Summertime is finally here! It is the best time of year for a family BBQ, which oftentimes involves hot dogs, hamburgers, and steaks. The most common staple at every summer cookout is hotdogs because they are quick and easy food to make. Recently, a popular hot dog brand company had its “dogs” recalled, due to concerns about safety.… Read the rest
The U.S. Food and Drug Administration (FDA) announced on July 1, 2009, that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) and to update the Medication Guides for patients that further discuss the risk of mental health events when using these products. The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal ideation and behaviors when taking these drugs.
The FDA has received additional information bolstering the suggestion of a possible association between both varenicline … Read the rest
In a press release dated June 16, 2009, the U.S. Food and Drug Administration (FDA) advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued “kids size” swabs. The FDA’s advisory stated that the products are associated with the loss of sense of smell, called anosmia.
Anosmia may be long-lasting or permanent. In addition to a loss of the sense of smell, patients have also complained of a loss of the sense of taste. The FDA has received more than 130 reports of loss of sense of smell associated with the … Read the rest
Recall after recall has resulted from the U.S. Food and Drug Administration (FDA) expansion of the Peanut Corporation of America’s (PCA) Salmonella related recall to include all peanut ingredient products produced in PCA’s Plainview, Texas facility since January 1, 2007. Just last week, the FDA announced recalls of 18 peanut-containing products because the products have the potential to be contaminated with Salmonella.
Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The government fails to inspect 95 percent of food processing plants. Referring to … Read the rest
In the first 10 months of 2008 the U.S. Food and Drug Administration (F.D.A.) received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them, according to a report from the federal Government Accountability Office (G.A.O.). Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations. The F.D.A. recently estimated that there are more than 50,000 minor and serious health problems a year related to dietary supplements.
For purposes of the G.A.O. report, dietary ingredient means an ingredient that is included in the dietary supplement definition in the Dietary Supplement Health and Education Act … Read the rest
The U.S. Food and Drug Administration warned clinical test giant Laboratory Corp. of America Holdings that it was marketing OvaSure, an ovarian cancer test, in violation of the law in that it did not have marketing clearance or approval from the FDA.
OvaSure measures six proteins in blood samples and calculates the chances that the woman has ovarian cancer. LabCorp made the $220 test available in June, under a provision that exempts tests developed and offered by a single lab from the usual FDA review. Thus OvaSure did not go through an FDA review.
But in a letter dated September … Read the rest
The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drugs containing papain must stop manufacturing these products on or before November 24, 2008, and must stop shipping such unapproved products on or before January 21, 2009, or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses, including eye inflammation, cloudy vision, permanent loss of visual acuity, a serious drop in blood pressure and increased heart rate.
Ophthalmic balanced salt solutions are used to irrigate the eye … Read the rest
Recent federal court filings in the Ortho Evra products liability litigation disclosed that Johnson & Johnson hid data from the FDA about their birth control patches’ side effects and failed to address flaws in the manufacturing process which could increase the risk of serious and potentially fatal problems.
The factual allegations were publicly released as part of the plaintiffs opposition to a motion by Johnson & Johnson to dismiss the claims of women injured by their birth control patch. The allegations include that Johnson & Johnson applied an apparently random correction factor of 60% to tests that measured the level … Read the rest
For several years the U.S. Food and Drug Administration has been reviewing a set of guidelines proposed in 2004 for advertising medical devices. Now, a television advertisement for a heart stent, metal mesh devices that are used to prop open arteries after they have been cleared of blockages, has been scrutinized and attacked in an op-ed article for failing to adequately warn consumers about the potential dangers of receiving a stent, including a ruptured coronary artery. The ad does warn of heart attack and stroke.
The ad for the Cypher stent, made by the Cordis subsidiary of Johnson & Johnson, … Read the rest
The U.S. Food and Drug Administration’s Ophthalmic Devices Panel convened last Friday to discuss post-LASIK surgery (laser-assisted in situ keratomileusis) quality-of-life issues. Of the 7.6 million people who have undergone the procedure in the United States since the mid-1990s, 140 have written letters of complaint to the FDA.
Approximately one in four people who seeks Lasik is not a good candidate. Perhaps 1 percent or fewer, suffer serious, life-changing side effects: worse vision, severe dry eye, glare, inability to drive at night. One young man committed suicide because of severe eye pain and fuzzy vision. Some patients have had to … Read the rest