2023-11-05 23:00:00
The circulation of counterfeit and suspicious medicines continues in Venezuela. The “Rafael Rangel” National Institute of Hygiene (Inhrr) published two new health alerts that warn regarding the marketing of a false drug and another dubious one.
At the end of October, the health regulatory authority ruled on the sale of Human Albumin not suitable for human use and consumption, as well as the distribution of allegedly counterfeit “Erbitux (Cetuximab)”.
With these new documents, the Inhrr accumulates six health alerts this 2023 on counterfeit and allegedly counterfeit medicines, the use or consumption of which represents a health risk.
By issuing an alert, the Inhrr calls on the population not to purchase or use the indicated product. If someone is using them, authorities urge suspend immediately its use and report to email [email protected] What are the places or who are the people who distribute or market it.
Find out which are the six counterfeit or dubious medications circulating in Venezuela according to Hygiene, how to differentiate them from the originals and what each 2023 health alert says:
Erbitux, the most recent
Through health alert No. 006/2023, information is provided on the marketing of a batch of Erbitux (Cetuximab), identified with the number G015VCfollowing receiving a complaint from Merck SA, representative of the product in Venezuela.
Erbitux is a medication used to treat colon or rectal cancer. It is also used to treat squamous cell cancer of the head and neck.
According to the Inhrr, the company stated that the counterfeit product under the same batch number (G015VC) was allegedly acquired through a distributor in Colombia.
“The representative company indicated that a batch manufactured by Merck Healthcare KGaA (Germany) was distributed in Ecuador, with the same number as the one questioned and that ERBITUX (CETUXIMAB) 5 mg / mL INJECTABLE SOLUTION PB1.197/21, It is not being marketed in Venezuela“, they detail in their alert.
Until the composition of the product, its safety and legal status are determined, and due to its potential risk to health, the Institute urges the population not to acquire or consume the lot.
If you detect it, call to report it to the email [email protected].
Photos: Inhrr
Human Albumin
In its health alert No. 005/2023, the Institute confirmed the warning previously issued by the company Medifarm, representative in Venezuela of the Kedrion laboratory, the original manufacturer of the presentation of Human Albumin (UMAN ALBUMIN 200 g/L), in intravenous solution.
Through a statement, Medifarm reported that the counterfeit product is identified under the batch 233517and its expiration date is June 2026.
From the Inhrr they indicated that said batch does not appear in the manufacturing history nor does it correspond to the numbering that Kedrion uses for albumin.
In addition, Higiene reported that the quality control tests carried out on the questioned samples determined the absence of the active ingredient and an altered pH. For these reasons, he concluded that the product is counterfeit and that the mentioned batch is “not compliant” for your use and consumption.
Medifarm, for its part, reported that the presentation that is authorized, and covered by the registration and import permit, is the batch 232915 of the product.
Antivenom Serum
In September, the fourth health alert was issued, which warned regarding the marketing of a batch of Multipurpose Antivenom Serum in intravenous solution, identified with the number 191which turned out to be a counterfeit of the original product not suitable for use and consumption.
Antivenom serum is an antivenom that is used in cases of snake bites. In Venezuela it is manufactured by the company Biotecfar from the Faculty of Pharmacy of the Central University of Venezuela (UCV).
When consulted by the health agencies, Biotecfar indicated that it does have batch 191 in its history, but the sample that generated the health alert, detected in the state of Táchira, was not manufactured by them.
The copied product had variations in product color and opacity, according to the Institute, and did not meet the chemical and analytical specifications of the legitimate product.
To distinguish between legitimate and fake products, the Inhrr highlighted differences in color, type and font size of labeling of the bottle, as well as the production and expiration dates.
The registered antivenom serum 191 has a manufacturing date of April 2020 and expires in April 2023, while the counterfeit serum appears to have been manufactured in April 2022 and expired in April 2025.
The Institute of Hygiene identified a presentation that did not contain the active ingredient | Photo: Inhrr
Pediatric Atamel
On July 28, Higiene warned regarding the falsification of a product for pediatric use: Atamel 100 mg/mL in drop solution in its 30 mL presentation, following receiving a complaint from the company representing the product, Calox International.
According to health alert No. 003/2023, the batch identified with the number L8771 It did not pass the quality tests and the solution, instead of being cherry colored, was brown.
After studying the documentation presented by the company, it was concluded that it is a counterfeit product that presents a health risk.
The authorities called on establishments, importers, distributors and marketers to acquire Products for Human Use and Consumption through suppliers certified and authorized by the Ministry of Health.
Menthol Davis Ointment
Another of the counterfeit medicines found in the country was Menthol Davis Ointment EF 537/17, presenting 14.18 grams.
Quality control tests carried out by the Inhrr determined that the product not only has a lower amount of menthol (37% of what was declared), but is also contaminated with fungus Candida famatawhich is why it is not suitable for use and consumption.
In addition, the company manufacturing the product in Venezuela, Genia Care Pharmaceutical, stated that the detected presentation of 14.18 g does not correspond to laboratory production, since It has not been manufactured since 2014.
There are also differences in the packaging of the original product and the packaging of the counterfeit product.
Currently, and since 2014, the laboratory only manufactures a larger presentation of Menthol Davis in ointment, 28.32 grams.
Herceptin (Trastuzumab)
One of the most sought-following medications among people with breast cancer also appeared in a health alert: it is Herceptin (Trastuzumab). In the private sector, a single vial can cost up to $1,850.
The first health alert of the year, published in March, highlighted that the batches N3924B02 y N3927 of Herceptin 440 milligrams, in lyophilized powder for intravenous infusion PB 1,164/20 did not have the active ingredient Trastuzumab, which is why they were “non-compliant” for use and consumption.
According to the alert, the company that owns the original product (F. Hoffman La Roche), through its representative in Venezuela (Roche Products), reported that batches N3924B02 and N3927 were not manufactured by them.
Additionally, lot N3927 differs from the original packaging art used by the lab.
In each of the health alerts, the Inhrr reiterated the call to suspend immediately the use of counterfeit medicines due to the risks they may pose to health.
He also highlighted the call to report the email [email protected]
and only purchase products from certified and authorized suppliers by the Ministry of Health.
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