Many kinds of Tylenol, the popular over-the-counter pain reliever and fever reducer, have been recalled in the past few years due to a moldy, musty smell and other quality concerns. That’s led to Tylenol shortages in some areas as cold and flu season approaches.
But consumers have some options that could be good for their health and pocketbook. They can talk with pharmacists about which over-the-counter remedies are safe and appropriate for them in light of new concern about liver damage from accidental overdoses of acetaminophen, the active ingredient in Tylenol.
Consumers accustomed to buying Tylenol also can choose a generic alternative that’s less expensive. Many drugstore chains offer their own store brands of acetaminophen, and they’re typically at least a dollar cheaper than Tylenol for the same quantity of identical-dosage drugs.
“Generics may use a different type of salt or sugar to compose it, but it has the same active ingredient, which is acetaminophen,” said Kristen Binaso, senior director of corporate alliances for the American Pharmacists Association and a pharmacist in Northern New Jersey.
Consumers should look for an asterisk or highlighted portion of the package that compares the generic drug to a known brand, she said. And they shouldn’t be shy about asking a pharmacist if they get stumped when trying to figure out which drug or combination of drugs is right for them.
“It’s a great opportunity to talk to their pharmacist about what their actual symptoms [are] and maybe we can find a better match for what they’re trying to treat.”
Tylenol products have been reappearing in parts of New Jersey, Binaso said. But people seeking Tylenol brands would be wise to tap an online resource from its manufacturer before heading out the door.
It manufacturer, McNeil Consumer Healthcare, a unit of Johnson & Johnson /quotes/zigman/230812/quotes/nls/jnj JNJ -1.08% , offers a product locator at this website that allows people to type in their zip code and find the nearest stores that have a variety of Tylenol products in stock.
The company updates the information weekly, said McNeil spokeswoman Bonnie Jacobs. Still, the website lists the stores’ phone numbers and advises consumers to call to make sure their desired product is indeed on the shelves. The locator doesn’t include Walmart stores.
Earlier this year, three McNeil-operated manufacturing facilities in Pennsylvania and Puerto Rico came under tighter scrutiny from the U.S. Food and Drug Administration. The FDA now requires independent reviews before certain products can be released, causing shipping delays.
McNeil-PPC Tylenol’s manufacturer has issued numerous recalls of product lots, including Children’s Tylenol, since 2009. The recalls extended to their other medicines available without prescription such as Benadryl, Sudafed and Motrin, causing some shortages of those drugs as well. The company maintains that health risks associated with taking recalled products are remote. Consumers can call McNeil’s recall help line at 888-222-6036 for more information.
Meanwhile, it’s a good time for consumers to check their pain-relief habits and assumptions. Acetaminophen can be found in more than 600 over-the-counter and prescription medications, according to McNeil-PPC. It’s in many combined cough and cold remedies in addition to stand-alone products, and consumers have to guard against harming themselves by unintentionally doubling doses when they take multiple medicines at the same time.
There were an estimated annual 21,000 emergency-room visits for unintentional acetaminophen overdoses between 2000 and 2007, according to federal data. About half of acetaminophen overdoses are accidental.
Taking more acetaminophen than advised can set people up for severe liver damage that might result in death or the need for a liver transplant in extreme cases, said Dr. Michael Carome, deputy director of Public Citizen’s Health Research Group in Washington.
“Limiting the dose, in terms of total amount in a particular dose and the total amount per day, and avoiding alcohol, are critical things to do when taking this medicine,” he said.
In January, the FDA lowered the per-dose limit of acetaminophen in prescription pain killers that contain it such as Vicodin and Percocet to no more than 325 milligrams per tablet. It didn’t change the standards for over-the-counter acetaminophen products.
But McNeil recently announced it would lower the maximum daily dose of its Extra Strength Tylenol to six pills a day, or 3,000 milligrams, down from eight pills a day, or 4,000 milligrams, in its dosing instructions. It’s also putting more space between doses, recommending two pills every six hours instead of every four to six hours.
Carome called the lower maximums a step forward but said they don’t go far enough to prevent accidental overdoses from popular products such as Extra Strength Tylenol.
“We believe the FDA should require that the over-the-counter 500 milligram tablets of acetaminophen be removed from the market.”
“For most people, regular-strength acetaminophen, whether you take it for pain or fever, should be more than sufficient,” Carome said.
