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Found 9 results

  1. JadedCPN

    Pfizer Approved by FDA

    Pfizer has been fully approved by the FDA. Curious what excuses will be used next as to why not to get it. FDA Approves First COVID-19 Vaccine
  2. Been engaged in alot of discussion under the COVID heading. Got me thinking. I find myself not trusting published data. There's so much politicization of everything. The government agencies are simply not independent and they are the source of most information. They want compliance. Period. Why wouldn't they change the data to fit? They certainly could and they have before. They constantly put out demands and conflicting information over and over again. Masks are BS. They don't protect anything. they stop a cough. GREAT! But they push masks like they are vital to life. People are wearing their masks while jogging in the woods. seriously? What the foxtrot!!? I hear all colors of reports about anecdotal stories of people being hurt by the vaccines. Those stories don't even exist as far as official sources are concerned. Do I risk the vaccine hurting me or COVID hurting me? Neither is a good option. COVID is a crap shoot. but taking the vaccine is a conscious choice. People come out of COVID without a problem. people take the vaccine without a problem. Both sides are valid in my mind. but now they are forcing the vaccine by law. This isn't a clear situation. It's very muddy. vaccinated still get infected but the narrative is the vaccine is totally safe, effective, and mandatory and will save the world. How do we know the vaccine isn't driving mutation? If I can't trust the source, how the hell can I make an informed decision? The drug companies have a massive profit motive to avoid any bad press. did they really disclose all their data? Every single positive case is counted as a case. Are vaccine injuries treated the same? How many people harmed by the vaccine are taken into account? There's no way to know. Positive case: Always assume regardless of symptoms. Vaccine injury claim: PROVE IT WITH AN AUTOPSY!! IT COULDN'T HAVE BEEN THE VACCINE!! ITS PROBABLY SOMETHING ELSE!! HERE'S A REFERRAL NOW GET OUT OF MY OFFICE!! (Yes I'm being hyperbolic). Its a double standard and there's no way we can get a clear picture with a double standard like that. This whole thing is a mess. Does anyone else feel like they have found an unbiased source of information that someone who doesn't trust CDC, FDA, government bodies can turn to to make an informed decision? I'm tired of all the fighting and politicization. I just want unbiased information. If you are like me, what did you do to get a clear picture of this mess and come to a conclusion about vax vs avoid? I'm seriously frustrated. I don't want to add to the problem. But I also don't want to get vaccination injury which can be just as bad as anything I can get from (yes liberals, vaccine injury happens. deal with it). Sigh....tired. I hope this makes sense. Does anyone else feel like this? I hope I'm not the only one.
  3. So y'all going to run out now and get it, now that it's no longer an "experimental, unapproved drug"? . . . . . Yeah, didn't think so.
  4. The FDA recently noticed an increase in hospitalizations and deaths linked to using nitrite “poppers”. On June 24, 2021, the agency issued a statement warning consumers not to buy or use poppers that are typically sold on-line and in adult novelty shops. They are marketed under the brand names of Super RUSH, Jungle Juice, Extreme Formula, Quick Silver, Premium Ironhorse and Super Rush Nail Polish Remover. What Are Poppers? Poppers are usually sold as a liquid and packaged as room deodorizers or leather cleaner. They are usually packaged in 10mL to 40mL bottles that look like energy shot products. The chemicals in the liquid produce a vapor that causes vasodilation in the body when inhaled. It is actually related to the nitrate inhalation medications that are prescribed by physicians for angina attacks. Street names may include: Aimes Aimees Snapper Bold Liquid gold Rush Purple haze Buzz How Are They Used? Poppers are usually used by inhaling the vapors from the bottle. Some people dip the end of a cigarette into the bottle and inhale through the cigarette to avoid sniffing the chemicals directly from the packaging. Why Are They Used? Poppers are typically used recreationally to produce a feeling of euphoria or to enhance sexual experiences. Instant High People often use poppers for the “head rush” that is caused by the sudden increased blood flow. This can cause a euphoric feeling or instant high that general lasts only a few