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Adults with diabetes may now have an alternative to some of the insulin injections they must now take.

Exubera (Pfizer), a powder form of recombinant human insulin, represents the first new method of delivery since the hormone’s discovery in the 1920s. Pfizer developed the drug and dispenser with Sanofi-Aventis and Nektar Therapeutics.

The device, about the size of an eyeglass case, delivers insulin as a dry powder, packaged in 1- or 3-mg inhalable capsules, to the lungs through the mouth. In clinical trials, it controlled glucose levels as effectively as injected insulin. However, its use does not mean the elimination of needles, pens, or pumps. Needles allow better dosage control.

An FDA review panel expressed concern about the bulkiness of the dispenser. Some patients using the drug experienced coughing or a slight decrease in lung capacity. buy antibiotics amoxicillin

Patients with type-1 and type-2 diabetes can use the rapid-acting, inhaled insulin before or after meals, but the device would not replace the longer-acting insulin injections that some patients, especially those with type-1 diabetes, need to take in the morning or before bed. Patients must continue pricking their fingers to test blood glucose levels.

Patients with poorly controlled or unstable lung disease, or who smoke or who have recently quit, should not use Exubera.

The FDA has tentatively approved Stavudine for Oral Solution, 1 mg/ml (Aurobindo Pharma Ltd., India). This antiretroviral agent is the first generic version of Generic Zerit Oral Solution (Bristol-Myers Squibb). This child-friendly agent is indicated for pediatric patients with HIV infection, from birth through adolescence.

Stavudine medication (d4T) helps to prevent the AIDS virus from reproducing. It is used in combination with other antiretroviral agents to treat HIV-1 infection.

The first immune globulin product for subcutaneous injection to prevent serious infections in patients with primary immune deficiency diseases (PIDDs) has been approved.

Vivaglobin (ZLB Behring GmbH, Germany) is manufactured from human plasma collected at U.S. licensed plasma centers. It is given under the skin on a weekly basis via an infusion pump. Patients can self-administer the product at home. Other immune globulins are given intravenously or intramuscularly.
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As with all immune globulin preparations, the plasma must be tested and found to be nonreactive for the human immunodeficiency virus (HIV) and hepatitis viruses prior to its use, and the manufacturing process includes steps that further reduce the risk of transmission of viruses.

The Heart Rhythm Society is recommending changes in how medical device manufacturers and the government oversee implanted heart devices, such as defibrillators and pacemakers. The group is requesting that (1) companies use outside experts to help them decide when to issue alerts about potential safety problems; (2) doctors test a heart unit at the time of a patient’s death to see whether it played any role; (3) the FDA create forms to track reports of problems; and(4) a consistent way be found to alert doctors and patients to defects.
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A study from Oulu University Hospital indicates that aspirin use may double the risk of death in patients with intra-cerebral hemorrhage (ICH). Regular aspirin use was a significant independent predictor of death within the first three months after the index stroke; it was also significantly associated with early hematoma growth.

The researchers evaluated 208 patients with ICH; 44 had used aspirin, 26 used warfarin (Generic Coumadin, Bristol-Myers Squibb), and 138 used neither. On hospital admission, the warfarin users had significantly larger hematomas than the aspirin users and non-users. In the 47 patients with an ICH score of 2 or higher, 55% had a Glasgow Coma Scale score of 3-4, 40% had a score of 5-12, and 74% had a hematoma volume of 30 cm³ or more.

Most patients (89%) had intraventric-ular hemorrhages, and 13% had infra-tentorial hemorrhages. Twenty-five percent were 80 years of age or older; these patients were also more likely to be taking aspirin.

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An FDA advisory panel has voted 9-2 against approving Eli Lilly’s cancer drug gemcitabine (Gemzar) to treat advanced ovarian cancer.

The panel said that the data did not support this use for the drug, which has already been approved in the U.S. to treat lung, pancreatic, and breast cancers.

Lilly is seeking to market Gemzar for relapsed cases of advanced ovarian cancer when used with the chemotherapy drug carboplatin. The FDA will make a final decision, but it usually follows the recommendation of its advisory panels.

Although company officials said the goal was to prevent the cancer from worsening, not to help patients live longer overall, most panel members said they were not convinced that the goal was worth their support.

Raloxifene (Evista tablet, Eli Lilly), which is indicated for preventing and treating osteoporosis in postmenopausal women, seems to work as well as tamoxifen citrate (Nolvadex medication, AstraZeneca) in reducing the risk of invasive breast cancer.

In the National Cancer Institute’s Study of Tamoxifen and Raloxifene (STAR) trial, raloxifene and tamoxifen reduced the risk of invasive breast cancer by about 50% in women at high risk for the disease; however, raloxifene did not lower the risk of earlier forms (lobular and ductal carcinomas in situ), which can become invasive. In those cases, tamoxifen is known to decrease that risk by half.

Women who took raloxifene 60 mg daily and who were monitored for about four years had 36% fewer uterine cancers and 29% fewer blood clots than the women who were assigned to take tamoxifen 20 mg. Raloxifene was also less likely than tamoxifen to cause cataracts. Women taking either drug had equivalent numbers of strokes, heart attacks, and bone fractures.

Eli Lilly is expected to apply to the FDA for permission to market raloxifene for breast cancer prevention in high-risk postmenopausal women.