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FDA, CDC warn of illegal, fungus-contaminated eye surgery drug

The Food and Drug Administration (FDA) and the Centers for Disease Control and Prevention (CDC) are warning eye doctors that a drug used in eye surgeries known as Brilliant Blue G (BBG) is illegal and has caused fungal endophthalmitis, or eye infections, in some patients. Both federal agencies, along with local and state public health agencies, are actively investigating these adverse events. The BBG was supplied by Franck’s Compounding Lab in Ocala, Florida. The company issued a recall on March 9, 2012, of all lots of Brilliant Blue G and issued a recall letter. The drug is not approved for ... Read More

New program helps identify previously unknown drug reactions

Just because the Food and Drug Administration (FDA) approves a drug doesn’t mean it is safe. Sometimes adverse events, side effects, allergic reactions, or unsafe drug interactions occur after approval and it can take years before anyone ever realizes there’s a problem. But a new algorithm designed by United States scientists is helping researchers pore through databases with mountains of drug interactions and has yielded thousands of previously unknown side effects. The work, published this month in the journal Science Translational Medicine, is designed to dig through the countless adverse events reported to the FDA’s MedWatch database. When the FDA ... Read More

Surgery immediately after TBI may cause more harm than good

Skull reconstruction immediately following a traumatic brain injury (TBI) in which the skull is penetrated or indented can aggravate brain damage caused by the initial injury, according to a study conducted by researchers at the University of South Florida. The study was published this month in the online Journal of PloS ONE. Cesar Borlongan, the study’s principal investigator, describes the inflammation and subsequent swelling of the brain tissue that occurs immediately following TBI as a “double edged sword.” When the skull is initially penetrated, whether it be by a sharp object or even by blunt force, inflammation helps drive the ... Read More

New rules for heart scan aims to reduce excessive radiation exposure

Instructions for a recalled device and drug used to produce scans to evaluate the heart have been revised in an effort to determine what may have caused excess radiation in some patients. The CardioGen-82 PET scan, made by Bracco Diagnostics Inc., is used to perform cardiac positron emission tomography (PET) scans with the radioactive drug rubidium (Rb)-82 chloride injection to evaluate the heart. The Food and Drug Administration (FDA) has received reports of two patients who received more radiation than expected from CardioGen-82. The excess radiation was due to strontium isotopes which may have been inadvertently injected into the patients ... Read More

Study links SSRI use to dangerous pregnancy complication

Recent studies have shown that some types of antidepressants increase the risk for birth defects when mothers take them while pregnant. But new studies suggest that the medication may also cause problems with the pregnancy itself. The new study, published in the British Journal of Clinical Pharmacology found that pregnant women who use antidepressants known as selective serotonin reuptake inhibitors (SSRIs) have a slightly higher risk of developing dangerously high blood pressure, a condition known as preeclampsia that can be harmful for both mother and the unborn child. SSRIs are among the most prescribed medications in the United States, and ... Read More

Johnson & Johnson sold unapproved transvaginal mesh for years, report claims

Johnson & Johnson sold its Gynecare Prolift vaginal mesh for three years without obtaining approval for the product, according to a March 21 report by Bloomberg. The Prolift mesh, which the U.S. Food and Drug Administration (FDA) eventually approved for use in 2008, is now the source of about 550 personal injury lawsuits in the U.S., filed by women who allege the product malfunctioned and harmed them. To gain FDA approval, manufacturers of medical devices such as surgical mesh and bladder slings must demonstrate that the products either have passed required clinical tests for safety and efficacy or are sufficiently ... Read More

CDC to launch graphic anti-smoking campaign

Just a week after a federal judge formally blocked new rules by the Food and Drug Administration (FDA) requiring tobacco firms to put graphic images on packages of cigarettes, the federal government announced that it is launching its own campaign warning the public about the dangers of smoking. Some states have paid for anti-smoking advertisements, but this is the first time the federal government has bankrolled a public service campaign focused on driving down the number of Americans who smoke. The FDA tried to tackle the nation’s tobacco addiction and prevent teenagers from picking up the habit by establishing strict ... Read More

U.S., Canada, Mexico join efforts in poison prevention week

To young children, grandma’s heart medicine looks like an enticing piece of candy, and a bottle of brightly colored, citrus-scented floor cleaner promises to be a fun, fruity drink. The typical household is full of such deceptive poisons for children who can’t yet read, as evidenced by more than one million emergency phone calls involving poisoned children made to U.S. poison control centers every year. This week (March 18-24) marks the 50th anniversary of National Poison Prevention Week. To help call attention to the everyday dangers of household poisoning, the U.S. Consumer Products Safety Commission has teamed with its Canadian ... Read More

UK advisory panel recommends approval of controversial Pradaxa

Boehringer Ingelheim GmbH’s blood thinner Pradaxa has won the recommendation from the United Kingdom’s medical-cost regulator as a treatment to prevent strokes in patients with a life threatening type of irregular heartbeat. The recommendation was made in spite of concerns that the drug may increase the risk of fatal bleeding episodes. Pradaxa, which comes in tablet form, offers an alternative to warfarin, which has been on the market for nearly 50 years. Unlike warfarin, Pradaxa does not require frequent blood tests to monitor treatment. UK’s National Institute for Health and Clinical Excellence (NICE) said its recommendation is based on trials ... Read More

Florida school fired whistleblower who voiced safety concerns, OSHA says

PALMETTO, FL–The Manatee School for the Arts in Palmetto, Florida, is being sued by the U.S. Occupational Safety and Health Administration (OSHA) for firing an employee who blew the whistle on alleged safety hazards at the school. According to OSHA, the employee submitted a letter to his supervisor on June 20, 2009, warning of improperly placed extension cords and the lack of sprinkler systems in the Manatee School’s two theaters. School authorities never responded to the letter or the concerns it expressed. The employee then filed a complaint with OSHA on July 14, and on July 30 regulators from OSHA’s ... Read More