December 18, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration (FDA) has approved Pfizer Inc. oral antibiotic drug Zithromax (azithromycin) as a single-dose and three-day regimen for the treatment of pediatric middle ear infections.
Previously, the drug was approved as a once-daily five-day regimen for the infections. The company said the single-dose regimen is effective and helps with patient compliance.
Pfizer said it expects to introduce Zithromax as a single-dose regimen early in 2002.
December 17, 2001
ST. LOUIS (MD Consult) - The US Food and Drug Administration has approved a posttraumatic stress disorder (PTSD) indication for the GlaxoSmithKline Plc antidepressant paroxetine (Paxil).
Glaxo estimates that 16 million Americans are affected by PTSD, a number which may rise due to the Sept. 11 terrorist attacks.
According to Glaxo, Paxil is the first approved medication to show efficacy in relieving all three of PTSD's major symptom clusters, which include reexperiencing the trauma, avoidance/numbing, and hyperarousal. Results of a trial funded by Glaxo and the National Institute of Mental Health and published in the Dec. 2001 American Journal of Psychiatry found PTSD patients given paroxetine did much better in all three areas than those given placebo.
SmithKline Beecham submitted a supplemental new drug application requesting the PTSD indication in July 2000.
In addition to depression and PTSD, paroxetine is approved for obsessive compulsive disorder, panic disorder, social anxiety disorder and generalized anxiety disorder.
October 23, 2001
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration (FDA) has approved Pharmacia Corporation and Pfizer Inc.'s Celebrex (celecoxib capsules) for the management of acute pain and primary dysmenorrhea in adults. Celebrex allows patients to take an additional dose if needed for relief of acute pain.
Celebrex is the only COX-2 specific inhibitor approved to date for the relief of pain and inflammation of osteoarthritis (OA) and adult rheumatoid arthritis (RA), according to Pharmacia. It is also approved to reduce the number of adenomatous colorectal polyps in familial adenomatous polyposis (FAP) -- a rare genetic disease that may result in colorectal cancer -- as an adjunct to usual care.
The FDA approval followed a review of data from the clinical studies of more than 1,700 patients with post oral-surgery pain, musculo-skeletal pain, post-orthopaedic surgery pain or primary dysmenorrhea where patients rated their pain as moderate to severe, according to Pharmacia.
Celebrex is now approved for the relief of the signs and symptoms of OA and adult RA in 83 countries worldwide and for the management of pain in Latin America, South Africa and the United States.
The recommended dose for OA is 200 mg daily and for RA, 100 mg to 200 mg twice per day. The recommended dose for acute pain is 400 mg initially, followed by an additional 200 mg dose if needed on the first day. On subsequent days, the recommended dose is 200 mg twice daily as needed.
Celebrex shouldn't be taken by patients who have aspirin-sensitive asthma or allergic reactions to aspirin or other arthritis medicines or certain sulfa drugs called sulfonamides, or who are in the third trimester of pregnancy. As with all NSAIDs, serious GI tract ulcerations can occur without warning symptoms. Physicians and patients should remain alert to the signs and symptoms of GI bleeding. As with all NSAIDs, Celebrex should be used with caution in patients with fluid retention, hypertension, or heart failure.
In overall clinical studies the most common side effects were dyspepsia, diarrhea and abdominal pain, which were generally mild to moderate. There have been infrequent post-marketing reports of increases in prothrombin time, sometimes associated with bleeding events, predominantly in the elderly. Anticoagulant activity should be monitored when therapy with Celebrex is initiated or changed in patients taking warfarin, particularly in the first few days.
October 4, 2001
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration (FDA)has approved AstraZeneca's Entocort EC (budesonide) capsules for the treatment of mild-to-moderate, active Crohn's disease involving the ileum and/or ascending colon.
Entocort is a new, locally active glucocorticosteroid that can provide a significant reduction in symptoms of a disease that is often difficult to treat, according to AstraZeneca. In five clinical trials involving approximately 1,000 patients with mild to moderate, active Crohn's disease involving the ileum and/or ascending colon, Entocort was effective and well-tolerated, AstraZeneca said.
In these studies, 48 to 69 percent of patients treated with Entocort EC 9 mg once daily experienced clinical improvement after eight weeks, AstraZeneca said. Clinical improvement was defined as achievement of a Crohn's Disease Activity Index (CDAI) score of < 150.1 At baseline, the median CDAI score ranged from 272 to 290.
