It’s amazing that Paramex has side effects from aplastic anemia, apparently BPOM knows

Jakarta, CNBC Indonesia – PT Konimex opens its voice regarding changes to side effects on the packaging of its headache medicine, Paramex. In these changes, there is a side effect of the risk of aplastic anemia.

Chief Executive Officer of PT Konimex Rachmadi Joesoef emphasized that the addition of information on the side effects of the risk of aplastic anemia in the packaging is the result of drug registration and is in accordance with the provisions of the Food and Drug Supervisory Agency (BPOM).

“The addition of information regarding the side effects of the risk of aplastic anemia is the result of the drug registration process and is in accordance with the provisions accompanying the Marketing Permit Number from BPOM DTL 7813003810A1,” wrote Rachmadi in a written statement received by CNBC Indonesia, quoted Saturday (19/4/2024).

In the same statement, PT Konimex emphasized that it had included information on usage rules and dosage in accordance with BPOM regulations on the Paramex packaging.

PT Konimex said that during monitoring of drug side effects since the product was marketed, no complaints regarding these side effects had ever been found.

“Paramex has also included information on usage rules, dosage according to BPOM regulations on the packaging, namely only for use for headaches and toothaches which of course should be taken if there are symptoms and can be stopped after the symptoms disappear,” explained Rachmadi.

“So, Paramex products which have been produced since 1976 and distributed according to BPOM regulations are safe to consume according to the recommended dosage,” he stressed.

BPOM response

Meanwhile, BPOM said that the inclusion of the side effect risk of aplastic anemia on Paramex packaging was in accordance with BPOM’s approval during the extension of the distribution permit on November 5 2020.

“The additional risk of aplastic anemia as a side effect of the drug must still be stated on the packaging. Although the frequency of this incident is categorized as rare, namely one case per one million users,” said Head of the BPOM RI Cooperation and Public Relations Bureau, Noorman Effendi, quoted from detikhealth .

In line with PT Konimex’s statement, Noorman said, to date there has been no reported incident data regarding the side effects of aplastic anemia even though it is written on the packaging.

Noorman also said that drug packaging also included warnings to consumers on the packaging.

“So even though the packaging lists the risk of aplastic anemia as a side effect, to date there is no data or report, either from BPOM e-MESO data (monitoring of drug side effects) or WHO, regarding the incidence of this side effect,” he stressed.

What is aplastic anemia?

Previously, social media was abuzz with netizens who discovered the addition of the side effect of aplastic anemia on the Paramex drug packaging. This disease is of concern because it was suffered by the late comedian, Babe Cabita.

Aplastic anemia is a spinal cord disorder that is unable to form new blood cells. This disease can be caused by several factors, namely heredity and other health problems.

Several factors can trigger aplastic anemia, such as autoimmune diseases that attack the immune system, including cells in the bone marrow; history of radiotherapy or chemotherapy treatment; history of consuming certain medications; infected with certain viruses; exposure to hazardous chemicals; until pregnancy.

[Gambas:Video CNBC]

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