Showing posts with label FDA. Show all posts
Showing posts with label FDA. Show all posts

Monday, 6 October 2025

US FDA slaps new requirements for Indonesia's shrimp and spices after radioactive contamination

The U.S. Food and Drug Administration (FDA) announced new import certification, opens new tab requirements for shrimp and spices from Indonesia after cases of radioactive contamination were detected earlier.
In a posting on its website on Saturday, Indonesian time, the agency said that it will implement the import certification requirements from certain regions of Indonesia starting on October 31, 2025.
The certification requires firms on the red list with evidence of Caesium 137 contamination to have an accredited third party to verify the control of the radioactive element.
Once the firms are taken off the red list, they will still be subject to restrictions and will need to provide information indicated under the yellow list for each shipment.
Firms on the yellow list covering certain foods with Caesium 137 contamination risks are required to have shipment certification from an entity designated by the FDA, which must be an agency or representative of the Indonesian government.
FDA's website says Caesium 137 is a radionuclide present in the environment mainly as the result of nuclear testing or accidents such as Chernobyl and Fukushima.
Indonesia does not possess nuclear weapons or nuclear power plants.

The FDA in August issued an advisory to consumers, distributors and sellers in the U.S. not to eat, sell or serve frozen shrimp processed by local seafood company PT Bahari Makmur Sejati, after their products were contaminated with Caesium 137.
The shrimp was processed at an industrial estate near Jakarta that was later found to be contaminated with the radioactive element and Indonesia's nuclear agency is seeking to pinpoint the size of the area affected.
Bara Hasibuan, a spokesperson for the investigation into the incident, told Reuters: "We just received the report few hours ago. Need time to figure what steps need to be taken."

Reporting by Dewi Kurniawati Editing by Shri Navaratnam 

Thursday, 25 September 2025

Tylenol is OK if needed


U.S. President Donald Trump's recent public warnings urging pregnant women to "fight like hell" not to take Tylenol (acetaminophen) have immediately triggered widespread concern among patients, prompting a flood of questions for doctors despite scant supporting scientific evidence.

At a White House press conference, Trump, flanked by health officials, warned of a link between the pain reliever and autism, announcing plans to add risk warnings to drug labels.

Patient Anxiety and Doctor Reassurance

The very next day, healthcare providers across the U.S. began fielding anxious questions:

  • Dr. Rana Alissa, President of the Florida Chapter of the American Academy of Pediatrics, reported pregnant women asking, "What should I do? Do you think it's safe? I just took Tylenol last month. Do you think I already hurt my baby?"

  • Dr. Rachel Blake, an OB-GYN in New York and New Jersey, has been reassuring her pregnant patients that Tylenol remains safe, emphasizing that "There has been no new research that suggests there should be a change in that guideline."

Medical Community Pushback

Dozens of major medical, research, and autism advocacy groups, including the American College of Obstetricians and Gynecologists and Tylenol maker Kenvue, have publicly decried the President's comments.

  • Kenvue maintains that independent, sound science shows the drug does not cause autism.

  • Dr. Sindhu Srinivas, president of the Society for Maternal-Fetal Medicine, noted that linking Tylenol use to autism only "heaps blame on pregnant women," who already experience significant guilt and fear about taking any medication.

  • The CDC and FDA issued warnings to providers, but added the crucial caveat that no causal relationship between acetaminophen and autism has been established.

  • European and British health agencies, along with the World Health Organization (WHO), have rushed to correct the record, uniformly stating there is no conclusive evidence linking the drug to autism.


The Risk of Untreated Fever

Doctors emphasize that while they counsel patients to use the least amount of Tylenol for the shortest time possible, it remains the only pain reliever considered safe during pregnancy.

Critically, untreated fever and pain during pregnancy pose a very real risk to the fetus, potentially leading to:

  • Birth defects

  • Preterm birth

  • Low birth weight

  • Miscarriage

  • Neurodevelopmental disorders (especially if fever occurs in the first trimester)

Experts like Dr. Caitlin Baptiste, a maternal fetal medicine specialist, stressed that the focus should be on evidence-based science, not adding unfounded worries that leave women vulnerable to misinformation.

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