On September 26, 2012, New England Compounding Center (NECC) recalled more than 17,000 steroids delivered to medical facilities in 23 states because of an outbreak of fungal meningitis suffered by patients injected with the contaminated product. Now this past week Med Prep Consulting, Inc. “voluntarily” recalled all lots of its products after being notified by a Connecticut hospital that it observed visible particulate contaminants confirmed to be mold in 50 ml bags of Magnesium Sulfate 2 grams in Dextrose 5% for Injection products compounded at its facility. Administration of an intravenous product found to be contaminated with mold could result in a fatal infection in broad array of patients.
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The recall applies to 359 different lots (as many as 359 million strips) of glucose test strips marketed under the following brand names: Precision Xceed Pro, Precision Xtra, Medisense Optium, Optium, OptiumEZ, and ReliOn Ultima. These strips are used with Abbotts blood glucose monitoring systems. The test strips being recalled may give falsely low blood glucose results. False results may lead patients to try to raise their blood glucose unnecessarily, or they may fail to treat elevated blood glucose because of a false, low reading. Both scenarios pose risks to a patients health.
The U.S. Food and Drug Administration recommends that special attention be paid to signs and symptoms of high blood sugar (hyperglycemia) and low blood sugar (hypoglycemia).-Symptoms of high blood sugar include excessive thirst, excessive urination, blur
Recall of Infant and Childrens Liquid Tylenol, Motrin, Zyrtec, and Benadryl: FDA Provides Advice to Consumers
Working in consultation with the United States Food and Drug Administration (FDA), McNeil Consumer Healthcare is implementing a voluntary recall of infant and childrens liquid products due to manufacturing deficiencies which may affect quality, purity or potency. Some of the manufacturing deficiencies include products that may contain a higher concentration of active ingredient than specified; others that contain inactive ingredients that may not meet internal testing requirements; and others that may contain tiny particles. Parents and caregivers are advised by the U.S. Food and Drug Administration to stop using these products. Instead, there a number of other products on the market, including generic versions of the recalled products, which are intended for use in infants and children and are not affected by the recall. The FDA states that the potential for serious medical problems is remote. However, if your child exhibits any unexpected symptoms after use of
Will Woody Johnsons New York Jets Fare Better in Today's Playoff Game Than His Pharmaceutical Company Did on Friday?
This afternoon the Jets face the San Diego Chargers for the chance to play the Indianapolis Colts in the AFC Championship Game. The Jets and their fans go into the game brimming with confidence and excitement. Butin a complaint filed Friday by the U.S. Attorney in Boston, prosecutorsalleged that health care giant Johnson & Johnson paid tens of millions of dollars in kickbacks so nursing homes wouldimproperly medicatemore patients on Risperdal, a powerful schizophrenia medicine, and other drugs - prescription pain relievers Duragesic and Ultram, and the antibiotic Levaquin. Although approved for treating schizophrenia and bi-polar disorder, Risperdal is not approved for use in elderly
Since the FDA Requires Corrective Language in TV Ad for Birth Control MedicationYaz, Why Not for Chantix as Well?
In a recent blog, we wondered why a television advertisement for the stop-smoking drug Chantix contained an exhaustive list of side-effects yet did not disclose that the drug was subject to a U.S. Food and Drug Administration (F.D.A.) black box warning. By virtue of this omission, a viewer might easily underestimate the seriousness of the televised side-effects. We honestly thought that Pfizer, the drugs manufacturer, would so tenaciously fight against mentioning the existence of a black box warning that its inclusion in an ad was not a realistic possibility. But shortly after this blog (maybe we are a bit behind), we viewed a television ad for the most popular birth control medication in the U.S., Yaz, that began, You may see some Yaz commercials that were not clear. The F.D.A. wants us to correct a few points in those a
Last week, just one week before the opening of Michael Moores new movie, Capitalism: A Love Story, the U.S. Food and Drug Administration (FDA) admitted what has been known for a while that its approval of the Menaflex device in December, 2008, came after intense political pressure from politicians made just months after they received significant campaign contributions from the manufacturer of Menaflex. In issuing its approval, the FDA overrode the agencys scientific reviewers who repeatedly and unanimously over many years decided that the device was unsafe because the device often failed, forcing patients to get another operation. This was the first time that the agency publicly questioned the process behind one of its approvals, admitted that a regulatory decision was influenced by politics, and accused a former commissioner of questionable cond
Should Television Ads for Chantix Be Required to State That Its Side Effects are the Subject of an FDA Black Box?
Yesterday morning an advertisement for smoking cessation drug Chantix came on my television. The ad featured a man extolling how much better his life is now that Chantix (and support, slips in the ad) has helped him kick his smoking habit. Then an announcer came on and read, for what seemed like an extraordinary time for the disclaimers usually heard on drug commercials, a litany of side-effects and warnings. These warnings included suicidal thoughts, personality changes, and skin rashes. The announcer did not state, however, that many of the side-effects announced are the subject of an FDA-mandated black box warning.
A black box warning is a type of warning that appears on the package insert for prescription drugs that may cause serious adverse effects. A black border usually surrounds the text of the
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 and bupropion and serious neuropsychiatric symptoms, in both patients with and those without previous history of psychiatric illness. The FDA first informed the public about the possibility of serious neuropsychiatric symptoms with Tagged with: Pharmaceuticals Dangerous Products Lawyer Chantix
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 FDAâ€™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 use of these three Zicam products.Â Â Many people experienced a loss of smell said the condition with the first dose; others reported a loss of the sense of smell after multiple uses. The active ingredient in Zicam is Zincum Gluconicum (Zinc Gluconate) which can cause nasal nerve damage.Â Â If you notice a burning sensation in the nasal cavity or a loss of smell or taste while using Zicam, stop usingÂ
A principal underlying assumption regarding limits on and ethics guidelines addressing pharmaceutical promotion is that smaller gifts are unlikely to exert influence on prescribing decisions. Nonetheless, a substantial body of marketing and psychology literature suggests that even trivial items can exert influence irrespective of economic value. Adding a small gift such as personalized mailing labels, a pen or a coffee mug to a solicitation for donations has been shown to significantly increase donations. These types of gifts can also influence prescribing behavior, according to a study that appears in The Archives of Internal Medicine. (Arch Intern Med. 2009;169(9):887-893). The experiment found that exposure to these items results in more favorable attitudes toward marketed products and that medical school policies that restrict pharmaceutical marketing mitigate this effect. The study was designed to measure the influence of exposure to branded promotional items on rel