minutes. Some have described the rush as a “warm fuzzy” feeling that is caused by the side effects of vasodilation, including: Sudden drop in blood pressure Dizziness Increase in heart rate Lightheadedness Warm sensation throughout the body Sexual Enhancement The vasodilation effects of amyl nitrites also relax smooth muscles in the anus and vagina, making sex more comfortable and sensations more intense. Some men also take use poppers to prolong erections. Serious Side Effects The FDA released the warning against poppers based on an increase in hospitalizations and deaths with problems such as Severe headaches Dizziness Increased body temperature Shortness of breath Extreme hypotension Methemoglobinemia Brain death Here is a look at other problems people may experience when using poppers. Respiratory problems (sinus issues, respiratory infections, wheezing) Chemical burns around lips or nose Allergic reactions Increased eye pressure Heart palpitations Nausea Poor coordination Nosebleeds Lowered inhibitions Impaired judgement Dangerous With Other Drugs Poppers are often used in combination with other illegal drugs to increase the high, including, cocaine, marijuana, methamphetamines and hallucinogens. This increases the risk of both psychiatric and physiological side effects. The following medications when taken with poppers can cause a dangerously low blood pressure: Viagra Monoxidil (Rogaine) Diuretics (I.e. furosemide, hydrochlorothiazide) Beta Blockers (I.e. carvedilol, atenolol) Calcium channel blockers (I.e. diltiazem, nicardipine) Angiotensin II receptor antagonist (I.e. losartan, valsartan) Vasodilators (I.e. terazosin, apresonline) There is also research that suggests amyl nitrate can reduce the effectiveness of certain HIV medications, particularly protease inhibitors, such as indinavir, saquinavir mesylate and ritonavir. Who Uses Poppers? Amyl nitrite began being used for a recreational drug in the gay community during the 1960s. Its use became widespread throughout the 70s, 80s and 90s in the club scene. Today, people of all ages, races and sexual orientations use poppers. Are Poppers Addictive? Repeatedly using poppers can lead to a substance use disorder (SUD). This occurs when someone continues to use poppers despite health problems or issues in everyday life. Signs of a SUD including failing to meet personal responsibilities at home, work or school. A SUD be mild to severe, and an addiction would be the most severe. People who have tried to quit using inhalants may have the following withdrawal symptoms: Nausea Poor appetite Sweating Sleep problems Mood changes For more information on inhalants and addiction, visit this National Institute on Drug Abuse website. Do you have a clinical or personal experience with inhalants you are willing to share? References Is amyl nitrite safe? Who uses poppers? Nitrite ‘Poppers’: Here’s Why FDA Warned Against Their Use For Fun, Sex
  5. The U.S. Food and Drug Administration has scheduled a meeting of its Vaccines and Related Biological Products Advisory Committee (VRBPAC) on Dec. 10 to discuss the request for emergency use authorization (EUA) of a COVID-19 vaccine from Pfizer, Inc. in partnership with BioNTech Manufacturing GmbH “The FDA recognizes that transparency and dialogue are critical for the public to have confidence in COVID-19 vaccines. I want to assure the American people that the FDA’s process and evaluation of the data for a potential COVID-19 vaccine will be as open and transparent as possible,” said FDA Commissioner Stephen M. Hahn, M.D.... ... The FDA intends to make background materials available to the public, including the meeting agenda and committee roster, no later than two business days prior to the meeting.... https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-announces-advisory-committee-meeting-discuss-covid-19-vaccine
  6. This test does not require any special swab or collection device extraction or storage and can be processed by most high-complexity labs with common reagents under an "open-source" protocol. Since it does not require a separate nucleic acid extraction kit the capacity for testing will greatly increase. This test is currently being validated through a program testing asymptomatic NBA players. Current results show that SalivaDirect is highly sensitive, yielding similar results as the more invasive nasal (NP) swabbing. The fact that this will decrease both testing times and costs as well is making it widely available should increase the effectiveness of timely tracking and prevention of COVID spread. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-issues-emergency-use-authorization-yale-school-public-health