The most common adverse events reported were headache, respiratory infection, nausea, and symptoms of hypercorticism. The frequency of glucocorticosteroid-associated adverse events was substantially reduced with Entocort compared with prednisolone (a systemic glucocorticosteroid used to treat Crohn's disease) at therapeutically equivalent doses.
Crohn's disease is a chronic inflammatory bowel disease of unknown origin. Flare-ups of the disease can range from mild to severe and involve symptoms such as diarrhea, crampy abdominal pain, fever and sometimes bleeding from the rectum. The condition can be difficult to manage, clinically. Treatment for the disease tends to consume a substantial amount of healthcare resources in terms of physician time, procedures and medications.
Entocort is taken once daily -- 9 mg (3x3 mg capsules) per day. The safety and efficacy of Entocort EC in the treatment of active Crohn's disease has not been established beyond eight weeks. The active ingredient is released in the intestines, the primary target site for Crohn's disease, and is quickly and extensively metabolized, preventing the majority of the drug from entering the systemic circulation, AstraZeneca said.
Entocort EC is contraindicated in patients with known hypersensitivity to budesonide. Glucocorticosteroids can reduce the response of the hypothalamus-pituitary-adrenal (HPA) axis to stress. In patients treated with Entocort EC, supplementation with a systemic glucocorticosteroid is recommended before surgery or other stress situations. Adrenocortical function monitoring may be required in patients being transferred to Entocort from a systemic glucocorticosteroid. Patients taking corticosteroids should avoid exposure to infections such as chicken pox or measles.
For more information about Crohn's disease, please call CCFA at 800-343-3637, or visit www.ccfa.org.
September 10, 2001
ST. LOUIS (MD Consult) - On September 10, Hoffman-La Roche (the U.S. division of the Swiss Roche Group) announced that the U.S. Food and Drug Administration (FDA) approved its cancer drug Xeloda (capecitabine) to be used in combination with Aventis SA's Taxotere (docetaxel) for the treatment of metastatic breast cancer.
Xeloda first received FDA approval in May 1998 as a treatment for metastatic breast cancer that was not responding to standard therapy. Taxotere was approved in May 1996 for the treatment of metastatic breast cancer that had progressed during treatment with anthracycline.
According to the FDA, this new approval was based on a study of 511 patients that compared the drug combination with Taxotere alone. The results demonstrated that the combination added 3 months to survival time and 1.9 months to disease progression as compared with Taxotere alone. Also, the tumor response rate was 32 percent with the combination therapy and 22 percent with Taxotere only.
Side effects include diarrhea, nausea, vomiting, inflammation of the mouth, fatigue, swelling or redness of the hands or feet, and bone marrow suppression. Xeloda has demonstrated a significant interaction with coumarin-derived anticoagulants; patients taking these drugs in addition to Xeloda should be monitored frequently.
September 4, 2001
ST. LOUIS (MD Consult) - On September 4, Ortho-McNeil Pharmaceutical received U.S. Food and Drug Administration approval to market the anti-epileptic drug Topamax (topiramate) as an adjunctive treatment of Lennox-Gastaut syndrome (LGS).
LGS is a severe form of epilepsy; about 10 percent of pediatric epilepsy cases are children with LGS. Patients with LGS can have dozens of seizures a day, and they are often resistant to most anti-epileptic drugs.
According to Ortho-McNeil, the new approval is based on a clinical study in which Topamax, when combined with one or two other epilepsy drugs, demonstrated a significant reduction in the both the overall number of seizures and the number of severe seizures. The study showed that 52 percent of the families caring for patients receiving Topamax reported improvement, whereas only 28 percent of families caring for patients receiving placebo reported such a change.
Side effect of Topamax use include drowsiness, appetite loss, fatigue, nervousness, concentration difficulty, weight loss, aggression, and memory loss. The safety and effectiveness of this drug for the treatment of children who are younger than 2 years old have not yet been determined.
August 17, 2001
ST. LOUIS (MD Consult) - On August 16, Pfizer's Zoloft (sertraline) received a broader post-traumatic stress disorder (PTSD) indication from the U.S. Food and Drug Administration (FDA).
Zoloft, which is mainly an antidepressant, is also approved for the treatment of panic disorder, obsessive-compulsive disorder in both adults and children, and the short-term treatment of PTSD. The new indication allows for longer-term treatment with the drug.
Currently Zoloft is the only medication sold for the treatment of PTSD. The FDA gave this new approval on the basis of a 28-week study that showed Zoloft to prevent relapse and maintain improvement of the three main symptoms of PTSD (intrusion, avoidance, and arousal) in both men and women. Patients in this study had already responded to the drug during a prior 6-month trial; the drug maintained a response in these patients for up to 28 weeks after the initial 6-month period.
