News you can use: health & drug safety updates
August 24, 2006
The U.S. Food and Drug Administration (FDA) today announced approval of Plan B, a contraceptive drug, as an over-the-counter (OTC) option for women aged 18 and older. Plan B is often referred to as emergency contraception or the “morning after pill.” It contains an ingredient used in prescription birth control pills—only in the case of Plan B, each pill contains a higher dose and the product has a different dosing regimen. Like other birth control pills, Plan B has been available to all women as a prescription drug. When used as directed, Plan B effectively and
July 14, 2006
FDA Warns Consumers About Dangerous Ingredients in "Dietary Supplements" Promoted for Sexual EnhancementThe U.S. Food and Drug Administration (FDA) is warning consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These products are promoted and sold on web sites as “dietary supplements” for treating erectile dysfunction (ED) and enhancing sexual performance, but they are in fact illegal drugs that contain potentially harmful undeclared ingredients. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their
July 10, 2006
The National Council on Patient Information and Education (NCPIE) has joined with 28 leading healthcare organizations to improve hospital care in the United States to ensure that all cardiac patients receive care consistent with nationally accepted standards. The new coalition—the Alliance for Cardiac Care Excellence (ACE) — includes leaders from the American Hospital Association, the Centers for Medicare & Medicaid Services, the Agency for Healthcare Research and Quality, the American Heart Association, the American College of Cardiology, the Heart
June 14, 2006
The U.S. Food and Drug Administration (FDA) and the Institute for Safe Medication Practices (ISMP) today launched a nationwide health professional education campaign aimed at reducing the number of common but preventable sources of medication mix-ups and mistakes caused by the use of unclear medical abbreviations. The campaign focuses on eliminating the use of potentially confusing abbreviations by healthcare professionals, medical students, medical writers, the pharmaceutical industry and FDA staff. The campaign will address the
May 22, 2006
An independent panel convened by the NIH Office of Medical Applications of Research and the Office of Dietary Supplements assessed the available evidence on the safety and effectiveness of multivitamin/minerals (MVMs). The panel made recommendations regarding certain specific supplements but ultimately concluded that more rigorous scientific research is needed before strong recommendations can be made regarding MVM use to prevent chronic diseases. The panel’s findings pertain to the generally healthy population, and do not include pregnant women, children, or those with disease.
May 4, 2006
Medicaid spending for outpatient prescription drugs increased by 20 percent per year on average from 1997 to 2002, jumping from $11.6 billion to $23.7 billion during that period, according to a new study by HHS' Agency for Healthcare Research and Quality. The increase reflects a rise in both the number of prescriptions written for Medicaid enrollees-from 301 million in 1997 to 429 million in 2002-and the rapid uptake of newer classes of drugs, which are often more expensive The increase also reflected rapidly growing spending on behalf of
April 26, 2006
FDA notified healthcare professionals and patients that cases of breathing problems, some causing death, have been reported to the FDA when the drug was used in children less than two years old. Parents and caregivers should also be careful and get a doctor’s advice about giving promethazine HCl in any form to children age two and older. The labeling on all products, brand name and generic, has been changed to reflect these strengthened warnings.
April 25, 2006
The Food and Drug Administration (FDA) lacks a clear and effective process for making decisions about and providing management oversight of post-marketing drug safety issues, the Government Accountability Office (GAO) said today. There is a lack of criteria for determining what safety actions to take and when to take them,” GAO stated. Squabbling between FDA’s Office of New Drugs (OND), the office that approves the marketing of medications, and the Office of Drug Safety (ODS), which oversees post-marketing safety reviews, has hindered the
March 13, 2006
The U.S Food and Drug Administration (FDA) is advising healthcare professionals and consumers that filling U.S. prescriptions abroad may give patients the wrong active ingredient for treating their health condition. Some FDA-approved products have the same brand names as drug products that are marketed outside the U.S. but contain completely different active ingredients. In addition, 105 U.S. brand names are so similar to foreign brand names used for products with different active ingredients that patients who fill prescriptions abroad may inadvertently get
January 30, 2006
There is a new, potential alternative for many of the more than 5 million Americans who take insulin injections, with the Food and Drug Administration’s approval today of the first ever inhaled insulin. Exubera, an inhaled powder form of recombinant human insulin (rDNA) for the treatment of adult patients with type 1 and type 2 diabetes, is the first new insulin delivery option introduced since the discovery of insulin in the 1920s. Diabetes is a disease that affects the amount of insulin and sugar in your body.