WebProNews

Tag: FDA

  • FDA Authorizes Pfizer’s Pill to Treat COVID-19

    FDA Authorizes Pfizer’s Pill to Treat COVID-19

    In a potential game-changer in the fight against COVID, the FDA has approved Pfizer’s pill to treat COVID.

    While governments are working hard to get as many people vaccinated as possible, companies have also been working on better ways of treating those that contract the virus in the hopes of preventing the worst symptoms from developing.

    Pfizer has now received authorization for the first pill designed to do just that.

    “Today’s authorization introduces the first treatment for COVID-19 that is in the form of a pill that is taken orally — a major step forward in the fight against this global pandemic,” said Patrizia Cavazzoni, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This authorization provides a new tool to combat COVID-19 at a crucial time in the pandemic as new variants emerge and promises to make antiviral treatment more accessible to patients who are at high risk for progression to severe COVID-19.” 

    The pill, Pfizer’s Paxlovid, is not designed as a preventative medication, but should be taken “soon as possible after diagnosis of COVID-19 and within five days of symptom onset.”

    Having an effective way to treat the virus after infection could save tens, or even hundreds of thousands of lives moving forward.

  • FDA Proposes Rule to Allow No-Prescription Hearing Aids

    The Federal Food and Drug Administration has proposed a rule that would allow Americans to buy hearing aids without a prescription.

    Some 15% of Americans have some degree of hearing loss, but getting hearing aids can be a difficult and expensive process, requiring a doctor’s visit and, often, a fitting with an audiologist.

    The FDA wants to make it easier and cheaper for Americans to get access to hearing aids, eliminating the need for a prescription. The move could open the door for hearing aids to be sold online or in stores.

    “Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra. “Today’s move by FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.”

  • FDA Approves Quidel QuickVue At-Home COVID-19 Test

    FDA Approves Quidel QuickVue At-Home COVID-19 Test

    The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test, another antigen test where certain individuals can rapidly collect and test their sample at home, without needing to send a sample to a laboratory for analysis.

    The QuickVue At-Home COVID-19 Test is authorized for prescription home use with self-collected anterior nasal (nares) swabs from individuals ages 14 and older or individuals ages 8 and older with swabs collected by an adult. The test is authorized for individuals suspected of COVID-19 by their healthcare provider within the first six days of symptom onset. 

    “The FDA continues to prioritize the availability of more at-home testing options in response to the pandemic,” said Jeff Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The QuickVue At-Home COVID-19 Test is another example of the FDA working with test developers to bring important diagnostics to the public.”

    In addition to this new prescription home test, Quidel also was issued an EUA in December 2020 for their QuickVue SARS Antigen Test which is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform high, moderate or waived complexity tests, as well as for point-of-care testing by facilities operating under a CLIA Certificate of Waiver. 

  • FDA: COVID Vaccine Variants Won’t Need Lengthy Testing

    FDA: COVID Vaccine Variants Won’t Need Lengthy Testing

    The Food and Drug Administration (FDA) has indicated that updates to COVID vaccines aimed at virus variants will not need lengthy testing.

    As governments around the world roll out COVID vaccines, a pressing concern is the emergence of variants, such as the UK strain and the South African strain. Experts are concerned that some strains may be more contagious and possibly resistant to existing vaccines.

    To successfully combat existing and emerging strains, it will be important for vaccine manufacturers to be able to quickly bring updated versions of their vaccines, or boosters, to market. The FDA has removed a big hurdle, indicating that vaccine boosters will not require the same lengthy testing as the original vaccine. Instead, manufacturers will be able to adopt a similar approach as that used with flu vaccines.

    “The FDA is committed to identifying efficient ways to modify medical products that either are in the pipeline or have been authorized for emergency use to address emerging variants,” said Acting FDA Commissioner Janet Woodcock, M.D. “We know the country is eager to return to a new normal and the emergence of the virus variants raises new concerns about the performance of these products. By issuing these guidances, we want the American public to know that we are using every tool in our toolbox to fight this pandemic, including pivoting as the virus adapts. We need to arm health care providers with the best available diagnostics, therapeutics and vaccines to fight this virus. We remain committed to getting these life-saving products to the frontlines.”

    The FDA’s new guidance is good news for vaccine manufacturers and citizens alike.

  • FDA Finds No Direct Link Between Cell Phones and Cancer

    FDA Finds No Direct Link Between Cell Phones and Cancer

    The Food & Drug Administration (FDA) has released its findings after reviewing a decade of studies, saying it has not found no proof of a link between cell phones and cancer.

    The FDA analyzed “peer-reviewed in vivo (animal) and epidemiological studies published from January 1, 2008 to August 1, 2018 for in vivo studies, and from January 1, 2008 to May 8, 2018 for epidemiological studies.” The goal was to determine what, if any, effect radiofrequency radiation (RFR) had on human beings and whether it was responsible for an increased risk of cancer.

    The FDA said there were approximately 125 articles considered most relevant to the analysis, none of which adequately demonstrated a link between the level of cell phone RFR and health risks. In fact, the reports says that “based on the FDA’s ongoing evaluation, the available epidemiological and cancer incidence data continues to support the Agency’s determination that there are no quantifiable adverse health effects in humans caused by exposures at or under the current cell phone exposure limits.”

