{"id":109,"date":"2013-09-01T16:07:09","date_gmt":"2013-09-01T23:07:09","guid":{"rendered":"http:\/\/toxichow.com\/?p=109"},"modified":"2013-09-01T16:10:46","modified_gmt":"2013-09-01T23:10:46","slug":"bottles-of-tylenol-acetaminophen-warning","status":"publish","type":"post","link":"https:\/\/toxichow.com\/?p=109","title":{"rendered":"Warning: Tylenol’s acetaminophen"},"content":{"rendered":"

\"tylenol\"<\/a>
\nWASHINGTON\u2014 Bottles of Tylenol sold in the U.S. will soon bear red warnings\u00a0 alerting users to the potentially fatal risks of taking too much of the popular\u00a0 pain reliever.<\/p>\n

The unusual step, disclosed by the company that makes Tylenol, comes amid a\u00a0 growing number of lawsuits and pressure from the federal government that could\u00a0 have widespread ramifications for a medicine taken by millions of people every\u00a0 day.<\/p>\n

Johnson & Johnson says the warning will appear on the cap of new bottles\u00a0 of Extra Strength Tylenol sold in the U.S. starting in October and on most other\u00a0 Tylenol bottles in coming months. The warning will make it explicitly clear that\u00a0 the over-the-counter drug contains acetaminophen, a pain-relieving ingredient\u00a0 that is the nation\u2019s leading cause of sudden liver failure.<\/p>\n

\u201cWe\u2019re always looking for ways to better communicate information to patients\u00a0 and consumers,\u201d says Dr. Edwin Kuffner, vice president of McNeil Consumer\u00a0 Healthcare, the Johnson & Johnson unit that makes Tylenol.<\/p>\n

Overdoses from acetaminophen send 55,000 to 80,000 people in the U.S. to the\u00a0 emergency room each year and kill at least 500, according to the Centers for\u00a0 Disease Control and Prevention and the Food and Drug Administration.\u00a0 Acetaminophen can be found in more than 600 over-the-counter and prescription\u00a0 products used by nearly one in four American adults every week, including\u00a0 household brands like Nyquil cold formula, Excedrin pain tablets and Sudafed\u00a0 sinus pills.<\/p>\n

Tylenol is the first of these products to include such a warning label on the\u00a0 bottle cap. McNeil says the warning is a result of research into the misuse of\u00a0 Tylenol by consumers. The new cap message will read: \u201cCONTAINS ACETAMINOPHEN\u201d\u00a0 and \u201cALWAYS READ THE LABEL.\u201d<\/p>\n

The move comes at a critical time for the company, which faces more than 85\u00a0 personal injury lawsuits in federal court that blame Tylenol for liver injuries\u00a0 and deaths. At the same time, the Food and Drug Administration is drafting\u00a0 long-awaited safety proposals that could curtail the use of Tylenol and other\u00a0 acetaminophen products.<\/p>\n

Much is at stake for McNeil and its parent company. Johnson & Johnson\u00a0 does not report sales of Tylenol, but total sales of all over-the-counter\u00a0 medicines containing acetaminophen were more than $1.75 billion last year,\u00a0 according to Information Resources Inc., a retail data service.<\/p>\n

Safety experts are most concerned about \u201cextra-strength\u201d versions of Tylenol\u00a0 and other pain relievers with acetaminophen found in drugstores. A typical\u00a0 two-pill dose of Extra Strength Tylenol contains 1,000 milligrams of\u00a0 acetaminophen, compared with 650 milligrams for regular strength. Extra Strength\u00a0 Tylenol is so popular that some pharmacies don\u2019t even stock regular\u00a0 strength.<\/p>\n

Most experts agree that acetaminophen is safe when used as directed, which\u00a0 generally means taking 4,000 milligrams, or eight pills of Extra Strength\u00a0 Tylenol or less, a day.<\/p>\n

