The FDA has granted marketing approval for a new generic estradiol/levonor-gestrel transdermal (skin patch) system (Climara Pro®) for the treatment of menopausal symptoms. This thin, translucent patch is the first once-weekly combined hormone therapy approved in the U.S. Schering’s U.S. subsidiary, Berlex, Inc., plans to launch Climara Pro® in January 2004.

The transdermal (patch) technology allows for a continuous delivery of hormones at doses much lower than those in pills. Easily affixed to the skin, Climara Pro® delivers 0.015 mg/day of levo-norgestrel and 0.045 mg/day of estra-diol. Estradiol canadian is the most active estrogen made by the ovary. This therapy is approved for the relief of moderate to severe vasomotor symptoms associated with menopause, such as hot flashes and night sweats.

Climara®, Schering’s once-weekly estrogen-only patch, is appropriate for women who have had a hysterectomy. With the addition of drug levonorgestrel, Climara Pro® is indicated for women with an intact uterus.

Abacavir sulfate (Ziagen®, GlaxoSmithKline), a nucleoside reverse tran-scriptase inhibitor (NRTI) used to treat human immunodeficiency virus 1 (HIV-1) infection in combination with other antiretroviral agents, is well tolerated except for the development of hyper-sensitivity reactions. These effects are the main reason for stopping the drug within the first months of therapy.

Abacavir can be associated with drugs that are known to induce allergic reactions in the Drug Reaction with Eosino-philia and Systemic Symptoms (DRESS) syndrome, such as nevirapine (Viramune drug, Roxane), efavirenz tablet (Sustiva canadian, Bristol-Myers Squibb), and generic cotrimoxazole (sulfamethoxazole medication/trimethoprim: Sep-tra®, Monarch/Bactrim®, Women First).

Gastrointestinal or respiratory symptoms that accompany a rash or fever suggest abacavir hypersensitivity, whereas rash with maculopapulous or morbilli-form eruption or bullous eruption is more common with generic nevirapine hyper-sensitivity, as are hepatic disorders.

If reactions worsen, drug therapy should be stopped. If symptoms resolve or do not worsen, the drug can be cautiously continued while other possible causes are investigated.

A new study suggests that five weekly infusions of a synthetic form of high-density lipoprotein-cholesterol (HDL, or “good,” cholesterol) can remove significant amounts of plaque from the arteries.

Approximately 25 to 30 years ago, researchers discovered 40 residents of Northern Italy who appeared perfectly healthy even though they had very low levels of HDL-cholesterol. Ordinarily, such people would have a high risk of heart disease, but these people did not. Intrigued, the researchers discovered that they had a variant in a protein known as apolipoprotein A-I, a component of HDL. This variant was named ApoA-I Milano (Esperion Therapeutics) after the city of Milan, where the initial laboratory work was performed. The company’s investigational treatment consists of a recombinant version of ApoA-I Milano plus a phospholipid.

The traditional therapies for atherosclerosis have focused on lowering levels of low-density lipoprotein-cholesterol (LDL-cholesterol). canadian cialis online

The ApoA-I Milano trial, which was con­ducted from November 2001 to March 2003, enrolled patients with acute coronary syndrome. All of the patients had experienced unstable angina or a heart attack. Patients were assigned to take a placebo, a low dose, or a high dose of intravenous recombinant ApoA-I Milano/phospholipid complex. The study drug was administered as a weekly IV infusion for a total of five weeks.

Patients who received the synthetic protein showed a dramatic decrease in arterial plaques, whereas a comparison group of patients who received saline showed no change.

More testing is needed, because the recent clinical trial was a small study.

Genentech, Inc., and Xoma, Ltd., have announced the approval of efalizumab (Raptiva™) by the U.S. Food and Drug Administration (FDA) for the treatment of chronic, moderate-to-severe plaque psoriasis in adults age 18 or older who are candidates for systemic therapy or phototherapy. This is the first biological agent that is designed to provide continuous control of the condition and that can be self-injected subcutaneously at home by patients once a week.

