NAFDAC has warned Nigerians about the sale and distribution of fake Paludex tablets and suspensions across the country.

The agency announced on its X account (formerly Twitter) that fake Paludex Artemether/Lumefantrine tablets (80mg/480mg) were falsely labelled as being made by Impact Pharmaceutical Ltd, located at Standard Industrial Layout, Emene, Enugu State.

It added that these fake drugs are being distributed by MD Life Sciences Ltd, also based in Emene Industrial Layout, Enugu.

NAFDAC further revealed the discovery of counterfeit Paludex dry powder for oral suspension (180mg/1080mg), meant for children.

NAFDAC stated that the counterfeit Paludex oral suspension was falsely labelled as being manufactured by Impact Pharmaceutical Ltd, located at No. 33A/33B Standard Industrial Layout, Enugu, and Ecomed Pharma Limited in Ogun State, and marketed by MD Life Sciences Ltd.

The agency revealed that laboratory tests conducted by a WHO-prequalified laboratory in Germany showed that both products contained zero per cent of the Active Pharmaceutical Ingredients (API). Additional tests conducted by NAFDAC also confirmed the absence of any API in the products.

The statement further disclosed that the fake products are not listed in NAFDAC’s database of registered drugs, and the NAFDAC registration numbers displayed on the packaging are fake.

NAFDAC emphasized that authentic Artemether/Lumefantrine tablets or suspensions are a combination of two active ingredients, Artemether and Lumefantrine, used for treating acute, uncomplicated malaria in both adults and children.

“The illegal marketing of medicines or counterfeit medicines poses a great risk to the health of people.

“By not complying with the regulatory provisions, the safety, quality, and efficacy of the products are not guaranteed.

“Also, poor-quality pediatric formulations or medicines in general have the potential of causing treatment failure when the API content is below the prescribed dose,” it said.

NAFDAC said that all its zonal directors and state coordinators have been directed to carry out surveillance and mop up the fake products within their zones and states.

It also implored distributors, healthcare providers, and patients to exercise caution and vigilance within the supply chain to avoid distribution, administration, and use of the products.

The agency said that all medical products must be obtained from authorised/licensed suppliers.

“The products’ authenticity and physical condition should be carefully checked.

“Anyone in possession of any of the above-mentioned products is advised to immediately discontinue the sale or use and submit stock to the nearest NAFDAC office.

The agency advised the public, especially those who have used any of the products to seek immediate medical advice from a qualified healthcare professional.

It also advised healthcare professionals and consumers to report any suspicion of substandard and falsified medicines to the nearest NAFDAC office, NAFDAC on 0800-162-3322 or via email: [email protected].

In another development, NAFDAC also identified Eziukwu Market, also known as Cemetery Market in Aba, Abia State, as a major hub for producing and distributing fake and substandard products.

This discovery followed an operation led by NAFDAC’s South-East Zonal Director, Martins Iluyomade, on Tuesday.

During the operation, Iluyomade described the market as a centre for large-scale production and distribution of counterfeit goods, comparing its impact to “weapons of mass destruction.” Despite earlier raids, including a major one in December 2023, the illegal activities have persisted.

Iluyomade expressed frustration that people continue to prioritize profits over public health and safety. He also pointed out that the market leaders had previously signed an agreement with NAFDAC during the last operation, promising to expose those involved in these illegal activities.

However, he stressed that the market’s leadership must now answer serious questions about their failure to stop the production and sale of fake products.

Towana Looney donated a kidney to her mother in 1999 only for the remaining one to fail years later due to pregnancy complications.

Now, the 53-year-old from Alabama has become the latest recipient of a gene-edited pig kidney — and is currently the only living person in the world with an animal organ transplant, New York’s NYU Langone hospital announced Tuesday.

“I’m overjoyed, I’m blessed to have received this gift, this second chance at life,” Looney said during a press conference, held three weeks after the procedure.

Xenotransplantation, transplanting organs from one species to another, has long been a tantalizing yet elusive scientific goal. Early experiments on primates faltered, but recent advances in gene editing and immune system management have brought the dream closer to reality.

Pigs have emerged as the ideal donors: they grow quickly, produce large litters and are already part of the human food supply.

Advocates hope this approach can help address the severe organ shortage in the United States, where more than 100,000 people are waiting for transplants, including over 90,000 in need of kidneys.

