The FDA Drug Safety and Risk Management Advisory Committee voted 8 to 7 in favor of adding a black box warning to the labeling of all stimulant drugs used to treat ADHD. The group also voted unanimously (15-0) in support of requiring that FDA medication guides be distributed with each stimulant prescription, explaining the potential risks to patients and their families.
The FDA has recalled all brands of Balanced Salt Solution manufactured by Cytosol Laboratories in Braintree, Mass., after product lots were found to have high levels of endotoxin. The solution is used to irrigate the eyes, ears, nose, and throat during surgical procedures.
There is more to choosing drugs for the intensive care unit than cost. How effective a particular agent is may be even more important than how much it costs.
Want to reduce errors in the pediatric critical care unit and other patient care areas? Slow down!
The results of a new study indicated that a previously uncommon strain of Clostridium difficile has become more resistant to fluoroquinolones.
A 76-year-old woman, D.N., is hospitalized with a severe E. coliurinary tract infection (UTI). She has taken ciprofloxacin 500 mgevery 12 hours and is responding to it. Prior to admission, becauseshe is allergic to sulfamethoxazole, D.N. was taking amoxicillinwhich has been discontinued. D.N. takes digoxin 0.125 mg andpravastatin (Pravachol, Bristol-Myers Squibb) 20 mg daily. Over thepast 24 hours, she developed severe diarrhea and a 101?Ftemperature. Her stool specimen is positive for C. difficile. D.N.is receiving replacement fluids and electrolytes, but her physicianis considering how to resolve the C. difficile infection. What doyou recommend?
The American Academy of Allergy, Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI) recently updated their practice parameter, "The diagnosis and management of sinusitis," for the first time since it was originally released in 1998.
Until now, patients with primary immunodeficiency (PI) were treated with intravenous immunoglobulin (IVIg) infusions, which were inconvenient and associated with serious adverse side effects, such as migraine headaches.
The Food & Drug Administration has announced a new format for prescription drug labeling that will organize the most important information needed by healthcare providers in a more accessible and easy-to-read fashion, according to the agency. But what may have started as an effort to decrease the 300,000 preventable adverse drug events that occur each year, has led some groups to accuse the FDA of attempting to protect manufacturers from consumer liability suits.
Less than 1% of outpatients who received medication in 2002 were prescribed a medicine that violated a prescription drug's black box warning, according to a study in the Feb. 13 issue of Archives of Internal Medicine. Researchers examined data from 51 outpatient practices and analyzed electronic health records of 324,548 outpatients who received at least one prescription between Jan. 1 and Dec. 31, 2002.
A study published in the Feb. 9 edition of the New England Journal of Medicine suggesting that the popular supplement saw palmetto is ineffective in easing problems associated with an enlarged prostate has several flaws, according to the National Nutritional Foods Association (NNFA). NNFA cited a substantial existing body of clinical studies, some with larger patient populations, that support the efficacy of this supplement for mild to moderate symptoms associated with benign prostatic hyperplasia (BPH).
The Partnership for Prescription Assistance (PPA) unveiled a national advertising campaign targeting the American Hispanic community to help draw attention to the free or nearly free medicines available to Americans in need. Montel Williams, syndicated talk show host, is the official national PPA spokesman.
McKesson Specialty, a subsidiary of McKesson Corp., has been certified by Celgene Corp. as one of a select group of RevAssist Program contract pharmacies to launch Revlimid (lenalidomide). To reduce fetal exposure to the drug, Revlimid is available only through RevAssist, a distribution network employing only certified, contracted specialty pharmacies.
Merck has launched an initiative to help consumers navigate government and private programs that offer free or discount medicines to low-income patients. The company's "Guide to Affordable Medicine" includes information about public programs, such as Medicaid and Medicare, and private programs, such as prescription assistance programs offered by drugmakers.
Sanofi-Aventis has voluntarily recalled 30 batches of syringes containing the anticoagulant Lovenox (enoxaparin), because of a problem related to the syringe-filling process. The company said the recalled syringes may contain too much of the active ingredient enoxaparin.
Bottles of fruit juice that appeared to be tampered with were found at a CVS store near where dozens of churchgoers in Connecticut recently fell ill. The bottles contained several different brands and types of juice and were found during an inventory check, according to police.
Benzocaine sprays used for numbing the mouth and throat are being investigated by the FDA for their tendency to cause methemoglobinemia, a condition in which the red blood cells are unable to carry oxygen. Until recently, the FDA considered the incidence of methemoglobinemia with these products to be low; however, new reports have prompted the agency to review all available safety data.
Cardinal Health has released a new software version for its Alaris System intravenous pumps, adding safety features and expanding the range of situations in which the pumps can be used.
Drug Mart, Tallman, N.Y., has filed a suit against Becton, Dickinson (BD), accusing the firm of "anti-competitive and illegal" behavior.
Patient advocate Betsy McCaughey gives hospitals and government a failing grade on infection control. As founder and chairman of the Committee to Reduce Infection Deaths, or RID, she calls infection control in most American hospitals "shoddy."
Delmarva, Medicare's Quality Improvement Organization for Maryland and the District of Columbia, has announced the winners of its Medicare Quality Excellence Awards. The hospital award recognizes the top 10% of institutions that improve the most in the composite of a set of 10 performance measures: five acute myocardial infarction (AMI), two congestive heart failure (CHF), and three pneumonia measures.
Radiological services encompass a broad array of diagnostic and treatment modalities used in patient care and performed by various healthcare practitioners. The number of radiological procedures performed in the United States per year has been estimated at 300 million, of which 20% involve a radiological pharmaceutical.
Missed laboratory tests recommended for safety monitoring is a serious problem, according to recently published studies supported by the Agency for Healthcare Research & Quality. One study showed that 47%, 45%, and 44% of patients did not receive one or more recommended lab tests over three years. Another showed that 49.6% of all prescriptions that should have been accompanied by a lab test at the time the drug was prescribed were not.
Research reported at the 47th Annual Meeting and Exposition of the American Society of Hematology, held recently in Atlanta, featured upbeat findings for a new multiple myeloma agent for leukemia patients and found evidence supporting much wider prophylaxis against venous thromboembolism.
To commemorate its 50th anniversary, the Avon Foundation recently sponsored a global research symposium in New York City titled "Breast Cancer 2005: From Discovery to Delivery." There were a number of significant takeaways from the meeting.
The Coalition for Pulmonary Fibrosis (CPF) has issued the first-ever treatment guidelines for idiopathic pulmonary fibrosis (IPF) based on medical evidence. The guidelines, developed with Cerner Health Insights, were published in the October 2005 issue of the Journal of Sarcoidosis, Vasculitis, & Diffuse Lung Diseases.
The pharmaceutical management of hypertensive patients during oral surgery requires controlling patient stress and anxiety and knowing the uses and adverse interactions of antihypertensive drugs, according to recently released guidelines by the American Association of Oral and Maxillofacial Surgeons (AAOMS).
Staring down the barrel of $6.3 billion in state and federal Medicaid reimbursement cuts over the next five years, NCPA and NACDS have vowed to take community pharmacy's case to HHS and the states, which must write regulations and implement the changes.