    In spite of what seems to be good news, the FDA does express concern that small subsets of the population who are already predisposed toward developing tumors may be at a greater risk and suffer more harm from RFR than the general population. The FDA recommends studies shift toward those population subsets.

    In the meantime, the report summarizes its conclusions by stating: “Existing epidemiological evidence indicates that if any risk does exist, it is extremely low compared to both the natural incidence of the disease and known controllable risk factors. As further research is conducted, we will continue to monitor the available information.”

  • Kim Kardashian Forced to Post a ‘Corrective Ad’ After FDA Called Previous One Misleading

    Kim Kardashian Forced to Post a ‘Corrective Ad’ After FDA Called Previous One Misleading

    Future first lady and Instagram queen Kim Kardashian has been forced to post a #CorrectiveAd on Instagram after she and a drugmaker ran afoul of the Food and Drug Administration over a deceptive ad.

    In now-deleted Instagram, Twitter, and Facebook posts, Kardashian touted the amazing benefits of a morning sickness drug called Diclegis, made by a drug company called Duchesnay.

    But according to the FDA, the post was “false and misleading.”

    “The Office of Prescription Drug Promotion of the U.S. Food and Drug Administration has reviewed the Kim Kardashian Social Media Post for DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use submitted by Duchesnay, Inc. under cover of Form FDA 2253. The social media post was also submitted as a complaint to the OPDP Bad Ad Program. The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts,” says the FDA in a letter addressed to Eric Gervais, Executive Vice President of Duchesnay, Inc., dated August 7th.

    “OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby,” wrote Kardashian in her original Instagram post.

    Now, Kardashian has been forced to post a follow up ad – this time including the appropriate risk information.

    “#CorrectiveAd. I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis,” she writes.

    The rest reads like any drug ad – a long list of warnings and possible side effects.

    #CorrectiveAd I guess you saw the attention my last #morningsickness post received. The FDA has told Duchesnay, Inc., that my last post about Diclegis (doxylamine succinate and pyridoxine HCl) was incomplete because it did not include any risk information or important limitations of use for Diclegis. A link to this information accompanied the post, but this didn’t meet FDA requirements. So, I’m re-posting and sharing this important information about Diclegis. For US Residents Only. Diclegis is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments. Limitation of Use: Diclegis has not been studied in women with hyperemesis gravidarum. Important Safety Information Do not take Diclegis if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis. You should also not take Diclegis in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse CNS effects of Diclegis. The most common side effect of Diclegis is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so. Do not drink alcohol, or take other central nervous system depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis. Severe drowsiness can happen or become worse causing falls or accidents. Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis. Additional safety information can be found at www.DiclegisImportantSafetyinfo.com or www.Diclegis.com. Duchesnay USA encourages you to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

    A photo posted by Kim Kardashian West (@kimkardashian) on

    Of course, #CorrectiveAd or not, it’s still an ad. Probably a win for Diclegis.

    Image via Kim Kardashian, Instagram

  • Kim Kardashian Posted a Misleading Drug Ad on Instagram and Ran Afoul of the FDA

    Kim Kardashian Posted a Misleading Drug Ad on Instagram and Ran Afoul of the FDA

    Kim Kardashian has 42.6 million Instagram followers and nearly 26 million Facebook likes. So when she promotes a product, it’s a pretty big deal.

    Paid social media promotion is everywhere, as companies look to provide their products a lucrative endorsement from the rich and famous. Kim Kardashian is far from the only celebrity who rents out space on their social media profiles for advertisements.

    But a recent endorsement from the most famous of the Kardashian clan has run afoul of the US Food and Drug Administration.

    In now-deleted Instagram and Facebook posts, Kardashian recently touted the amazing benefits of a morning sickness drug called Diclegis, made by a drug company called Duchesnay.

    But according to the FDA, the post was “false and misleading.”

    “The Office of Prescription Drug Promotion of the U.S. Food and Drug Administration has reviewed the Kim Kardashian Social Media Post for DICLEGIS (doxylamine succinate and pyridoxine hydrochloride) delayed-release tablets, for oral use submitted by Duchesnay, Inc. under cover of Form FDA 2253. The social media post was also submitted as a complaint to the OPDP Bad Ad Program. The social media post is false or misleading in that it presents efficacy claims for DICLEGIS, but fails to communicate any risk information associated with its use and it omits material facts,” says the FDA in a letter addressed to Eric Gervais, Executive Vice President of Duchesnay, Inc., dated August 7th.

    Basically, Kardashian’s social media posts failed to illuminate the limitations and potential side effects of the drug.

    The post is still up on Twitter:

    Here’s what it said:

    OMG. Have you heard about this? As you guys know my #morningsickness has been pretty bad. I tried changing things about my lifestyle, like my diet, but nothing helped, so I talked to my doctor. He prescribed me #Diclegis, and I felt a lot better and most importantly, it’s been studied and there was no increased risk to the baby. I’m so excited and happy with my results that I’m partnering with Duchesnay USA to raise awareness about treating morning sickness. If you have morning sickness, be safe and sure to ask your doctor about the pill with the pregnant woman on it and find out more www.diclegis.com; www.DiclegisImportantSafetyInfo.com.