(MORE:\u00a0<\/strong>Acetaminophen Linked to Fatal Skin Reactions<\/a>)<\/p>\n

Each year, some 100 million Americans use acetaminophen, but liver damage\u00a0 occurs in only a fraction of 1 percent of users. Still, liver specialists say\u00a0 those cases are preventable. Part of the problem, they say, is that there are\u00a0 sometimes hundreds of pills in a bottle, making it easy for consumers to pop as\u00a0 many as they please. For example, McNeil sells Extra Strength Tylenol in bottles\u00a0 containing up to 325 tablets<\/p>\n

\u201cThe argument goes that if you take acetaminophen correctly you will\u00a0 virtually never get into trouble,\u201d says Dr. William Lee of the UT Southwestern\u00a0 Medical Center, who has studied acetaminophen toxicity for four decades. \u201cBut\u00a0 it\u2019s the very fact that it\u2019s easily accessible over-the-counter in bottles of\u00a0 300 pills or more that puts people in harm\u2019s way.\u201d<\/p>\n

Lee applauded the new warning, but said McNeil\u2019s marketing has contributed to\u00a0 the \u201cfreewheeling\u201d way that Americans take the drug. For decades, McNeil has\u00a0 advertised Tylenol as \u201cthe safest kind of pain reliever\u201d when used as directed.\u00a0 \u201cThat has been their standard ploy in the past, and I would argue that safest it\u00a0 is not,\u201d he says.<\/p>\n

McNeil\u2019s Kuffner stands by the company\u2019s safety claim: \u201cWhen taken as\u00a0 directed, when people read and follow the label, I believe that Tylenol and the\u00a0 acetaminophen ingredient is one of the safest pain relievers on the market.\u201d<\/p>\n

McNeil is the only major drugmaker adopting the bottle cap warning at this\u00a0 time, according to the Consumer Healthcare Products Association, a trade group\u00a0 for over-the-counter medicine companies.<\/p>\n

\u201cWhile this is not an industrywide initiative at this time, it fits squarely\u00a0 within the many ongoing industrywide educational initiatives to further\u00a0 acetaminophen safe and responsible use by consumers,\u201d said Emily Skor, a vice\u00a0 president with the trade group, which represents McNeil, Bayer Healthcare,\u00a0 Procter & Gamble and other nonprescription drugmakers.<\/p>\n

(MORE:<\/strong>\u00a0How Our Web Searches Could Expose Drug Side Effects<\/a>)<\/p>\n

20 YEARS OF WARNINGS<\/p>\n

McNeil has updated the safety warnings on Tylenol periodically since the\u00a0 1990s.<\/p>\n

In 1994, the company added a warning about the risk of liver damage when\u00a0 combining alcohol with Tylenol following a lawsuit brought by Antonio Benedi, a\u00a0 former aide to President George H.W. Bush, who fell into a coma and underwent\u00a0 emergency liver transplant after mixing Tylenol with wine at dinner.<\/p>\n

A jury awarded him $8.8 million in damages after concluding that McNeil\u00a0 failed to warn consumers about the risk. The FDA made the alcohol warning\u00a0 mandatory for all manufacturers of acetaminophen in 1998.<\/p>\n

Then, in 2002, an expert panel of FDA advisers recommended that the\u00a0 government agency require all acetaminophen products to carry a warning about\u00a0 the risk of \u201csevere liver damage\u201d when not taken as directed. The group\u2019s votes\u00a0 are non-binding, though the FDA usually follows them. McNeil voluntarily added\u00a0 the warning to its products in 2004, five years before the FDA made it\u00a0 mandatory.<\/p>\n

Today, McNeil appears to be moving ahead of regulators again. In 2009, the\u00a0 FDA assembled another expert panel to consider more sweeping changes to reduce\u00a0 acetaminophen overdoses. The panel recommended a half-dozen major changes,\u00a0 including lowering the maximum nonprescription daily dose for adults. McNeil\u00a0 voluntarily adopted that recommendation, lowering the recommended adult dose of\u00a0 Extra Strength Tylenol to 3,000 milligrams per day, or six pills of Extra\u00a0 Strength Tylenol, down from 4,000 milligrams per day, or eight pills. The label\u00a0 stipulates that patients can still take a higher dose under doctor\u2019s\u00a0 directions.<\/p>\n

