The Food and Drug Administration (FDA) has announced the accelerated approval of gefitinib (Iressa^TM, Astra-Zeneca) tablets as a single-agent treatment for patients with advanced non-small cell lung cancer (NSCLC), the most common form of lung cancer in the U.S. Cancer of the lung and bronchus is the leading cause of cancer death in men and women in the U.S. NSCLC accounts for almost 80% of lung cancers.

The drug is intended for patients whose cancer has continued to progress despite chemotherapy with platinum and docetaxel (Taxotere®, Aventis), the two drugs that are currently the standard of care for this disease.

The drug was developed to block growth stimulatory signals in cancer cells. These signals are mediated, in part, by enzymes called tyrosine kinases. The drug blocks several of these tyrosine kin-ases, including one associated with epidermal growth factor receptor (EGFR).

The FDA has approved laronidase (Aldurazyme®, BioMarin), the first treatment for certain forms of a rare genetic disease called mucopolysaccharidosis I (MPS I), which includes Hurler’s syndrome. This disease results from the absence or malfunctioning of an enzyme that breaks down molecules called glycosaminoglycans (GAG) in the cells. The buildup of GAG results in progressive cellular damage that affects appearance, physical abilities, organ function, and, in some cases, mental development.
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In one study, treated patients showed improved lung and walking capacity in a six-minute walking test after 26 weeks.

The most serious adverse drug event was an anaphylactic (allergic) reaction approximately three hours after infusion. Safety concerns related to infusion reactions included flushing, fever, headache, and rash.

The recent “black-box” warning about life-threatening prolongation of the QT interval caused by droperidol (Inapsine®, Akorn/Taylor) use has probably come as a surprise to emergency-department physicians and their staffs who have been using the drug for years. In fact, it so alarmed researchers from Indiana University School of Medicine and the University of Virginia School of Medicine that they decided to investigate the basis for the warning.

Droperidol is widely used as a tran-quilizer for agitated patients, as a pre-surgical medication before the administration of anesthesia, and as an emetic agent to prevent nausea after surgery. A black-box warning is the most serious type of warning for an FDA-approved drug.
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After reviewing data from several sources, the investigators noted a shortlived and dose-dependent association between droperidol and QT prolongation but not between droperidol and torsades de pointes.

Although the FDA recommended the warning to advise caution and ongoing cardiac monitoring, the researchers are concerned that this warning might have the effect of halting the use of a “time-tested” therapy that is still often a safe and appropriate choice.

Thalidomide (Thalomid®, Celgene), a drug that was blamed for birth defects years ago, is finding a new respectability as an experimental therapy for various malignancies, including multiple myeloma, gliomas, Kaposi’s sarcoma, and advanced breast cancer. The treatment, however, appears to be dogged by a complication: the more frequent occurrence of venous thromboembolism (VTE). A study of 70 men with advanced andro-gen-independent prostate cancer bears this out.

The men, aged 50 to 80, were given intravenous docetaxel (Taxotere®, Aven-tis) or docetaxel with thalidomide. None of the 23 who received docetaxel alone developed VTE, compared with nine of 47 (19%) who received the combination treatment.
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The researchers could not determine why thalidomide might have a pro-thrombotic effect. The only measured factor that declined appreciably after the initiation of thalidomide/docetaxel therapy—which was not seen in the men taking docetaxel alone—was protein C.

Although the change was statistically significant, it wasn’t great enough to raise the risk of thrombosis; however, it was noted that thalidomide might cause endothelial damage. Agents used in combination with thalidomide that are toxic to the endothelium might be exposing the subendothelial tissue to the pro­thrombotic effect of the anti-angiogenic agent. The authors suggest that thalido-mide and docetaxel, which has anti-angiogenic effects in vitro, might have a synergistic harmful effect.

The Food and Drug Administration (FDA) has announced the accelerated approval of enfuvirtide (Fuzeon^TM, Roche) for use with other anti-HIV medications in adults and children ages six years and older with advanced human immunodeficiency virus (HIV) infection. Enfuvirtide is the first in a new class of medications called fusion inhibitors, which interfere with the fusion of viral and cellular membranes, thus hindering the entry of HIV-1 into cells.

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Approximately 75% of menopausal women experience such symptoms as vaginal dryness and temperature fluctuations (“hot flushes”). Many women who have taken estrogen tablets or patches still experience vaginal symptoms. The FDA has approved an estradiol acetate vaginal ring (Femring™, Galen), the first vaginal estrogen product that is indicated to treat both the hot flushes and the vaginal symptoms associated with menopause. Galen plans to introduce the drug into the U.S. market in June 2003.

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Barr Laboratories has announced that the FDA has approved its application to manufacture and market a generic version of Accutane tablet (canadian isotretinoin, Roche) capsules, in strengths of 10, 20, and 40 mg. The company plans to market Clar-avis^TM as a generic brand and to launch it in May 2003.

Claravis^TM is indicated for the treatment of severe recalcitrant nodular acne. Because of the significant adverse effects associated with its use, this drug should be reserved for those patients who have not responded to conventional therapy, including systemic antibiotics. The drug is indicated only for women who are not pregnant and will not become pregnant.