New regulation: Prescription-free pain relievers will only be available in the future with a warning
Over-the-counter pain relievers such as ibuprofen, aspirin or acetaminophen are often taken much longer than is medically recommended. Long-term use of such medications in particular can have serious side effects. In the future, warnings should draw attention to the fact that the medicines should not be used for longer than necessary.
Analgesic Warning Ordinance
Many people assume that medications such as aspirin, ibuprofen or paracetamol are harmless because they are over the counter. But some over-the-counter pain relievers can be associated with extremely dangerous side effects and, among other things, increase the risk of cardiac arrest. Politicians have now reacted: Over-the-counter pain relievers will be accompanied by warnings in the future: The Federal Council approved the Analgesica Warning Ordinance a few days ago.
Application time often too long
As reported on the website of the Federal Council, the regulation covers over-the-counter pain relievers that are used to treat mild to moderate pain or fever and that contain, for example, the active ingredients paracetamol, ibuprofen, diclofenac or acetylsalicylic acid (aspirin).
According to the information, the mandatory warning is intended to prevent consumers from taking the medication beyond the recommended maximum duration.
The notice must be "on the outer wrapper or, if there is only one container, on the container", according to a current Federal Council document.
This must read: "In the event of pain or fever, without medical advice, do not use longer than specified in the package insert!"
Product information is often ignored
According to the Federal Association of German Pharmacists' Associations. V. (ABDA), around 100 million packs of OTC analgesics (non-prescription pain relievers) in the form of finished medicinal products were dispensed in pharmacies in Germany in 2015.
According to studies, a fifth of women and almost a third of men take such analgesics longer than the specified four days.
Although the relevant package inserts and specialist information contain extensive information about the possible side effects - especially with long-term use or in the event of an overdose - it is known from various studies that "consumers do not always pay sufficient attention to the warnings and contraindications listed in product information" it in the printed matter.
"To limit the risk when using OTC analgesics, this analgesic warning regulation is therefore issued."
The regulation still has to be announced in the Federal Law Gazette. It is to take effect on the first day of the following month.
Severe side effects
Over-the-counter pain relievers are often used thoughtlessly against a wide variety of forms of pain. However, the intake can be accompanied by considerable side effects - including for the heart.
A study by the McGill University Health Center in Montreal (Canada) showed that some of these drugs significantly increase the risk of heart attack.
And Italian researchers reported that some pain relievers can cause heart failure. Scientists from Denmark also found that drugs such as ibuprofen and diclofenac significantly increase the risk of cardiac arrest.
Furthermore, such drugs can lead to gastrointestinal bleeding and kidney damage, and can also cause strokes. (ad)