Patients treated with the drug Palexia (tapentadol) are no longer allowed to take the drug.
All lots have been recalled.
The manufacturer Grünenthal has recalled all batches of the drug Palexia *.
The prescription pain reliever, tapentadol, may contain microbial contaminants.
Patients should contact their doctor or pharmacist, as abrupt discontinuation can cause withdrawal symptoms.
Berlin - The pain reliever Palexia with the active ingredient tapentadol must no longer be taken.
According to information from the Drugs Commission of German Pharmacists (AMK), the pharmaceutical company Grünenthal has recalled all batches with 4 and 20 mg / ml oral solution.
The reason for this is possible microbial contamination.
Grünenthal announces: “In the course of routine stability tests”, a possible microbial contamination of some batches with Burkholderia contaminans was found.
The origin of this possible microbial contamination cannot currently be conclusively identified.
Therefore, “as a precautionary measure, all marketable batches of Palexia 4 mg / ml and 20 mg / ml oral solution on the market were recalled” - even if they do not necessarily have to be affected.
Palexia (Tapentadol) Recall - These lots are affected:
Palexia 20 mg / ml
oral solution to
100 ml
(delivered from 04.01.2018, including and from the expiry date February 2022)
Palexia 20 mg / ml
oral solution of
200 ml
(delivered from 08.02.2018, including and from the expiry date February 2022)
Palexia 4 mg / ml
oral solution to
100 ml
(pure hospital product, batch 00938P with expiry date April 2024, delivered from October 16, 2019)
Severe
acute or chronic pain is
treated with Tapentadol
.
Affected patients are not allowed to continue using their medicine.
According to Grünenthal, the possibly contained contamination has the potential to develop resistance.
In particular in patients with immunodeficiency, this can lead to severe infections and even sepsis.
This serious complication of an infectious disease can lead to a life-threatening condition.
Since the active ingredient tapentadol is an opioid, the dose is slowly increased at the beginning of the treatment - it is actually discontinued by slowly tapering off.
This is also why Grünenthal warns, in consultation with the Cologne district government, against an abrupt withdrawal.
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Patients Treated with Tapentadol (Palexia): Now You Can Do It
There are currently no Palexia lots available that are not affected by the recall.
A further treatment with the tapentadol active ingredient under the name Palexia is therefore not possible.
The manufacturer Grünenthal advises: "We absolutely ask you to ensure further treatment with alternative therapy options." It should be noted that withdrawal symptoms can occur after abrupt discontinuation of treatment with tapentadol.
Pharmacies are requested to inform patients.
Regardless of this, those affected should contact their doctor or pharmacist.
There are always drug recalls.
In 2020, for example, packaging was incorrectly printed and package inserts were incorrect.
You can read in a summary * why recalls are so common - especially in the food sector.
(nap) * merkur.de is part of the nationwide Ippen-Digital editors network.