Recent Event Highlights: News Update: Cumberland Pharmaceuticals Shares Down 8.3%, Transdel Pharma Worth A Look - Daily Markets, PediaCare Recall Linked to Children's Tylenol Recall - InjuryBoard.com (blog), Woman Requires Organ Transplant After Too Many Pain Relievers - KMGH Denver, Keller Rohrback L.L.P. Announces Investigation of Lung and Liver Problems ... - MarketWatch (press release), Tylenol recalls referred to FDA crime division - CNNMoney, and 61 more...
Created by dipity on Jun 30, 2009
Last updated: 11/19/10 at 12:01 PM
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Ortho-McNeil-Janssen is notifying healthcare professionals about strengthened warnings for Ultram (tramadol hydrochloride) and Ultracet (tramadol hydrochloride/acetaminophen). These drugs contain tramadol, which is a synthetic opioid analgesic used to manage chronic pain. The new warnings emphasize that certain patients have a higher risk of suicide if they are treated with tramadol. Because of this, tramadol should not be prescribed for patients who are suicidal or addiction-prone. In addition, tramadol should be prescribed with caution for patients who are taking tranquilizers or antidepressants, who use alcohol excessively, or who suffer from emotional disturbances. The labeling changes also emphasize the additive effects and risk of overdose if tramadol is used with alcohol or other CNS depressants, including sedatives, tranquilizers, muscle relaxants, and tricyclic anti-depressants. The revised warnings also highlight the possibility that the drug could be diverted, misused and abused. FDA Patient Safety News: September 2010 For more information, please see our website: www.accessdata.fda.gov
Cumberland Pharmaceuticals (NASDAQ:CPIX) shares are trading 8.31% lower at $5.52 on news that the FDA has extended its deadline on issuing a decision on the company's liver failure drug into December. Acetadote, the liver failure drug, is already on the market to treat liver failure due to acetaminophen overdosing, which is also known as the brand name Tylenol. The company is looking to have the drug approved for acute liver failure that is not caused by an overdose of acetaminophen. AJ Kazimi, Chief Executive Officer of Cumberland Pharmaceuticals commented, "We look forward to continued discussion with the FDA regarding this potentially life-saving treatment for patients who have few alternatives."
Transdel Pharma Worth A LookDaily MarketsOur understanding of the ICH-E9 guidelines are that Transdel's exclusion of the 35 “non-qualifiers” will be accepted by the US FDA, and the modified ITT and ...and more »
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InjuryBoard.com (blog)PediaCare Recall Linked to Children's Tylenol RecallInjuryBoard.com (blog)... FDA inspectors found it was filthy, had a hole in the ceiling and inconsistent formulations including some that were “super potent” with acetaminophen. ...and more »
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Woman Requires Organ Transplant After Too Many Pain RelieversKMGH DenverAs of April 2010, the FDA started requiring manufacturers to update warning labels about the risk of severe liver damage from too much acetaminophen, ...and more »
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Keller Rohrback L.L.P. Announces Investigation of Lung and Liver Problems ...MarketWatch (press release)The FDA further observed super potent batches that contained more of the active ingredient (acetaminophen) than represented, because there was no product ...and more »
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New York TimesTylenol recalls referred to FDA crime divisionCNNMoney... concentrations of the active ingredient acetaminophen. However, Sharfstein also referenced an "extraordinary" meeting in February 2010, in which the FDA ...Washington Week: Senate Recess, FDA Legal Threats Top the NewsMedPage TodayFDA Refers Tylenol Issue to Crime DivisionMedPage Todayall 8 news articles »
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Babble Magazine (blog)FDA Inspection Report Cited 20 Violations for J&JWall Street Journal (blog)Using the wrong container of acetaminophen when making infants' Tylenol. Failing to appropriately respond when consumers complained about particles or ...Tylenol Cases Enter FDA Crime DivisionSeven Sided CubeQuestions for Makers on Defects in DrugsNew York TimesFDA docs: J&J knew of problems with Motrin in 2008The Associated PressMyFoxOrlando.com -San Bernardino Sun -Washington Postall 1,257 news articles »