    According to the FDA, directing people to the company’s website in order to “find out more” isn’t enough.

    When looking to celebrity endorsements for guidance on medication, it probably pays to be discerning. This goes double for social media, where brevity is king.

    Image via Toglenn, Wikimedia Commons

  • 3D Printed Drug: FDA Approves Its First, an Epilepsy Medication

    Medical tech is a huge market where 3D printing is attempting to make a splash, and now we have another first for the industry.

    The US Food and Drug Administration has approved its first-ever 3D-printed medication.

    The drug is called Spritam, and it’s used in the treatment of seizures.

    Spritam is a “prescription adjunctive therapy in the treatment of partial
    onset seizures, myoclonic seizures and primary generalized tonic-clonic seizures in
    adults and children with epilepsy,” according to Aprecia Pharmaceuticals.

    The 3D printing tech allows Aprecia to produce a pill that’s easier to administer.

    Spritam utilizes Aprecia’s proprietary ZipDose Technology platform, a groundbreaking advance that uses three-dimensional printing (3DP) to produce a porous formulation that rapidly disintegrates with a sip of liquid.

    “By combining 3DP technology with a highly-prescribed epilepsy treatment, SPRITAM is
    designed to fill a need for patients who struggle with their current medication
    experience,” said Don Wetherhold, Chief Executive Officer of Aprecia. “This is the first in
    a line of central nervous system products Aprecia plans to introduce as part of our
    commitment to transform the way patients experience taking medication.”

    The drug will become available in early 2016. 3D printing has been used to create medical devices and models, but this is the first time a medication has ever received full FDA approval.

  • Trader Joe’s Recall Also Affects Other Stores

    The Trader Joe’s recall that has fresh produce going to waste all over the nation is not actually just affecting Trader Joe’s.

    The alert is also for Costco, Kroger, and Wal-Mart stores, including Sam’s, among others. According to the recall statement,

    “Wawona Packing Company of Cutler, Calif is voluntarily recalling certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 1, 2014 through July 12,2014 due to the potential of the products being contaminated with Listeria monocytogenes.”

    It continued in explanation, “Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Although healthy individuals may suffer only short-term symptoms such as high fever, severe headache, stiffness, nausea, abdominal pain and diarrhea, Listeria infection can cause miscarriages and stillbirths among pregnant women.”

    1,600 illnesses and 260 deaths are caused by Listeria each year in the United States. Outbreaks have been slowing down since 2001, but 2011 saw the largest outbreak in US history from contaminated cantalopes grown at a Colorado Farm. That outbreak caused 127 illnesses and killed nearly three dozen.

    “Fruit sold as individual pieces should have a sticker on it; the recalled product stickers will read ‘Sweet2Eat.” Wawona stated.

    https://www.youtube.com/watch?v=7_CgRlmD5oQ

    No illnesses have been reported yet, and the recall is simply a fast reaction to an alert of possible contamination from an Australian customer. After the alert, equipment was tested and listeria was detected.

    “We are aware of no illnesses related to the consumption of these products,” said Wawona President Brent Smittcamp. “By taking the precautionary step of recalling product, we will minimize even the slightest risk to public health, and that is our priority.”

    Wegmans Food Markets, Inc. has also recalled several of its baked goods that contain fruit from the Wawona Fruit Company.

    For a complete list of what to avoid, read the recall statement here.

    Image via YouTube

  • Fruit Sold at Costco and Trader Joe’s Recalled

    Wawona Packing Company, based in the Central Valley of California, has voluntarily recalled white and yellow peaches, white and yellow nectarines and various plum varieties.

    The whole fruits were packed between June 1 and July 12, and distributed to Trader Joe’s and Costco stores.

    The Food and Drug Administration issued a statement on the matter:

    “FOR IMMEDIATE RELEASE – July 19, 2014 – Wawona Packing Company of Cutler, Calif is voluntarily recalling certain lots of whole peaches (white and yellow), nectarines (white and yellow), plums and pluots packed between June 1, 2014 through July 12,2014 due to the potential of the products being contaminated with Listeria monocytogenes. Wawona Packing has notified retailers of the specific lots being recalled. No other products are impacted by this recall. No illnesses have been linked to this recall to date.”

    Listeria monocytogenes is the bacterium that causes the infection listeriosis, an illness which causes death in 20% to 30% of cases. Listeria is most dangerous to pregnant women, children and the elderly. If an infection progresses to listeric meningitis, mortality rate may reach 70%.

    Here is a small scientific piece on listeria:

    No listeriosis infections have been reported, and Brent Smittcamp, President of Wawona Packing Co., commented, “We are aware of no illnesses related to the consumption of these products. By taking the precautionary step of recalling product, we will minimize even the slightest risk to public health, and that is our priority.”

