Tagged Articles

Food and Drug Administration 231 articles

North Carolina woman says prescription drug-induced psychosis led husband to kill daughters

depression

The moment Kim Crespi of Charlotte, N.C., heard that her husband David had stabbed their 5-year-old twin daughters to death, she knew that the real culprit behind the horrific act wasn’t her spouse but a cocktail of prescription drugs, including Selective Serotonin Reuptake Inhibitors, or SSRIs – a form of antidepressants. According to Charlotte’s WBTV, David Crespi, a Charlotte-area banker, called 911 on the morning of Jan. 20, 2006 to report that he had just killed his own daughters. Mr. Crespi was arrested and ultimately took a plea bargain to avoid the death penalty. He is now serving two life ... Read More

FDA sued for failure to publish approval of generic testosterone drug

androgel-pump

Multinational generic drug manufacturer Perrigo Israel Pharmaceuticals sued the U.S. Food and Drug Administration (FDA) last Friday in a Washington D.C. federal court after the agency failed to take the appropriate measures that would allow sales of Perrigo’s generic testosterone gel product, even though it had received FDA approval. Ireland-based Perrigo, the largest manufacturer of private label over-the-counter prescription drugs in the United States, said that the FDA failed to update its “Orange Book” listing Approved Drug Products with Therapeutic Equivalence Evaluations. As a result, Perrigo’s testosterone-replacement gel, a generic equivalent of AbbVie’s AndroGel, is not included in the FDA’s therapeutic equivalents (TE) – ... Read More

FDA services scaled back, employees furloughed due to government shutdown

fda-logo

The government shutdown that began midnight Tuesday will result in the Food and Drug Administration (FDA) temporarily stopping routine facility and food safety inspections. However, the agency will continue to conduct activities vital to public health, including emergencies, high-risk recalls, civil and criminal investigations and import entry reviews. The FDA is a federal agency within the Department of Health and Human Services. The agency is charged with protecting the public health by assuring the safety, effectiveness, quality and security of human and veterinary drugs, vaccines and other biological products, medical devices, most of our nation’s food supply, all cosmetics, dietary ... Read More

New Jersey medical manufacturer ceases production after mold is found in its intravenous drugs

syringe

A U.S. District Judge has shuttered a New Jersey-based manufacturer of medical products for manufacturing and distributing contaminated drugs and other products and for failing to meet the minimum federal standards for safety and current good manufacturing practice requirements, the U.S. Justice Department said in a statement. Med Prep Consulting Inc. of Tinton Falls, N.J., was ordered to halt production after a Connecticut hospital discovered intravenous drugs containing visible contaminants and reported the products to the U.S. Food and Drug Administration (FDA). FDA officials investigated and found the injectable drugs contained mold. Med Prep manufactures a range of drug products ... Read More

Peanut Corporation of America executive indicted by Grand Jury on charges stemming from Salmonella Outbreak

peanut-butter

The owner of Peanut Corporation of America (PCA), where one of the deadliest Salmonella outbreaks in U.S. history originated, has been indicted by a federal Grand Jury on 76 criminal charges. A group of employees and associates of the now-defunct company have also been arraigned in connection to the 2009 outbreak, which killed 9 people and sickened more than 700. According to the indictment, unsealed this week, PCA’s former owner, Stewart Parnell, 58, is charged with committing criminal fraud and conspiracy for allegedly selling and shipping out peanut products known to be contaminated. The Salmonella-tainted peanut butter and other peanut-based ... Read More

New algorithm detects adverse reactions caused by drug combinations

A new algorithm developed by researchers to search through the U.S. Food and Drug Administration’s (FDA) enormous and complex record of drug interaction data reveals what can happen when patients take prescription drugs in combination. The FDA’s Adverse Event Reporting System (AERS) data, an ever-growing database of hundreds of thousands of drug reactions reported directly to the agency from health care professionals and consumers, provides valuable information about prescription drugs and their possible side effects. The new algorithm, however, unlocks more of the database’s potential by finding previously unknown relationships between different drugs and their consequences for patients. Russ Altman, ... Read More

Group offers support network for girls injured by Gardasil

Girls who believe they have been harmed by Merck’s human papillomavirus (HPV) vaccine and their families shouldn’t have to feel alone when dealing with the devastating effects many people believe the drug can have, thanks to an international outreach of volunteers who can help answer questions and provide emotional support. The Guardian Angels, a support group encompassing 23 states and eight countries (including the United States), is made up of 42 volunteers who share knowledge and even personal — in some cases tragic — experience with the Gardasil vaccine. “We would eventually like to have a Guardian Angel in every ... Read More

Despite risks, pediatrics group now recommends Gardasil vaccine for boys

The American Academy of Pediatrics (AAP) is now including Gardasil® on its list of recommended vaccines for boys as well as girls, claiming the vaccine can effectively prevent the spread of the human papillomavirus (HPV), which in rare cases can lead to genital warts and cervical cancer. It’s a significant win for manufacturer Merck, which had positioned the vaccine to be its next big moneymaker after it had to pull its blockbuster drug Vioxx from the market in 2004 over safety concerns. Although the AAP has maintained that Gardasil® is appropriate for boys, until now the shot has never been ... Read More

New recommendations for Gardasil vaccine may put boys at risk

Despite outcry from parents of girls who have received the HPV vaccine Gardasil, and criticism about the vaccine’s effectiveness from one of its own creators, this month the American Academy of Pediatrics endorsed its use for boys. This follows a similar recommendation from the Centers for Disease Control and Prevention (CDC). Critics of the vaccine, which has been linked to thousands of complaints of serious adverse side effects, are left to wonder why their voices are not being heard. When it was introduced by manufacturer Merck, Inc., in 2006, Gardasil was marketed as a preventative treatment for cervical cancer. A ... Read More

Overestimating benefits of HPV vaccines could lead to increased risks

A new study published in the Archives of Pediatric & Adolescent Medicine indicates girls who receive HPV (human papillomavirus) vaccines like Gardasil and Cervarix may overestimate the amount of protection the drug offers. According to the report, funded by the National Institutes of Health, some girls think they no longer have to practice safe sex after receiving the vaccination, or that they are protected from all types of HPV or protected from HPV indefinitely. In fact, vaccines such as Gardasil only protect against four of hundreds of types of HPV, and the vaccine’s effectiveness diminishes after about five to seven ... Read More