Commonly, dangerous drugs are recalled when they have a defect that may result or has already resulted in harm to an individual consumer. According to the FDA, recalls are intended to remove the dangerous drug from the market in order to avoid harm to the consumer. The manufacturer can initiate a recall, the FDA can request the drug be recalled, or the law may mandate a recall. In addition to recalls, there may also be a market withdrawal or safety alert issued to the public in order to protect consumers against harm from a dangerous drug or medical device.… 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
Common falls can have an unpredictable impact on the bodies of older people. Falls are now recognized as complex, often preventable events with multiple causes and consequences, calling for a wide range of interventions, both psychological and physiological, that many patients never receive. Even falls that cause only minor can be a real warning sign that something serious is wrong.
A recent article in the New York TImes by John Leland on November 7, 2008, contained an interesting discussion about falls and the various outcomes that can result from them.Each year, 1.8 million Americans over age 65 are injured in … 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
Advocates for children are upset that Alloy Media and Marketing has run ads for prescription drugs from its Channel One website. Channel One provides free news and original programming to about 10,000 middle and high schools. Channel One is, in the opinion of many, a controversial in-school news program that makes viewing ads a compulsory part of the school day for grades six through twelve.
One of Channel One’s drug ads links to Acneheroes.com, a kid-targeted website created by the pharmaceutical company Sanofi-Aventis to promote BenzaClin, a prescription drug for acne. The website features actor Cody Linley, who introduces himself … Read the rest
The U.S. Food and Drug Administration said the number of deaths possibly associated with the drug heparin, made from pig intestines, had risen to 21 from 4. The reported number of those suffering adverse reactions increased from approximately 350 to 455. Both increases have been reported within just a 2 week time period. But the F.D.A. cautioned that many of those patients were already seriously ill and that the drug might not have caused their deaths.
Officials described the linkage of heparin to the additional 17 deaths as more tenuous than the 4 initially reported. Federal drug regulators said … Read the rest
The 8th annual national MEDMARX(R) Data Report released last month by the U.S. Pharmacopeia (USP) revealed that more than 1,400 commonly used drugs are involved in errors linked to drug names that look alike or sound alike. USP’s review revealed a near doubling since 2004 of the pairs of drug names that look or sound alike, from 1,750 pairs to 3,170 pairs.
According to findings in the MEDMARX report, 1.4% of the errors resulted in patient harm, including seven errors that may have caused or contributed to patient deaths. Medication errors are often the basis of medical malpractice cases.… Read the rest
Since Baxter International announced recently that it was suspending sales of its multidose vials of heparin after four patients died and 350 suffered complications including allergic reactions, many of them serious and potentially life-threatening, significant concerns have arisen as to the effectiveness of the U.S. Food and Drug Administration’s oversight of imported drugs. Baxter bought the active ingredient for heparin, which is derived from an enzyme in pig intestines, from Scientific Protein Laboratories, which produces heparin’s active ingredient in its factory in Changzhou, China.
Scientific Protein moved production to China three years ago because the country is the world’s largest … Read the rest
Merck and Schering- Plough, the makers of the popular cholesterol drug, Zetia, announced that Zetia and Vytorin, a pill containing Zetia and Zocor, had failed to benefit patients of a two-year trial which was completed in April of 2006. Merck and Schering-Plough’s press release stated that Zetia not only failed to slow down the accumulation of fatty plaque in the arteries, it contributed to the formation of plaque. Patients taking Vytorin to reduce the growth of fatty plaque in the arteries actually experienced a growth of plaque in their arteries twice as fast as those taking Zetia alone.
This … Read the rest