Sunday, 2 December 2012

FDA WARNING


According to MacKay, in the first full year the law was in effect, the FDA reported 1,080 adverse events linked to the use of vitamins and minerals, as well as herbal, sports, and weight loss supplements. A total of 672 adverse events were considered serious.
"For the same year, FDA received over 526,000 adverse event reports related to drugs and biologic products, overn 300,000 of which were considered serious, including close to 50,000 deaths," he writes.

HERBAL VS HEART SIDE EFFECT

Herbal supplements may not mix with heart medicines

 

Some herbal supplements can have dangerous interactions with heart medications.

By Mayo Clinic staff Herbal supplements are natural, so they must be safe, right? Not necessarily. Herbal supplements can have strong effects in the body, and some can interact with prescription medications used to treat heart and circulatory problems, such as high blood pressure and heart failure. Some of these interactions can even be dangerous.

Herbal supplements and prescription medications

At least a quarter of adults who take prescription medications also take dietary supplements, including herbal supplements. That number is even higher among adults older than age 70 — three-quarters report using both prescription medications and dietary supplements.
Yet many herbal supplements interact with medications for cardiovascular disease — which are widely prescribed for older adults. The chances of herbs and drugs interacting are high. Indeed, 8 of the 10 most widely used supplements interact with the blood-thinning medication warfarin (Coumadin). Here are just a few of the herbal supplements that can affect warfarin:
  • Danshen
  • Dong quai
  • Evening primrose oil
  • Garlic
  • Ginkgo
  • Ginseng
  • St. John's wort
That's why it's so important to talk with your doctor before taking herbal supplements if you take prescription medications. Your doctor and pharmacist can help you avoid risky interactions. 


Herbal supplements may not mix with heart medicines

Herbal supplements and drug interactions

This table shows popular herbal supplements and interactions with common heart medications. It's not a complete list, however, so be sure to discuss with your doctor the medications and supplements you take.
Herbal supplementMedicationPotential effect
Garlic
  • Aspirin
  • Clopidogrel (Plavix)
  • Warfarin (Coumadin)
Increases risk of bleeding
Ginkgo
  • Aspirin
  • Warfarin
Increases risk of bleeding
Ginseng
  • Warfarin
Decreases effectiveness of warfarin
Hawthorn
  • Beta blockers, such as atenolol (Tenormin), nadolol (Corgard) and propranolol (Inderal, Innopran XL)
Increases blood pressure and heart rate
  • Calcium channel blockers, such as diltiazem (Cardizem, Dilacor, others), nifedipine (Procardia) and verapamil (Calan, Covera-HS,Verelan)
  • Nitrates, such as nitroglycerin (Nitro-Bid, Nitrostat,others) and isosorbide (Monoket, Isordil)
Decreases blood pressure
  • Digoxin (Lanoxicaps, Lanoxin)
Increases effects of digoxin
Licorice
  • Warfarin
Decreases levels of warfarin
St. John's wort
  • Calcium channel blockers
  • Digoxin
  • Warfarin
  • Dabigatran (Pradaxa)
  • Rivaroxaban (Xarelto)
  • Statins, such as atorvastatin (Lipitor), lovastatin (Mevacor) and simvastatin (Zocor)
Reduces effectiveness of drugs

Playing it safe with herbal supplements

If your doctor tells you it's OK to use an herbal supplement combined with a medication, make sure you follow dosing instructions carefully. Watch for any unusual signs or symptoms that you could be having a drug interaction, such as rapid heartbeat, low blood sugar or changes in blood pressure. 


There are many medicines that you'll need to avoid when you have heart failure. Some are over-the-counter drugs that you can buy without a prescription. Others are drugs that a doctor may prescribe.
Do not start taking any of the medicines listed in the table below unless your doctor says it is okay and he or she knows that you have heart failure. If your heart failure is mild, you may be able to use some of the medicines for a short time, but it's very important to ask your doctor first.
If you are already taking a medicine on the list below, be sure to ask your doctor or pharmacist if it is okay to take it.

