Level 2 results of the National Institute of Mental Health's STAR*D trial show that 25% of patients who switched to a new antidepressant after having no response to the SSRI citalopram in Level 1 became symptom-free within 14 weeks. Of the 1,439 patients studied, 727 were switched to sertraline (Zoloft, Pfizer), bupropion-SR, or venlafaxine-XR (Effexor-XR, Wyeth) and the improvement of depression was similar for each of the three drugs.
After reviewing data on ADHD drugs and their propensity to cause psychosis, mania, aggression, or cardiovascular side effects in children, the FDA's Pediatric Advisory Committee told the agency that black box warnings are not necessary, but rather warnings should be rewritten in a language that is better understood. This decision follows a recommendation in February from the agency's Drug Safety & Risk Management Advisory Committee to add the strongest possible warning regarding cardiovascular risk.
GlaxoSmithKline is attaching radio frequency identification (RFID) tags to all bottles of its HIV drug Trizivir (abacavir/lamivudine/zidovudine) distributed in the United States as part of a patient safety pilot project. Glaxo chose Trizivir for the pilot because it's on NABP's list of the 32 drugs most susceptible to counterfeiting and diversion.
The Federal Trade Commission plans to investigate the likely short- and long-term competitive effects of authorized generic versions of brand drugs. FTC staffers have been authorized to subpoena about 80 drug companies, 10 authorized generic companies, and 100 independent generic manufacturers.
Previously approved in 1998 to treat bladder cancer and discontinued in 2002 by then-manufacturer Anthra Pharmaceuticals, valrubicin (Valstar) may make another debut, this time from Valera Pharmaceuticals. Valera has just completed its acquisition of the NDA for the drug, and the company said it hopes to have the product available by the end of 2006.
A new guide has been published by the CDC in part to aid clinicians with the difficult task of diagnosing tick-borne rickettsial diseases (TBRDs). According to the agency, the incidence of these diseases has risen in the past 10 years, causing severe illness and death in adults and children in the United States despite the fact that the conditions are easily treated with antibiotics in the early stages.
The National Comprehensive Cancer Network (NCCN) has announced new guidelines for the diagnosis, treatment, and prevention of venous thromboembolic (VTE) disease. According to the organization, cancer patients are at high risk for VTE, which could lead to a deadly pulmonary embolism if not recognized and treated appropriately.
Disetronic Medical Systems has announced a voluntary nationwide recall of faulty Accu-Chek Ultraflex insulin infusion sets following a recent increase in complaints of fully or partially separated luer lock tubing connections. The company is advising customers to examine their infusion sets at the luer lock tubing connection every three hours and before bedtime for possible insulin leakage.
A new survey that NCPA faxed to 5,000 pharmacies found that even though some Medicare Part D problems have moderated since the drug benefit started in January, many problems remain. Out of 525 pharmacies that responded to the survey, more than nine out of 10 respondents said their cash flow is worse than before the drug benefit started.
Cardinal Health has sold its pharmacy staffing business to Soliant Health. The wholesaler's pharmacy staffing unit provides temps and direct hires for retail and hospital pharmacies and other practice settings out of four locations?Boston; West Palm Beach, Fla.; Houston, Texas; and Irvine, Calif.
With an ear out for pharmacy owners hollering that allowing logos on Part D Rx cards tilts the playing field toward their big chain rivals, the Centers for Medicare & Medicaid Services has proposed tightening the rules for co-branding Medicare drug plans. And the agency also wants to hear whether co-branding should be outlawed altogether.
Pharmacists, patient advocacy groups, and drugmakers are trying to revive the latest unintended victim of Medicare Part D?patient assistance programs, or PAPs. Most manufacturers are cutting back on free or discounted pharmaceuticals distributed under PAPs because of potential conflicts with antikickback laws.
President Bush nominated acting FDA commissioner Andrew vonEschenbach, M.D., to permanently head the agency. Eschenbach, whoalso heads the National Cancer Institute, may faceconflict-of-interest charges at his confirmation hearings, andSenate Democrats have threatened to hold up his confirmation overFDA's inaction on OTC status for the emergency contraceptive PlanB. NCPA and NACDS had no comment on the Eschenbach nomination, butAPhA views him as an "excellent choice."
Wyeth is launching "Dialogues: Time to Talk," a nationwide program for Spanish-speaking patients with depression who are taking Effexor XR (venlafaxine HCl). Patients who enroll in the program will receive educational materials.
President Bush nominated acting FDA commissioner Andrew vonEschenbach, M.D., to permanently head the agency. Eschenbach, whoalso heads the National Cancer Institute, may faceconflict-of-interest charges at his confirmation hearings, andSenate Democrats have threatened to hold up his confirmation overFDA's inaction on OTC status for the emergency contraceptive PlanB. NCPA and NACDS had no comment on the Eschenbach nomination, butAPhA views him as an "excellent choice."