  7. On Saturday, April 27, 2019, participating communities will partner with law enforcement for the National Prescription Drug Take-Back Day. The ‘no questions asked” event is hosted by the U.S. Drug Enforcement Agency (DEA) in April and October of each year. Collection sites are set up in cities throughout the U.S. for the safe disposal of prescription medications people have at home. Dropping off unused or expired medications is free to the public and no questions are asked about the medications, including opioids. The DEA launched the take-back event in October of 2010 and since that time 5,439.5 tons of medications have been collected. The October 2018 event collected 457.12 tons of medications. To put this amount into perspective, compare 457 tons to four blue whales with each weighing approximately 100 tons. The Strategy of No Questions Asked Opioid abuse continues to be a public health concern and remains at epidemic levels in the U.S. The CDC reports 46 people die everyday of overdose related to prescription medications. In 2017, more than 35% of all opioid overdose deaths involved prescription opioids. Methadone, oxycodone and hydrocodone are the most common cause of opioid overdose deaths. Unused prescriptions discarded in the garbage can be retrieved, abused or sold illegally. The strategy of “no questions asked” is to promote safe disposal through anonymous means without consequences. Children are especially at risk for accidental exposure to prescription medications. Approximately 60,000 emergency department visits are made due to children under the age of 6 finding and ingesting medications when unsupervised. Children age 1-2 years old represent over two-third of all ED visits for accidental medication exposure and approximately 20% require hospitalization. According to the American Academy of Pediatrics, the number of children hospitalized for opioid poisoning increased 3x from 1997 to 2012 with toddlers and preschoolers representing the largest overall increase. Take-Back Day is an opportunity to discard medications to help prevent misuse, accidental exposure, overdose and possibly death from dangerous drugs. Take Back Events Do Not Accept Some Items The following items are generally not accepted at the collection site: Needles and other sharps Inhalers Mercury thermometers Iodine-containing medications Illicit drugs or substances (this includes marijuana which is a schedule 1 drug under federal law), and any prescriptions medications obtained illegally. *Individuals can call the collection site ahead of time to determine what items are not accepted. No Take Back Collection Site Nearby? If disposal instructions are not given on drug labeling and no prescription drug take back program is available, then follow these directions to discard in your home trash: Scratch out any identifying information on the prescription container to protect your identity and personal health information. Remove the medicine from its container and mix it with a substance that would make it undesirable to ingest (kitty litter, coffee grounds, dirt). Do not crush tablets or capsules before mixing. Place the mixture in a bag (sealable) or other container to prevent the medicine from leaking out of the trash bag. The FDA recommends disposing of fentanyl patches immediately after removing by folding the patch in half (sticky sides meet) and then flushing it down the toilet. Children and pets can find fentanyl patches if disposed in trash. Instructions for disposal can be found in the product medication guide. If disposal by the above method is not possible, one option is to flush the medication down the sink or toilet. Keep in mind- some communities may prohibit flushing medications out of concern of trace levels of the drugs found in rivers, lakes and drinking water supplies. Be sure to comply with the communities regulations and laws concerning medication disposal. Do not flush medications in the toilet or sink unless prescription labeling or patient information instructs you to. Locate available year round disposal locations here. Do you plan to take advantage of National RX Drug Take Back Day? Want to know more? Check out these links: Locate a local take back collection site here Read the DEA’s Disposal Act here Center for Disease Control- Healthy Water/ Prescription Drug Take Back Day
  8. Full story will be broadcast tonight Sunday 6/28/20 7PM ET/PT CBS 60 minutes 6/25/20 Federal officials allowed distribution of COVID-19 antibody tests after they knew many were flawed
  9. Brenda F. Johnson

    Has Medication Advertising Affected Drug Intake?

