Class 1 Recall Initiated for Covidien Puritan Bennett 980 Ventilator System

On July 16, the Food and Drug Administration (FDA) announced that Covidien had initiated a recall of … [Continue Reading]

Public Health Watchdog Breaking News

FDA Addresses Dangers of Pure Powdered Caffeine with Warning Letters to Producers

After the deaths last of two otherwise healthy young men who used too much pure caffeine, the Food … [Continue Reading]

Public Health Watchdog Breaking News

European Medicines Agency Bans 700 Generic Medicines Due to Flawed Testing But FDA Leaves Them on the Market

The U.S. Food and Drug Administration (FDA) said it has found no systemic issues affecting the … [Continue Reading]

European Medicines Agency Bans 700 Generic Medicines

FDA Asks Food Company Cooperation in Pathogen Database for Foodborne Illnesses

Whole genome sequencing is enabling Food and Drug Administration (FDA) officials to more quickly … [Continue Reading]

FDA Asks Food Company Cooperation in Pathogen Database

Tobacco Companies’ Marketing Claims Draw FDA Warning Letters

Three tobacco companies have received warning letters from the Food and Drug Administration (FDA) … [Continue Reading]

Tobacco Companies’ Marketing Claims Draw FDA Warning

Public Health Watchdog Breaking News

Class 1 Recall Initiated for Covidien Puritan Bennett 980 Ventilator System

On July 16, the Food and Drug Administration (FDA) announced that Covidien had initiated a recall of 657 Puritan Bennett 980 Ventilator System units. When the recalled ventilator is in neonatal Volume Control Plus (VC+) mode with active humidification, a software error may cause the amount of air being delivered to the patient (tidal volume) […]

Public Health Watchdog Breaking News

FDA Addresses Dangers of Pure Powdered Caffeine with Warning Letters to Producers

After the deaths last of two otherwise healthy young men who used too much pure caffeine, the Food and Drug Administration (FDA) has issued warning letters to five producers of the product. “[T]hese products are dangerous and present a significant or unreasonable risk of illness or injury to consumers,” the FDA says, according to the […]

European Medicines Agency Bans 700 Generic Medicines

European Medicines Agency Bans 700 Generic Medicines Due to Flawed Testing But FDA Leaves Them on the Market

The U.S. Food and Drug Administration (FDA) said it has found no systemic issues affecting the safety or efficacy of about 700 generic drugs tested at GVK BioSciences, though the European Medicines Agency (EMA) has banned the drugs. The EMA ban was instituted last week, based on an inspection the EMA conducted last year, for […]

FDA Asks Food Company Cooperation in Pathogen Database

FDA Asks Food Company Cooperation in Pathogen Database for Foodborne Illnesses

Whole genome sequencing is enabling Food and Drug Administration (FDA) officials to more quickly identify the sources of foodborne illnesses and act to prevent additional cases. Previously, samples from sick patients were sent to state and federal labs, where they were tested to see if the infections were caused by the same bug. When enough […]

Tobacco Companies’ Marketing Claims Draw FDA Warning

Tobacco Companies’ Marketing Claims Draw FDA Warning Letters

Three tobacco companies have received warning letters from the Food and Drug Administration (FDA) over “additive-free” and/or “natural” claims on their cigarette labels. The FDA sent the warning letters to ITG Brands LLC for Winston cigarettes labeled additive-free, to Santa Fe Natural Tobacco Company Inc. for Natural American Spirit cigarettes labeled additive-free and natural, and […]

FDA Puts Stronger Stroke & Heart Attack Warning on NSAIDs

FDA Puts Stronger Stroke and Heart Attack Warning on NSAIDs

Nonsteroidal anti-inflammatory drugs (NSAIDs) currently carry a warning about the risks of heart attack and stroke. The U.S. Food and Drug Administration (FDA) is strengthening this warning based on a review of new safety information, the agency said in a safety alert. All prescription NSAIDs are required to update their labels. The FDA also requests […]

CDC Accused of Withholding MMR Vaccine & Autism Data

CDC Accused of Withholding Data Linking MMR Vaccine and Autism

Rep. Bill Posey recently gave Congress evidence that the Centers for Disease Control and Prevention (CDC) withheld study data linking the MMR vaccine, (measles, mumps and Rubella) and autism. Posey, who represents Florida’s 8th congressional district, presented allegations from Dr. William Thompson, a senior scientist at the CDC who became a whistleblower and charged that […]

A veteran was hospitalized after an electronic cigarette he was smoking exploded in his hand.

E-Cigarette Explodes, Injuring Veteran

A veteran was hospitalized after an electronic cigarette he was smoking exploded in his hand. In light of the incident, Michigan Congresswoman Debbie Dingell (D-Dearborn) is calling on the U.S. Food and Drug Administration (FDA ) to regulate the devices. Dingell wants the devices, which have become increasingly popular, to be regulated the same as […]

FDA to Evaluate Risk of Childrens Codeine Medicines

FDA to Evaluate Risk of Codeine Cough-and-Cold Medicines in Children

In a Drug Safety Communication, the U.S. Food and Drug Administration (FDA) has issued a Drug Safety Communication said it is investigating the risks of using cough-and-cold medicines containing codeine in children due to “the potential for serious side effects, including slowed or difficult breathing.” Codeine is found in many over-the-counter (OTC) cough-and-cold medicines. It […]

Sen. Blumenthal Introduces Used Car Recall Legislation

Sen. Blumenthal Introduces Legislation to Prevent Sale of Used Cars with Unrepaired Recalls

U.S. Sen. Richard Blumenthal says CarMax is selling used cars with potentially lethal outstanding safety recalls and he has proposed new legislation to regulate used-car sales. An investigation by the Consumers for Auto Reliability and Safety Foundation found that CarMax dealerships in Hartford and East Haven recently offered 74 cars for sale with unresolved safety […]