You may want to think twice before popping that next Ibuprofen, Motrin, Advil, Aleve or other NSAID – non-steroidal anti-inflammatory drug.
The FDA is strengthening warnings of heart attack and stroke risk for non-steroidal anti-inflammatories, both for over the counter (OTC) and prescription drugs.
FDA warns of risk with OTC and Prescription NSAIDS
Deputy director of the FDA’s Division of Anesthesia, Analgesia, and Addiction Products, Judy Racoosin, M.D. M.P.H., announced this month on the FDA website: “Today we know that the risk of heart attack and stroke may occur early in treatment, even in the first weeks. (There) is no period of use shown to be without risk.”
The FDA just issued a warning on various popular prescription and non-prescription drugs. These “pain relievers” can kill you even if you follow the recommended dosage.
FDA Warning from Web Site
“FDA is strengthening an existing warning in prescription drug labels and over-the-counter (OTC) Drug Facts labels to indicate that nonsteroidal anti-inflammatory drugs (NSAIDs) can increase the chance of a heart attack or stroke, either of which can lead to death. Those serious side effects can occur as early as the first few weeks of using an NSAID, and the risk might rise the longer people take NSAIDs.”
Death a “Side Effect” for Motrin IB, Aleve, Celebrex
The FDA further states: “The OTC drugs in this group are used for the temporary relief of pain and fever. The prescription drugs in this group are used to treat several kinds of arthritis and other painful conditions. Because many prescription and OTC medicines contain NSAIDs, consumers should avoid taking multiple remedies with the same active ingredient.”
Ibuprofen triples Stroke Risk
The New York Times includes “Motrin IB, Aleve and Celebrex” in this group of “widely used painkillers.” One can suffer a heart attack or stroke “as early as the first few weeks of using” them, according to the Times.
Google News on the topic
• “The FDA’s Dilemma About Ibuprofen And Cardiovascular Risk” – Forbes
• “Doctors issue Ibuprofen toxicity warning” – Daily Telegraph
• “Warning: Runners May Be At Risk From Ibuprofen Use. – Australian Marathon Review
• “Ibuprofen ‘trebles the risk of a stroke’ doctors warn” – Daily Mail Online
• “Ibuprofen Side Effects Land Thousands in the Hospital” – Side-Effects.com
• “Ibuprofen Blunts Aspirin’s Cardioprotection. FDA Issues Warning” – lexi.com
• “Aspirin, Ibuprofen Warnings Advised – Health: Consumers need to be told the painkillers can cause internal bleeding and kidney damage, a panel tells the FDA” – LA Times
FDA caught Spying on own Scientists
Why has it taken the FDA so long to warn us of these dangers when so many millions of us use NSAIDS daily? Some may recall that just two years ago, FDA was caught in a “spying program on its own scientists, lawmakers, reporters and academics” to “discourage whistleblowing.” According to Truthout’s Martha Rosenberg: “[T]op FDA managers “committed the most outrageous misconduct by ordering, coercing and intimidating FDA physicians and scientists to recommend approval, and then retaliating when the physicians and scientists refused to go along.” Review procedures at the agency (which approves stents, breast implants, MRIs, and other devices and machinery) were so faulty that unsafe devices – including those that emit excessive radiation – were approved, charged the scientists, provoking an OSC investigation.” For reporting the safety risks, the scientists became targets of the FDA spy program. Some lost their jobs simply for doing them.
FDA Reviewer Ronald Kavanagh
FDA drug reviewer Ronald Kavanagh disclosed: “While I was at FDA, drug reviewers were clearly told not to question drug companies and that our job was to approve drugs. We were prevented, except in rare instances, from presenting findings at advisory committees. In 2007, formal policies were instituted so that speaking in any way that could reflect poorly on the agency could result in termination. If we asked questions that could delay or prevent a drug’s approval – which of course was our job as drug reviewers – management would reprimand us, reassign us, hold secret meetings about us, and worse. Obviously in such an environment, people will self-censor.” (Truthout)
Some may recall the FDA boondoggle drug “Vioxx.” Merck Pharmaceuticals paid several thousands of people for having suffered heart attacks and strokes as a result of taking Vioxx. The company also agreed to pay $950 million and plead guilty to a criminal charge over the marketing and sales of Vioxx.
The New York Times noted, “The FDA had initially approved Vioxx (after a hasty ‘priority review’) in May, 1999 to treat osteoarthritis, acute pain, and menstrual cramps. By September 30, 2004, when Merck announced its ‘voluntary recall,’ some 25 million Americans had been prescribed the widely hyped drug. Evidence that using Vioxx doubled a patient’s risk of suffering a heart attack or stroke – based on a review of 1.4 million patients’ records – was about to be published in Lancet by David Graham, MD, an FDA investigator. The FDA director’s office, devoted valet of Big Pharma, had contacted the Lancet in a futile effort to stop publication of their own scientist’s findings.”
Graham’s data indicated that 140,000 Americans suffered Vioxx-induced heart attacks and strokes; 55,000 died, many more were permanently disabled. Early clinical trials had alerted Merck to Vioxx’ coronary damage propensities. The company’s executive response was to design future trials that excluded anyone with heart trouble.