GlaxoSmithKline has announced the accelerated approval of nelarabine (Arranon®) Injection by the FDA. This chemotherapy agent is indicated for the treatment of patients with T-cell acute lymphoblastic leukemia and T-cell lymphoblastic lymphoma whose disease has not responded to, or has relapsed following treatment with, at least two chemotherapy regimens.

This use is based on the induction of complete responses. Randomized trials demonstrating increased survival or other clinical benefits have not been conducted. Postmarketing evaluation will be pursued though a randomized, multi-center, phase 3 trial.
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In December 2003, nelarabine received a “fast track” designation and was later granted orphan drug status. In September 2005, the FDA’s advisory committee voted to recommend that the FDA grant accelerated approval of nelarabine for both children and adults.

Novo Nordisk Inc. has announced the FDA’s approval of insulin detemir injection of rDNA origin (Levemir®) for use in children. This basal (long-acting) form of insulin lasts for up to 24 hours and causes little weight change in adults.

It is indicated for once-daily or twice-daily subcutaneous administration for adults and children with type-1 diabetes mellitus or adults with type-2 diabetes mellitus who require long-acting insulin to control hyperglycemia.

This product was approved for use in adults in June 2005.

The FDA has approved the marketing of tamoxifen oral solution (Soltamox™, Savient) for the treatment and prevention of breast cancer. This is the first liquid form of drug tamoxifen to be available in the U.S.

This product has caused uterine cancer, strokes, and blood clots, but the benefits may outweigh the risks in women who already have breast cancer. It should not be used in women who need a coumarin-type anticoagulant. Cataracts may also be more common with the use of this drug. Adverse reactions include hot flashes and vaginal discharge.

Myoclonic movements and pain on injection are common problems during induction of anesthesia with etomidate (Amidate^®, Bedford Labs). Researchers from Turkey, investigating ways to pre-treat the pain, randomly assigned 100 patients to four groups: ketamine 0.2 mg/kg, ketamine 0.5 mg/kg, magnesium sulfate 2.48 mmol, and normal saline.

Pre-treatment with magnesium sulfate reduced the incidence and intensity of myoclonic movements; 19 patients (76%) had none. By contrast, 18 patients (72%) in the 0.5-mg ketamine group, 16 (64%) in the 0.2-mg ketamine group, and 18 (72%) in the control group had myoclonic movements.

After magnesium treatment, 64% of patients experienced mild-to-moderate pain associated with the etomidate injection. However, both doses of ketamine provided better pain relief; at the lower dose, 44% of the patients experi­enced pain, and at the higher dose, only 28% of patients had pain.

Despite the better analgesia, however, ketamine did not effectively reduce myo-clonus. At the higher dose, it caused mild-to-severe sedation in all patients and respiratory depression in 80% of patients.

The researchers say that this is the first reported clinical study showing that pre-treatment with magnesium reduces myoclonic muscle movements without any adverse effects.

The FDA has approved updated labeling for Ortho-McNeil’s contraceptive patch, Ortho Evra^®, to warn health care providers and patients that this product exposes women to higher levels ofestrogen than most oral contraceptives. Ortho Evra^® was the first skin patch approved for birth control.

The patch releases the estrogen hormone ethinyl estradiol and the drug progestin hormone norelgestromin through the skin into the bloodstream.

Women taking this product should consult their health care providers to balance the potential risks related to increased estrogen exposure against the risk of pregnancy if they do not follow the daily regimen associated with typical birth control pills. Because the patch is changed once a week, it decreases the chance that one or more daily doses might be missed, as may occur with birth control pills.

The new bolded warning states that users of the product are exposed to about 60% more estrogen than if they were taking a typical birth control tablet containing 35 mcg of estrogen. However, the maximum amount of estrogen to which women are exposed is about 25% lower with Ortho Evra® than with the tablets.

The FDA is continuing to monitor safety reports for problems with the patch.

Telephones; hallway conversations; announcements; heavy rolling equipment and carts; waking patients up for meals, medications, and checks for vital signs; intercoms; pagers; televisions; and medical monitoring equipment may make it impossible for patients to rest in a hospital.

Johns Hopkins University acoustical engineers have found that hospital noise levels have grown steadily over the past five decades, disturbing patients and staff members, raising the risk of medical errors, and hindering efforts to modernize hospitals with speech-recognition systems. Some studies even show that excessive noise can slow healing and contribute to stress and “burnout” among hospital workers.

During a two-year research project, acoustics experts learned that noise is among the top complaints of patients and hospital staff members, but little is being done to address the problem.

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The federal government is warning Medicare Part D beneficiaries about a telephone scam in which they are being asked to supply checking account information. The scam is known as the “$299 Ring,” because that is the usual amount of money being forfeited to pay for a phony drug plan. The CMS warns that no legitimate Medicare Prescription Drug Plan can ask for bank account or other personal information over the phone. No one should be visiting their home uninvited, and no one should be asking for payment over the phone or via the Internet.
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