December 23, 1999
ST. LOUIS, (MD Consult) - The U.S. Food and Drug Administration (FDA) on December 23, 1999, approved Celebrex (celecoxib capsules) as an oral adjunct to usual care (e.g., endoscopic surveillance and surgery) for patients with familial adenomatous polyposis. Celebrex is co-promoted by Searle and Pfizer Inc. Celebrex, the only COX-2 specific inhibitor indicated for the treatment of both osteoarthritis and adult rheumatoid arthritis, is the first pharmacologic agent to be indicated to reduce the number of adenomatous colorectal polyps in patients with FAP.
A six-month, 83-patient clinical trial, sponsored by the National Cancer Institute's Division of Cancer Prevention in collaboration with Searle, is the largest randomized, double-blind, placebo-controlled trial to date in FAP. The clinical study demonstrated that an oral dose of Celebrex 400 mg twice a day significantly reduced the number of adenomatous colorectal polyps by an average of 28 percent -- compared to a 5 percent reduction with placebo. The study was conducted at the University of Texas, MD Anderson Cancer Center in Houston, as well as at St. Mark's Hospital in London.
Since the current trial did not include a cancer endpoint, the effect of Celebrex on the development of cancer has not yet been established. Searle and Pfizer will be conducting further studies to assess the clinical benefit of Celebrex in this setting.
Patients who have a known allergic reaction to celecoxib, certain sulfa drugs called sulfonamides, aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) should not use Celebrex. As with all NSAIDS, serious gastrointestinal (GI) tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to signs and symptoms of GI bleeding. In the FAP trial, common side effects were diarrhea and dyspepsia. Celebrex has not been shown to reduce the risk of GI cancer or the need for any FAP-related surgeries; therefore, usual endoscopic surveillance and surgery schedules should not be altered.
Searle and Pfizer are also conducting research, in collaboration with the National Cancer Institute, into the use of Celebrex in patients with sporadic adenomatous polyps (SAP) of the colon, Barrett's esophagus (considered a precursor to esophageal cancer), actinic keratosis (a precursor to skin cancer) and superficial bladder cancer.
Celebrex is available in 100 mg and 200 mg capsules.
December 23, 1999
ST. LOUIS, (MD Consult) - Aventis Pharmaceuticals, a US pharmaceutical subsidiary of Aventis SA, announced on December 23, 1999, that Taxotere (docetaxel) for Injection Concentrate, 75 mg/m2, was cleared for marketing by the US Food and Drug Administration (FDA) for the treatment of patients with locally advanced or metastatic non-small-cell lung cancer (NSCLC) after failure of prior platinum-based chemotherapy.
This FDA approval is one of the first to be received by the newly created Aventis Pharmaceuticals, the recent merger between Hoechst Marion Roussel, Inc. and Rhone-Poulenc Rorer Pharmaceuticals, Inc.
In a worldwide, multicenter Phase III trial, 204 patients who had previously failed platinum-based chemotherapy received either 75 mg/m2 or 100 mg/m2 of Taxotere every three weeks plus best supportive care (BSC), or BSC alone. BSC refers to measures aimed at maintaining patient comfort, including nutritional support and control of symptoms such as nausea, vomiting, pain and shortness of breath.
Patients treated with Taxotere, 75 mg/m2, had a median survival of 7.5 months versus 4.6 months in patients who received BSC. The time to disease progression was 12.3 weeks and seven weeks in the Taxotere, 75 mg/m2, and BSC groups, respectively. The one-year survival rate was significantly higher in the Taxotere group (37 percent) versus the comparator group (12 percent).
The clinical-benefit analysis showed that patients treated with Taxotere, 75 mg/m2, did not experience deterioration in performance status (daily life activities) or body weight compared to the other treatments.
In the other Phase III study, 373 patients with advanced NSCLC who were resistant to platinum-based chemotherapy received either treatment with Taxotere, 75 mg/m2 or 100 mg/m2, every three weeks, or treatment with either vinorelbine, 30 mg/m2 weekly, or ifosfamide, 2 gm/m2 daily for three days every three weeks. The study, which was carried out at 23 US cancer centers, found that the one-year survival rate in patients treated with 75 mg/m2 of Taxotere was 30 percent, compared to 20 percent in patients treated with vinorelbine or ifosfamide.
The major side effects of Taxotere, 75 mg/m2, in both studies were myelosuppression (low blood cell counts), fatigue, nausea and alopecia. In patients with normal liver function, side effects reported to date include neutropenia, thrombocytopenia (low platelet count), anemia, fluid retention, hypersensitivity, nausea and diarrhea. A premedication regimen with corticosteroids is recommended in order to prevent or reduce hypersensitivity and fluid retention. Taxotere is generally not appropriate therapy for patients with liver impairment.