Community Care Rx, the Part D plan created by NCPA, has enrolled more than one million Medicare beneficiaries in its three plan offerings. CCRx will roll out its medication therapy management (MTM) component in June, using pharmacists for face-to-face patient consultation.
Signing up at the rate of 380,000 per week, more than 27 million Medicare beneficiaries are now enrolled in the Part D drug plan, according to CMS. Only about seven million of the enrollees are individuals who have signed up voluntarily.
Just when Biogen Idec and Elan were hoping for the red light to turn green, it changed to yellow instead, as the FDA announced it would wait up to another 90 days before giving its final decision on the reintroduction of natalizumab (Tysabri). According to the FDA, extensions such as this often occur after a manufacturer submits a major amendment to the existing application, requiring extra time for the agency to review.
Seattle-based Bartell Drugs announced the purchase of Fairwood Pharmacy, a family-owned drugstore serving the Renton, Wash., area since 1970. With the acquisition, Bartell Drugs will own and operate 53 stores in King, Pierce, and Snohomish counties. The store will operate under the Bartell Drugs banner.
Kroger Co. has filed a civil antitrust lawsuit against Sanofi-Aventis, Bristol-Myers Squibb, and Apotex Inc., alleging the three drugmakers have entered into an illegal settlement of a patent lawsuit involving the blood thinner, Plavix (clopidogrel). In documents filed in the U.S. District Court in the Southern District of Ohio, Kroger said the three drug firms, in settling a dispute over the patent for Plavix, agreed to keep the patent protection for the drug in place until 2011.
Wyeth is launching "Dialogues: Time to Talk," a nationwide program for Spanish-speaking patients with depression who are taking Effexor XR (venlafaxine HCl). Patients who enroll in the program will receive educational materials.
CMS began notifying 500,000 Medicare beneficiaries enrolled in two Part D plans that they must indicate which plan they wish to use for their drug benefit. Beneficiaries who want to remain in their original plan must contact the insurer, while beneficiaries who do nothing will be dropped from their original plan and remain covered by the second plan.
A group of seven drug plans has filed a class action lawsuit against Pfizer Inc., claiming the company used off-label promotion of atorvastatin (Lipitor) to boost sales. According to New York-based Grant & Eisenhofer, P.A., the securities litigation firm representing the group, the plaintiffs contend that Pfizer's physician and hospital marketing materials have misrepresented treatment protocols established by the National Cholesterol Education Program's Adult Treatment Panel III (ATP III), and that the drug was approved by the FDA only for use in accordance with ATP III.
Which were the top 10 branded biotech drugs in 2005? In descending order, they are Procrit, followed by Aranesp, Epogen, Neulasta, Remicade, Enbrel, Rituxan, Lupron Depot, Lantus, and Avastin.
Since 1998, the Food & Drug Administration has had theregulatory authority to require pharmacies to distribute MedicationGuides to patients getting certain high-risk drugs. MedGuides,which provide written information to patients on their Rxs, areprepared by drug manufacturers and approved by the FDA. To date,the FDA lists more than 75 drugs on its Web site that require thedistribution of a MedGuide from a community pharmacy or uponhospital discharge. They include antidepressants, nonsteroidalanti-inflammatory drugs (NSAIDs), and others. Manufacturers ofthese high-risk drugs are responsible for ensuring that asufficient number of MedGuides are available in pharmacies.
The Food & Drug Administration would like to alert healthcare practitioners to three cases of medication dispensing errors in which the Alzheimer's medication Razadyne (galantamine, Janssen Pharmaceutica) was dispensed instead of the insomnia agent Rozerem (ramelteon, Takeda Pharmaceuticals) to geriatric patients. In two cases the wrong drug was actually administered to the patient but with no reported adverse outcomes, while the third error was caught prior to patient administration. Errors between these products could result in unnecessary adverse events or lack of efficacy.
Pharmacists say Medicare Part D caused chaos in their pharmacies at start-up; they hope for better days ahead
Among the sources of confusion accompanying the implementation of Medicare Part D is the distinction between drugs covered under Part B and Part D. CMS officials held a teleconference late in January to listen to provider concerns, answer questions, and correct misinterpretation.
The third echinocandin to hit the market in five years, anidulafungin (Eraxis, Pfizer) received Food & Drug Administration approval in February and joins both caspofungin (Cancidas, Merck) and micafungin (Mycamine, Astellas Pharma) in the fight against fungal infections in seriously ill patients. Anidulafungin is indicated to treat candidemia, other forms of Candida infections (intra-abdominal infections and peritonitis), and esophageal candidiasis.