    Costco, the members-only warehouse club based in Issaquah, Washington, has been having some food issues, as of late. Back in March, the company dumped $2.8 million worth of perfectly good peanut butter into a New Mexico landfill due to a previous salmonella scare. The makers of the peanut butter, Sunland Inc., had asked Costco to at least donate the peanut butter to food banks, but the big box retailer declined.

    Image via Wikimedia Commons

  • Caffeine Powder Blamed for Teen’s Death

    Caffeine Powder Blamed for Teen’s Death

    The sudden death of a high school wrestler due to a massive caffeine overdose prompted federal health authorities to warn consumers to avoid the substance.

    Keystone High School prom king Logan Stiner, 18, had a lethal amount of caffeine in his system when he died May 27 at his home in LaGrange, Ohio, southwest of Cleveland. An autopsy revealed that Stiner had over 70 micrograms of caffeine per milliliter of blood in his body, which equates to roughly 23 times the amount of a typical soda drinker or Starbucks patron.

    Caffeine is a naturally occurring substance found in seeds, leaves and fruit, and acts as a natural pesticide that paralyzes and kills certain insects, and likewise enhances the euphoric recall of pollinating bugs.

    A caffeine overdose at times results in a state of central nervous system over-stimulation called caffeine intoxication. Symptoms include restlessness, twitching, anxiety, excitement, insomnia, a jumbled flow of thought and speech, irritability, heart palpitations and impaired psychomotor skills. Extreme overdoses can lead to psychosis, seizures and death.

    Here rapper Riff Raff demonstrates caffeine-induced elation:

    While a caffeine overdose would typically require 80-100 cups of coffee for an average adult, it is easier to achieve caffeine toxicity while ingesting caffeine in pill and powdered forms.

    The U.S. Food and Drug Administration said Friday that it’s taking a look at caffeine powder products and will ‘‘consider taking regulatory action.’’ It’s also been reported that three states have sued Living Essentials, the manufacturer of the popular 5-Hour Energy shot, for false advertising. It’s been suggested that the only active ingredient in the substance is a high amount of caffeine.

    A 1/16th of a teaspoon of caffeine powder, which is commonly used by athletes and those trying to lose weight, can contain about 200 milligrams of caffeine, roughly the equivalent found in two large cups of coffee. Dr. Robert Glatter, an emergency physician at Lenox Hill Hospital in New York, warns that a large teaspoon can be fatal.

    FDA spokeswoman Jennifer Dooren commented, ‘‘The difference between a safe amount and a lethal dose of caffeine in these powdered products is very small.’’

    Dr. Bob Hoffman, a New York University medical toxicologist, remarked, ‘‘The thing about caffeine is just because you see it every day, just because it’s naturally occurring – it comes from a plant – doesn’t mean that it’s safe.’’

    Image via Youtube

  • Hummus Recalled Due To Listeria Contamination

    Hummus Recalled Due To Listeria Contamination

    Food manufacturer Lansal has made the decision to voluntary recall over seven tons of hummus due to the fear of listeria contamination.

    The recall was announced on Thursday and directly impacts Target and Trader Joe’s stores. According to the U.S. Food and Drug Administration (FDA), nearly 15,000 pounds of hummus and dip products were removed from the stores as a precautionary action.

    The possibility of contamination was discovered during a routine test of Target Archer Farms Traditional Hummus by the Texas Department of Health. Lansal immediately contacted all of their retailers and distributors. So far, no illnesses have been reported.

    Below is a list from the FDA of all of the products that were affected by the recall:

    Item: Target Archer Farms Traditional Hummus 10oz. UPC: 85239233405 Use By Date: JUN/11/2014 Affected Areas: National

    Item: Target Archer Farms Traditional Hummus 2lb. (Non-retail item; Ingredient item used in SuperTarget store production of 2 items, Archer Farms Mediterranean Veggie Hummus Wrap and Archer Farms Hummus Veggie Snacker) UPC: 8968630 01823 Use By Date: JUN/11/2014 Affected Areas: National

    Item: Target Archer Farms Roasted Garlic with Roasted Garlic Tapenade 17 oz. UPC: 85239233498 Use By Date: JUN/9/14 & JUN/12/14 Affected Areas: National

    Item: Target Archer Farms Roasted Red Pepper with Roasted Red Pepper Topping 17 oz. UPC: 85239233481 Use By Date: JUN/12/2014 Affected Area: National

    Item: Giant Eagle Chipotle Hummus 8oz. UPC: 30034065881 Use By Date: MAY/7/2014 & MAY/14/14 Affected Areas: Pennsylvania, West Virginia, Ohio, and Maryland.

    Item: Giant Eagle Garlic Hummus 8oz. UPC: 30034064747 Use By Date: MAY/7/2014 & MAY/14/14 Affected Areas: Pennsylvania, West Virginia, Ohio, and Maryland.