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Examiner.comOrlistat in Xenical, Alli can cause sever liver injuryExaminer.comBecause of potential damage, alcohol, acetaminophen, and other liver toxic drug use should be avoided or watched carefully. Liver dysfunction can present ...and more »
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Michigan Business Review - MLive.comFDA slams Perrigo for metal-tainted tabletsFiercePharmaThis isn't the first time Perrigo's manufacturing has run afoul of FDA rules. Four years ago, the company recalled acetaminophen pills that contained pieces ...Painful Pain 'Relief': Metal Shavings Found in IbuprofenCare2.com (blog)Perrigo Plant Released Drugs Contaminated With MetalBusinessWeekall 30 news articles »
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BNETSome Recalled Infants' Tylenol Had Too Much AcetaminophenPharmaceutical Technology Magazine (blog)According to a committee press statement: “FDA and McNeil Consumer Healthcare have given conflicting accounts of the circumstances surrounding the recall, ...Robert Lincoln McNeil Jr., chemist and arts patron, dies at 94Philadelphia InquirerJ&J chief won't testify at House Tylenol hearingReutersJ&J chief's back surgery delays House testimonyFiercePharmaDailyFinance -Newsinferno.com -BNETall 19 news articles »
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TopNews Arab EmiratesSome Infant Tylenol Recalled by J&J Had Too Much of Active IngredientWall Street Journal (blog)Liver damage from acetaminophen would require higher doses, for longer. Still, it's concerning to parents who are already worried about the black specks and ...J&J Details Medicine-Recall TroublesWall Street JournalJohnson And Johnson Tylenol For Children Had Too Much Active IngredientPortfolio.com (blog)all 107 news articles »
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budurl.com - buyprovigil.modafinilonline.info If you hate being awake and wanting to do things during the day, DO NOT TAKE PROVIGIL! She hit the nail right on the head, 'cause that's my problem with Provigil, it makes me want to do things during the day. It's so aggravating, now I want to go to work (every day), I want to play with the kids, I want to do housework... all those things I used to happily sleep through, ahhh, the good ol days. Maybe I could get my doctor to prescribe me some heroin so I can go back to the way it was...
New Diclofenac Formulation Offers Novel Route to Fast Relief From Migraine ...PR Newswire (press release)Warn patients to avoid acetaminophen-containing products while taking CAMBIA. The liver metabolizes almost 100% of diclofenac and there is insufficient ...and more »
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CareFusion Hits Acquisition Trail, Cadence Pharmaceuticals Enlists ...XconomyThe FDA recently told Cadence it could not approve its intravenous acetaminophen because of manufacturing problems. The drug is being produced by a ...
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Qutenza(R) (capsaicin) 8% Patch for Treatment of Post-Shingles Pain Now AvailablePR Newswire (press release)The Company's early-stage product pipeline includes pre-clinical compounds which are prodrugs of acetaminophen and various opioids. ...Three Stocks with Something to Celebrate: WRES, TUES, NGSXSmall Cap Networkall 32 news articles »
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When a pill can lead to poisoningExplore Howard CountyThe group has also set up a Facebook page, "Safe Acetaminophen Use." "We'll put tidbits out and as information from the FDA becomes available, we'll send it ...
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Acetadote(R) Supplemental New Drug Application for Acute Liver Failure ...NEWS.GNOM.ES (press release)... the US Food and Drug Administration (FDA) for the use of Acetadote® (acetylcysteine) Injection in patients with non-acetaminophen acute liver failure. ...and more »
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Naproxen, acetaminophen dull migraine painReutersAcetaminophen is not currently approved by the FDA as a migraine treatment except as part of an aspirin or aspirin and caffeine compound. ...Naproxen, acetaminophen dull migraine painWHTCall 8 news articles »
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Pharma: Other News To NoteBehavioral Health Central (blog)... Tenn., submitted a supplemental new drug application to the FDA for the use of Acetadote (acetylcysteine) injection in patients with non-acetaminophen ...and more »
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Avandia and the Heart: A Reminder That Drugs Can HarmHuffington Post (blog)... albeit with a warning from the FDA. An example is acetaminophen, the active ingredient in some over-the-counter painkillers (such as Tylenol) and many ...
