Washington, DCWe've been taking them for years, for everything from toothaches to menstrual cramps. Some pop them like candy whenever they get a headache. So it will surprise many that over-the-counter (OTC) stalwarts such as Advil, Tylenol and Motrin will soon carry bold warnings mandated by the US Food and Drug Administration (FDA) for stomach bleeding and liver damage.
The warnings will reveal concerns which, according to the FDA have been known for years—so long in fact that these risks actually spurred the development of COX-2 inhibitors such as Bextra and Vioxx, two drugs that have since been pulled from the market over safety concerns (Celebrex remains).
The new rules for the OTC pain relievers were first proposed in 2006 and are finally coming through the pipeline three years later.
The risks for adverse reactions related to OTC pain relievers consumers may be taking every day appear substantial.
Pain relievers that contain acetaminophen—Tylenol among them—will soon carry bold warnings regarding the risk for severe liver damage when taken in high dosages.
Additionally, consumers buying well-known products such as Bayer Aspirin, Advil and Motrin will be soon be warned about the risks for stomach bleeding.
The latter three products are non-steroidal anti-inflammatory drugs, also known as NSAIDS. The new labeling will also apply to any generic versions of either NSAID, or acetaminophen products that don't carry the marquee names such as Bayer AG, Motrin, Advil, or Tylenol.
It was hinted yesterday that some manufacturers have already adopted the stricter warnings on their product packaging. The remainder will have a year to comply.
According to the FDA, there are certain situations that serve to highlight and intensify the risk. They include the possibility of severe liver damage for anyone who takes too much Tylenol, which is made by Johnson & Johnson. There is also increased risk of liver damage for consumers of Tylenol (and generic acetaminophen) who regularly consume three, or more alcoholic drinks each day. Consumers who take warfarin, a widely-used blood thinner, will be strongly urged to consult their doctor before taking acetaminophen products.
"We believe the new labeling requirements will add information concerning severe adverse effects of over-the-counter pain relievers and fever reducers that many consumers may not be aware of," said Matthew Holman, the FDA's deputy director for the Division of Nonprescription Regulation Development.
That could be an understatement, given the familiarity most consumers have with OTC medications. Most hold the view that only prescription drugs are the ones they really need to worry about—otherwise they wouldn't need the prescription. If it's available over-the-counter, then the product must be either safe, or carry mild adverse reactions that would be of little concern.
Yesterday's announcement dispels that myth.
The question now, will be the length of time before consumers become conditioned to the new concerns. Drug manufacturers routinely advertise new drugs in order to gain market share, but will often leave drugs that have attained the status of 'household name' well enough alone. Consumers have been popping Motrin, Aspirin, Tylenol and Advil for years for everything from muscle aches to headaches. A manufacturer may step up the advertising of a product if they suddenly lose market share—and bolder warnings would be included in the advertising.
However, it is not known if the manufacturers involved are required to advertise the changes to product labeling. The FDA is planning a public meeting in late June to discuss further ways and means to curb the risk of liver damage from products containing acetaminophen.
It should be noted that other products, such as cold medications, also contain NSAIDS and acetaminophen.
And while the manufacturers have until next April to comply with the new rules with regard to product labeling, it does not address the supply of medications consumers already have in their medicine cabinets that do not feature the updated warning labels. Many consumers do not heed best-before dates, using the same bottle of medication for years.
While most consumers will diligently read the product label on a new drug of which they are unfamiliar, an old favorite would not be met with the same scrutiny.
Beyond the mandate to beef up product labels, there was no mention as to how the public would be alerted to the new concerns over old favorites.
In truth, according to a Reuter's report, the concerns are not new at all. Consumers have been using OTC acetaminophen and NSAIDS-containing products for years, without any knowledge of the risks they were taking.
Until now. It will be interesting to see just what decisions are made towards alerting consumers about the new labeling beyond the presence of the labeling itself.
Critics will also be watching the courts; to see if prior cases of stomach bleeding and severe liver damage will suddenly be met with litigation given the new information about an old friend that possessed a darker personality nobody knew…