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FDA warns public against injectable glutathione for skin whitening

by Aileen Cerrudo   |   Posted on Tuesday, July 9th, 2019

Courtesy : Unsplash

The Food and Drug Administration (FDA) has warned the public about the dangers of injectable glutathione for skin whitening.

The FDA said there are no published clinical trials that evaluated the use of injectable glutathione for skin lightening. There are also no guidelines for appropriate doses and duration of treatment.

In the Philippines, there are beauty salons, wellness spas and beauty clinics offering beauty enhancements like intravenous drip using skin lightening agents.

“Side effects on the use of injectable glutathione for skin lightening include toxic effects on the liver, kidneys, and nervous system. Also of concern is the possibility of Stevens Johnson Syndrome,” their statement reads.

The FDA adds that they also have not approved any injectable products for lightening skin. They said they only approved the ones that are being used as an adjunct treatment in cisplatin chemotherapy.

Other potential risks include transmission of infectious agents such as HIV, hepatitis C and B.—AAC

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Brewer tagged in ‘poisoning’ taps third-party labs to test banned Carabao Cosmic Gin

by Robie de Guzman   |   Posted on Friday, July 19th, 2019

Cosmic Carabao | Courtesy: Juan Brew Facebook page

MANILA, Philippines – The manufacturer of the recently recalled Cosmic Carabao Gin said it is now investigating reports of alleged methanol poisoning and has tapped third-party laboratories to test the craft gin.

“This is to determine any possible issue in the production of the Cosmic Carabao Gin,” Juan Brew said in a statement posted on its Facebook page.

Last week, the Food and Drug Administration (FDA) ordered the seizure and confiscation as well as the banning of the clear liquid craft gin after gin samples collected and subjected to analysis were found positive for methanol.

The order was issued following reported incidents involving two women who fell ill shortly after allegedly consuming the said gin. The victims were rushed to separate hospitals where one of them reportedly died.

READ: FDA orders seizure, warns public of cosmic carabao gin

Methanol, according to the FDA, is a widely available chemical that has many industrial applications. It is also found in household products and fuel for aircraft.

Although it can occur naturally, the agency said, high concentrations of methanol could mean adulteration of the product.

The FDA also warned the public against the consumption of the said product as “this is currently unregistered and has been confirmed to contain a high level of methanol.”

But Juan Brew insists the company has been registered with the FDA since 2016 and its License to Operate is valid until 2023.

“Since 2016, the Company was granted ten individual Certificates of Product Registration (CPRs) for several varieties of beverages and not a single complaint was brought to our attention since then,” it said.

It also stressed it is aware of the unverified reports on social media about a case of methanol poisoning involving its product and that it has coordinated with the FDA probe.

“We assure the public that JBI is exerting all efforts to coordinate and cooperate with the FDA and other relevant agencies,” the brewer said.

“In the meantime, JBI has recalled Cosmic Carabao and has suspended the distribution thereof. Rest assured, JBI is continuously dedicated in creating quality products with equal regard for consumer health,” it added.

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FDA orders seizure, warns public of Cosmic Carabao Gin

by Robie de Guzman   |   Posted on Tuesday, July 9th, 2019

Cosmic Carabao | Courtesy: Juan Brew Facebook page

MANILA, Philippines – The Food and Drug Administration (FDA) on Tuesday ordered the seizure of Cosmic Carabao Gin products after its samples were found positive for methanol.

In an advisory, the FDA said the order was issued following the reported incidents involving two women who fell ill shortly after allegedly consuming the said gin. The victims were rushed to separate hospitals where one of them reportedly died.

FDA officer-in-charge Eric Domingo earlier said he received a report that one of the victims had methanol poisoning.

Methanol, according to the FDA, a widely available chemical that has many industrial applications is also found in household products and fuel for aircraft.

Non-toxic trace amounts of methanol can also be naturally found in fruit juices. It can also be a product of natural fermentation and is found in both alcoholic and non-alcoholic drinks.

The FDA said higher concentrations of methanol in alcoholic drinks can happen when methanol is deliberately added to alcoholic drinks.

Signs and symptoms of methanol poisoning include vomiting, abdominal pain, hyperventilation and feeling of breathlessness. Blindness can also happen in severe cases.

The FDA said the Cosmic Carabao Gin was manufactured by Juan Brewing, Inc.

In its website, Juan Brew said the clear liquid craft gin is “an out of this world citrus-forward Gin,” made with “distilled water, neutral spirit (from sugarcane), juniper berries, coriander seeds, dayap lime, angelica plant root, kaffir leaves, green, cardamom pods.”

In its Facebook post, the company said it is now verifying reports but did not address questions regarding the product’s certificate of product registration.

“We would like to emphasize that our company is dedicated to the highest standard in [the] processing of our products and puts the health of our consumers above all,” it said.

In a separate advisory, the FDA said it has ordered the “sealing of all raw materials, including in-process distillates, and seizure of all unregistered Cosmic Carabao Gin” in the facility of Juan Brewing Inc. and all those that are on sale in the market.

It also requested local government units and law enforcement agencies to ensure that this product is not sold or made available in their areas of jurisdiction.

The FDA also warns the public against the consumption of the said product as “this is currently unregistered and has been confirmed to contain a high level of methanol.”

“Consumers must also exercise extreme caution in buying alcoholic drinks, especially those that do not have labels, poorly printed labels or with broken seals,” it added.

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FDA warns against counterfeit anti-rabies vaccine for human use

by Aileen Cerrudo   |   Posted on Friday, July 5th, 2019

File photo: Vaccine | Courtesy: Reuters / Bernardo Montoya

The Food and Drug Administration (FDA) warns the public against counterfeit versions of anti-rabies for human use.

The FDA also reminds distributors and retailers to only purchase Rabipur PCEC rabies vaccine from establishments with FDA license.

Based on the inspection of the FDA, Rabipur have two counterfeit versions. This was also verified by its Marketing Authorization Holder, GlaxoSmithKline Philippines Inc.

The box label of the fake version of the vaccine has a paler shade of gray compared to the original. Its font is not in bold format and the QR code is printed in darker ink.

There is also an email address — ‘E-Mail:CS@bd.com’ — printed in the label of the sterile syringe and needle.

For the original version, the box label should be in a darker shade of gray, with a bold format. Its QR code should be printed in lighter ink. The ‘E-Mail:CS@bd.com’ should not be in the label of the sterile syringe and needle.

The FDA also confirmed that Batch no. 3503 and Batch no. 3479 were counterfeited.

The agency also called on the Bureau of Customs (BOC) to block entry of counterfeit Rabipur vaccines at all ports of entry in the country.—AAC

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