Two more highly caffeinated energy drinks —marketed as dietary supplements—are being linked to serious injuries or deaths in reports to federal regulators. In the last four years, the Food and Drug Administration has received reports of 13 deaths that cited possible involvement of 5-Hour Energy, according to a report in The New York Times. The article said that since 2009, 5-Hour Energy has been mentioned in some 90 filings with the FDA, including more than 30 that involved serious or…
More High Caffeine Energy Drinks Cited in Injury Reports to FDA
Long-acting reversible contraceptives such as intrauterine devices (IUDs) and hormonal implants have been gaining popularity in the United States. According to a recent article in USA Today, the portion of women who rely on these types of contraceptives increased from 2.4 percent a decade ago to 8.5 percent in 2009. The trend toward long-acting contraceptives is likely to continue with the new federal health law requiring insurers to cover all contraceptive methods. Among the hormonal contraceptives mentioned in the article…
Nearly eight in 10 prescriptions filled in the United States are generic medicines, and the number is expected to increase through 2015 as patents expire on a number of popular drugs. Extended time-release medicines represent a growing portion of generic medications. It’s noteworthy that federal drug regulators announced the Food and Drug Administration will be looking more closely at the way pharmaceutical companies make extended time-release generic medications, as reported in a Nov. 1 article in The New York Times….
SimplyThick, an additive used to thicken formula and breast milk for babies, may increase the risk of infants’ developing life-threatening intestinal problems, the Food and Drug Administration warns. SimplyThick is a brand of thickening agent sold to consumers and medical centers used to manage infants’ swallowing difficulties. It is added to breast milk and infants’ formula to help premature babies swallow food and keep it down without spitting up. Expanding a previous safety warning, the FDA says in the latest…
The U.S. Food and Drug Administration issued a new safety announcement on Nov. 2 about the risk of serious bleeding associated with Pradaxa, a blood thinner prescribed to reduce the risk of stroke and blood clots in patients with non-valvular atrial fibrillation, a common heart rhythm abnormality. Since the approval of Pradaxa in October 2010, the FDA has received a large number of reports of bleeding among Pradaxa users. The FDA said its latest analysis indicates the rates of stomach…
Ameridose, a major supplier of sterile injectable medications to hospital pharmacies across the United States, is voluntarily recalling all of its unexpired products after an inspection by federal drug regulators raised concerns about potential contamination of the company’s products, the Food and Drug Administration said in a release. Most products distributed by Ameridose such as antibiotics, anesthetics and tranquilizers are represented as sterile products. The use of non-sterile injectable medications represents a serious threat to patient health and can cause…
Two studies published this year in highly respected medical journals add to the concerns about the contraceptive NuvaRing. A flexible plastic ring, NuvaRing is available by prescription and is inserted into the vagina. It prevents pregnancy by releasing hormones into the body over a three-week period that prevent ovulation. NuvaRing is known as a combination hormonal contraceptive because it contains both an estrogen and a progestin. There has long been a concern about the risk of serious cardiovascular complications for…
An unprecedented $3 billion settlement with a pharmaceutical manufacturer ranks as the largest health care fraud case in U.S. history. For people injured by unsafe drugs, it’s a strong reminder that drug manufacturers should be held accountable. According to the U.S. Justice Department release, pharmaceutical giant GlaxoSmithKline LLC agreed recently to plead guilty and pay $3 billion to resolve its criminal and civil liabilities stemming from the company’s unlawful promotion of prescription drugs Paxil and Wellbutrin and its failure to…
A recent article in The New England Journal of Medicine raises concerns about how long women at risk of osteoporosis should take bone-building drugs such as Fosamax. Fosamax is among a group of drugs known as bisphosphonates that are widely prescribed for osteoporosis, a disease characterized by increasing bone fragility and low bone density. The concern flagged in the systematic review by the Food and Drug Administration is that bone-building drugs may in rare cases lead to weaker bones in…
The pharmaceutical manufacturer Abbott Laboratories, Inc., was ordered this month to pay a $500 million criminal fine after pleading guilty to unlawful promotion of the prescription drug Depakote for uses not approved as safe and effective, the U.S. Justice Department announced in a press release. It’s the second largest criminal fine for a single drug. The criminal fine handed down by U.S. District Judge Samuel G. Wilson of the Western District of Virginia is part of a larger $1.5 billion…
