January 23, 2012
By Donna Earnest Pravel
“Super-foods rock. Chlorella is one of the best.” –KTRN
Chlorella is a green algae that is considered to be one of the most powerful superfoods known to man. Chlorella contains vasts amount of chlorophyll within its cell walls. The cell walls of chlorella are tough and indigestible, so many chlorella producers break the cell walls before selling the product. Broken cell chlorella releases the nutrients inside the cell walls so the human body can use them. Besides being possibly the richest source of chlorophyll on Earth, chlorella is also very high in plant protein. Chlorella contains fifty-eight grams of protein per one hundred grams of weight. By comparison, beef and chicken have twenty-four to twenty-eight grams of protein per one hundred grams of weight. Chlorella is a pain reliever, reduces hypertension, enhances the immune system in some cases, and chelates heavy metals.
Chlorella has been found to reduce pain
In 2000, a pilot study was conducted in which fibromyalgia patients consumed 10g of a commercially available chlorella tablet and 100mL of chlorella in liquid form. Symptoms were measured at the beginning of the trial, and again after one and two months of treatment with chlorella. After two months on chlorella, the fibromyalgia patients reported a significant 22% reduction in pain and tenderness. One-third of the patients believed their health was better after taking chlorella. Scientists involved with this study stated that a full double-blind, placebo-controlled clinical trial was warranted.
Chlorella reduces or stabilizes blood pressure, even when medication is stopped
In another clinical study, patients with hypertension were given 10g chlorella tablets and 100 mL chlorella extract for two months. Patients were taken off all blood pressure medications, then treated with chlorella. One-fourth of the patients saw a decrease in blood pressure after taking chlorella for two months. The other three-fourths did not see a rise in blood pressure, despite being taken off their blood pressure medication.
February 25th, 2011
By: Dr. Tyrone M. Reyes, M.D.
Pain relievers can work wonders, allowing many people to carry on with their lives despite disabling arthritis, for instance, or recurrent headaches. But all pain relievers, prescription or over-the-counter (OTC), have potential risks, especially when taken in high dosages or for a long term. Recent events have raised concerns about these widely-used drugs, in particular the No. 1 non-prescription pain reliever, acetaminophen.
For a long time, acetaminophen, the active ingredient in Tylenol, has seemed to be the safe bet among the commonly available pain relievers. Although acetaminophen is one of the safest and most effective drugs on the market, this pain reliever can damage your liver when taken in too high a dose. In fact, acetaminophen overdoses are the No. 1 cause of acute liver failure in the United States. One key reason: So many medications contain acetaminophen that it’s easy to take too much of the drug without realizing it. Although the problem of accidental overdoses isn’t new, the issue became headline news last year when an advisory committee of the US Food and Drug Administration (FDA) put new restrictions on drugs containing acetaminophen. Here’s more of what you should know about acetaminophen and how to take it safely.
WHAT IS ACETAMINOPHEN?
Acetaminophen, which in other countries is called paracetamol, was first synthesized and used in patients in the late 19th century. But it was dropped in favor of a related drug, phenacetin, and fell into obscurity until it was rediscovered in the 1950s after phenacetin proved to have too many side effects. Acetaminophen did not catch on until the early 1980s, when it filled the void left by aspirin as the safe pain reliever and fever reducer for children after aspirin was linked to Reye’s syndrome, a rare but potentially fatal condition that affects the brain and the liver.
Today, although OTC acetaminophen is often associated with the brand-name drug Tylenol, it can be found in numerous other products designed to treat headaches, cold and flu symptoms, sinus problems, sleeplessness, arthritis pain, and even menstrual cramps. But that’s not all. The drug also is an active ingredient in some popular pain medications, such as Dolcet, and muscle relaxants, such as Norgesic Forte.
