Paracetamol, aspirin and ibuprofen prescription-free painkillers in the future only with warning

New prescription: In the future, prescription-free painkillers will only be available with warnings

Over-the-counter painkillers such as ibuprofen, aspirin or acetaminophen are often taken much longer than is medically recommended. Especially the long-term use of such drugs can be associated with serious side effects. In the future, warnings should alert people to stop using the drugs longer than necessary.

Analgesics-warning-Regulation

Many people assume that medicines like aspirin, ibuprofen or paracetamol are safe because they are over the counter. But some over-the-counter painkillers can be associated with extremely dangerous side effects, including increasing the risk of cardiac arrest. The policy has now responded: over-the-counter painkillers will be accompanied by warnings in the future: a few days ago, the Federal Council approved the analgesic warning directive.

Over-the-counter painkillers such as aspirin and ibuprofen are not harmless, but can be associated with serious side effects. Now it was decided that such drugs must be provided with warnings in the future. (Image: denisismagilov / fotolia.com)

Application time often too long

As reported on the Federal Council's website, the regulation covers over-the-counter painkillers used to treat mild to moderate pain or fever, such as those containing paracetamol, ibuprofen, diclofenac or aspirin.

The mandatory warning is said to discourage consumers from taking the medication beyond the recommended maximum duration.

The note must be "on the outer wrapping or, if only one container is present, on the container", it says in a recent printed matter of the Federal Council.

This must read: "In pain or fever without medical advice do not use longer than specified in the leaflet!"

Product information is often not properly considered

According to the Federal Association of German Pharmacist Associations e. V. (ABDA), about 100 million packages of OTC analgesics (non-prescription painkillers) in the form of finished medicinal products were sold in pharmacies in Germany in 2015.

According to studies, one-fifth of women and almost one-third of men take such analgesics for longer than the given four days.

Although the respective package leaflets and technical information detail the possible side effects - especially in case of prolonged use or overdose - it is known from various studies that "consumers do not always sufficiently comply with the warnings and contraindications listed in the product information" it in the printed matter.

"To limit the risk of using OTC analgesics, this analgesic warning label regulation is therefore issued."

The ordinance must still be promulgated in the Federal Law Gazette. It should come into effect on the first day of the following month.

Most severe side effects

Over-the-counter painkillers are often used relatively unconsciously against a variety of forms of pain. However, the ingestion with significant side effects - including the heart - go along.

For example, a study by the McGill University Health Center in Montreal, Canada, found that some of these drugs significantly increase the risk of heart attack.

And Italian researchers reported that some painkillers can cause heart failure. Danish scientists also found that drugs such as ibuprofen and diclofenac significantly increase the risk of cardiac arrest.

In addition, such medications can cause gastrointestinal bleeding and kidney damage, as well as cause strokes. (Ad)