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Cumberland applies for expanded use of liver drugBusinessWeekCumberland's Acetadote is already approved to counteract overdoses of acetaminophen, widely used in pain relievers, and can be used for pediatric patients. ...Cumberland Pharma submits supplemental FDA applicationNashville Post (subscription)Acetadote(R) Supplemental New Drug Application for Acute Liver Failure ...PR Newswire (press release)Liver failure drug extension bidPharmacy Europeall 35 news articles »
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Cadence Pharmaceuticals reports 4Q lossBusinessWeekA response has been submitted to the FDA by the manufacturer, and Cadence plans to resubmit the drug for approval once the problems are resolved, ...Cadence Pharmaceuticals Reports Fourth Quarter and Full Year 2009 Financial ...CNNMoney.com (press release)Cadence Loss Wider Than Expected - Analyst BlogBenzingaall 22 news articles »
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What if you were injured and developed severe pain that wouldn't go away? Would your government let you take the kind of pain medication you need? If federal officials follow the recommendation of a Food and Drug Administration panel, many of the most effective prescription painkillers—including Vicodin, Percocet, and countless generics—would be banned. Scott Gardner says that kind of a move would be "intensely cruel." "I took Vicodin for three years," says Gardner. "I needed it. It got me through a very tough period of my life." The tough period began after a cycling accident shattered the left side of his body. After eight surgeries and countless hours of physical therapy, Gardner's once active life is now filled with limitations. He suffers from chronic pain that prevents him from sleeping more than a few hours at a time, and yet his pain today is nothing compared to the agonizing days and months following his accident. "When there's nothing but pain, there's no reason to live," says Gardner. "There were times where the only way I could stay sane and civil was because I could take painkillers." The fear of addiction and abuse already makes many suspicious of pain medication. Media reports about celebrities like Rush Limbaugh or Matthew Perry suggest that it's common for people to become addicted to medications they once took for legitimate medical conditions. And countless public service announcements remind us of the dangers of prescription drug abuse. Now the old ...
Expert commentary by Dr. Virender Sodhi regarding the use of nsaid's For details visit us at www.ayurvedicscience.com
Expert commentary by Dr. Virender Sodhi regarding the use of NSAID's For details visit us at www.ayurvedicscience.com
If your child has a cold, what over-the-counter medications you use largely depend their age What you should know: •The child's age is important •You should always read drug label directions •Aspirin shouldn't be given to anyone under 20 for fever Related Videos: •Childs Allergies, www.youtube.com •Nebulizer for Childs or Toddlers Asthma, www.youtube.com •Spacer for Childs Asthma, www.youtube.com Related Health Articles: •Children and Medication Safety Anyone can make mistakes taking medication, but kids are especially vulnerable. According to the American Academy of Pediatrics, half of all kids don't take their medicines properly... Read More: bit.ly •Colds and Kids Why does my child get so many colds?... Read More: bit.lyRelated Products: The following are products sold by CVS/pharmacy that may be of interest to you: EarCheck Middle Ear Monitor $49.99 Buy Now: bit.ly Transcript Hi, I'm Greg Collins and I'm a CVS pharmacist. If your child has a cold, what over-the-counter medications you use largely depend on your child's age. Doctors have gone back and forth about the health benefits of over-the-counter cough and cold medications for children under six. Because of that, the FDA has a list of recommendations you should always follow: never give children medications labeled for adults; check the "active ingredients" section of the Drug Facts label of the medicines and follow the directions closely; and always use the measuring device that comes with the medicine or one ...
OTC medication be have serious consequences if are not used properly. Medilyzer iphone application allows consumers to check drug interaction to avoid adverse side effect by proving valuable drug fact and drug interaction data to their finger tips.
OTC medication be have serious consequences if are not used properly. Medilyzer iphone application allows consumers to check drug interaction to avoid adverse side effect by proving valuable drug fact and drug interaction data to their finger tips.
