NSAIDs and Cardiovascular Effects News

• Pain Drugs to Carry Stronger Warnings: U.S. FDA Over-the-counter pain relievers such as Tylenol and Advil will carry new, bolder warnings about the risk of liver damage or stomach bleeding, the U.S. Food and Drug Administration said on Tuesday.
  Reuters Health Information, April 2009
• Anti-Inflammatory Drugs Do Not Prevent Dementia, Alzheimer's Disease Study results contradict earlier findings.
  Medscape Medical News, April 2009
• FDA Safety Changes: Celebrex, Crixivan, Rifater The FDA has approved revisions to the safety labeling for celecoxib capsules (Celebrex), indinavir sulfate tablets (Crixivan), and isoniazid plus pyrazinamide and rifampin tablets (Rifater).
  Medscape Medical News, March 2009
• More Evidence That NSAIDs Are Harmful to Heart-Failure Patients Even commonly used NSAIDs available without prescription can increase risk of death and cardiac events, a new Danish study has found.
  Heartwire, January 2009
• FDA Safety Changes: Prevacid NapraPAC 500, Prezista, Arixtra The FDA has approved revisions to the safety labeling for lansoprazole delayed-release capsules and naproxen tablet kit, darunavir tablets, and fondaparinux sodium injection.
  Medscape Medical News, January 2009
• What Your Patients Are Reading: Long-Term NSAID Use Protective Against Alzheimer's Long-term use of NSAIDs (particularly ibuprofen) may ward off dementia, hypertension is responsible for a large percentage of disease burden worldwide, chocolate may lower the risk for preeclampsia, exclusively breast-fed children are smarter than their classmates, and cosmetic filler injections may cause acute renal failure.
  Medscape Medical News, May 2008
• Vioxx Documents Offer Glimpse Into Ghostwritten Manuscripts, "Hire-A-PI," and Data Manipulation One study documents how Merck hired medical writing companies to conduct reviews or conducted clinical-trial research in-house, then shopped around for an academic author/principal investigator. A second study evaluates mortality reporting in internal documents vs published papers and FDA communications.
  Heartwire, April 2008
• What Your Patients Are Reading: Moderate Caffeine Intake Associated With Increased Miscarriage Risk Recent news stories have examined the link between moderate caffeine intake and risk for miscarriage, the prevention of urinary tract infections with cranberries, use of NSAIDs for low back pain, the link between fitness levels and all-cause mortality, and use of prednisone for rheumatoid arthritis.
  Medscape Medical News, January 2008
• Mouse Study Suggests Mechanism Behind COX-2-Inhibitor Cardiovascular Risk Researchers suggest that blocking the COX pathway triggers a cascade of events that leads to an increase in the amount of circulating tissue factor, an initiator of coagulation.
  Heartwire, August 2007
• FDA Advisory Panel Votes "No" to Etoricoxib Merck's new arthritis drug--another COX-2 inhibitor--was shut out 19-1 by the mixed FDA panel. Some members argued passionately that it was time to drop the class of drugs, due primarily to their cardiovascular risk profile.
  Heartwire, April 2007
• MEDAL: Are the GI Benefits of Etoricoxib Worthwhile? Detailed gastrointestinal results from the trial, comparing Merck’s new COX-2 inhibitor etoricoxib with diclofenac, show significantly fewer uncomplicated upper-gastrointestinal clinical events with etoricoxib, but no difference in complicated GI events, leading to questions about whether this benefit is clinically relevant.
  Heartwire, February 2007
• MEDAL: Etoricoxib Shows Same Thrombotic Cardiovascular Risk as Diclofenac Both drugs were similar in effectiveness against arthritis symptoms, but diclofenac was associated with more upper-GI and hepatic events, whereas etoricoxib showed more heart failure and discontinuations due to edema and hypertension. Discussion is focusing on whether diclofenac was the appropriate comparator drug, as it is also believed to carry an increased cardiovascular risk.
  Heartwire, November 2006
• Alert Ibuprofen May Reduce Protective Effects of Aspirin According to the FDA, patients should be instructed on the appropriate timing of ibuprofen dosing if they are also taking aspirin for cardioprotective effects.
  Medscape Medical News, September 2006
• Short-term Use of Rofecoxib May Increase Cardiovascular Risk A correction notice was issued regarding APPROVe, and an additional analysis reports an increased risk for confirmed thrombotic events associated even with short-term use of rofecoxib.
  Medscape Medical News, June 2006
• New England Journal of Medicine Corrects Vioxx Data, and Experts Warn of Risks with Similar Drugs Editors report the trial that prompted Merck to pull the popular COX-2 inhibitor off the market had important errors — problems that could crop up with similar drugs, if investigators are not vigilant.
  Medscape Medical News, June 2006
• Therapies for Reducing Gastric Acid Linked to Increased Risk of Clostridium difficile Both proton pump inhibitors and histamine 2 receptor antagonists are associated with a greater likelihood of CDAD.
  Medscape Medical News, December 2005
• FDA Safety Labeling Changes: Striant, Naprosyn, EC-Naprosyn, Anaprox, Anaprox DS, AndroGel The FDA has approved revisions to the safety labeling for a testosterone buccal system (Striant mucoadhesive); naproxen suspension/tablets (Naprosyn) and enteric-coated delayed-release tablets (EC-Naprosyn); naproxen sodium regular and double-strength tablets (Anaprox, Anaprox DS); and testosterone gel, 1% (AndroGel).
  Medscape Medical News, February 2005