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Examples of recent “popular” articles posted include:

For more information see:

http://www.medscape.com/mostpopular/profession/pharmacists/toprated

FDA notified healthcare professionals and patients that the antidepressant Celexa (citalopram hydrobromide) should no longer be used at doses greater than 40 mg per day because it can cause abnormal changes in the electrical activity of the heart. Changes in the electrical activity of the heart (prolongation of the QT interval of the electrocardiogram [ECG]) can lead to an abnormal heart rhythm (including Torsade de Pointes), which can be fatal. Patients at particular risk for developing prolongation of the QT interval include those with underlying heart conditions and those who are predisposed to low levels of potassium and magnesium in the blood.

Studies did not show a benefit in the treatment of depression at doses higher than 40 mg per day. Previously, the citalopram drug label stated that certain patients may require a dose of 60 mg per day. The citalopram drug label has been revised to include the new drug dosage and usage recommendations, as well as information about the potential for QT interval prolongation and Torsade de Pointes. See the FDA Drug Safety Communication Data Summary for additional information.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm269481.htm

Related articles

• Antidepressant Tied to Dangerous Heart Rhythm (nlm.nih.gov)
• Celexa (citalopram Hydrobromide) At Over 40mg Per Day Linked To Abnormal Heart Rhythm Risk, Warns FDA (medicalnewstoday.com)

A recent study suggests that consuming dark chocolate and cocoa products may lower low-density lipoprotein (LDL or “bad cholesterol”) and total cholesterol levels.

Cocoa and chocolate are derived from the cacao bean. Chocolate flavonoids, which are found in the highest amounts in dark chocolate, have been studied for a variety of potential health benefits.

Researchers analyzed 10 clinical trials with a total of 320 participants. Subjects in the trials were treated with coca from dark chocolate for 2-12 weeks.

After treatment with dark chocolate and cocoa products, trial participants in short-term studies experienced an average decrease in LDL of 5.9 milligrams per deciliter of blood and an average decrease in total cholesterol of 6.23 milligrams per deciliter of blood. No significant changes were found for high-density lipoprotein (HDL or “good cholesterol”) or triglyceride levels.

Researchers found a greater benefit in cholesterol reduction in short-term treatment versus long-term studies. Though a benefit was seen in longer-duration trials, results were not significant. Authors also concluded that consuming dark chocolate was more effective than drinking cocoa beverages.

Though promising, additional research is needed. For more information about cocoa, please visit Natural Standard’s Foods, Herbs and Supplements database.

http://naturalstandard.com/news/news201108031.asp

The shortage of cancer drugs, which has been on the rise since 2010, stems from several factors, according to Valerie Jensen, the associate director of the Drug Shortage Program at the FDA’s Center for Drug Evaluation and Research, in an interview with MSN. Those factors include problems at manufacturing plants, such as contamination; late delivery of raw materials; and misprints in drug labels and packaging.

MSN suggested that delayed inspections by the FDA after problems arise might also contribute to shortages, though Jensen disagreed.

On its Drug Shortages Website, the FDA writes that:

“These shortages occur for many reasons, including manufacturing and quality problems, delays, and discontinuations. FDA is aware that in 2010 there was a record number of shortages and in 2011 FDA has continued to see an increasing number of shortages, especially those involving older sterile injectable drugs”

http://news.consumerreports.org/health/2011/08/fda-says-cancer-drug-shortage-is-getting-worse.html

Related articles

• Shortage of cancer drugs hits Atlanta (ajc.com)
• US Sees Dangerous Shortage of Cancer Drugs (newser.com)
• Letter: Cancer Drug Shortages: 2 Senators’ View (nytimes.com)

Selection of Notable Mutations

Vanderbilt-Ingram Cancer Center has launched the nation’s first personalized cancer decision support tool, “My Cancer Genome,” to help physicians and researchers track the latest developments in personalized cancer medicine and connect with clinical research trials for their patients.

This web-based information tool is designed to quickly educate clinicians on the rapidly expanding list of genetic mutations that impact different cancers and, at the same time, enable them to more easily research various treatment options based on specific mutations.

My Cancer Genome is the latest addition to VICC’s Personalized Cancer Medicine Initiative, which was unveiled last year.

“Next-generation, or genetically informed cancer medicine, holds the promise of tailoring anti-cancer treatment according to individual patient tumor characteristics,” said William Pao, M.D., Ph.D., associate professor of Medicine and director of Personalized Cancer Medicine at VICC.

“Staying abreast of these fast-paced research changes may be difficult for time-pressed oncologists and medical caregivers. In particular, knowledge about rare variants found in cancers may be hard to track down, especially in busy clinics. We launched this web-based tool to enable a genetically informed approach to cancer medicine that we believe can be more efficient and effective.”

http://www.vicc.org/news/2011/03/vicc-launches-genetic-research-tool/

The next Drug Enforcement Administration (DEA) National Prescription Drug Take-Back Day will take place Saturday, October 29, 2011, from 10 AM to 2 PM, and will be the third event coordinated by DEA to help consumers safely dispose of unused, unneeded, and expired prescription medications, including controlled substances. More than 309 tons of pills were turned in at collection sites across the US during the first two DEA National Prescription Drug Take-Back Days held September 25, 2011 and April 25, 2011, illustrating the continued need for a safe, convenient means for consumers to dispose of unwanted medications. Nearly 4,000 state and local law enforcement agencies throughout the nation partnered with DEA to provide take-back sites. Disposing of unwanted medications helps prevent the drugs from being misused, abused, or diverted from patient’s medicine cabinets. DEA will provide an online drug take-back site locator in the fall. More information about the upcoming DEA Prescription Drug Take-Back Day is available on the DEA web site.

