Data Dose January 2025 #3

Drug Colors and Childhood Curiosity.

When does a bright red liquid become more than medicine? When it tempts a child as a sweet treat. While appealing colors and flavors make medications easier for kids to take, they can also pose serious risks. This article delves into the unintended dangers of colorful drugs, their potential to harm children, and the critical role of pharmacovigilance in safeguarding young patients. Read More...

FDA Requires GBS Warning for RSV Vaccines.

The FDA has mandated safety labeling updates for respiratory syncytial virus (RSV) vaccines, adding a warning about the potential risk of Guillain-Barré syndrome (GBS) following vaccination. This change applies to both RSVPreF (Abrysvo, Pfizer) and RSVPreF3+AS01 (Arexvy, GSK). Read More...

DOH, FDA knew Dengvaxia's adverse effects.

Former Department of Health (DOH) and FDA officials were reportedly aware of Dengvaxia's potential risks before the 2016 mass vaccination. Documents from The Manila Times reveal Sanofi Pasteur disclosed these risks in December 2015 to the DOH and FDA. An FDA-certified document confirms the disclosure, while medical expert Dr. Clarito Cairo testified to its existence during Dengvaxia case hearings. These findings raise critical concerns about decision-making and transparency in the vaccine rollout. Read More...

Streamlining Drug Approvals Without Compromising Safety.

Balancing the urgency of delivering new drugs with the need for stringent safety standards is a critical challenge in biopharmaceutical policy. The COVID-19 pandemic highlighted the potential of streamlined regulatory processes, with vaccines developed and approved at unprecedented speeds. While faster approvals can save lives and address public health crises, they also raise concerns about the long-term safety and efficacy of therapies. Read More...