    Before the FDA gained control of how networks can air medication commercials, several doctors did some research and wrote if their findings in, "Television Advertising and Drug Use", by Barry Peterson, Ph.D., et al. They take the stance that advertisements of over the counter drugs contributes to public misconceptions and encourage drug use. "In promoting OTC drugs for the relief of everyday symptoms such as pain, nervousness, or lethargy, drug companies may deceive the public into thinking that drugs are an easy way out of everyday discomfort". That was 42 years ago, but the same concern is echoed by doctors in 2001. In the article, "Ban TV ads For Prescription Drugs?" it tells us that the American Medical Association would advocate for banning prescription drugs ads from television, newspapers, and magazines. They feel that the misinformation is causing problems with the patient population. They also say that these ads undermine their credibility. Doctors find themselves in a quandary when patients demand a medication they saw advertised, but the doctor feels another medication would better fit the patient's problem. Dr. Angelo Agro, an ear, nose, and throat doctor says this about medication ads, "Ads by their nature are biased and compressed and are driven more by drug companies' financial concern than by concern for the patients' best interest". Although there were doctors meeting to lobby against the drug companies advertising, there were also doctors who felt that a ban would violate free speech. The latter group of doctors that felt the ban was unnecessary and made it known to the committee that they saw medication advertisements as a positive because they may encourage patients to see their doctor, even those who wouldn't normally seek medical treatment. They also felt that these ads help to take the stigma out of certain conditions such as depression. Present day research is related in the article written in 2018, "Coverage By The Media Of The Benefits And Risks Of Medications", by Roy Moynihan B.A. et. al. They discuss how news stories need to cover adverse effects as well as benefits, and often research is focused on the results to favor the company. They found that out of the 207 newspapers and television stories they looked at exhibited shortcomings in their reporting. Moynihan reported that only 15 percent of the media outlets presented relative and absolute benefits; 83 percent gave information in relative terms only which can be misleading. Declaring only absolute or relative benefits does not tell the full story. 53 percent did not talk about potential harms, and 70 percent did not mention cost. Cost can be a deciding factor for many patients in whether they will choose a particular medication. Disclosure was an issue also. Scientific literature underreports the ties between research results and industry. They conclude that the news media should "focus" more. They suggest an educational program for journalists that would help them to focus on the reporting and interpretation of clinical findings. The FDA states on their website under the title "Background on Drug Advertising", the following: The FDA oversees the approval and marketing of prescription drugs through the law, "Federal Food, Drug, and Cosmetic Act". We have a lot of regulation in regards to getting medications on the market compared to other countries. The mid-80s saw more involvement of the media in direct to consumer advertising instead of only to doctors and pharmacists. You have probably noticed that there are some commercials that are really vague, and others that go into great detail. There are several classifications of drug ads: Product Claim Advertisements - These are the only ads that state the benefits and risks of a drug Reminder Advertisements - These ads give the name of the drug, but not the drug's uses. Help-Seeking Advertisements - These describe a disease or condition but do not suggest a specific drug. Ex. are ads for allergies, asthma, or erectile dysfunction. I have noticed an increase in advertisements for medications, especially on television and in magazines. Ever since the FDA approved advertising for medications years ago, the number per commercial break has skyrocketed. According to the article, "Think You're Seeing More Drug Ads on TV? You Are, and Here's Why" by Joanne Kaufman, 771,368 medication ads were shown in 2016. She states that it is "an increase of almost 65 percent over 2012". Not only has the number increased for medical advertising, but the class of drugs as well. Years ago, we saw ads for allergy medication or reflux, but now we see chemo drugs, cardiology drugs, and insulin. The marketing is towards those who are older (and still watching TV), rather than the younger generations. The professional opinions are varied in regards to advertising of drugs, some have reasons they are for them, and those opposed have their thoughts. Research shows that the average consumer can be misled by these advertisements. This misinformation can cause issues between the caregiver and the patient. The doctor may have several reasons why a particular medication may not be right for their patient but the patient feels that it is the best choice for them. Cost is another factor, especially with new medications. Insurance may not pay for a new drug, and the patient is left with a large bill or having to go back and ask the doctor for another alternative. Some patients are more pill driven than life-changing driven in regards to treatment and end up on a long list of medications. Should drug companies be allowed to advertise at all? Should the government be involved? It's difficult to turn back federal regulation, and advertising is money driven. What would you like to see happen regarding the advertising of medications? References "Background on Drug Advertising". www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising. 20 July, 2018. Web. "Ban TV Ads For Prescription Drugs?". CBS News. 18 June, 2001. 20 July, 2018. Web. "Basics of Drug Ads". www.fda.gov/Drugs/ResourcesForYou/Consumers/PrescriptionDrugAdvertising. 20 July, 2018. Web. Bell, Robert A. Phd, Kravitz, Richard L. MD MSPH, Wilkes, Michael S. MD PHD. "Direct to Consumer Prescription Drug Advertising and the Public". 14(11)651-657. Journal of General Internal Medicine. 14 Nov, 1999. 20 July, 2018. Web. Kaufman, Joanne. "Think You Seeing More Drug Ads on TV? You Are, and Here's Why." The New York Times. 24 Dec. 2017. 20 July, 2018. Web. Moynihan, Ray B.A. et al. "Coverage By The News Media Of The Benefits And Risks Of Medication". The New England Journal Of Medicine. Vol. 342 Nu. 22, 11 July, 2018. 20 July, 2018. Web.