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Teen’s death prompts FDA warning for consumers to avoid pure caffeine powder

Logan Stiner was just days away from his high school graduation when he died after consuming a lethal dose of powdered caffeine. The teen’s death prompted a Food and Drug Administration (FDA) investigation resulting in the agency issuing a warning to consumers to avoid pure caffeine products, especially those sold in bulk bags over the internet. “A single dose is essentially 100 percent caffeine. A single teaspoon of pure caffeine is roughly equivalent to the amount in 25 cups of coffee,” the FDA warning stated. “Pure caffeine is a powerful stimulant and very small amounts may cause accidental overdose. Parents ... Read More

Pharmacy group wants black box warning added to antibiotic Levaquin

A University of South Carolina pharmacy group is petitioning the Food and Drug Administration (FDA) to put the strongest warning possible on Johnson & Johnson’s antibiotic Levaquin alerting consumers about the potential for cellular damage that could lead to serious diseases. The Southern Network on Adverse Reactions, a project of the South Carolina College of Pharmacy, says the public should be aware that the antibiotic commonly prescribed to treat infections can damage mitochondria that reside in the cells, resulting in mitochondrial toxicity, which is associated with Alzheimer’s disease, Parkinson’s disease, Lou Gehrig’s disease, and liver damage. Levaquin, also known as levofloxacin, ... Read More

Mislabeled ibuprofen, seizure drugs recalled

American Health Packaging (AHP) is recalling packages of the anti-inflammatory drug ibuprofen and the anti-seizure drug oxcarbazepine because the individual blister packs may be mislabeled and contain the wrong drug. Thus, patients prescribed oxcarbazepine may inadvertently take a dose of ibuprofen, and patients prescribed ibuprofen may inadvertently receive oxcarbazepine. Patients who miss a scheduled dose of oxcarbazepine are at an increased risk of having a seizure. And, inadvertent consumption of ibuprofen may cause side effects in patients for which the medication is contraindicated. The recall involves Lot #142588, Expiration Date, 01/2016 of ibuprofen tablets USP, 600 mg, in a hospital ... Read More

Hormonal contraceptives may increase risk of gestational diabetes

Women who use contraceptives that contain hormones before they become pregnant may be at greater risk for developing gestational diabetes once they do get pregnant, according to a new study. Researchers are quick to say more study is needed to confirm hormonal birth control products are a potential risk factor for gestational diabetes. But the study does raise questions about the safety of contraceptive hormone therapy. Gestational diabetes is a type of diabetes that occurs in pregnant women who have not been previously diagnosed with the disease. It is generally diagnosed in the second trimester and often controlled with a healthy diet ... Read More

Pre-diabetes diagnoses benefit drug companies more than patients

Non-diabetics with higher-than-recommended blood sugar levels and thus at risk for developing type 2 diabetes are considered pre-diabetic, however classifying large numbers of people with pre-diabetes offers more benefit to drug companies than those diagnosed with the condition, researchers argue. In an editorial published in the British Medical Journal, researchers with University College London and the Mayo Clinic in Minnesota said that labeling people as pre-diabetic increases the likelihood that they will be prescribed medication prematurely, which would at best only briefly delay the onset of illness. It would also prematurely expose them to potential side effects from the drugs. John ... Read More

Celexa, Lexapro birth defects lawsuits returned to state court

Fifteen lawsuits over birth defects in children born to women who took the antidepressants Celexa or Lexapro while pregnant were remanded to state court, a federal judge in Camden, N.J., ruled. Attorneys for the drugs’ maker Forest Laboratories unsuccessfully argued that federal jurisdiction was proper because there were questions about the Food and Drug Administration’s (FDA) labeling of the drugs. Defendants’ claims that Forest Research Institute was fraudulently joined as a defendant were rejected as well. The 15 lawsuits are among 20 that were filed in state courts in New Jersey and removed to federal court by the drug companies. ... Read More

Sleeping pills, anti-anxiety drugs send more people to the ER

Bad reactions to anti-anxiety medications and sedatives send more people to the emergency room than any other drugs, according to a new study published in JAMA Psychiatry. The findings come from an analysis of medical records from 63 hospitals from 2009 to 2011. Researchers noted that most of the ER visits involved adverse side effects or overdoses, and nearly 20 percent of those resulted in hospitalizations. The biggest problem-maker was the sedative zolpidem tartrate, the active ingredient in the brand-name sleep aid Ambien. The drug is available in other brands as well as in generic. The drug accounted for nearly ... Read More

FDA warns doctors, consumers not to use compounded drugs from Unique Pharmaceuticals

The Food and Drug Administration (FDA) is warning health professionals, pharmacies and consumers not to use drugs marked as sterile manufactured by Unique Pharmaceuticals Ltd., because they may be contaminated and using them may result in serious and potentially life threatening infections or death. The FDA conducted two recent inspections of Unique Pharmaceuticals and found unsanitary conditions that inspectors say could compromise the sterility of the purportedly sterile products, which puts patients at risk. The inspections revealed sterility failures in several lots of drug products intended to be sterile, reoccurring contamination problems, and poor sterile production practices. Unique Pharmaceuticals’ products ... Read More

Implantable birth control microchip to enter pre-clinical trials next year

A new implantable birth control device containing the hormone levonorgestral that lasts 16 years and can be turned off and on with a wireless remote is currently in development and will enter pre-clinical testing next year. The chip is designed to be implanted under the skin at the buttocks, upper arm, or abdomen, and if tests prove it to be safe and effective, the device could be on the market as early as 2018. The concept of a birth control chip originated two years ago when Bill Gates and his colleagues visited Massachusetts Institute of Technology (MIT) and asked technicians ... Read More

Hospira recalls intravenous fluid replacement due to mold contamination

Hospira Inc. is issuing a nationwide recall of one lot of Lactated Ringers and 5 % Dextrose Injection because a bag of the intravenous fluid replacement was found to be contaminated with mold. One customer reported seeing particulate within the solution of the primary flexible container of Lactated Ringers and 5% Dextrose Injection. “The particulate was identified as a filamentous-like structured particulate indicative of mold,” according to a Food and Drug Administration (FDA) safety communication. “Analysis of the primary container and overwrap indicated a puncture in the same physical location, causing the primary container to leak.” If a patient is ... Read More