Medicines you may need to avoid

Over-the-counter medicines you may need to avoid (talk to your doctor or pharmacist) Prescription medicines you may need to avoid (talk to your doctor or pharmacist)
Pain relievers called NSAIDs
  • Ibuprofen, such as Advil and Motrin
  • Naproxen, such as Aleve
  • Aspirin, such as Bayer
    • If your doctor has told you to take a low-dose aspirin every day for your heart problems, it's probably okay to take it. Low-dose aspirin can help prevent blood clots and may prevent a stroke or a heart attack.
    • Higher doses of aspirin may make your heart failure worse. Do not take aspirin for pain, such as from headaches or arthritis. Use acetaminophen, such as Tylenol, instead.
Pain relievers
  • Celecoxib
  • Etodolac
  • Indomethacin
  • Ibuprofen
  • Ketoprofen
  • Nabumetone
  • Naproxen
  • Piroxicam
  • Sulindac
Cold, cough, flu, or sinus medicines
  • Be sure to check the label. Do not take medicines that contain pseudoephedrine, ephedrine, phenylephrine, or oxymetazoline, such as:
    • Sudafed.
    • Nose sprays (decongestants), such as Afrin and Dristan.
    • Herbal remedies, such as ma huang and Herbalife.
  • Make sure your cough and cold medicines don't contain aspirin or ibuprofen.
Antiarrhythmics
  • These are drugs used to treat a fast or uneven heart rhythm. You may need to avoid the following:
    • Disopyramide
    • Dofetilide
    • Flecainide
    • Procainamide
    • Propafenone
    • Quinidine
    • Sotalol
Antacids or laxatives that contain sodium
  • Check the label for sodium or saline. Examples include:
    • Antacids, such as Alka-Seltzer.
    • Laxatives, such as Fleet Phospho-Soda.
Calcium channel blockers
  • People with a certain kind of heart failure may need to avoid the following medicines:
    • Diltiazem
    • Verapamil
  • If you need to take a calcium channel blocker for another health problem, such as high blood pressure, your doctor will watch your health carefully.

Certain diabetes medicines
  • Most diabetes drugs are safe to take, but avoid the following:
    • Metformin
    • Rosiglitazone and pioglitazone1

Certain antibiotics
  • Some antibiotics may interfere with how your body uses the medicine digoxin. If you take digoxin, talk with your doctor before taking antibiotics.

Citations

  1. Kaul S, et al. (2010). Thiazolidinedione drugs and cardiovascular risks: A science advisory from the American Heart Association and American College of Cardiology Foundation. Circulation, 121(16): 1868–1877.
Last Revised: April 26, 2012
Author: Healthwise Staff
Medical Review: Rakesh K. Pai, MD, FACC - Cardiology, Electrophysiology & Margaret Hetherington, PHM, BsC - Pharmacy


Garlic, ginkgo, St John's Wort could all upset bleeding/clotting balance, study found

THURSDAY, May 13 (HealthDay News) -- People taking the prescription blood thinner warfarin (Coumadin) may up their risk for health complications if they also take herbal or non-herbal supplements, new research reveals.
In fact, eight out of the 10 most popular supplements in the United States could spark safety concerns with respect to warfarin, while also impacting the drug's effectiveness.
"I specifically looked at warfarin use, but the real issue is that even though herbal supplements fall under the category of food, and they're not regulated like prescription drugs, they still have the effects of a drug in the body," cautioned study author Jennifer L. Strohecker, a clinical pharmacist at Intermountain Medical Center in Salt Lake City.
"Warfarin is a very high-risk medication, which can be associated with severe consequences when it's not managed properly," she added. "However, warfarin is derived from a plant, sweet clover. In fact, many of our prescription drugs came from plants. So, it's very important for patients to recognize that just because an herb is marketed not like a prescription drug [that] doesn't mean it doesn't have similar effects in the body."
Strohecker and her colleagues are slated to present their findings Thursday at the Heart Rhythm Society annual meeting in Denver.
The authors note that almost 20 percent of Americans currently take some type of herbal or non-herbal supplement.
To gauge how these products might interact with warfarin, the researchers ranked the 20 most popular herbals and 20 most popular non-herbal supplements based on 2008 sales data, and then looked at how their use affected both clotting tendency and bleeding.
More than half of the herbal and non-herbal supplements were found to have either an indirect or direct impact on warfarin. Nearly two-thirds of all the supplements were found to raise the risk for bleeding among patients taking the blood thinner, while more than one-third hampered the effectiveness of the medication.
An increase in bleeding risk was specifically linked to the use of cranberry, garlic, ginkgo and saw palmetto supplements, the team said.
Glucosamine/chondroitin, essential fatty acids, multi-herb products, evening primrose oil, co-enzyme Q10, soy, melatonin, ginseng and St. John's wort all affected warfarin's effectiveness so much so that they prompted a need for adjustments in the drug's prescribed dosage.
"I'm not against herbal supplement use at all," Strohecker stressed. "But physicians need to proactively discuss this issue with their patients because of the consequences that can occur."
Dr. Richard L. Page, a cardiologist and chair of medicine at University of Wisconsin, Madison, and president of the Heart Rhythm Society, believes the larger problem here is poor patient-doctor communication.
"Doctors don't always know what their patients are taking," he said. "Supplements may perform a very good service. Or they may not be providing the sort of care that patients are looking for when they're essentially self-medicating. And where this becomes especially important is that these supplements can interact with the prescription drugs that your doctor may be giving you."
"This report is important," Page said, "because they look at a very common drug, warfarin, which has a narrow therapeutic window. Which means too much is bad cause you bleed, and too little is bad because it won't do the job of thinning the blood that you want. So the bottom line is, be careful of adding new supplements if you are on existing prescription medications, and talk to your doctor if you do."
A representative of the supplements industry took a slightly different view.
Duffy MacKay, vice president of scientific and regulatory affairs for the D.C.-based Council for Responsible Nutrition, the leading dietary supplement industry trade association, said that, "the issue here is really more with warfarin."
"It's just a very sensitive medication," he said. "Warfarin itself has a huge list of drugs, foods and over-the-counters that it interacts with. If you take too much or too little, it can become dangerous."
"So it's sort of a form of sensationalism to suggest that here you have this situation with dietary supplements specifically," MacKay added.
More information
There's more on warfarin at the U.S. National Institutes of Health.
 =====================