(August 21, 2009 - Insidermedicine) From Hong Kong - According to research presented to the American Chemical Society, frying fatty foods can make cholesterol even worse for the arteries. In a study of hamsters, researchers found that an otherwise identical diet produced 12% to 22% higher blood lipid levels if cholesterol was oxidized, as it is in fried foods. Oxidized cholesterol also produced more atherosclerotic plaque, and worsened arterial function. From Milwaukee - According to research in the Annals of Emergency Medicine, ibuprofen may be better than acetaminophen and codeine for children with broken arms. In a study of over 330 children, researchers found that ibuprofen reduced pain just as effectively as the combination of acetaminophen and codeine, but was associated with fewer adverse events. And finally, from Washington - The FDA has opened its new center for regulating tobacco products. Representatives of the Center for Tobacco Products have stated that their mission is to develop "effective public health strategies to reduce the burden of illness and death caused by tobacco products". The center will have the authority to regulate tobacco, but not to ban it. For Insidermedicine in 60, I'm Dr. Susan Sharma.
a Know What to do about the Flu Webcast Federal officials answer questions about the ongoing H1N1 outbreak and preparations around the upcoming flu season. More H1N! (Swine) flu and seasonal flu info at www.flu.gov We allow comments according to our comment policy newmedia.hhs.gov
This is a video about acetaminophen, how to take it, what to watch out for, general safety issues, and what it does. By Paul Tran pharmd Candidate 2012 Youth Health Alliance 501 (c) 3 www.yhalive.org
attn 6 mp3 available: amiestreet.com ATTN shirts now available: www.districtlines.com disclaimer: DON'T TAKE PILLS WITH GIN! (OR ELSE YOU WILL WAKE UP DEAD!!) the beat is a lightly remixed version of 100th Sight by Kapluckus (a Gregory Residence band consisting of Constance Waddell, Michael Gregory, Jamie Forrest, Stuart Harrison and Jacob Crigler)--find the original song here: itunes.apple.com Lyrics: NG: Hey-ohhhh! Congress! Climate change bill! Let's get our debate on--1,2,3 MB: It is time to stand up and say We get to choose We get to choose It's one of the two liberty or tyranny EG: can we please choose something in between? mediocrity? MG: chastity? HW: puppetry? OB: obesity? JE: marijuanity? pretty please?! MB: The underlying bill represents the tyranny of the government It's our choice, what will we choose today? Will we choose liberty, or will we choose tyranny? MG: it all depends--who gets to be the tyrant? SG: I thought this bill was about the climate NP: Just remember these 4 words For what this legislation means Jobs, jobs, jobs, and jobs Let's vote for jobs CC: and jobs NP: and jobs CC: don't forget about jobs Speaker: Those in favor say "aye". CC: AAAAYYE! Speaker: Those opposed, "no". JB: Hell no! Hell no! Hell noooooooo!! The fight that we have between the 2 sides of the aisle boils down to one word: JB: freedom CC: freedom! JB: freedom CC: freedom! JB: freedom that will allow the American people to live their lives hell no! Nano Man: hell no! JB: hell no ...
Soon, the pain meds you may have depended on to relieve terrible pain, and to function, may become totally illegal and banned. If you take Vicodin, Darvon, Percocet, Darvocet, Tylenol, this action proposed by an FDA panel may turn your life into a pain filled living hell.