    Item: Trader Joe’s Edamame Hummus 8oz. UPC: 988582 Use By Date: APR/28/14 & APR/29/14 & MAY/9/24 Affected Areas: Arizona, California, Colorado, Florida, Georgia, Idaho, Louisiana, North Carolina, Nevada, New Mexico, Oregon, South Carolina, Tennessee, Texas, Utah, Virginia (Southern), Washington

    Item: Trader Joe’s 5 Layered Dip Small 11.5oz. UPC: 435451 Use By Date: APR/15/2014 Affected Areas: Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio & Wisconsin

    Item: Trader Joe’s 5 Layered Dip Large 24oz. UPC: 274043 Use By Date: APR/15/2014 Affected Areas: Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, Ohio & Wisconsin

    Item: Tryst Yellow Lentil Hummus with Sunflower Seeds & Apricots 10oz UPC: 8968630 01410 Use By Date: USE BY JUN/10/14 E Time stamp & USE BY JUN/12/14 E Time Stamp Affected Areas: Midwest & Pacific Northwest regions of United States

    Customers with questions about the recall have been asked to call 877-550-0694, and have been urged to return the product to the store for a full refund.

    Image via Wikimedia Commons

  • Drinkable Sunscreen Will ‘Vibrate on Your Skin’

    Colorado company Osmosis Skincare has developed a drinkable sunscreen that is said to provide 30 SPF-like protection. The product falls under Osmosis’ “Harmonized Waters” line, and comes in “tan enhancement” and “no tan enhancement” flavors.

    According to Osmosis, Harmonized H20 UV Neutralizer works by “isolating the precise frequencies needed to neutralize UVA and UVB,” and will “vibrate on your skin in such a way as to cancel approximately 97 percent of the UVA and UVB rays.” The site goes onto explain that the revolutionary new Osmosis formula allows the drinker/wearer to “reverse engineer the frequencies of substances found in nature and/or the human body.”

    To apply the UV Neutralizer, a user drinks 2ml of the product (preferably with 2+ oz of water), waits an hour before going out into sunlight, and repeats the process every 4 hours. Osmosis suggests that for extended, intense exercise outdoors, or if taking sun-sensitizing medications, use alternate protection after 30-40 minutes.

    Here is a small documentary concerning snake oil salesmen:

    Dermatologist James Pehoushek of Phoenix’s Allergy and Dermatology Specialists is skeptical of the effectiveness of the product – “It sounds like an easy way to get your sun protection without a lot of mess and trouble,” Pehoushek commented, adding, “But I think you might be getting lead down the Primrose path on this one.”

    While Pehoushek goes on to point out that while staying hydrated is a good thing, it won’t protect one from sunburn. “It’s good not to get dehydrated when you’re out in the heat and the sun, but that in and of itself, being well hydrated is not going protect from (the) sun or sun damage,” he said. “So I would take this with a very big grain of salt.”

    While the Osmosis site provides product testimonials, there is no mention of any formal testing or FDA approval.

    The product was featured on The Late Show with David Letterman:

    Osmosis intrigue via Twitter:

    Pehoushek added, “I would be very wary of this and wear your sunscreen; that would be my advice to patients.”

    Image via YouTube

  • Sleep Apnea Implant Approved by the FDA

    Sleep Apnea Implant Approved by the FDA

    According to the Centers for Disease Control and Prevention, between 50 and 70 million Americans suffer from sleep disorders. While some people struggle with insomnia, others have difficulty resting at night because of sleep apnea.

    Sleep apnea is described as a “potentially serious sleep disorder in which breathing repeatedly stops and starts” by Mayo Clinic. Fortunately for people with this disorder, the Food and Drug Administration (FDA) just approved a sleep apnea implant that could make a regular good night’s sleep a reality.

    Sleep apnea is considered one of the more serious sleep disorders because of the potential complications associated with it, which include a higher risk of stroke and congestive heart failure. While treatments, such as medications and Continuous Positive Airway Pressure (CPAP) masks, have existed for sleep apnea for some time, the Inspire Upper Airway Stimulation implant will be particularly helpful for patients who can’t be treated with CPAP masks.

    Check out the Inspire sleep apnea implant below.

    The implant is the first fully installed implant to ever be approved by the FDA. According to Inspire, the sleep apnea implant works by delivering “mild stimulation to keep a patient’s airway open during sleep.”

    View the graphic below to see what the sleep apnea implant looks after it has been surgically placed in the patient.

    “The FDA approval of Inspire therapy represents a new era of choice for a subset of patients with moderate to severe Obstructive Sleep Apnea who are unable to use CPAP,” said Tim Herbert, Inspire Medical Systems president and CEO. “All of us at Inspire Medical Systems are committed to improving the health and quality of life for these individuals with OSA, and we are excited to make this innovative and much needed treatment available to patients and physicians.”

    As you can see below, the news that the FDA approved the sleep apnea implant has been met with a positive reaction:

    Image via Wikimedia Commons

  • FDA’s E-Cigarette Regulations Manage to Disappoint People on All Sides

    The U.S. Food and Drug Administration currently regulates your traditional forms of tobacco–cigarettes, cigarette tobacco, and smokeless tobacco. Of course, some new players have joined the nicotine party as of late-the most notable being the electronic cigarette, or e-cig (or vape pen), which has been unregulated for years now. We’ve all known it was coming for some time, and Thursday the FDA finally revealed their proposals on how to regulate the multi-billion dollar e-cig industry.

    And what do you know, they have found a way to irk all sides of the e-cig issue. Imagine that.

