cumulative incidence of endoscopic gastroduodenal ulcers in patients taking low-dose (81 mg) enteric coated aspirin plus VIOXX 25 mg daily, as compared to those taking ibuprofen 2400 mg daily alone. Patients taking low-dose aspirin plus ibuprofen were not studied.

At steady state, VIOXX 50 mg once daily had no effect on the anti-platelet activity of low-dose (81 mg once daily) aspirin, as assessed by ex vivo platelet aggregation and serum TXB2 generation in clotting blood. Because of its lack of platelet effects, VIOXX is not a substitute for aspirin for cardiovascular prophylaxis. Therefore, in patients taking VIOXX, antiplatelet therapies should not be discontinued and should be considered in patients with an indication for cardiovascular prophylaxis. Prospective, long-term studies on concomitant administration of VIOXX and aspirin have not been conducted.

Cimetidine

Co-administration with high doses of cimetidine [800 mg twice daily] increased the C_max of rofecoxib by 21%, the AUC_0-120hr by 23% and the t_1/2 by 15%. These small changes are not clinically significant and no dose adjustment is necessary.

Digoxin

Rofecoxib 75 mg once daily for 11 days does not alter the plasma concentration profile or renal elimination of digoxin after a single 0.5 mg oral dose.

Furosemide

Clinical studies, as well as post-marketing observations, have shown that NSAIDs can reduce the natriuretic effect of furosemide and thiazides in some patients. This response has been attributed to inhibition of renal prostaglandin synthesis.

Ketoconazole

Ketoconazole 400 mg daily did not have any clinically important effect on the pharmacokinetics of rofecoxib.

Lithium

NSAIDs have produced an elevation of plasma lithium levels and a reduction in renal lithium clearance. In post-marketing experience there have been reports of increases in plasma lithium levels. Thus, when VIOXX and lithium are administered concurrently, subjects should be observed carefully for signs of lithium toxicity.

Methotrexate

VIOXX 12.5, 25, and 50 mg, each dose administered once daily for 7 days, had no effect

on the plasma concentration of methotrexate as measured by AUC_0-24hr in patients receiving single weekly methotrexate doses of 7.5 to 20 mg for rheumatoid arthritis. At higher than recommended doses, VIOXX 75 mg administered once daily for 10 days increased plasma concentrations by 23% as measured by AUC_0-24hr in patients receiving methotrexate 7.5 to 15 mg/week for rheumatoid arthritis. At 24 hours postdose, a similar proportion of patients treated with methotrexate alone (94%) and subsequently treated with methotrexate co-administered with 75 mg of rofecoxib (88%) had methotrexate plasma concentrations below the measurable limit (5 ng/mL). Standard monitoring of methotrexate-related toxicity should be continued if VIOXX and methotrexate are administered concomitantly.

Oral Contraceptives

Rofecoxib did not have any clinically important effect on the pharmacokinetics of ethinyl estradiol and norethindrone.

Prednisone/prednisolone

Rofecoxib did not have any clinically important effect on the pharmacokinetics of prednisolone or prednisone.

Rifampin

Co-administration of VIOXX with rifampin 600 mg daily, a potent inducer of hepatic metabolism, produced an approximate 50% decrease in rofecoxib plasma concentrations. Therefore, a starting daily dose of 25 mg of VIOXX should be considered for the treatment of osteoarthritis when VIOXX is co-administered with potent inducers of hepatic metabolism.

Theophylline

VIOXX 12.5, 25, and 50 mg administered once daily for 7 days increased plasma theophylline concentrations (AUC_(0-¥)) by 38 to 60% in healthy subjects administered a single 300-mg dose of theophylline. Adequate monitoring of theophylline plasma concentrations should be considered when therapy with VIOXX is initiated or changed in patients receiving theophylline. These data suggest that rofecoxib may produce a modest inhibition of cytochrome P450 (CYP) 1A2. Therefore, there is a potential for an interaction with other drugs that are metabolized by CYP 1A2 (e.g., amitriptyline, tacrine, and zileuton).

Warfarin

Anticoagulant activity should be monitored, particularly in the first few days after initiating or changing VIOXX therapy in patients receiving warfarin or similar agents, since these patients are at an increased risk of bleeding complications. In single and multiple dose studies in healthy subjects receiving both warfarin and rofecoxib, prothrombin time (measured as INR) was increased by approximately 8% to 11%. In post-marketing experience, bleeding events have been reported, predominantly in the elderly, in association with increases in prothrombin time in patients receiving VIOXX concurrently with warfarin.