Latin America Roundup: ANMAT sanctions more domestic drugmakers

Regulators with Argentina’s National Administration of Drugs, Food and Medical Devices (ANMAT) have increased plant inspections and enforcement actions of local drugmakers after a rash of deaths in hospitals was traced to the use of contaminated fentanyl products.

The locally manufactured fentanyl vials were found to contain Klebsiella pneumoniae and Ralstonia picketii bacteria. Most of the deaths were reported in May, and while the country’s epidemiology officials confirm 48 deaths through the end of July, news reports suggest the final count could end up being closer to 70. In the past week relatives of the victims have protested outside one of the affected hospitals, demanding results from ongoing investigations.

ANMAT officials suspended all activities of the products’ manufacturer, HLB Pharma, and its affiliate laboratories and distributors following plant inspections after the deaths were reported. Since then, they have appeared to step up plant inspections of other manufacturers, resulting in further suspensions.

On 22 July, the agency announced that it had suspended all production by a major cancer drug manufacturer, Filaxis, after an inspection revealed violations of good manufacturing practices. ANMAT also ordered the withdrawal from the market of three of that company’s products, all of them chemotherapy drugs, as a result of those findings.

Popular toothpaste banned by multiple Latin American agencies

A popular brand of toothpaste has been banned by regulators across Latin America following more than 11,000 reports from Brazil of adverse effects, including mouth ulcers and pain, associated with its use. The product, branded as Colgate Total Active Prevention Clean Mint, was made in Brazil, marketed there starting in July 2024, and exported to other Latin American countries.

In March 2025 the Brazil Health Regulatory Agency (ANVISA) suspended sales of the product, in response to the adverse event reports, and later ordered its withdrawal from the market. Last month, Colgate-Palmolive Brazil announced that it was discontinuing production of the toothpaste, though it did not reveal the likely ingredient or ingredients associated with the complaints.

While stannous fluoride, a common toothpaste ingredient, was first hypothesized to be the culprit, officials with Argentina’s ANMAT agency pointed to an unnamed “new flavoring agent” in a 20 July report. The toothpaste is now banned in Argentina, while regulators in Uruguay, the Dominican Republic, Paraguay, Venezuela, and Colombia have issued alerts and/or prompted the withdrawal of the same formulation from local markets. Other variations of Colgate toothpaste remain on the market in these countries. It is unclear whether the formulation associated with the adverse events was ever manufactured or sold outside Latin America.

Brazil eases import rules for cancer drugs

Drugs containing the active ingredient mitotane, used in the treatment of adrenocortical carcinoma, a rare cancer, can be imported without prior approval by ANVISA, the agency said on 31 July. No company currently holds a marketing authorization for this molecule in Brazil, the agency noted, adding that the policy change “should result in more agility in the treatment of patients.”

Hospitals and clinics requiring mitotane for their patients “will follow the usual import procedure, with the analysis of health requirements by ANVISA approval stations at the time of product entry,” the agency said. Proof of the drug’s registration in the exporting country is required. Mitotane was previously available in Brazil, but its license holder stopped importing it in 2022, and in 2024 canceled its registration, leaving no mitotane-based drug on the market.

Statement (Portuguese)

Gene therapy suspended in Brazil after FDA action

A gene therapy approved last year in Brazil was suspended by ANVISA, the agency said on 24 July. Marketing, distribution and importation of Elevidys (delandistrogene moxeparvovec), a treatment for Duchenne muscular dystrophy, a muscle-wasting disorder affecting mainly boys, will remain in effect “until the recent safety uncertainties related to reports of fatal cases of acute liver failure in patients treated with the product in the United States are fully clarified,” ANVISA said.

Last month, following reports of two patient deaths in the United States, the US Food and Drug Administration halted clinical trials of Elevidys and related experimental products and requested that its manufacturer, Sarepta, voluntarily suspend its distribution. In an announcement 25 July, FDA that in addition to the two fatal US cases, both of non-ambulatory patients, it was also investigating the death of an 8-year-old boy in Brazil.

ANVISA clarified in its statement that the Brazilian child likely died from a severe flu infection exacerbated by the immunosuppression that is part of the gene therapy regimen, a finding with which the FDA concurred. On 28 July, the FDA recommended that the manufacturer resume distribution of the treatment to ambulatory patients in the US.

ANVISA said the Brazil death did not constitute “a new or unexpected health safety signal in the population of Brazilian ambulatory patients with DMD,” adding that the Brazilian labeling already includes warnings about the risk of serious liver damage, infections and immunosuppression.

Nonetheless, because Elevidys is “an innovative, complex and restricted-use product, any reasonable doubt about its safety profile” requires immediate regulatory action, ANVISA said. The agency has not made further announcements about Elevidys since the 24 July statement.

Statement (Portuguese)

Paraguay issues compassionate-use import rules

Paraguay’s National Directorate of Health Surveillance (DINAVISA) has issued a new rule easing the importation of medications and devices that remain without authorization Paraguay. The new rule, published online on 30 July by the Paraguayan media outlet ABC, allows clinics to acquire non-approved medications for specific patients or groups of patients for compassionate or emergency use. Products whose equivalents are available in Paraguay do not qualify for the exceptions. In addition, products must have marketing authorization in the exporting country or be under investigation in an approved clinical trial.

Ecuador, Peru agencies team up along shared border

Regulators with Ecuador’s National Agency for Health Regulation, Control and Surveillance (ARCSA) and Peru’s General Directorate of Medicines, Supplies and Drugs (DIGEMID) are mounting joint operations to combat cross-border medicines smuggling and verify that medications for sale are compliant with the national regulations of each country.

According to a 21 July report in Edición Médica, the operations are concentrated in the border cities of Zarumilla, Peru, and Huaquillas, Ecuador, and have resulted in the closure of at least one distributor in Peru.

Report (Spanish)

Latin America Roundup: ANMAT sanctions more domestic drugmakers

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