Clinical News

New safety information has been added to the label for the HIV antiviral drug saquinavir (Invirase, Genentech), describing potentially life-threatening side effects on heart function when used with ritonavir (Norvir, Abbott Laboratories), another HIV antiviral medication, FDA announced.

FDA is requiring a labeling change and Medication Guide to warn patients and healthcare providers about the possible risk of atypical thigh-bone (femoral) fracture in patients who take bisphosphonates for the prevention and treatment of osteoporosis.

For women with epilepsy, the risk of infertility increases with each additional antiepileptic drug, and more than one-third may be unable to conceive, according to research published online October 11 in Neurology and reported by HealthDay News.

Older cancer patients who receive intravenous bisphosphonate therapy may be at a modestly increased risk for atrial fibrillation (AF), supraventricular tachycardia (SVT), and stroke, according to research published online October 12 in the Journal of Clinical Oncology, HealthDay News reported.

Bromfenac ophthalmic solution (Bromday, ISTA Pharmaceuticals) 0.09% has been granted FDA approval as a once-daily prescription eyedrop for the treatment of postoperative inflammation and reduction of ocular pain in patients who have undergone cataract extraction.

In patients with chronic knee pain due to osteoarthritis, 60 mg to 120 mg of duloxetine hydrochloride, a serotonin-norepinephrine reuptake inhibitor (SNRI), administered daily, was found to provide both significant pain control and improve physical functioning.

FDA has approved onabotulinumtoxinA (Botox, Allergan Inc.) injection to prevent headaches in adult patients with chronic migraine. To prevent chronic migraine, onabotulinumtoxinA is injected about every 12 weeks in multiple sites around the head and neck to try to dull future headache symptoms.

FDA has approved acetaminophen injection (Ofirmev, Cadence Pharmaceuticals), the first intravenous formulation of acetaminophen for the management of mild-to-moderate pain, moderate-to severe-pain with adjunctive opioid analgesics, and the reduction of fever.

FDA approved trastuzumab (Herceptin, Genentech) for use in combination with cisplatin and capecitabine or 5-fluorouracil to treat patients with human epidermal growth factor receptor 2-overexpressing metastatic gastric or gastroesophageal junction cancer who have not received prior treatment for metastatic disease.

Dabigatran etexilate (Pradaxa, Boehringer Ingelheim) has received FDA approval for the prevention of stroke and blood clots in patients with atrial fibrillation.

APP Pharmaceuticals, Inc., a wholly owned subsidiary of Fresenius Kabi Pharmaceuticals Holding, Inc., will launch its new APP Drug Hotline on Wednesday, November 10, 2010.

An updated consensus statement on the management of hypertension among African Americans places significant emphasis on a comprehensive assessment and appropriate risk stratification of individual patients with hypertension, stated a report published online October 4 in Hypertension, HealthDay News reported.

In a new randomized, placebo-controlled clinical trial published in the October 13, 2010 Journal of the American Medical Association, trial investigators demonstrated that the use of buprenorphine implants (Probuphine, Titan Pharmaceuticals) could reduce opioid use over a 24-week study period.

According to the findings of the DECISIONS survey study published in a September/October supplement of Medical Decision Making, Americans frequently find themselves faced with high blood pressure, high cholesterol, and depression medication decisions that they are ill prepared to make.

According to the findings of the DECISIONS survey study published in a September/October supplement of Medical Decision Making, Americans frequently find themselves faced with high blood pressure, high cholesterol, and depression medication decisions that they are ill prepared to make.

A growing body of evidence links use of proton pump inhibitors to increased risk of nosocomial Clostridium difficile infection and other morbidities.

The former commander of U.S. and international forces in Afghanistan, General Stanley McChrystal, will be the keynote speaker for the 12th Annual National Association of Chain Drug Stores (NACDS) Foundation Dinner on November 30, 2010, in New York City.

The American Pharmacists Association has announced 6 new 2010 offerings of the Pharmacy-Based Immunization Delivery certificate program.

"Know Your Medicine, Know Your Pharmacist" is the theme of American Pharmacists Month (APhM). Sponsored by the American Pharmacists Association, APhM is a time to recognize the significant contributions to healthcare made by pharmacists around the country.

The National Community Pharmacists Association announced a new division of the association dedicated to advancing the interests of independent long-term-care pharmacy providers.

The California Pharmacists Association has appointed Jon Roth its new CEO.

The National Institutes of Health awarded ScriptPro a contract to provide pharmacy automation systems to assist in the internal control and identification of drugs and to enhance the safety and efficiency of medication dispensing as well as use by patients.

Four acute-care hospitals have chosen ROBOT-Rx, an automated medication-dispensing and pharmacy-integration system manufactured by McKesson Corp., as part of a total bar-code-based pharmacy system for medication safety and operational efficiency.

With this issue of Drug Topics' e-newsletter, we expand our OTC Product Update page to showcase products and product news that fell outside the parameters of recently featured categories or ran up against space limitations in the print edition. Look for more OTC Product News in upcoming issues of the Drug Topics e-newsletter!

Pfizer plans to acquire King Pharmaceuticals for $3.6 billion in cash, expanding its current portfolio of treatments for pain relief and pain management.

The Arnold & Marie Schwartz College of Pharmacy and Health Sciences at Long Island University's Brooklyn campus and the Liberty Partnership Program debuted a "Future Pharmacists Program" this past summer.

Taking Care of Myself: A Guide for when I Leave the Hospital/Como cuidarme: Guia para cuando salga del hospital, is a new, bilingual guide produced by the Agency for Healthcare Research and Quality (AHRQ), to help hospitals reduce their rates of readmission by better preparing patients before they leave the hospital.

The Accreditation Council for Continuing Medical Education, the Accreditation Council for Pharmacy Education, and the American Nurses Credentialing Center have jointly awarded accreditation to the Institute for Healthcare Improvement and VHA Inc.

The C.A.R.E.S. Alliance, a new patient-safety organization sponsored by Covidien, recently launched a range of online tools designed to help solve the growing problem of misuse and abuse of opioids by identifying the risks associated with these medications.

From the National Institute for Occupational Safety and Health: "Preventing Occupational Exposure to Antineoplastic and Other Hazardous Drugs in Health Care Settings," an approach to handling hazardous drugs safely.