Taxotere was first approved in the US in 1996 for the treatment of advanced breast cancer after failure of anthracycline-based therapy. Taxotere is now approved in more than 80 countries, including the US and the European Union, for the treatment of advanced breast cancer after failure of prior chemotherapy. It is presently approved for the treatment of advanced non-small-cell lung cancer in more than 40 other countries, including Japan, Australia and Canada.
December 15, 1999
ST. LOUIS, (MD Consult) - Sigma-Tau Pharmaceuticals, Inc., the only supplier of prescription form carnitine, announced that it received approval on December 15, 1999 from the U.S. Food and Drug Administration (FDA) to market Carnitor Injection for the prevention and treatment of carnitine deficiency in patients with end stage renal disease (ESRD) who are undergoing dialysis. This indication applies only to the intravenous formulation of Carnitor and not the available oral formulations.
ESRD patients on maintenance hemodialysis may have low plasma carnitine concentrations and an increased ratio of acylcarnitine/carnitine because of reduced intake of meat and dairy products, reduced renal synthesis, and dialytic losses. Certain clinical conditions common in hemodialysis patients such as malaise, muscle weakness, cardiomyopathy and cardiac arrhythmias may be related to abnormal carnitine metabolism.
Pharmacokinetic and clinical studies with intravenous Carnitor have shown that administration of levocarnitine to ESRD patients on hemodialysis results in increased plasma levocarnitine concentrations.
Sigma-Tau, who more than 10 years ago pioneered the development of the only prescription form of carnitine, maintains its leadership in the U.S. market today. In 1989, Carnitor (levocarnitine) tablets and oral solution were approved for the treatment of primary systemic carnitine deficiency. Carnitor Injection was approved in 1992 for the acute and chronic treatment of patients with an inborn error of metabolism which results in secondary carnitine deficiency.
December 14, 1999
ST. LOUIS, (MD Consult) - SmithKline Beecham announced on December 14, 1999, that the FDA has approved expanded labeling on Engerix-B [Hepatitis B Vaccine (Recombinant)] to include a description of hepatitis B vaccines as preventing hepatitis B infections which can lead to primary liver cancer. Studies of hepatitis B vaccine use demonstrate that vaccination can significantly reduce the development of chronic hepatitis B infections and decrease the risk and incidence of primary liver cancer.
In addition to the FDA, leading medical organizations including the CDC and the World Health Organization (WHO) have recognized the hepatitis B vaccine as a significant tool to reduce chronic hepatitis B infections which may develop into primary liver cancer. In 1991, the CDC recommended hepatitis B immunization for all infants and in 1994 further recommended vaccination for those adolescents not previously immunized. Routine immunization against hepatitis B for infants and adolescents is also endorsed by the WHO, the American Academy of Pediatrics and the American Medical Association.
SmithKline Beecham's Engerix-B has been licensed in the United States for ten years. Engerix-B is generally well tolerated. Commonly seen adverse reactions include injection site soreness, fatigue and fever. However, as with all vaccines, rare adverse reactions may occur.
December 7, 1999
ST. LOUIS, (MD Consult) - On December 7, 1999, the U.S. Food and Drug Administration approved Pfizer's anti-depressant Zoloft (sertraline hydrochloride) for an indication of posttraumatic stress disorder (PTSD). A selective serotonin reuptake inhibitor, Zoloft is the first medicine to receive a FDA approval for the treatment of PTSD.
Approximately 50 percent of the general population are exposed to a traumatic event during their lifetime. Ten to twenty percent of those develop PTSD. The prevalence of PTSD is twice as high in women as in men.
"Patients suffering from PTSD experience significant distress or impairment in normal functioning," said Dr. Joseph Feczko, Senior Vice President, Pfizer Inc. "In clinical trials, Zoloft was shown to have considerable impact on these symptoms, thus giving physicians a new treatment option for this major medical need."
Zoloft is currently indicated for major depression, panic disorder, and obsessive-compulsive disorder. Zoloft is contraindicated until at least 14 days have passed since discontinuing a monoamine oxidase inhibitor (MAOI) and a MAOI is contraindicated for at least 14 days after discontinuation of Zoloft. The most common side effects of Zoloft include nausea, insomnia, diarrhea, ejaculation problems (mainly ejaculatory delay) and somnolence.
November 29, 1999
ST. LOUIS, (MD Consult) - On November 29, 1999, the Food and Drug Administration approved twice daily dosing of Viracept (nelfinavir mesylate) for the treatment of HIV infection. Approval supports 1250mg BID dosing of Viracept based on data that showed comparable anti-HIV effects and safety to the previously approved 750mg three times daily dosing.
Viracept has been shown to be well-tolerated when taken 1250 mg BID or 750 mg TID. Diarrhea of moderate or greater intensity occurred in 14% to 18% of patients receiving Viracept 1250 mg BID or 750 mg TID with stavudine or lamivudine. New onset or exacerbation of diabetes mellitus and hyperglycemia, changes in the distribution of body fat, and increased bleeding in patients with hemophilia types A and B have been reported with protease inhibitors.
