The changes being announced apply to prescription non-steroidal anti-inflammatory drugs, or NSAIDs, including arthritis treatments like Celebrex. The Food and Drug Administration said it plans to make similar changes to over-the-counter drugs in the same class, such as Advil and Motrin.
Language on the pills currently warns that they can increase the risk of heart-related problems if used long term.
However, the FDA’s new warning states that heart attacks and strokes can occur in the first few weeks of taking the drugs. The agency also warns that the risks increase with higher doses of the drugs. The updates are based on an FDA review of recent studies and recommendations by outside advisers.
“In general, patients with heart disease or risk factors for it have a greater likelihood of heart attack or stroke,” the agency notes in the announcement posted to its website.
The labeling change is the latest step in the FDA’s ongoing safety review of the drugs which stretches back to 2004. That’s when Merck & Co Inc. pulled its blockbuster pain reliever Vioxx off the market because of links to heart attack and stroke.
Vioxx had been heavily advertised as a new kind of NSAID that was supposed to be easier on the stomach. But its withdrawal shook the medical establishment and ushered in a new era of drug safety at the FDA.
- In 2005, the agency added boxed warnings to all prescription NSAIDS, including Pfizer’s Celebrex and high-dose versions of ibuprofen and naproxen. Celebrex is the only drug from the same class as Vioxx that remains on the market. The prescription NSAIDs are generally used for long-term chronic pain conditions like arthritis.
The agency also added similar warnings to lower-dose, over-the-counter NSAIDs like Aleve and Advil. Those drugs currently warn patients to take the lowest dose possible for as short a period as possible. They are not intended to be used for pain longer than 10 days, according to their labels. (like that’s going to happen)
Advil is marketed by Pfizer Inc., while Aleve is sold by Bayer. Many generic drugmakers market cheaper versions of the drugs.
continuing: . . . almost anything one reads tells us that inflammation is a cause factor of most modern, current diseases. We read/hear this a lot, but hardly anyone has anything truly useful which aids us to know what to do. How do we help ourselves by just knowing that? We know inflammation by it symptoms — pain, tenderness and stiffness in muscles and joints. So what causes inflammation? Its the FOOD, of course, but a more complicated ball of wax, depending on the individual. In arthritis, there is the cooked food syndrome. One needs far more raw (uncooked) fruits and vegetables (for minerals and vitamins) and this enables a more balanced ph level of approximately 7 (normal human figure). The Standard American Diet (SAD) is loaded with too many useless calorie carbohydrates, far too many “sweet” things (sugar) and with some others — too much animal protein. All these add up to being overly acidic which is the soil in which to grow disease of all kinds. So when cooking food, enzymes are destroyed > digestion impaired, gut is harmed, nutritive needs not met. . .stuff breaks down. I did a post 11-17-15 called Walter Last holistic healer, from whom I’m attempting to reference now. There is nothing that I could say which might even come close to his evidence based words. I suggest you see it and perhaps download anything you might want to know about any disease. He lives abroad and everything he wrote is on one of his sites – FREE.
We seriously need to care for our digestive issues, (especially as we age) taking hydrochloric acid as our ability to make it drops. There’s much simple, easy, fairly cheap stuff that can be done without so much as one prescription drug. (I DL’d his 21 page article on Arthritis and Rheumatism. Haven’t finished reading it to be sure, but love what I’ve read. I’m not really so much a “label person.” I think it can be a trap – convenient way out. I just need to know WHY and WHAT I can do to correct it. And because of Walter Last, I found what works for me. The Borax Conspiracy ( a 10 pager), turned out to be my solution. Wasn’t easy wrapping my mind around it, .. kinda struggled. But I accepted his logic , theory,. . .then evidence of 1000’s who found blessed relief . . .took the stuff and never looked back. . .glad to leave their pain behind.
If I were younger and had a bottomless pit of money, I’d head for the courts and stop only when I was dead or in the supreme court. No corporate structure in the world has the RIGHT to deny people the natural solution that our earth provided and smart men discovered how to use to the benefit of so many who suffered and could so easily be put to rest (corrected – neutralized), returning those in pain to full utilization of their body parts which had been too painful to move before. It’s outrageous! and criminal. And why? This stuff works for pennies which was costing PhRMA millions in lost revenue!. . but not helping those who were ill. They did it because they could!
So of course, I did this thing. The hardest part for me was finding out how much water was in a liter. Then checking and sure enough, had this old box on a shelf – maybe 20 years old, now in the form of a brick. Had to break it down, then with mortar and pestle ground down only a teaspoon of it to put in the liter of water. Stirred around, dissolving it. 1 tsp to the quart of water is the ‘solution’; needing 1 tsp daily of the ‘solution’ to restore balance to body from the acidic (inflammatory) state, or I should say maintain it once it has been tamed. To bring a very painful arthritic condition to a pain-free point of mobility and usefulness will take about 2 – 3 months (give or take) @ 1 tsp two or three times a day. Its easy to do, has no taste. Pain and inflammation is just one of its benefits — so much more – Hormonal, but another time.
I’m an eager, willing person with arthritic hands. Took my first dose that night and woke next day feeling ‘something’ but didn’t know what, except I felt pretty good and wanted to get up and have at it. Yeah, guess, I did feel a tad better than usual. So I hadn’t hurt myself — I’m going for the gold! So that day, took 3 doses; repeated next and every day. It’s a week now. Haven’t noticed my hips or knee bothering me. Hands not home free, but no shooting pains, numbness not as bad. Got nothing to loose. Always use my body as my personal laboratory for all the stuff I make. Haven’t used pharmaceuticals in over 5 – 6 years. And with 2 exceptions, no OTC stuff either. Able to maintain pretty good health with my EFT and Eden Energy medicine. Lo, these 86 years, still counting my blessings. . .which just keep comin’ . . . . . . Jan