There is a national obsession and witch hunt against prescription pain relievers. I have been talking about this developing for about a year, but recently, certain events show that unfortunately, I am right. The fda's panel voted to do a BAN, ie completely eliminate, Vicodin, Darvon, and Percocet. And, on the over the counter side, to decrease Acetaminophen dosages from 500 to 325 milligrams. Well, as I write this, today, on July 9, 2009, the State Troopers of Texas, the DPS , were stopping ALL traffic on Interstate 20 between Tyler and Longview, and searching all vehicles for drugs, especially prescription meds. I cannot see why they could assert they had "probable cause" to search all vehicles on an Interstate, but this shows the mania which is going on. Texas has an Intractable Pain Act that advises physicians that they should not be reluctant to prescribe opiates / opiods if they are indicated to manage pain, and yet, if physicians DO begin prescribing Vicodin much, they are apt to get an intimidation visit from a "Compliance Officer" (I think they get ex-sheriffs or ex-constables to do this job from the ones I've seen). So, on the one hand, there is wording to make you THINK that doctors should not be intimidated, but in the real world, the Texas Medical Board is quick to act in such a way as to intimidate certain doctors if they think they are prescribing Vicodin too much. IF you take away Vicodin, Darvon, Darvocet, Percocet, and even decrease over the counter pain ...
From Seattle - According to research in the journal Hepatology, diet may influence the risk of liver disease. In a study of over 9200 patients, researchers found that greater consumption of cholesterol was associated with a higher risk of cirrhosis and liver cancer. A diet high in protein was also associated with increased liver risk, while a diet high in carbohydrates was associated with decreased risk. From Providence - According to research in the Journal of Alzheimer's Disease, chemical exposure may be linked to rising death rates from disease. Increased exposure to nitrosamines in the food supply and environment have been found to parallel rising death rates from diabetes, Alzheimer's and Parkinson's. Nitrosamines can cause DNA damage, cell death and cancer, and have been linked to insulin resistance. And finally, from Baltimore - According to research in the journal Liver Transplantation, acetaminophen tops the list of drugs implicated in liver damage requiring transplantation. In a study of over 500 adults, researchers found that acetaminophen was the drug implicated in 40% of cases. The FDA has recommended that the maximum single adult dose be reduced from 1000 mg to 650 mg. For Insidermedicine in 60, I'm Dr. Susan Sharma.
Some very real insight from someone who can speak on experience! Here's the article that sparked the video: www.msnbc.msn.com The subject matter of this video, while it may be boring to some, is extremely important, especially those among you who can identify from life experience. Follow bayarealen on Twitter: www.twitter.com Subscribe to the spontaneous live show at blogtv: www.blogtv.com Music by Bill Childress: www.youtube.com Additional music courtesy of: www.Incompetech.com
An over-the-counter painkiller widely used around the globe is not as safe as many people think. An expert panel told the US Food and Drug Administration that acetaminophen is responsible for acute liver damage if taken in too high a dose. voa's Carol Pearson reports.
An administration panel of the FDA voted 20 to 17 to ban sales of Vicodin (Hydrocodone Hydrochloride). This comes as they are trying to implement changes to reduce the dosage of over the counter Acetaminophen. They are blaming the major of liver damage to "overuse" of acetaminophen, but, interestingly enough, the point at which it allegedly can damage the liver, is also the strength at which it can help (allegedly) with osteoarthritic pain. For many, Vicodin is the only prescription analgesic which helps them with their pain and banning it would be like blowing the head off a patient to fix a headache. It is a crazy, knee jerk reaction to a phantom problem. Sign the petition at : www.ipetitions.com
Highly-regarded pain management and addiction management specialist Dr. George Graf comments on the recent FDA ruling in regards to acetaminophen. Dr. Graf offers a unique perspective with his treatment of drug-addicted patients. As key member of the multidisciplinary approach at DISC Sports and Spine Center, Dr. Graf works closely with the spine and orthopedic surgeons as it relates to addressing the needs of patients who are chemically dependent and/or are in need of pain management therapies both pre and post operative.
FDA Considers Restrictions On Acetaminophen KTVI
The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
The primary topic area for discussion is how to address the public health problem of liver injury related to the use of acetaminophen in both over-the-counter (OTC) and prescription (RX) products. FDA recognizes that acetaminophen is an important drug used to treat pain and fever in both settings and is not seeking to remove it from the market. The risk of developing liver injury to the individual patient who uses the drug according to directions is very low. However, acetaminophen containing products are used extensively making the absolute number of liver injury cases a public health concern.
Prof. Sheila Weiss from the University of Maryland School of Pharmacy was interviewed concerning the FDA ruling n Acetominophen.
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