- Acetaminophen – one of the most common drug ingredients in the US found in over the counter painkillers like Tylenol, Midol, and Excedrin – might get a cancer warning in California.
- California has the most cancer labels of any US state because of Proposition 65, a law that requires anything with even a loose link to cancer to be labelled by the state.
- A panel of scientists will decide in spring 2020 whether or not the substance will be considered a carcinogen by the state.
- No existing studies have firmly linked the chemical to cancer.
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Acetaminophen – a common ingredient used in over-the-counter painkillers like Tylenol, Excedrin, and Midol – might be given a cancer warning label in California, adding to the state’s growing list of 900 chemicals considered carcinogens.
Also known as paracetamol, acetaminophen has been available without a prescription since the 1950s. It is usually used to treat migraines, muscle aches, and to reduce fevers.
State officials have agreed to review the drug’s safety after a handful of studies found it may increase risks of certain types of cancer. There are also concerns that acetaminophen is similar to phenacetin, a painkiller that served the same purpose before it was banned in 1983 because it causes cancer.
But regulators in California, and across the US, are divided: a report analysing 133 peer-reviewed studies found mixed results. Few of the studies could parse the risks of acetaminophen from the danger of other factors, like alcohol and cigarettes.
The US Food and Drug Administration told California state officials that labelling the substance as a carcinogen without a direct link is illegal under federal law because it is “false and misleading.”
However, the review will go ahead, sanctioned by a panel of state-appointed scientists back in 2011, who, concerned about studies linking acetaminophen to cancer, voted that it was a “high priority” to explore cancer warning labels.
Kim Montagnino, director of global issues management for Johnson & Johnson, wrote a statement in response to California’s proposal stating: “We stand behind the efficacy and safety profile of acetaminophen and firmly believe that the evidence does not warrant a listing under Proposition 65.”
California has tried to put cancer warning labels on coffee and headphones in the past
Proposition 65 is a strict California law, passed in 1986, and also known as the Safe Drinking Water and Toxic Enforcement Act.
It requires the state to label all chemicals “known to the State of California to cause cancer or reproductive toxicity,” to compile them in a list accessible to the public, and put cancer warning labels on those items.
Crucially, there does not need to be proof that the product or drug causes cancer, just that there is a link.
Since the law was passed over three decades ago, more than 900 chemicals have been added to the growing list, which is updated at least once a year according to the American Cancer Society.
But not all proposed carcinogens have made it onto the list.
State officials came under fire in 2018 after proposing coffee should get a state cancer-warning label because it contained high levels of acrylamide, a chemical linked to cancer.
The FDA put a stop to the proposal. Soon after the state announced its plan, FDA Commissioner Scott Gottlieb made a public statement that labelling coffee as a carcinogen could “mislead consumers to believe that drinking coffee could be dangerous to their health when it actually could provide health benefits.”
The state also made headlines when officials tried to add headphones to the list of chemicals, another attempt that was promptly shut down.
Families who bought Infants’ Tylenol just won a $US6.3 million class-action lawsuit against Johnson & Johnson
While the jury is still out on whether or not Tylenol can cause cancer, manufacturer Johnson & Johnson has found itself in hot water in the past for misleading customers about its ingredients.
The company has agreed to pay $US6.3 million to families who bought Infants’ Tylenol between October 2014 and January 2020.
Families filed a class-action suit against the firm for suggesting that Infants’ Tylenol contained a reduced amount of acetaminophen, specially designed for infants. But Children’s Tylenol, a cheaper product, was found to contain the same amount of acetaminophen as Infants’ Tylenol.
People who qualify can claim back up to $US15.05, the equivalent worth of seven bottles.
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