Acetaminophen is sometimes confused with nonsteroidal anti-inflammatory drugs (NSAIDs) which include aspirin, naproxen, ibuprofen, and others. That’s because these medications all belong to a class of pain-relieving drugs called analgesics and are readily available without a prescription. Acetaminophen, however, is usually put in its own category, separate from the NSAIDs, because it doesn’t have their anti-inflammatory effects. Some research shows that it does interfere with prostaglandin synthesis, like NSAIDs, but in a way that doesn’t produce widespread effect on inflammation.
However, in recent years, acetaminophen has often been recommended instead of aspirin as a day-to-day pain reliever because it’s much easier on the stomach and is considered safe when taken properly. In fact, new pain management guidelines released by the American Geriatric Society in 2009 highly recommend acetaminophen as an initial and ongoing therapy for common forms of muscle and bone pain in older adults.
With NSAIDs, the main concern is stomach bleeding. This is especially true in adults who are over age 60, are taking prescription blood thinners, and have a history of stomach bleeding or ulcers. The regular use of NSAIDs also can raise blood pressure, damage kidneys, and cause cardiovascular complications in some adults. With acetaminophen, the main concern is liver damage which can cause everything from abnormalities in liver function tests to acute liver failure and even death.
To add insult to injury, acetaminophen may have deleterious effects beyond the liver. Harvard researchers have linked the drug to high blood pressure. Other researchers have identified a possible connection to asthma. These are preliminary findings, not proof of cause and effect. Still, they’re another reason the perception of acetaminophen as a harmless drug is changing.
DANGER TO CHRONIC DRINKERS
If you drink a lot of alcohol in one session and take a normal dose of acetaminophen, you probably are not going to have liver problems. It also seems that heavy drinkers aren’t any more likely than nondrinkers to suffer liver damage from a single large dose of acetaminophen
The trouble starts when heavy drinkers take a lot of acetaminophen over a period of time several days, at least, and maybe longer. A drinking habit and a poor diet often go hand in hand. Multiple high doses of acetaminophen are more dangerous for drinkers partly because they don’t eat well.
However, early signs and symptoms of liver damage caused by acetaminophen, such as loss of appetite, nausea, and vomiting, can sometimes be difficult to spot. That’s because they may take time to appear or be mistaken for something else, such as the flu.
Within a few days, however, liver damage can progress to liver failure and produce more serious symptoms. If you or someone you know suddenly develops a yellowing of the eyes and skin, tenderness in the upper abdomen, disorientation, or confusion, seek medical attention immediately. Liver failure caused by acetaminophen overdose is life threatening. But it often can be treated with medications used to reverse poisoning.
HOW MUCH IS TOO MUCH?
It’s difficult to pinpoint the exact amount of acetaminophen that will result in a liver-damaging overdose. People’s reactions vary, depending on the health of their livers and may be some other unknown factors. Some sources say 12,000 mg. over a 24-hour period will have toxic effects on the liver (That’s taking 37 regular strength pills at 325 mg. each!)
But there’s evidence that much lower amounts can harm the liver. According to the FDA working group, the median daily dose associated with liver injuries recorded in the agency’s adverse event data base and in a large liver failure study was 5,000 to 7,000 mg. That’s uncomfortably close to 4,000 mg., the current daily limit for safe intake.
Experts agree that the dangers associated with taking too much acetaminophen shouldn’t be downplayed. According to recent studies, acetaminophen overdoses cause 56,000 emergency room visits, 26,000 hospitalizations, and nearly 500 deaths each year in the United States.
That is why the FDA is currently considering several new measures to address the problem, including:
• Lowering the maximum daily dose. Currently, it is recommended that adults take no more than 4,000 mg. of acetaminophen a day. However, research suggests that taking this amount in a 24-hour period could be toxic in some adults. As a result, it’s been proposed that the maximum daily dose be lowered to 2,600 mg.