Herbal Remedies May Be Risky 

With Heart Drugs

       Researchers Say Some Supplements Should be Avoided by Patients Taking Heart Drugs
 By WebMD Health News Reviewed by Louise Chang, MD
Feb. 1, 2010 -- Patients taking heart drugs are at risk for potentially dangerous interactions when they also take herbal supplements such as ginkgo biloba, St. John's wort, and garlic, an analysis shows.
Investigators with the Mayo Clinic identified herbal and alternative products that they say should be avoided by patients with heart disease.
They claim the products could cause problems when taken with drugs commonly prescribed to lower blood pressure, control cholesterol, stabilize heart rhythms, or prevent blood clots.
The research analysis appears in the Feb. 9 issue of the Journal of the American College of Cardiology.
Researcher Arshad Jahangir, MD, tells WebMD that heart patients often fail to tell their doctors about the alternative remedies they take because they don't recognize the potential for harm.
"Many people think that natural is synonymous with safe," he says. "Many of these herbal remedies have been used for centuries, but they may not be safe in the current era when used by patients taking many other medications."

Older Patients Most at Risk

Jahangir says the danger is especially great in elderly heart patients, who are often also taking drugs for other chronic conditions and who may already have an increased risk for bleeding.
Bleeding was one of the most frequently cited interaction risks identified by the Mayo researchers, along with reducing or increasing the potency of the prescribed medications.
Some specific examples they cited included:
  • St. John's wort, which is typically used to treat depression, anxiety, and sleep problems, has been shown in some studies to decrease the effectiveness of the arrhythmia drug digoxin, as well as blood-pressure-lowering medications and cholesterol-regulating statins. 
  • The herbal remedies alfalfa, dong quai, bilberry, fenugreek, garlic, ginger, and ginkgo biloba were all identified by the researchers as increasing bleeding risk when combined with the widely prescribed anti-clotting drug Coumadin (warfarin). Ginseng and green tea were identified as decreasing Coumadin's effects. 
  • The banned herbal product ephedra (ma-huang) has been linked to stroke, heart attack, seizures, and death from cardiac arrhythmia in otherwise healthy adults who used the product to boost energy or lose weight.
  •  
Not all interactions identified by the researchers involved herbal or alternative remedies.
Jahangir says taking heart medications with grapefruit juice is a common cause of drug toxicity.
For almost two decades, researchers have known that grapefruit juice can increase dosages of some drugs to toxic levels by inhibiting a key enzyme in the intestine that breaks down medications.
He says patients on cholesterol-lowering statins who take the drugs with grapefruit juice may end up with blood statin levels that are three to four times higher than intended.
"I think it is a good idea for anyone taking medication to avoid grapefruit juice because the effects can last as long as 24 hours," he says.
The Mayo researchers conclude that there is a clear need for increased regulation to protect the public from herbal and alternative supplements that can harm them.

Supplement Industry Reaction

A spokesman for the dietary supplement industry's leading trade group was highly critical of the claim and the research analysis in general in a written statement released today.
Council for Responsible Nutrition Vice President for Scientific and Regulatory Affairs Douglas MacKay, ND, writes that the analysis represents a "biased, poorly written and contrived attack on herbal supplements," which contained "sweeping generalizations, often not backed by relevant citations, and copious factual errors."
He faults the researchers for not acknowledging recent changes in federal law that require dietary supplement manufacturers to report serious adverse events to the 

2 comments:

  1. Herbalife

    Herb life means products from herbs, which are more effective, no side effects, provide completely relax with lowest prices, available on herbal-market.com

    ReplyDelete
  2. I would be interested to find out how many manufacturing facilities are able to be inspected by the FDA.
    http://ezsupplements.com/

    ReplyDelete