But the company has not embraced a more drastic recommendation by the FDA\u2019s\u00a0 expert panel: eliminating the over-the-counter \u201cextra-strength\u201d formulation\u00a0 altogether, which would mean lowering the acetaminophen dose from 1,000\u00a0 milligrams to 650 milligrams, or two tablets of 325 milligrams each. The panel\u00a0 said the 1,000 milligram dose should only be available via prescription.<\/p>\n

McNeil argues that the lower dose is less effective and could drive people to\u00a0 take anti-inflammatory pain relievers, a different class of drugs that includes\u00a0 aspirin and ibuprofen. Those medicines can cause stomach ulcers and dangerous\u00a0 gastrointestinal bleeding.<\/p>\n

FDA spokeswoman Erica Jefferson says the agency is actively working on new\u00a0 rules for both children and adult acetaminophen products. While the agency won\u2019t\u00a0 give a timeframe for completion, the federal government\u2019s website that tracks\u00a0 new regulations lists December as the target date for publishing the proposed\u00a0 rules.<\/p>\n

As early as 1977, FDA advisers recommended adding more warnings to the\u00a0 acetaminophen label about liver damage, but the agency didn\u2019t require the\u00a0 language until 2009.<\/p>\n

\u201cThey are very slow to respond to these things and it\u2019s always a little\u00a0 frustrating,\u201d says Dr. Lewis Nelson of New York University, who chaired the 2009\u00a0 FDA panel.<\/p>\n

ANATOMY OF AN OVERDOSE<\/p>\n

Experts first identified acetaminophen overdose as a major public health\u00a0 concern in the 1990s, but it has taken years to form a clearer picture of the\u00a0 problem.<\/p>\n

Acetaminophen overdoses occur when the liver is overwhelmed by too much of\u00a0 the drug, producing a toxic byproduct that kills liver cells. Liver failure\u00a0 occurs when most cells are no longer able to function. At that point, a patient\u00a0 then generally has 24 to 48 hours to live without a transplant.<\/p>\n

Of the roughly 500 acetaminophen deaths reported annually, about half are\u00a0 accidental, with the rest deemed suicides. About 60 percent of the unintentional\u00a0 overdoses involve prescription opioid-acetaminophen combination drugs such as\u00a0 Percocet and Vicodin, according to a database of liver failure cases run by Dr.\u00a0 Lee at the Southwestern Medical Center in Dallas. Those two products alone were\u00a0 prescribed more than 173 million times last year, according to IMS Health.<\/p>\n

(MORE:<\/strong>\u00a0FDA Cuts Acetaminophen Dose in Opioid Painkillers<\/a>)<\/p>\n

So how do these accidental acetaminophen deaths occur? Imagine you\u2019ve had\u00a0 major dental surgery, and your dentist prescribes a five-day supply of Percocet.\u00a0 You take the recommended two pills every six hours for 2,600 milligrams of\u00a0 acetaminophen, well below the 4,000-milligram-a-day safety threshold.<\/p>\n

But you\u2019re still experiencing pain, so you decide to add Extra Strength\u00a0 Tylenol, six caplets a day for another 3,000 milligrams. Now you\u2019re feeling\u00a0 better but you still have trouble sleeping, so you take Nyquil, for another 650\u00a0 milligrams. After a few days on this 6,250 milligram regimen, experts say acute\u00a0 liver damage is a real risk.<\/p>\n

The labels on all of these products warn against mixing them. But researchers\u00a0 say many consumers either don\u2019t read or don\u2019t understand such warnings.<\/p>\n

Even after taking into account people who ignore labels, there are still\u00a0 cases of liver damage that stump researchers. These are the people who have\u00a0 apparently taken about 4,000 milligrams a day or less, well within the safety\u00a0 threshold.<\/p>\n

