Paracetamol and ibuprofen: how long after the expiry date are these drugs still effective ?

Des médicaments “périmés” qui seraient encore efficaces (illustration).

UFC-Que Choisir reveals that the overwhelming majority of medications based on paracetamol or ibuprofen remain effective well after the expiration date displayed on the boxes. A shocking revelation at a time when shortages and supply tensions have been increasing in recent years.

On the one hand, supply tensions in paracetamol and non-steroidal anti-inflammatory drugs (such as ibuprofen); on the other, apparently unjustified expiry dates. UFC-Que Choisir has poked its nose into this problematic situation. Following a test on the relevance of expiry dates affixed to medicine boxes by pharmaceutical laboratories, the consumer association denounces environmental, economic and health mismanagement. In fact, most of these drugs have been shown to be effective up to 30 years after their expiration date.

8 out of 10 expired drugs contain enough active substance

UFC-Que Choisir had a specialized laboratory analyze the quantity of active substances in 30 boxes of paracetamol and ibuprofen tablets, capsules or sachets considered expired by the manufacturers. The result is clear: in 80% of cases, the medicines still contain enough active substance to be considered effective, according to the association. In addition, the results show that there is no correlation between the year of expiry and the quantity of active substance remaining. For example, a paracetamol that was supposed to have expired since 1992 still contained 100% of the active substance.

Arbitrary standards ?

The test was based on the standard of the American Food and Drug Administration (FDA), which considers that a medicine is still effective if it contains at least 90% of the active substance indicated on the box. On the other hand, the ANSM requires a minimum of 95%. But even by applying this stricter criterion, the majority of the medicines tested retained their effectiveness. The consumer association therefore questions the relevance of the ANSM standards for determining whether a medicine retains its therapeutic properties. This same health authority that regularly issues warning bulletins on supply tensions for these first-line painkillers, as well as many other essential medicines.

In 2021, the Fondation pour la Recherche Médicale had already nuanced this debate with the intervention of Dr. Marina Carrère d'Encausse, patron of the foundation: “This expiry date, set three to five years after the manufacture of the drug, is determined by the manufacturer himself, who generally exercises great caution. In reality, there is very little deterioration in the active ingredient content of tablets, even five years after their manufacture."

The French-Speaking Pneumology Society, which based its findings on several scientific studies, also recently explained that "many solid forms stored under reasonable conditions and in their original intact packaging retain 90% or more of their potency for at least 5 years after the expiry date on the packaging".

A waste that poses a problem… and fuels doubt

Throwing away medicines that are still effective, on the pretext that they have expired, has significant economic, environmental and health consequences. This results in additional costs for the health system and patients, generates unnecessary waste (40% of French people say they do not systematically drop off their expired or unused medicines at the pharmacist) and contributes to medicine shortages.

UFC-Que Choisir is thus questioning the current practices of laboratories, which set the expiry date of their own medicines (often 3 years for those tested). The association emphasizes that there is no obligation forcing laboratories to extend this date, even if they know that the medicines remain effective beyond that date. This raises questions about the priority given to economics over scientific criteria, when we have been told for years that “expired medicines have no place in a family medicine cabinet”.

In June 2023, the drug agency even ran a campaign entitled “A mummy is preserved forever. Medicines are not. Poorly stored or expired medicines can lose their effectiveness or become contaminated by bacteria. Those that are unused, expired or whose appearance has changed must be returned to the pharmacy.” The Ministry of Health warned about expired medications: “the effectiveness is no longer guaranteed and some molecules can even become dangerous“.

Following its analyses, UFC-Que Choisir is urging ANSM to take measures to avoid what it considers to be a waste of medications. But be careful! We are still here in the context of medications composed of paracetamol and ibuprofen. Indeed, for example, the alteration over time of a drug can lead to the formation of toxic compounds, as is the case with a family of antibiotics, tetracyclines. We should therefore not generalize.

Read the interview by Destination santé with Professor Milou-Daniel Drici, director of the Nice-Alpes-Côte d'Azur regional pharmacovigilance center.