    First, what did the FDA actually say?

    The administration wants to extend its tobacco authority to put other “tobacco” products, such as e-cigs, under their regulatory umbrella. E-cigs are tobacco-less products, remember, but the FDA would still like to classify them as an alternative tobacco product.

    In doing so, e-cig makers, e-liquid makers, and vape accessory makers would be forced to register their products with the FDA and could only market their products after an FDA review and approval process.

    Herein lies one of the main issues that the vaping community has with FDA regulations–that oftentimes lengthy approval process.

    Some fear it could stifle innovation within the industry, and prevent better products from hitting the market in a timely fashion. You can find some discussion on this over on reddit’s e-cig subreddit.

    That’s where you can find a discussion on the a White House petition that opposes the newly proposed FDA restrictions. It asks for a veto (?) of the proposed (and not yet adopted) FDA guidelines for electronic cigarettes.

    “The FDA has classified E-Cigarettes as ‘Tobacco Products’ and will now severely restrict their use. These regulations are not like those of tobacco, but instead all manufactures will be required to complete a lengthy and expensive application just for putting new products on the market. This includes Mechanical Mods, Variable Voltage, tanks, drippers,etc. Any new ‘Model’ after 2015 will be required to complete this application. The FDA has over stepped their boundaries. E-Cigarettes CAN NOT be classified as a ‘Tobacco Product’ as there is no tobacco in it. They fret about the nicotine, but there is nicotine in many plants including tomatoes. They fret about the flavors, yet allow Smirnoff Vodka to advertise candy and fruit flavors. DoNot, allow the FDA to take control of a life saving prod…”

    If you ignore the grammatical errors, you can see the crux of many anti-regulation advocates’ concern.

    Of course, this only represents a certain selection of e-cig users. Some have welcomed FDA oversight, and have so for a while.

    Another proposal by the FDA attempts to ban the distribution of “free samples,” which could impact so-called “vape lounges.”

    The Consumer Advocates for Smoke-free Alternatives Association (CASAA), which has been an advocate of the electronic cigarette industry, had this to say about the FDA proposal:

    “On its face, it appears that it is not as bad for consumers as it might have been, but there are still serious concerns. The FDA approval process is very complicated, and the details matter. Unlike some commentators, we are not prepared to say much more until we have a chance to examine them and consider them in the context of existing institutions.”

    CASAA said that they would be reviewing the documents and then issuing a “Call to Action” for its members.

    CASAA’s official position on electronic cigarettes is that they support FDA classifying and regulating them as a tobacco product.

    Now, if we take a look at the other side of the aisle, we have those who are miffed that the FDA hasn’t gone far enough–specifically when it comes to advertising. The FDA’s proposals do not take aim at e-cig advertising.

    “It’s very disappointing because they don’t do anything to rein in the wild-west marketing that is targeting kids,” Stanton Glantz, a professor at the Center of Tobacco Control Research and Education at the University of California, San Francisco, told Reuters.

    The FDA’s proposal also fails to mention any restriction on flavorings, which some groups lament as the kid-magnet aspect of the industry. Of course, placing bans on e-liquid flavorings would cripple the industry.

    “Tobacco-related disease and death is one of the most critical public health challenges before the FDA,” said Mitch Zeller, director of the FDA’s Center for Tobacco Products. “The proposed rule would give the FDA additional tools to protect the public health in today’s rapidly evolving tobacco marketplace, including the review of new tobacco products and their health-related claims.”

    “The window is still open for a more draconian approach,” Jason Healy, president blu eCigs, told Reuters. “I think the proposal shows a good science-based reaction here from the FDA, but there is a lot we have to go through during the public comment period.”

    But it’s no really blu, which holds the majority of the e-cig market, that has the most to worry about from regulatory control. It’s the upstarts, the new guys on the block, and even the modding community that have the most to lose.

    There will be a public comment period (75 days), so expect a cacophony over the next few months. These will be highly-debated regulations, and you can be sure that everyone from the vaping community to health advocates, from children’s groups to big tobacco, will chime in with their two cents.

    Image via Wikimedia Commons

  • Powdered Alcohol Coming To Stores In Fall

    Powdered Alcohol Coming To Stores In Fall

    In fall of this year you’re going to be strolling through the booze section of a Safeway and notice a little black package labeled “Palcohol” – powdered alcohol you can mix with water, liquids, and food. Yes, food.

    This week, The Alcohol and Tobacco Tax and Trade Bureau signed off seven flavors of Pacohol: V (vodka), R (rum), Cosmopolitan, Mojito, Powderita (Margarita) and Lemon Drop. Add 5 ounces of water to the mix and you’ll wind up with a standard cocktail – with the same strength of one as well.

