Can Ibuprofen and Codeine Cause Serious Harm?
The Pharmacovigilance Risk Assessment Committee (Prac) of EMA has recommended an update of the package insert of drugs containing the combination ibuprofen and codeine. Here because
New information on the package insert of drugs containing the combination ibuprofen and codeine.
If taken for prolonged periods and at higher doses than those recommended they can "cause severe kidney and gastrointestinal damage". This was stated by the Pharmacovigilance Risk Assessment Committee (Prac) of the European Medicines Agency (EMA), which recommended a modification of the leaflet.
WHAT IS IBUPROPHEN
Ibuprofen belongs to the family of non-steroidal anti-inflammatory drugs, the so-called NSAIDs, or those drugs particularly indicated for pain caused by an inflammatory process, but which also have pain-relieving and antipyretic properties.
WHAT IS THE CODEIN
Like ibuprofen, codeine is also an analgesic, but if used alone it has a limited action from this point of view, so it becomes instead "an effective painkiller" – specifies the Higher Institute of Health (ISS) – if associated with paracetamol in a single drug. Drugs containing this combination are subject to medical prescription.
In Italy and in the rest of Europe, codeine-based products cannot be prescribed to children under the age of 12.
WARNINGS
As already indicated by the ISS, both analgesics should not be taken for an extended period without medical supervision. In fact, ibuprofen could "irritate the stomach, causing ulcers and bleeding in the most serious cases, and favor the onset of heart or kidney problems".
Codeine, on the other hand, as belonging to the pharmacotherapeutic group of opioids – even if for mild-moderate and not moderate-severe pain such as morphine, oxycodone and fentanyl – "can induce dependence and addiction".
WHAT THE PRAC RECOMMENDS
The Prac, according to the last meeting which was held from 26 to 29 September, recommended a modification of the information of medicines containing the combination codeine and ibuprofen as repeated use can lead to addiction and abuse.
BECAUSE THEY CAN CAUSE SERIOUS DAMAGE
These drugs, when taken in higher than recommended doses or for a prolonged period of time, can "cause damage to the kidneys, preventing them from properly removing acids from the blood in the urine (renal tubular acidosis)".
“The malfunction of the kidneys – explains the note – can also cause very low levels of potassium in the blood (hypokalaemia), which in turn can cause symptoms such as muscle weakness and lightheadedness. Therefore, renal tubular acidosis and hypokalaemia will be added to the product information as new side effects ”.
BUT IN ITALY CAN IT BE OBTAINED WITHOUT RECIPE?
In Italy, among the drugs that contain codeine and ibuprofen we find Brufecod , but it is available only on medical prescription to be renewed from time to time.
Furthermore, the indications suggested by the Prac are already present on the package leaflet. Regarding renal complications, in patients with mild renal impairment it is recommended to use it at the lowest possible dose, while it is completely not recommended in patients with severe renal insufficiency.
AND IN THE EU?
In other states of the European Union, however, there are drugs of this type that can be purchased without a prescription.
The Committee, in fact, ruled after examining several cases of renal, gastrointestinal and metabolic toxicity reported by countries where these medicines are available without a prescription, which is therefore recommended as the "most effective risk minimization measure to mitigate damage. associated with the abuse and addiction of these products ".
This is a machine translation from Italian language of a post published on Start Magazine at the URL https://www.startmag.it/sanita/perche-ibuprofene-e-codeina-possono-provocare-gravi-danni/ on Mon, 03 Oct 2022 09:01:36 +0000.