Viracept and Agouron are registered trademarks of Agouron Pharmaceuticals, Inc.
November 10, 1999
ST. LOUIS, (MD Consult) - On November 10, 1999, the Food and Drug Administration approved Centocor's Remicade (infliximab) for use with methotrexate in the treatment of rheumatoid arthritis patients who have had an inadequate response to methotrexate alone.
Remicade, previously approved in the US for the treatment of Crohn's disease, is the first monoclonal antibody that has demonstrated the ability to reduce the signs and symptoms of rheumatoid arthritis. In clinical studies, 50% of patients treated with Remicade and methotrexate experienced a reduction in signs and symptoms of rheumatoid arthritis compared with 20% of patients who received methotrexate alone.
November 3, 1999
ST. LOUIS, (MD Consult) - Epogen (epoetin alfa), a drug approved by the FDA 10 years ago for the treatment of dialysis-associated anemia in adults, was approved by the FDA on November 3, 1999 for the treatment of anemia in children with chronic renal failure who are currently undergoing dialysis therapy.
Pediatric studies of Epogen showed the drug is safe and effective for children in relieving anemia associated with end-stage renal disease, markedly reducing blood transfusion dependency.
October 28, 1999
ST. LOUIS, (MD Consult) - On October 28,1999, the Food and Drug Administration gave approval to Kos Pharmaceuticals, Inc. to market Niaspan for the indication of elevating HDL in patients with dyslipidemia.
Niaspan is a niacin extended-release tablet, and one of only two drugs approved for such an indication in the US.
September 17, 1999
ST. LOUIS, (MD Consult) - On September 17, 1999, the US Food and Drug Administration (FDA) approved Accolate (zafirlukast) for prophylactic and chronic asthma therapy in children as young as seven years old.
Accolate (zafirlukast) has been used in the US for patients 12 years of age or older since 1996. Accolate will now be available in a 10 mg non-flavored mini-tablet designed specifically for younger patients. The recommended dosage in children 7 to 11 years old is one 10 mg tablet twice daily.
August 5, 1999
ST. LOUIS, (MD Consult) - On August 5, 1999, the US Food and Drug Administration (FDA) approved Merck & Co.'s Zocor (simvastatin) as an adjunct to diet for increasing HDL in patients with primary hypercholesterolemia (heterozygous familial and nonfamilial) and mixed dyslipidemia (Frederickson Types IIa and IIb).
Zocor is the first cholesterol-modifying drug to raise HDL cholesterol and reduce LDL cholesterol and triglycerides.
July 27, 1999
ST. LOUIS, (MD Consult) - Granisetron, an antiemetic, antinauseant drug manufactured by SmithKline Beecham received FDA approval on July 27, 1999. The drug is used primarily for patients undergoing radiation, including total body irradiation and fractionated abdominal radiation, though it has been used with some chemotherapy regimens for nausea prophylaxis.
Granisetron is a serotonin receptor antagonist that works by binding to 5-HT3 receptors to block emetogenic impulses caused by serotonin stimulation. The drug has been found to have fewer side effects than ondansetron and to be more effective than other antiemetic agents in a handful of clinical trials.
July 23, 1999
ST. LOUIS, (MD Consult) - On July 23, 1999, the Food and Drug Administration (FDA) approved Ortho-McNeil Pharmaceutical's Topamax (topiramate) as adjunctive therapy in pediatric patients ages 2 - 16 years with partial onset seizures. Topiramate was initially approved by the FDA in 1996 as an add-on treatment for adults with partial onset seizures.
TOPAMAX (topiramate) is a new antiepileptic drug. It reduces the frequency of seizures up to 33%, particularly among patients who are not controlled by other antiepileptic drugs. The most frequently reported side effects were related to the central nervous system and were mild.
For full prescribing information on Topamax, visit the Web site of Ortho-McNeil Pharmaceutical. Complete prescribing information for this product is provided in Adobe's Portable Document Format (PDF). To view these documents you will need Adobe Acrobat Reader.
June 29, 1999
ST. LOUIS, (MD Consult) - On June 29,1999, ALZA Corp's Doxil (doxorubicin HCl liposome injection) was approved by the U.S. Food and Drug Administration (FDA) for use in women with ovarian cancer refractory to paclitaxel- and platinum-based chemotherapy regimens.
The first and only liposomal cytotoxic agent approved to treat a solid tumor, Doxil was first approved by FDA in 1995 for the treatment of AIDS-related Kaposi's sarcoma.
The FDA has evaluated Doxil as a supplemental new drug application under accelerated approval regulations. Doxil was granted orphan drug status for ovarian cancer. Alza Corp. was given seven years of market exclusivity for Doxil.
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