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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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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 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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Mercury in whitening products damages the skin — FDA warns

by Marje Pelayo   |   Posted on Tuesday, July 2nd, 2019

Courtesy : Pexels

MANILA, Philippines – Skin whitening brands are just anywhere.

Most are readily available in the markets and in online shops.

For some, skin whitening creams can improve their looks, “the fairer, the prettier.”

Whitening products can fade wrinkles and make you young, says 39-year-old Marcelina Tadong.

“Sa ibang bansa maputi tapos tayo sa Pilipinas maitim. Siyempre gusto rin nila gayahin iyon, (People from other countries are white-skinned and Filipinos are dark skinned. Of course, [some people] want to look like them),” she said.

Experts said skin whitening products must be registered under the Food and Drugs Administration (FDA) to ensure that they are safe to use.

According to the FDA, any whitening product that contains one part per million of mercury poses health hazards.

“Nagdi-decrease ng pigmentation ng ating balat kaya siya ginagamit na pampaputi. kaya lang kung mataas ang kaniyang concentration isa siyang poison, (Skin pigmentation decreases that’s why they use skin whitening. But when it [skin whitening] is of high concentration, it turns to poison),” noted FDA Acting Officer in Charge Eric Domingo.

Mercury poisoning can damage the kidney and prolonged exposure to the chemical has fatal effects to the human brain.

“Nakaka-irritate siya ng balat. Maaaring sumakit ang balat, magkaroon ng sugat, magkaroon ng peklat (It can irritate the skin, can harm the skin, rashes, wounds and scars may develop),” Domingo said.

“Maaari din itong problema kapag mataas talaga ang concentration, maaari siyang ma-absorb ng katawan ng tao, (Taken in high concentration can cause severe damage because (the chemicals) can be absorbed by the human body),” he added.

In the case of pregnant women, mercury poisoning can be fatal to the unborn child.

Skin expert Dr. Cathy dela Rosa explained many fall victim to counterfeit or fake skin whitening products for not reading the label or ignoring the chemical contents written on the packaging.

“The problem nowadays is kung anu-anong products po ang naglalabasan. Minsan walang labels or minsan, hindi natin alam kung anong ingredients ang nandito na maaaring harmful sa ating skin, (The problem nowadays is a lot of products have come out in the market. Some are labeled. But sometimes we do not read the ingredients and they can be harmful to the skin,)” Dr. Dela Rosa, an aesthetic dermatologist and anti-aging specialist, explained.

“My advice to my patients is to be able for them to read labels,” she added.

Dela Rosa said it is still best to consult professional dermatologists to determine the proper beauty products that are appropriate to your skin type.

She also noted that Filipinos have naturally brown skin which is adaptable to the Philippines’ tropical climate.

“We live in a tropical country so itong melanin itong kulay natin is actually our protection at swerte po tayo dahil sa balat natin (we are lucky to have this type of skin). It doesn’t cause burning,” she noted.

“Maganda siya talaga (It’s a very good type). It protects us from skin cancer. It protects us from other illnesses caused by the sun,” she added.

Friends Lea Vergis and Mary Rein Quijano believe they do not need skin whitening products to have beautiful skin.

“Mas prefer ko iyong natural way lang na paglilinis ng mukha, (I prefer the natural way of cleansing my face,)” Lea said.

“Wala po akong ginagamit especially sa gabi. Naghihilamos lang kasi mas prefer ko iyong kusa akong pumuti, (I don’t use anything especially at night. I just wash my face with water because I prefer the natural glow,)” said Mary Rein.

“Huwag na pong gumamit ng products lalo na iyong hindi hiyang, (Refrain from using any (skin) products especially those that are not appropriate for your skin type,)” added Mary Rein.

Rhea Manansala, for her part, said she will not risk her skin’s health on products that are not tested by experts.

“Kapag whitening medyo nakakatakot kasi siya na kapag nasira na kasi iyong balat mo baka hindi na bumalik sa dati, (I’m afraid of using skin whitening products because they can damage the skin and my skin may not return to its natural state,)” she said.

“Mas malaki iyong damage, (They may cause larger damage,)” she concluded. — (with reports from Aiko Miguel)

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