A last chance

Looney had been living with dialysis since December 2016 — eight grueling years. High blood pressure caused by preeclampsia had taken its toll, leaving her with chronic kidney disease.

Despite receiving priority on transplant waiting lists as a living donor, her search for a compatible kidney was a frustrating dead end. Her unusually high levels of harmful antibodies made rejection almost inevitable, and as her body lost viable blood vessels to support dialysis, her health declined.

Out of options, Looney applied to join a clinical trial for pig kidney transplants, and finally underwent the seven-hour surgery on November 25.

Asked how she felt afterward, Looney’s joy was infectious. “I’m full of energy, I’ve got an appetite… and of course, I can go to the bathroom. I haven’t been going in eight years!” she laughed, adding that she plans to celebrate at Disney World.

Jayme Locke, a surgeon on the transplant team, described the results with awe. “The kidney functioned essentially exactly like a kidney from a living donor,” she said, adding that Looney’s husband saw a rosiness in her cheeks for the first time in years.

“That is the miracle of transplantation.”

Cautious optimism

Looney’s surgery is the third time a gene-edited pig kidney has been transplanted into a human who is not brain dead.

Rick Slayman, the first recipient, died in May, two months after his procedure at Massachusetts General Hospital. The second, Lisa Pisano, initially showed signs of recovery following her surgery at NYU Langone, but the organ had to be removed after 47 days, and she passed away in July.

Looney, however, was not terminally ill before the transplant, noted Robert Montgomery, who led the surgery. Each case, he emphasized, provides critical lessons for refining the techniques.

The kidney was provided by biotech company Revivicor, which breeds genetically modified herds in Virginia. A Massachusetts-based company, eGenesis, provided the kidney for Slayman.

Looney’s organ has 10 genetic edits to improve compatibility with the human body — an advance over Revivicor’s earlier efforts that used kidneys with a single gene edit and included the pig’s thymus gland to help train the host’s immune system and prevent rejection.

Montgomery, a pioneer in the field who performed the world’s first gene-edited pig organ transplant in a brain-dead patient in 2021, said both methods are likely to enter clinical trials “probably by this time next year, or even sooner.”

“This is a watershed moment for the future of transplantation,” said Kevin Longino, CEO of the National Kidney Foundation. The nonprofit’s polling shows that patients and families favor faster clinical trial progress, believing the risk of inaction outweighs the uncertainties of xenotransplantation.

Looney was discharged December 6 to a nearby New York City apartment. Though her high antibody levels remain a concern, doctors are monitoring her closely using wearable technology and are trying a novel drug regimen to prevent rejection.

Periodic hospital visits may still be required, but the team remains optimistic she can return home in three months.

AFP

The Republican attorney general of Texas has filed a lawsuit against a New York doctor who mailed abortion pills to a woman in the southern state.

Texas has some of the toughest laws restricting abortion in the country, and the case pits state laws regulating the procedure against each other.

Texas Attorney General Ken Paxton filed the civil suit on Thursday against Margaret Carpenter, the New York-based founder of the Abortion Coalition for Telemedicine.

The attorney general’s office said Carpenter provided a 20-year-old Texas woman with “abortion-inducing drugs that ended the life of an unborn child and resulted in serious complications for the mother.”

“Texas laws prohibit a physician or medical supplier from providing any abortion-inducing drugs by courier, delivery, or mail service,” it said.

In addition, “no physician may treat patients or prescribe Texas residents medicine through telehealth services unless the doctor holds a valid Texas medical license.”

Carpenter is not a licensed physician in Texas.

Texas is seeking an injunction against Carpenter barring her from illegally practicing medicine in the state and from prescribing abortion pills to Texas residents.

He is also seeking a $100,000 fine for each violation.

“In Texas, we treasure the health and lives of mothers and babies, and this is why out-of-state doctors may not illegally and dangerously prescribe abortion-inducing drugs to Texas residents,” Paxton said.

Democratic-controlled New York has passed a so-called shield law which provides legal protection to New York doctors who send abortion pills to women in states where the procedure has been outlawed.

Eighteen Democratic-ruled states have enacted shield laws since the US Supreme Court struck down the nationwide right to abortion in 2022, according to the Center for Reproductive Rights.

In June of this year, the top court rejected a bid by anti-abortion groups to restrict mifepristone, the pill widely used to terminate pregnancies in the United States.

The Texas lawsuit raises thorny legal questions for the courts about what is known as extraterritoriality, the application of one state’s laws to another.

AFP