News you can use: health & drug safety updates
October 23, 2008
Half of U.S. doctors report using placebos several times a month, according to a study published in the British Medical Journal (BMJ). However, nearly 70% of those that use placebos described the treatment to their patients as “a potentially beneficial medicine not typically used for your condition.” Only 5% of doctors explicitly called it a placebo treatment. Most doctors used actual medicines as a placebo treatment: 41% used painkillers, 38% used vitamins, 13% used antibiotics, 13% used sedatives, 3% used saline injections and 2% used sugar pills.
October 23, 2008
A record number of deaths and serious injuries associated with drug therapy were reported to the U.S. Food and Drug Administration (FDA) in the first quarter of 2008. Serious injuries associated with drug therapy reached a total of 20,745 new cases; reported deaths totaled 4824 cases, a 2.6 fold increase from the previous quarter. In addition, varenicline (Chantix, Champix), an aid to stopping smoking, accounted for more reported serious injuries than any other prescription drug for a second quarter, a total of 1001 new cases, including 50 additional deaths. Varenicline was
October 15, 2008
Consumers and health care professionals can now go to a single page on the U.S. Food and Drug Administration’s Web site to find a wide variety of safety information about prescription drugs. The Web page,www.fda.gov/cder/drugSafety.htm, provides links to information in these categories:
- Drug labeling, including patient labeling, professional labeling, and patient package inserts;
- Drugs that have a Risk Evaluation and Mitigation Strategy (REMS) to ensure
October 13, 2008
We are saddened to report that the Hon. Paul G. Rogers, NCPIE’s founding Chairman, died Monday, October 13, 2008 in Washington, DC. He was 87.
October 8, 2008
Background: The Consumer Healthcare Products Association (CHPA), an association that represents most of the makers of nonprescription over-the- counter (OTC) cough and cold medicines in children, recently announced that its members are voluntarily modifying the product labels for consumers of OTC cough and cold medicines to state “do not use” in children under 4 years of age. Additionally, the manufacturers are introducing new child-resistant packaging and new measuring devices for use with the products.
October 1, 2008
23rd annual NCPIE “Talk About Prescriptions” Month observance works to improve medicine communication and reduce preventable adverse drug reactions.
September 28, 2008
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September 16, 2008
FDA Issues Warning Letters to Ranbaxy Laboratories Ltd., and an Import Alert for Drugs from Two Ranbaxy Plants in IndiaThe Food and Drug Administration (FDA) today issued two Warning Letters to Ranbaxy Laboratories Ltd., of the Republic of India, and an Import Alert for generic drugs produced by Ranbaxy’s Dewas and Paonta Sahib plants in India. The Warning Letters identify the agency’s concerns about deviations from U.S. current Good Manufacturing Practice (cGMP) requirements at Ranbaxy’s manufacturing facilities in Dewas and Paonta Sahib (including the Batamandi unit), in India. Because of the extent and nature of the violations, FDA today issued an Import
September 12, 2008
The Kaiser Family Foundation issued an updated fact sheet on Prescription Drug Trends. This updated fact sheet provides trend information about prescription drug expenditures and coverage, key factors that contribute to rising prescription spending, and efforts to contain certain rising drug costs.
September 3, 2008
to provide information for consumers and industry about how FDA regulates the promotion of medical products. The sites are:
- The “Advertising Prescription Drugs and Medical Devices” - this site provides a “one-stop shop” portal to information on FDA regulation of medical product promotion. Industry and policy users can get directly to relevant laws, regulations, and guidances.
- The “