New indication for Oncaspar given OK
July 31st 2006The PEG-enhanced version of L-asparaginase, pegaspargase (Oncaspar, Enzon Pharmaceuticals), has been approved by the FDA as a component of a multi-agent chemotherapeutic regimen for the first-line treatment of patients with acute lymphoblastic leukemia (ALL). The biologic was approved in 1994 only for patients with ALL who were allergic to L-asparaginase.
Pearly sheen not just for nail polish
July 31st 2006The FDA has given the go-ahead to EMD Chemicals, a division of Merck KGaA, to market pigments that make pharmaceuticals more ?sthetically pleasing. The pearlescent pigments can produce a metallic, stained, or shimmery finish in tablets and liquids, and they come in different colors.
Risk of heart failure found with Gleevec
July 31st 2006A study published in the July 23 issue of Nature Medicine found that patients with chronic myelogenous leukemia (CML) receiving imatinib (Gleevec, Novartis) are at increased risk for heart failure. Researchers found that the ABL enzyme that is turned off by imatinib is actually a necessary component in maintaining the health of cardiac muscle cells.
New biologic approved for Hunter syndrome
July 31st 2006Replacement enzyme idursulfase (Elaprase, Shire Human Genetic Therapies) has been approved by the FDA as the first treatment for Hunter syndrome (mucopolysaccharidosis II), a rare disease in which the body cannot produce iduronate-2-sulfatase. The enzyme is necessary to break down complex sugars produced in the body, and its deficiency can lead to growth delay, coarsening of facial features, and joint stiffness
New report shows treatment for drug abuse is worthwhile
July 31st 2006A recently released report from the National Institute on Drug Abuse (NIDA) shows that effective treatment of drug abuse and addiction can take a bite out of crime and save communities money. Principles of Drug Abuse Treatment for Criminal Justice Populations is based on a review of the scientific literature on drug abuse treatment and criminal behavior, according to NIDA.
GAO: Genetic tests bought on-line often misleading
July 31st 2006The Government Accountability Office has found that four genetic tests purchased from four Web sites mislead consumers by making predictions that are medically unproven and so ambiguous that they do not provide meaningful information to consumers. GAO purchased tests from four Web sites and created fictitious consumers by submitting for analysis 12 DNA samples from a female and two samples from an unrelated male.
New doxycycline capsule cleared for rosacea
July 24th 2006CollaGenex Pharmaceuticals received approval from the Food & Drug Administration in late May to market Oracea. According to the company, this is the first systemically delivered treatment for the treatment of rosacea. Affecting an estimated 14 million adults in the United States, rosacea is a dermatological condition characterized by papules and pustules, erythema, and telangiectasia.
Disetronic D-TRONplus Power Packs recalled
July 24th 2006Disetronic Medical Systems and the FDA announced a voluntary nationwide recall of the Disetronic D-TRONplus Power Packs, which power the D-TRON Insulin Pump. There is the potential that the power pack could shut down the D-TRONplus Insulin Pump without any warning.
Will Takeda's DTC campaign cause spike in Rozerem Rxs?
July 24th 2006Pharmacists may wake up to a rise in prescriptions for insomnia medication Rozerem (ramelteon), as Takeda Pharmaceuticals North America gets set to launch its first DTC campaign for the medication. The campaign, which includes print, on-line, and broadcast ads, carries the theme "Your Dreams Miss You."
Calif. bill requires proper disposal of home-generated sharps
July 24th 2006California Senate Bill 1305 has been passed. The new law requires the proper disposal of home-generated sharps waste (syringes, needles, lancets, etc.) and acknowledges mail-back programs as one of the most convenient alternatives for the collection and destruction of home-generated sharps.
Illinois launches initiative to require e-prescribing
July 24th 2006Illinois Gov. Blagojevich has launched a patient safety initiative aimed at reducing medication-related errors by requiring all healthcare providers to use "e-prescribing" paperless doctor prescriptions. The initiative creates a division of patient safety within the Illinois Department of Public Health focused on reducing medical mistakes, developing standard medication practices to reduce adverse drug interactions, and creating on-line physician databases so patients can check out their doctors.