Psoriasis occurs when new skin cell growth rapidly accelerates, resulting in thick, red, scaly, inflamed patches on the skin surface. Plaque psoriasis, the most common form of the disease, is characterized by inflamed patches of skin (lesions) topped with silvery-white scales. Although several medications do help to control the symptoms of psoriasis, no cure is available.
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Raptiva™ is a humanized therapeutic antibody that selectively and reversibly blocks the activation, reactivation, and trafficking of T cells that lead to the development of psoriasis symptoms. Rap-tiva™ has demonstrated a rapid onset of action in reducing psoriasis-associated symptoms in some patients within four weeks of initiating treatment.

Adverse events included headache, infection (mostly upper respiratory), chills, nausea, pain, myalgia (muscle pain), flu syndrome, fever, back pain, and acne. Fewer than 1% of patients discontinued treatment because of acute adverse events.

Raptiva™ is an immunosuppressive agent and has the potential to increase the risk of infection and to reactivate latent, chronic infections. Many immuno-suppressive agents have the potential to increase the risk of malignancy. The role of Raptiva™ in the development of malig­nancies is not known.

The FDA has approved a New Drug Application for insoluble Prussian blue capsules (Radiogardase™) to treat people exposed to radiation contamination caused by harmful levels of cesium 137 or thallium. The capsules contain ferric hexacyanoferrate.

The approval of the Radiogardase™ application is part of the FDA’s continuing efforts to provide the American public with medical countermeasures in the event of a terrorist attack.

Radiogardase™ works by increasing the rate of elimination of these substances from the body. For several decades, Prussian blue has been used to enhance the excretion of cesium 137 and thallium from the body into the stool. Contamination with cesium 137 or thallium can occur through various routes, including ingestion, inhalation, or wounds, and can cause serious illness or death when high radiation doses are absorbed and delivered to critical organs. At lower doses, such contamination has been associated with the development of cancer.

Cesium 137 is widely used in industry and to treat certain cancers. Non-radioactive thallium is used in industry and as a rat poison. The radioactive form of thallium (²⁰¹l) is an approved drug for use in medical imaging procedures and is very safe at low doses.
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Contamination by cesium 137 is of particular concern because of its potential use as a component of conventional explosive devices containing radioactive material (“dirty bombs”). Although this radiological dispersal device is not a nuclear bomb, it can spread radioactive material and contaminate people and property.

Possible side effects include constipation and upset stomach. Treatment should begin as soon as possible after exposure to radioactive cesium or thallium. When the sources of radiation contamination are multiple or unknown, other drugs (such as potassium iodide) can be used together with Radio-gardase™.)

The FDA has approved Rexin-G™ (Epeius Biotechnologies), the world’s first tumor-targeted injectable gene therapy vector, as an orphan drug for pancreatic cancer.

Epeius has executed a screening agree ment with the National Cancer Institute to study the drug. The goal is to develop and commercialize the first effective targeted delivery system that can be injected directly into a vein to deliver genes and molecular therapeutics, preferentially, to cancerous tumors that have spread throughout the body without eliciting systemic side effects or organ damage.

Rexin-G™ is the first targeted inject-able gene therapy vector that has been approved by both the U.S. FDA and the Philippine FDA counterpart for use in phase I and II cancer clinical trials.

For clinicians who would like to simplify their patients’ HAART regimens (highly active retroviral therapies) by replacing the protease inhibitor (PI), nevirapine (Viramune drug, Boehringer Ingelheim) or efavirenz (Sustiva drug, Bristol-Myers Squibb Oncology) might be a better choice than abacavir (Ziagen®, Glaxo-SmithKline), according to the Nevira-pine/Efavirenz/Abacavir Study Team.

The researchers randomly assigned 460 adults who were virologically steady (maintaining plasma HIV-1 RNA levels below 200 copies/ml for at least six months) to switch from their current PI:

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