    Post by Palcohol.
    According to Palcohol’s website, the product is a solution to the rising cost of liquid alcohol: What’s worse than going to a concert, sporting event, etc. and having to pay $10, $15, $20 for a mixed drink with tax and tip. Are you kidding me?! Aside from mixing Palcohol with liquids, the website also recommended that it can be enjoyed with food: …we have found adding Palcohol to food is so much fun. Sprinkle Palcohol on almost any dish and give it an extra kick. Some of our favorites are the Kamikaze in guacamole, Rum on a BBQ sandwich, Cosmo on a salad and Vodka on eggs in the morning to start your day off right. Experiment. Palcohol is great on so many foods. Remember, you have to add Palcohol AFTER a dish is cooked as the alcohol will burn off if you cook with it…and that defeats the whole purpose. For you vegans out there, the adult Kool-Aid is gluten free, you can pretty much get drunk off salad. The website does warn to apply Palcohol responsibly: As Palcohol is a new product, we have yet to explore its potential of being added to food. As always, please use it responsibly. Because it adds alcohol to the dish, do not serve the dish to minors. The internet has reacted; some people are disgusted with the announcement of the US legalizing powdered alcohol: Some fear: Some imagine worst case scenarios: Besides passing red tape and becoming marketable, powdered alcohol isn’t something fairly new; Dutch students came up with some powdered alcoholic concoction back in 2010: https://www.youtube.com/watch?v=tGRahYQ8EAU Palcohol hits stores this fall and will also be available for purchase online. Image via Facebook

  • Powdered Alcohol Approved, Will Hit Stores Later This Year

    It won’t be long before your next trip to the liquor store involves deciding whether to buy liquid or powdered alcohol. Yes, powdered alcohol. There is such a thing.

    The Alcohol and Tobacco Tax and Trade Bureau approved several flavors of Palcohol this week, which is a powdered version of alcohol that you can add to a mixer or water to start working on that much-needed buzz. Palcohol is expected to be available to purchase sometime in the fall.

    Palcohol was created by Mark Phillips. According to the Palcohol website, it took Phillips years of working with scientists to create his powdered alcohol. There will be vodka and rum Palcohol that you can add to a mixer, plus four flavors that only require water to get the party started: Cosmopolitan, Mojito, Powderita (margarita), and Lemon Drop.

    Post by Palcohol.

    Palcohol will come in small packets that are equivalent to one shot of alcohol each. If you’re wondering why, exactly, there is a need for powdered alcohol, the answer is simple: convenience. From the website:

    Why? Sometimes liquid isn’t convenient. Because Palcohol is powder and very light, you can take it just about anywhere to enjoy a cocktail! That’s why we say: “Take your Pal wherever you go.”

    According to Telegraph, the Palcohol website also promoted using the powder when going out to avoid paying for expensive cocktails (this information was removed after news of Palcohol being approved made headlines):

    What’s worse than going to a concert, sporting event, etc. and having to pay $10, $15, $20 for a mixed drink with tax and tip. Are you kidding me?! Take Palcohol into the venue and enjoy a mixed drink for a fraction of the cost.

    While the Palcohol website suggests mixing the substance with water and mixers and says that it is okay to mix it with food, it does advise against snorting the substance. “Don’t do it!” the website warns. “It is not a responsible or smart way to use the product.” Despite the convenience of Palcohol, it’s easy to see why there is cause for concern regarding the potential dangers of the product. If young people will use alcohol tampons to get drunk faster, there’s no doubt that Palcohol will be used in the wrong way.

    The news that there is such a thing as powdered alcohol and that it will be available in the United States soon was met with skepticism, horror, and sheer delight:

    Take a look at a powdered vodka created in Russia below to get an idea of what to expect when Palcohol is released:

    Image via Wikimedia Commons

  • New Grass Allergy Treatment Approved by the FDA

    The long, terrible winter that gripped the U.S. this year seems to finally be gone. With spring, however, comes a whole new set of challenges for those Americans who suffer from pollen and grass allergies. Luckily for them, the U.S. Food and Drug Administration (FDA) today approved a new treatment for those with grass allergies.

    The treatment, named Oralair, has been approved by the FDA for the treatment of allergic rhinitis, commonly known as hay fever and brought on through grass pollens. The drug is approved for use by patients aged 10 to 65.

    The FDA estimates that around 30 million Americans suffer from hay fever, a small subset of the more than 500 million people around the world that suffer from the allergy.

    The new drug is a once-daily tablet that dissolves under the tongue. It contains freeze-dried extracts from common grasses including Kentucky Blue Grass, Orchard, Perennial Rye, Sweet Vernal, and Timothy. It is manufactured by the European pharmaceutical company Stallergenes.

    “While there is no cure for grass pollen allergies, they can be managed through treatment and avoiding exposure to the pollen,” said Dr. Karen Midthun, director of the Center for Biologics Evaluation and Research at the FDA. “The approval of Oralair provides an alternative to allergy shots that must be given in a health care provider’s office. Oralair can be taken at home after the first administration.”

    Oralair was approved following a safety and effectiveness trial performed in the U.S. and Europe. The trial gave around 2,500 people either Oralair or a placebo. Those that received the real drug were found to have a 16% to 30% reduction in hay fever symptoms.

    As with all allergy medications, Oralair comes with a list of potential side effects. The most dangerous may be the risk the drug has of sparking severe allergic reactions itself. The most common side effect reported in the study, though, was itching of the mouth, ears, and tongue.