http://www.nabp.net/news/third-dea-national-prescription-drug-take-back-day-in-october/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+NabpNewsroom+%28NABP+Newsroom%29

Related articles

• Combating Misuse and Abuse of Prescription Drugs: Q&A (everydayhealth.com)
• Six-plus tons of prescription drugs collected in DEA take-back program (boston.com)

“The fake online pharmacy crisis has reached an epidemic level – they prey on prescription drug abusers and the most vulnerable members of society who rely on medicine every day for their health,” said NABP President Malcolm J. Broussard, RPh. “They offer easy access to potent medicines without a prescription and indiscriminately push dangerous counterfeit drugs. This problem poses a clear danger to Americans’ health and safety and weakens the essential relationships between pharmacists and patients. By issuing a public health alert, we are calling on pharmacists, physicians, and other health professionals to educate their patients about the growing public health threat posed by these illegal online enterprises.”

http://www.nabp.net/news/nabp-issues-rogue-online-pharmacy-public-health-alert/?utm_source=feedburner&utm_medium=feed&utm_campaign=Feed%3A+NabpNewsroom+%28NABP+Newsroom%29

The U.S. Food and Drug Administration today approved the blood-thinning drug Brilinta (ticagrelor) to reduce cardiovascular death and heart attack in patients with acute coronary syndromes (ACS).

ACS includes a group of symptoms for any condition, such as unstable angina or heart attack, that could result from reduced blood flow to the heart. Brilinta works by preventing the formation of new blood clots, thus maintaining blood flow in the body to help reduce the risk of another cardiovascular event.

Brilinta has been studied in combination with aspirin. A boxed warning to health care professionals and patients warns that aspirin doses above 100 milligrams per day decrease the effectiveness of the medication.

“In clinical trials, Brilinta was more effective than Plavix in preventing heart attacks and death, but that advantage was seen with aspirin maintenance doses of 75 to 100 milligrams once daily,” said Norman Stockbridge, M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research.

The boxed warning also says that, like other blood-thinning agents, Brilinta increases the rate of bleeding and can cause significant, sometimes fatal, bleeding. The most common adverse reactions reported by people taking Brilinta in clinical trials were bleeding and difficulty breathing (dyspnea).

Brilinta was approved with a Risk Evaluation and Mitigation Strategy, a plan to help ensure that the drug’s benefits outweigh its risks. As part of that plan, the company must conduct educational outreach to physicians to alert them about the risk of using higher doses of aspirin. In addition, Brilinta will be dispensed with a Medication Guide that informs patients of the most important information about the medication. The guide will be distributed each time a patient fills their prescription.

Brilinta is made by AstraZeneca of Wilmington, Delaware.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm263964.htm

Model of the Influenza Virus

The influenza vaccine formulation that will be used for the 2011–12 vaccine has been approved by FDA. The formulation will be used by the six manufacturers that are licensed to produce and distribute influenza vaccine for the United States market.

FDA, the World Health Organization, CDC, and others in the public health community study virus samples and patterns from all over the globe to identify the strains that are likely to cause the most illness during the next influenza season. That information and the recommendations of FDA’s Vaccines and Related Biological Products Advisory Committee resulted in the following strains being selected for the 2011–12 season:

• A/California/7/09 (H1N1)-like virus (pandemic (H1N1) 2009 influenza virus)
• A/Perth/16/2009 (H3N2)-like virus
• B/Brisbane/60/2008-like virus

According to FDA, the formulation for the 2011–12 vaccines protects against these three virus strains and includes the same virus strains used for the 2010–11 season.

Each year, between 5% and 20% of Americans develop influenza, and more than than 200,000 hospitalizations occur from flu-related complications, according to CDC. Deaths from influenza in the United States can range from about 3,000 to 49,000 people on a yearly basis.

The manufacturers and brand names of vaccines for the upcoming season are as follows:

• CSL Limited: Afluria
• GlaxoSmithKline Biologicals: Fluarix
• ID Biomedical Corporation: FluLaval
• MedImmune Vaccines Inc.: FluMist
• Novartis Vaccines and Diagnostics Limited: Fluvirin
• Sanofi pasteur: Fluzone, Fluzone High-Dose, and Fluzone Intradermal (approved on May 9, 2011, Fluzone Intradermal will be available for patients aged 18 through 64 years and is delivered into the skin, rather than muscle, using a microinjection [i.e., very small needle] system).

FDA asked that health care organizations encourage members to follow CDC’s Advisory Committee on Immunization Practices recommendations to get vaccinated. ACIP recommends that everyone 6 months or older receive an annual influenza vaccination. Additional information on the ACIP recommendations is available here.

Other influenza resources

• Consumer site for flu information
• Influenza vaccine safety and availability
• List of strains included in 2011–12 influenza vaccine
• CDC seasonal influenza webpage
• CDC intradermal influenza vaccination webpage

http://www.pharmacist.com/AM/Template.cfm?Section=Home2&CONTENTID=26412&TEMPLATE=/CM/HTMLDisplay.cfm