• Reducing dosage strengths. Many non-prescription acetaminophen products contain 500 mg. of the drug per single tablet or capsule, and it’s recommended that single doses not exceed 1,000 mg. To lower the chances of an overdose, it’s been suggested that maximum single doses be limited to 650 mg and that OTC pills or tablets contain no more than 325 mg.
• Eliminating combination prescription medications. It’s been proposed that acetaminophen and narcotic drugs be prescribed separately, rather than being combined in one medication.
Whether or not new restrictions go into place, it’s important to be careful when using acetaminophen. To avoid overdose:
• Read labels. Look on the label or package insert for either the word acetaminophen or paracetamol or the abbreviation APAP.
• Follow dosing directions. Make sure you understand how much acetaminophen you can take at one time, how many hours you must wait between dosages, and how many doses you can safely take each day.
• Don’t take more than one medicine containing acetaminophen at a time.
• Talk to your doctor before taking acetaminophen if you have risk factors for liver damage. You’re at greater risk if you consume three or more alcoholic drinks every day or have existing liver damage.
The bottom line: Acetaminophen, when used correctly and within dosage guidelines, is still probably the safest nonprescription pain reliever available. But you should view it as a serious drug not something you can pop like candy!
January 17th, 2011
By: Catherine Donaldson-Evans
The Food and Drug Administration has ordered the makers of prescription drugs containing acetaminophen to limit the per-pill dosage, the agency said Thursday.
Manufacturers of acetaminophen combination medications, such as Vicodin and Percocet, have been asked to restrict the amount of the pain reliever in them to 325 milligrams or less.
The drug makers also must ensure that their labels warn patients of the possible risk of serious liver problems, the agency said.
“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” Dr. Sandra Kweder, a deputy director at FDA’s Center for Drug Evaluation and Research (CDER), said in a statement on the agency’s website.
She said there is heightened concern over severe liver complications related to prescription drugs containing acetaminophen.
“Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death,” said Kweder.
The move is a step to phase out high-dose prescription drugs that have acetaminophen in them, which the FDA says will happen over the next three years. The agency says the new regulations “should not create a shortage of pain medication” and believes that 325 milligrams in each capsule or tablet is a sufficient dose for relieving pain.
Acetaminophen alleviates fever as well as pain and is found in prescription and over-the-counter drugs including Tylenol. Tylenol and other OTC medications containing the painkiller aren’t affected by the new FDA requirements.
Many prescription painkillers combine acetaminophen with other ingredients, typically codeine and other opioids (i.e. Tylenol with Codeine), oxycodone (Percocet), and hydrocodone (Vicodin).
People who already are taking the higher-dose prescription acetaminophen painkillers shouldn’t fret over the latest mandate, however.
“There is no immediate danger to patients who take these combination pain medications, and they should continue to take them as directed by their health care provider,” Kweder said.
She explained that the risk of serious liver injury and other complications generally arises only when patients take multiple acetaminophen combination drugs at the same time, drink alcohol when taking prescription acetaminophen or exceed the maximum dosage of 4,000 milligrams in 24 hours.
The new regulations were developed after an advisory meeting on the matter in June 2009. For more information on products affected by the new regulations, click here
January 13th, 2011
By: Steven Hoffer
The Food and Drug Administration said Thursday that it will ask combination prescription drug manufacturers to limit the content of the common pain reliever acetaminophen in their products.
The new stipulation, which also requires companies to warn consumers of “the potential risk for severe liver injury” associated with the drug, will limit acetaminophen levels to 325 milligrams per dose.
“FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use,” Dr. Sandra Kweder, deputy director of the Office of New Drugs in FDA’s Center for Drug Evaluation and Research, said in the statement.
“Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen-related liver failure in the United States; many of which result in liver transplant or death.”
Acetaminophen is often combined with other pain relievers and is found in many prescription and over-the-counter medicines including Tylenol with Codeine, Percocet, and Vicodin.