    Image via Thinkstock

  • Multiple Sclerosis Drug Delayed by FDA

    Multiple Sclerosis Drug Delayed by FDA

    Biogen Idec Inc. has stated that the U.S. Food and Drug Administration extended the review process its multiple sclerosis drug called Plegridy by three months to evaluate the application, though the FDA didn’t request any further studies. Biogen had planned to launch the new drug sometime in mid-2014, but is now delayed.

    Plegridy is an injectable medication designed to reduce the dosing schedule of standard interferon drugs like Biogen’s own Avonex, which are typically taken at least once a week. Interferon has intense side effects, leading to flu-like symptoms for a couple of days after each dose, causing some patients to be weary to continue treatment.

    According to Biogen, Plegrity (peginterferon beta-1a) is a pegylated compound derived from interferon beta-1a and is being investigated as a potential treatment dosed once every two weeks or every four weeks via subcutaneous injection for relapsing-remitting multiple sclerosis (RRMS), the most common form of multiple sclerosis (MS).

    Multiple sclerosis (MS), also known as disseminated sclerosis or encephalomyelitis disseminata, is an inflammatory disorder in which the insulating covers of nerve cells in the brain and spinal cord become damaged. Communication between parts of the nervous system are affected, which leads to problems with motor skills and cognitive functions. MS can occur in acute attacks, or build up in a progressive form. Symptoms may completely disappear during acute episodes, though permanent neurological damage typically occurs as the disease progresses.

    MS was first described by Jean-Martin Charcot in 1868, and has no known cure. Existing drugs aren’t very effective, and the aforementioned side effects can be severe. While the cause is not completely clear, it has been theorized that a compromised immune system mistakenly begins to attack and destroy the protective sheath that envelopes nerve cells in the brain, optic nerve and spinal cord.

    It is thought that genetics and environmental factors that had lead to infections cause the onset of the disease.

    Image via Wikimedia Commons.

  • FDA Approves Cefaly Migraine Treatment Marketing

    The U.S Food and Drug Administration (FDA) today approved the marketing of Cefaly, a device marketed to provide drug-free preventative treatment for migraine headaches.

    Cefaly is a transcutaneous electrical nerve stimulation (TENS) device that provides electrical stimulation to a user’s head. As a sort of battery-powered portable headband the device produces an electrical current meant to stimulate the trigeminal nerve, which the FDA states has been linked to migraines. The agency suggests that consumers use the device for only 20 minutes once per day.

    The FDA approved Cefaly marketing following a premarket review that found the device to be low- to moderate-risk and non-equivalent to an existing legal medical device. The agency also determined the device’s effectiveness through a small clinical trial that found Cefaly to be associated with a reduced number of migraines per month for patients who experience them on a frequent basis. Contrary to how the device is marketed in other countries, however, Cefaly was not found to reduce the intensity of migraines and does not totally prevent migraines.

    “Cefaly provides an alternative to medication for migraine prevention,” said Christy Foreman, director of Device Evaluation at the Center for Devices and Radiological Health at the FDA. “This may help patients who cannot tolerate current migraine medications for preventing migraines or treating attacks.”

    This announcement comes just months after the FDA approved another portable device for the treatment of migraines. That device, the Cerena Transcrania Magnetic Stimulator, uses magnetic pulses to the back of a users head to sometimes relieve migraine pain.

    Image via Cefaly

  • New Painkiller Zohydro At Heart Of Major Controversy

    There is no doubt that the proper dosage and usage of medication can go a long way towards helping individuals who suffer from conditions such as depression and anxiety. Even dangerously psychotic conditions that could lead persons to harm themselves or others can be greatly improved with the right medication.

    When a person is suffering from physical pain that is simply too much for over-the-counter medicine, prescription strength solutions are also available.

    However, a problem arises when medication prescribed for various conditions has the potential to be abused or to cause more harm than good to the patient. The abuse of prescribed drugs along side entirely illegal drugs is a serious problem for the United States today.

    A new prescription painkiller is feared to not only potentially contribute to this ongoing problem, some medical professionals think it has the potential to be the most disastrous prescription drug approved to date. That is the fundamental argument in a letter to Margret Hamburg, commissioner at the head of the U.S. Food and Drug Administration.

    The letter was written by a group of doctors who came together to voice their concerns about the drug Zohydro ER. Their argument against the drug’s approval is said to “echo” that of members of Congress and State Attorneys General.

    Zohydro is an opiate that packs 5 to 10 times the power of Vicodin. It is also, according to various legal and medical experts, far too dangerous a substance for the FDA to have gifted its seal of approval.

    There is already concern about the number of opiates being subscribed to patients in the United States. The letter touched on the startling fact that while Americans account for 5% of the global population, the country is consuming the vast majority of the world’s opiate-based prescription drugs— anywhere from 84 to 99% in some cases.

    But Zohydro is a new beast all together. If a person has never taken opioids in their life and they accidentally overdose on Zohydro, it would only take TWO pills to kill them. If a small child accidentally swallowed a Zohydro pill, the single dose would be fatal.

    When a drug is that potent and that lethal, it is seriously questionable that the FDA would allow it to be sold legally to American citizens.

    Image via Wikimedia Commons