Bill may force military families to use mail order
July 24th 2006The House and Senate are considering a bill that would force many U.S. military families to fill most of their prescriptions through mail order. The TRICARE provisions of the Defense Authorization Act are headed for a House-Senate conference after different versions of the bill passed in each chamber.
NCPA outraged at low reimbursement for generic Zocor
July 24th 2006Complaints from NCPA members have been steadily building over low maximum allowable cost (MAC) reimbursement from Express Scripts for generic Zocor. According to NCPA, it has received numerous reports that Express Scripts, one of the largest PBMs in the country, has set a MAC for simvastatin at approximately two-thirds of the pharmacy acquisition price.
ALF issues warning on dangers of excess acetaminophen
July 24th 2006The American Liver Foundation (ALF) has issued a warning based on a recent study dealing with the effects of high doses of acetaminophen on the liver. The study, published recently in the Journal of the American Medical Association, showed that healthy adults who took the maximum recommended dose of acetaminophen for two weeks had drastically increased liver enzyme levels, which could lead to liver damage.
SmartCare centers to open in Fred Meyer stores
July 24th 2006SmartCare Family Medical Centers, a Colorado-based operator of retail healthcare centers, has signed a partnership agreement with the Fred Meyer Division of the Kroger Co. to open its SmartCare Centers inside sports stores located in Alaska, Idaho, Oregon, and Washington. SmartCare Centers will open centers in Seattle this fall.
Free trial program for hemophiliacs
July 24th 2006Bayer Healthcare has announced the launch of a program designed for patients with hemophilia A. The Kogenate FS with Bio-Set Free Trial Program will allow enrollees to receive up to six free infusions of the product delivered to their home or location of choice.
R.Ph. accused of making false insurance claims
July 24th 2006Pharmacist William Schobert, who used to work at Nugent's Apothecary, in Medford, N.J., could face up to 20 years in prison for allegedly creating more than 500 false prescriptions for himself and his family members. Investigators have charged that he sought reimbursement to the tune of $80,000 for the fake claims over a two-year period from his insurer.
FDA issues warning on treatment of depressed mothers-to-be
July 24th 2006Results from two recent studies have led the FDA to notify healthcare professionals and consumers to new concerns about treating pregnant women who take antidepressants. One study showed that women who stopped taking their antidepressants were five times more likely to experience a relapse of their depression during pregnancy compared with those who continued to take the medication.
FDA Safety Page: Mucomyst and Mucinex name confusion
July 24th 2006The FDA wants to alert healthcare providers about name confusion between Mucomyst and Mucinex. These errors may be occurring due to the increased off-label use of Mucomyst for the prevention of acute renal failure associated with radiographic contrast media. To date, all errors reported to the FDA MedWatch system occurred during the prescription order, transcription, and product selection phases of inpatient medication use. No adverse events were reported as a result of these errors.
FDA: Many barriers remain on generic biologics
July 24th 2006The generic pharmaceutical industry has been at odds with the Food & Drug Administration over several key issues lately, including authorized generics, facilitating the development of more generic agents, and approving generic biopharmaceuticals. At a recent conference in New York City sponsored by the Pharmaceutical Care Management Association (PCMA), Scott Gottlieb, M.D., deputy commissioner for medical and scientific affairs at FDA, attempted to clarify the agency's position on several hot-button topics.
Most states now allow collaborative practice
July 24th 2006When the Governor signed the legislation in May, New Hampshire became, by at least one count, the 41st state to permit pharmacists to enter collaborative practice agreements with physicians. But no one knows for sure how many pharmacists are taking advantage of the professional privilege.
New guidelines issued for Parkinson's disease
July 24th 2006At the American Academy of Neurology's (AAN) 58th annual meeting in April, new guidelines were released for the diagnosis and treatment of Parkinson's disease (PD). The recommendations were later published in the April 11, 2006, issue of Neurology as four separate practice parameters.