\u201cIt\u2019s still a little bit of a puzzle,\u201d says Dr. Anne Larson, of the Swedish\u00a0 Medical Center in Seattle. \u201cIs it genetic predisposition? Are they claiming they\u00a0 took the right amount, but they really took more? It\u2019s difficult to know.\u201d<\/p>\n

The question is critical in the lawsuits piling up against McNeil in the\u00a0 Eastern District of Pennsylvania, near McNeil\u2019s headquarters in Fort Washington,\u00a0 Pa. Virtually all of the 85 cases claim that the plaintiffs suffered liver\u00a0 failure despite taking Tylenol as directed.<\/p>\n

According to one of those complaints, Madeline Speal, of Salzburg, Pa., took\u00a0 Tylenol for three days in November 2009 \u201cat appropriate times and in appropriate\u00a0 doses.\u201d But on Nov. 28, she was admitted to Latrobe Area Hospital with\u00a0 catastrophic liver damage. She was then transferred to the University of\u00a0 Pittsburgh Medical Center where she underwent an emergency liver transplant.<\/p>\n

The cases against McNeil, which share the same legal wording, allege that the\u00a0 company risked the lives of consumers by making \u201cconscious decisions not to\u00a0 redesign, re-label, warn or inform the unsuspecting consuming public.\u201d<\/p>\n

The lawsuits have been consolidated under a single federal judge to\u00a0 streamline the pretrial process, though they will eventually be returned to\u00a0 judges in their original districts for trial.<\/p>\n

J&J and McNeil continue to reiterate that Tylenol is safe. \u201cWe remain\u00a0 confident in the safety and efficacy of Tylenol products, which rightfully have\u00a0 been trusted by doctors, hospitals and consumers for more than 50 years,\u201d McNeil\u00a0 said in a statement.<\/p>\n

But lawyers for the patients suing McNeil say Tylenol can still be dangerous\u00a0 even when used at or just above recommended levels.<\/p>\n

\u201cProducts that are available to consumers should have a reasonable margin of\u00a0 safety,\u201d said Laurence Berman, one of several attorneys representing Tylenol\u00a0 users.<\/p>\n

Reported by By Matthew Perrone<\/p>\n

Read more: http:\/\/healthland.time.com\/2013\/08\/30\/tylenol-bottles-will-have-new-cap-and-warning-to-prevent-overdoses\/#ixzz2dgXajp7b<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"

WASHINGTON\u2014 Bottles of Tylenol sold in the U.S. will soon bear red warnings\u00a0 alerting users to the potentially fatal risks…<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[9],"tags":[],"class_list":["post-109","post","type-post","status-publish","format-standard","hentry","category-overdose-warning","wpcat-9-id"],"_links":{"self":[{"href":"https:\/\/toxichow.com\/index.php?rest_route=\/wp\/v2\/posts\/109","targetHints":{"allow":["GET"]}}],"collection":[{"href":"https:\/\/toxichow.com\/index.php?rest_route=\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/toxichow.com\/index.php?rest_route=\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/toxichow.com\/index.php?rest_route=\/wp\/v2\/users\/1"}],"replies":[{"embeddable":true,"href":"https:\/\/toxichow.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcomments&post=109"}],"version-history":[{"count":4,"href":"https:\/\/toxichow.com\/index.php?rest_route=\/wp\/v2\/posts\/109\/revisions"}],"predecessor-version":[{"id":115,"href":"https:\/\/toxichow.com\/index.php?rest_route=\/wp\/v2\/posts\/109\/revisions\/115"}],"wp:attachment":[{"href":"https:\/\/toxichow.com\/index.php?rest_route=%2Fwp%2Fv2%2Fmedia&parent=109"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/toxichow.com\/index.php?rest_route=%2Fwp%2Fv2%2Fcategories&post=109"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/toxichow.com\/index.php?rest_route=%2Fwp%2Fv2%2Ftags&post=109"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}