“There is no immediate danger to patients who take these combination pain medications and they should continue to take them as directed by their health care provider,” added Kweder. “The risk of liver injury primarily occurs when patients take multiple products containing acetaminophen at one time and exceed the current maximum dose of 4,000 milligrams within a 24-hour period.”
July 14, 2010
by Rita Rubin
A large clinical trial of Avandia, sponsored by its maker, “was inadequately designed and conducted to provide any reassurance” that the controversial diabetes drug does not increase cardiovascular risk, a Food and Drug Administration scientist wrote in a memo released Friday.
The lengthy memo by Thomas Marciniak, a medical team leader in the Division of Cardiovascular and Renal Products, is part of a 765-page briefing document prepared by FDA scientists in advance of next week’s advisory committee meeting on Avandia’s fate.
The RECORD trial, a study ordered by the European Medications Agency, enrolled 4,447 patients. It compares Avandia, the trade name for rosiglitazone, combined with metformin or a sulfonylurea, which are two other diabetes drugs, to metformin combined with sulfonylurea.
It is an “open label” trial, which means that the patients and researchers are aware of who’s getting which drugs, knowledge that could bias the findings, Marciniak wrote.
He cited a number of other problems with the study, including a lack of complete information about which study participants had died, information that could have made Avandia look riskier.
Next Tuesday and Wednesday’s advisory committee meeting will be the second in three years to review Avandia’s risk/benefit profile.
At a July 2007 meeting, the panelists voted 20-3 that Avandia did raise heart attack risk. Yet, the panel voted 22-1 to recommend keeping the drug on the market. The FDA usually, but not always, follows its advisory committee recommendations.
Although their terms have expired, the FDA has taken the unusual step of inviting the 2007 advisory committee members to vote alongside their successors at next week’s meeting.
Concerns surfaced in ’07
Concerns about Avandia’s safety were raised in May 2007, when Steven Nissen, chair of cardiovascular medicine at the Cleveland Clinic, and coauthor Kathy Wolski published a report in The New England Journal of Medicine suggesting Avandia increased users’ risk of heart attacks. That term refers to problems related to an inadequate blood supply to the heart, including angina and heart attacks.
In February of this year, an investigation by the Senate Finance Committee concluded that maker GlaxoSmithKline, or GSK, knew of possible Avandia heart risks for several years before publication of Nissen’s study.
In a statement Friday, Murray Stewart, vice president for clinical development at GSK, said the company stands by its conviction that Avandia does not have unique cardiovascular risks.
“Since 2007 we have seen results from six controlled clinical trials looking at the cardiovascular safety of Avandia,” Stewart said, “and together they show that this medicine does not increase the overall risk of heart attack, stroke or death.”
The FDA has compiled a list of eight questions for the advisory panel members to consider. The next-to-last question asks them to recommend a specific regulatory action, ranging from keeping Avandia on the market and removing all warnings on its label about heart attack risk to pulling the drug off the market.
A split decision?
Committee members have their choice of five answers to that question, reducing the odds “of an overwhelming/unanimous vote for any one option,” according to a report released Friday by Concept Capital’s Washington Research Group, which advises institutional investors.
The Concept Capital report speculated that the FDA advisory panel might end up evenly split between allowing Avandia to stay on the market, with additional label revisions and restrictions on prescribing, or taking it off the market.
However, the Concept Capital report said, the most important question might be the one before that: “Based on the available data, please discuss the benefit-to-risk profile of rosiglitazone in the context of other available anti-diabetic therapies.”
As Concept Capital’s Cole Werble, Michael McCaughan and Ramsey Baghdadi write, “this is the critical question FDA decision-makers ask of a therapy that might have serious safety risks when other therapies exist on the market.” The agency did not ask that question of advisory committee members in 2007.
David Graham, the FDA scientist who made headlines in 2004 when he testified before a Senate committee that the agency was not equipped to prevent another Vioxx — the pain-reliever pulled from the market after a study found it increased heart attack risk — said in an interview Thursday that studies consistently have shown that Actos, the only other drug in the same class as Avandia, protects against heart attacks.
