News you can use: health & drug safety updates
November 25, 2008
Comments on a study examining the impact on consumer comprehension of inclusion of a toll-free number to report side effects in direct-to-consumer (DTC) prescription drug television advertisements are being sought by FDA. The study will examine the placement of the toll-free statement and the length of time the statement is presented on-screen in a DTC television advertisement for a prescription drug. Federal Register Pre-Publication Notice
October 31, 2008
More and more U.S. children are being given drugs to fight chronic conditions such as asthma and hyperactivity, according to a study published on Monday. From 2002 to 2005 prescriptions for medicines to treat type-2 diabetes doubled, asthma medications rose by more than 46 percent, medicines for attention-deficit hyperactivity disorder increased by more than 40 percent and prescriptions for cholesterol-lowering drugs were up by 15 percent. The study was conducted by Emily Cox of Express Scripts Inc. in St. Louis, a manager of pharmacy insurance
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