Tag: The Food and Drug Administration

Hepatitis A Case Linked to Recalled Frozen Strawberries Sold in Los Angeles County

LOS ANGELES—The Los Angeles County Department of Public Health announced April 14 it recently identified a case of hepatitis A linked to a multistate outbreak from frozen organic strawberries imported from Mexico and sold in Los Angeles County. The Food and Drug Administration has recalled several brands of frozen strawberries, and different suppliers are taking…


Paxlovid, Advertised for Mass Use, Has Contraindications With Hundreds of Drugs

One of the most robustly campaigned and well-known drugs for treating COVID is Paxlovid. Yet the drug’s limited clinical studies and numerous drug interactions raise questions of safety for COVID patients. Approved for Emergency Use Authorization (EUA) in December 2021 and promoted by the Food and Drug Administration (FDA), health officials, and politicians alike, Paxlovid…


Highly Prescribed ‘Benign’ Medication Detected in 10 Percent of Overdose Deaths

A commonly prescribed painkiller and anticonvulsant (seizure medication) widely believed to be “benign” has become increasingly associated with overdose deaths in the United States. The medication is gabapentin, commonly marketed as Neurontin, Horizant, and Gralise. Over the years, gabapentin prescribing has steadily increased, with 64 million prescriptions dispensed in 2016, making the drug the 10th…


Fixed Packaging of Alzheimer’s Drug May Waste $605 Million a Year for Medicare, Experts Warn

Medicare could potentially waste up to $605 million annually from the packaging of controversial Alzheimer’s drug aducanumab if it is approved for widespread use, according to a University of California Los Angeles (UCLA) study. “Given Medicare’s premium increase in 2022 partly due to aducanumab, greater focus on efficient vial packaging could improve the value of…


FDA Warns Against Use of Neck Floats After Death of Baby

Baby neck floats are under fire again after the Food and Drug Administration (FDA) warned against their use in water therapies following the death of one baby and hospitalization of another in unsupervised usage. “Do not use baby neck floats for water therapy intervention,” the FDA wrote in a media statement released on June 28….


FDA Issues Two Warning Letters to E-cigarette Businesses for Unauthorized Sales

The Food and Drug Administration (FDA) posted warning letters on June 28 to two e-cigarette businesses, VAPORIZIT LLC and Elk River Vapor Shop, for selling e-cigarette products not previously on the market. According to the Federal Food, Drug, and Cosmetic Act, new tobacco products, including vapes, need a pre-market authorization order to be sold in…


FDA Bans JUUL E-Cigarettes

The Food and Drugs Administration (FDA) banned all of JUUL Labs Inc’s products on June 23 from the market, delivering a blow to the popular e-cigarette company. “Today’s action is further progress on the FDA’s commitment to ensuring that all e-cigarette and electronic nicotine delivery system products currently being marketed to consumers meet our public…


FDA Advisory Panel Rejects Acadia’s Antipsychotic for Alzheimer’s

The U.S. Food and Drug Administration advisory panel voted against the approval of Acadia Pharmaceutical’s drug for hallucinations and delusions associated with Alzheimer’s disease psychosis on Friday. The advisory voted 3 to 9 with no abstention after eight hours of discussion. The panel concluded that the studies were not enough to support the efficacy of…


94 Percent of Medication Not Supported by High-Quality Evidence, Harms Underreported: Study

Less than 6 percent of medical drugs have high-quality evidence to support their benefits, according to a recent study by the University of Oxford. The study found that, of the 1,567 eligible medications approved under the Cochrane Reviews from 2008 to 2021, more than 94 percent were not supported by high-quality evidence. Cochrane Reviews is…


Existing Cancer Therapy Demonstrates Significant Effect Against Other Cancers: Study

An approved cancer therapeutic, once used in only 1 percent of cancers, may have significant uses in the remaining 99 percent, according to a new study. “Ivosidenib, previously called AG-120, may be applicable to the large majority of cancers,” said senior author Dr. Jordan Winter, division chief of surgical oncology at University Hospitals Seidman Cancer Center in…