Octreotide acetate (Sandostatin - Sandoz), a synthetic octapeptide that mimics the actions of somatostatin, was recently approved by the US Food and Drug Administration for symptomatic treatment of patients with metastatic carcinoid or VIPomas (vasoactive intestinal peptide-secreting tumors).

The most important prognostic variable in early breast cancer is axillary lymph node involvement. Based on past experience, after 10 years about 70% of node-negative patients will be alive and apparently free of disease; about 30% will have relapsed or died. Patients with positive nodes may have a 30% to 60% relapse rate, depending on the number of positive nodes and other prognostic factors, such as the presence of estrogen receptors (IC Henderson et al, in VT DeVita, Jr et al, eds, Cancer: Principles and Practice of Oncology, 3rd ed, Philadelphia:Lippincott, 1989, p 1197). Which of...

Recent articles in the press have suggested that mifepristone (RU 486 - Roussel Uclaf) can effectively and safely induce an abortion. The drug is currently available only in France and China, but the manufacturer has also applied for a license in the United Kingdom. Mifepristone has been used on an investigational basis in the USA as an abortifacient and for treatment of Cushing's disease and breast cancer, but no manufacturer has applied to the US Food and Drug Administration for approval to market the drug in this country.

Flumazenil (Mazicon - Roche), a benzodiazepine receptor antagonist, has been approved by the US Food and Drug Administration to reverse the sedative effects of benzodiazepines after anesthesia, sedation for brief surgical or diagnostic procedures, or after benzodiazepine overdosage. The drug does not antagonize opioids, non-benzodiazepine sedatives, or anesthetic drugs.

Serum measurements of prostate specific antigen (PSA) are now being used in the diagnosis and management of prostate cancer. Produced by prostatic epithelium, PSA is a protease involved in liquefaction of the seminal coagulum. Whether this test should be used for routine screening is a matter of controversy; it is currently approved by the US Food and Drug Administration (FDA) only for monitoring after treatment for prostate cancer.

Teniposide (ten i poe' side; VM 26; Vumon - Bristol), an anticancer drug that has been under investigation in the USA for 20 years, has now been approved for use in combination induction treatment of refractory acute lymphoblastic leukemia (ALL) in children. A semisynthetic derivative of podophyllotoxin, teniposide is chemically related to etoposide (VePesid - Medical Letter, 26:48, 1984).

Desogen (Organon) and Ortho-Cept (Ortho), two oral contraceptives each containing a low dose (30 mcg) of the estrogen ethinyl estradiol plus 150 mcg of the progestin desogestrel, were recently approved by the US Food and Drug Administration for marketing in the USA. They are the first US oral contraceptives to contain desogestrel, which is widely used in oral contraceptive combination products in other countries. Desogestrel is one of three new progestins (norgestimate and gestodene are the others) considered less androgenic than previously available progestins (L Speroff et al, Obstet...

Enoxaparin (Lovenox - Rh ne-Poulenc Rorer), the first low-molecular-weight heparin to become commercially available in the USA, was recently approved by the US Food and Drug Administration for prevention of deep vein thrombosis following hip replacement. Five other products have been marketed in Europe.

An aqueous formulation of alprostadil (prostaglandin E 1 ; - Upjohn) has been approved by the US Food and Drug Administration (FDA) for injection into the corpus cavernosum to treat erectile dysfunction. The drug is also marketed as Prostin VR, an alcohol-containing formulation, for intravenous use in newborns with congenital heart disease to maintain the patency of the ductus arteriosus.

Nalmefene (Revex - Ohmeda), an i methylene analog of naltrexone (Trexan), is a long-acting opioid antagonist that has been approved by the US Food and Drug Administration for reversal of postoperative opioid drug effects, including respiratory depression, sedation and hypotension and for management of known or suspected opioid overdose in the emergency department. The only other opioid antagonists available in the USA are naloxone (Narcan), which is also injectable but has a short duration of action, and naltrexone, which has a long duration of action but is marketed only for oral...