On the other hand, Graham says, Avandia, which has never been shown to be more effective than Actos in controlling blood sugar in diabetes, consistently appears to be riskier to the heart in comparisons with other drugs. Graham will be presenting an overview of the research at the advisory committee meeting.
“Really, what is most clinically relevant is the comparison of Avandia vs. Actos in the same study,” Graham said.
In a paper published online June 28 by The Journal of the American Medical Association, Graham and his coauthors analyzed data from 227,571 Medicare beneficiaries who’d been prescribed Avandia or Actos. They concluded that Avandia was associated with a higher risk of stroke, heart failure and death from any cause than Actos.
At the advisory meeting, Graham will report on eight other studies comparing patients prescribed Avandia to those prescribed Actos. All eight, he says, suggest Actos is safer.
To definitively answer whether Avandia increases cardiovascular risk, the FDA asked GSK to conduct the TIDE trial. The trial, which aims to study 16,000 patients in countries around the world, began enrolling participants in May. It is designed to compare the risk of heart attacks, stroke and cardiovascular death in diabetes patients randomly assigned to take either Avandia or Actos. It is also designed to test the impact of vitamin D supplement use on risk of death and cancer.
He called the TIDE trial unethical because “it’s treating humans as if they are laboratory rats. Why on Earth would anyone want to be randomized to Avandia in a clinical trial the purpose of which is to prove with absolute certainty that Avandia increases risk?”
In April 2010, the FDA asked the Institute of Medicine, or IOM, to answer five questions about ethical and scientific issues in studying the safety of approved drugs. The IOM is part of the National Academies, created to advise the government and the public. In light of the Avandia advisory committee meeting, the FDA asked the IOM to answer one question first: “What are the ethical and informed consent issues that must be considered when designing randomized clinical trials to evaluate potential safety risks?”
In a letter released today, the IOM said, “It is appropriate for FDA to require that a properly designed trial be conducted to provide additional evidence about an approved drug’s efficacy and safey” when there is too much uncertainty about risks vs. benefits to make “a responsible policy decision.”
In addition, the IOM said, the FDA should ensure that the trial includes an ongoing, “comprehensive and meaningful” informed consent process. But Graham says the TIDE informed consent process is more like “misinformation.” For example, he says, it does not mention the 2007 advisory committee’s overwhelming vote that Avandia raises heart attack risk or that the American Diabetes Association says Avandia shouldn?t be prescribed.
Graham and colleague Kate Gelperin?s critique of both the TIDE and RECORD trials is among the briefing documents for the advisory committee.
At a news conference Thursday, Deputy FDA Commissioner Joshua Sharfstein said he couldn’t predict when the agency would make a decision based on the advisory committee’s recommendations.
“Obviously, we’re going to have to look at a lot of information,” Sharfstein said. “We’re going to try to make a decision as quickly as we can under the circumstances.”
November 06, 2009
New research shows that the widely used pain reliever acetaminophen may be associated with an increased risk of asthma and wheezing in both children and adults exposed to the drug. Researchers from the University of British Columbia, Vancouver, BC, Canada, conducted a systematic review and metaanalysis of 19 clinical studies (total subjects=425,140) that compared the risk of asthma or wheezing with acetaminophen exposure.
The analysis showed that the pooled odds ratio (odds ratio for all studies combined) for asthma among users of acetaminophen was 1.63. The risk of asthma in children who used acetaminophen in the year prior to asthma diagnosis or in the first year of life was elevated to 1.60 and 1.47, respectively.
Furthermore, results showed a slight increase in the risk of asthma and wheezing with prenatal use of acetaminophen by mothers. Researchers speculate that acetaminophen’s lack of inhibition of cyclooxygenase, the key enzyme involved in the inflammatory response of asthma, may be one explanation for the potential link between acetaminophen use and asthma.