Acetaminophen, a drug renowned for its safety, has been the source of more than 1,500 deaths in the United States in the last 10 years. The popular pain reliever is an active ingredient in brand-name drugs such as Tylenol and it is used by tens of millions of individuals on a weekly basis. However, given the rising death toll connected to use of acetaminophen, arguments for the drug’s safety are now at an all-time high.
There’s no denying the fact that when taken at the recommended dosage level, acetaminophen is safe for use. Unfortunately, statistics such as the one above have proven that it’s far too easy to misuse the drug. Studies identifying the risks of using acetaminophen have been at the forefront of the U.S. Food and Drug Administration’s (FDA) agenda, yet the medication has remained a popular seller in drugstores across the country.
Despite the attention that has been drawn to the uncomfortably small margin between the amount of acetaminophen that is effective for pain relief and the amount that can cause serious harm, federal regulators have continually delayed – and sometimes even failed – to adopt any measure designed to potentially reduce the number of injuries and deaths from overdose. Records reveal that the FDA has repeatedly deferred decisions of this nature, dating as far back as 1977 when an expert panel advised for an urgent obligation to warn consumers of the drug’s propensity to cause severe liver damage among users. It took 32 years and countless debates before the FDA heeded this advice and added the warning label.
The evidence for the serious side effects caused by taking too much acetaminophen is so compelling that other nations throughout the world have already taken active measures to limit the amount of the drug that can be purchased by consumers. Countries such as Great Britain, New Zealand, and Switzerland have all imposed their own limits on how much acetaminophen can be purchased at one time, or even how much of the drug can be sold in any given pharmacy. Why hasn’t the U.S. done the same?
McNeil Consumer Healthcare – a branch of Johnson & Johnson – which built Tylenol into the billion-dollar brand leader that it is today has acknowledged the risks of acetaminophen, but has done little more. Currently, the company’s efforts to protect consumers involve contributing to funds for the development of an antidote to acetaminophen poisoning. However, this effort does not take away from the fact that the company fought against adding a warning label to the product for more than 30 years; nor does it make up for the failed attempt at a safer version of acetaminophen, the details of which the company staunchly refused to disclose even to the FDA. The McNeil company was even documented as openly opposing a government campaign for public education about acetaminophen’s risks – fearing that any advertisement of this nature could hurt the drug’s overall sales.
Over the years, McNeil has expressed the seriousness with which it attends to claims of acetaminophen risks, stating that the company has “taken significant steps…to mitigate the risk.” For a drug that has evolved over the years, McNeil feels that it has sufficiently implemented safety measures to correspond with changes to the drug. Very soon, the company will begin adding red lettering to each Tylenol medicine bottle cap which will warn consumers that the product contains acetaminophen and advise users to read the label. But is this really enough?
According to FDA officials, the higher-ups at McNeil believed that the benefits of keeping acetaminophen available to consumers outweighed the “relatively rare” risk of liver damage or death. While the FDA has taken an active, recent role in addressing the issues concerning acetaminophen use, it has also admitted to the sluggish action taken regarding the matter. As noted by the FDA, the agency has much more authority over prescription drugs than non-prescription medications. It has taken action to apply a “black box warning” on all prescriptions containing acetaminophen. However, similar action has not been made for over-the-counter drugs containing acetaminophen.
As many as 78,000 Americans are sent to the emergency room each year from acetaminophen overdose, and 33,000 hospitalizations occur for the same reason. The long and controversial history behind acetaminophen use, and Tylenol in particular, is likely to continue. Authorities can’t seem to reach an agreement on the safety and health concerns related to the drug. Despite the many unanswered questions that are still out there concerning the matter, the drug is still readily available to individuals looking for it. We urge you to use the medication with caution and to contact us immediately if you or someone you love were seriously injured or otherwise harmed from use of the drug.