Pfizer recommends that patients taking Zoloft on a long-term basis be reassessed periodically to determine the necessity of continuing treatment. The drug is contraindicated in patients who are also taking monoamine oxidase inhibitors.
August 07, 2001
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration has granted Abbott Laboratories the right to market its longer-acting form of Biaxin (clarithromycin) for the treatment of community-acquired pneumonia.
Biaxin XL has been approved for mild to moderate degrees of the condition; it should be taken once a day for seven days to treat pneumonia caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, Streptococcus pneumoniae, Chlamydia pneumoniae, or Mycoplasma pneumoniae.
Biaxin XL had previously been approved for acute bacterial exacerbations of chronic bronchitis and acute maxillary sinusitis. This new indication was based on Biaxin XL's comparison with levofloxacin. Biaxin XL was shown to have a cure rate of about 88 percent as compared with levofloxacin's cure rate of about 86 percent.
It is estimated that as many as 3 million Americans each year develop community-acquired pneumonia. The Centers for Disease Control and Prevention recommend the use of macrolides, a drug family that includes Biaxin XL, as a first-line treatment for outpatient care of this condition.
June 26, 2001
ST. LOUIS (MD Consult) - GlaxoSmithKline has received U.S. Food and Drug Administration approval for Augmentin ES-600 (amoxycillin and clavulanic acid), an extra-strength form of the company's Augmentin, for the treatment of children with acute otitis media that is recurrent or persistent.
The new form was shown in clinical trials to kill the three most common causes of otitis media in children: it eliminated 94 percent of penicillin-resistant S. pneumonia, 93 percent of H. influenzae, and 100 percent of M. catarrhalis.
Augmentin ES-600 provides two times the dose of amoxicillin that regular Augmentin does. Those taking the new drug will receive 90 mg/kg/day rather than 45 mg/kg/day.
June 15, 2001
ST. LOUIS (MD Consult) - The U.S. Food and Drug Administration has approved American Home Products' Protonix (pantoprazole), a proton pump inhibitor, for long-term use.
Previously Protonix had been approved as a 16-week course of therapy for symptoms associated with gastroesophageal reflux disease, namely erosive esophagitis. This new approval will allow the drug will be used for the maintenance of erosive esophagitis, and it will also be used to reduce daytime and nighttime heartburn in patients with gastroesophageal reflux disease.
According to American Home Products, two double-blind studies showed that, at 12 months, Protonix was effective in maintaining healing erosive esophagitis in 86 percent of patients and that it also relieved heartburn in 90 percent of cases.
In the United States, approximately 60 million people have health issues that involve gastric acid; the yearly rate of increase of use of proton pump inhibitors for their treatment is 21 percent. Protonix is available in both tablet form and a recently approved intravenous form.
April 2, 2001
ST. LOUIS (MD Consult) - The FDA has approved new labeling language allowing manufacturers to claim that B vitamins reduce the risk of vascular disease, according to news reports earlier this month.
The new claim will read, "As part of a well-balanced diet that is low in saturated fat and cholesterol, Folic Acid, Vitamin B6 and Vitamin B12 may reduce the risk of vascular disease." It may appear on any product containing the three vitamins mentioned.
However, the labeling claim must be followed immediately by additional language: "FDA evaluated the above claim and found that, while it is known that diets low in saturated fat and cholesterol reduce the risk of heart disease and other vascular disease, the evidence in support of the above claim is inconclusive."
The FDA approved a labeling claim regarding vitamin B and vascular disease last year. However, members of the dietary supplement industry complained that the approved claim was too long and confusing. In approving the new claim, the FDA has reversed a previous decision, apparently ending a legal action by members of the dietary supplement industry.
February 8, 2001
ST. LOUIS (MD Consult) - On February 8th, Watson Pharmaceuticals announced that the U.S. Food and Drug Administration (FDA) has approved Ferrlecit (sodium ferric gluconate complex in sucrose injection), its injectable iron therapy product.
According to a press release from Watson Pharmaceuticals, the new labeling for Ferrlecit allows undiluted intravenous injection to be given without the need for a test dose. Undiluted injections of the therapeutic dose (125mg) may be given at a rate not to exceed 12.5mg/min over a period of 10 minutes.
In the past, administration of Ferrlecit required a test dose to be given to confirm a patient's lack of hypersensitivity and allergic reactions. In addition, it required that both the test dose and subsequent therapeutic doses be diluted in normal saline and administered over extended periods. Because of the aforementioned changes, the bold type on the warning section of the drug's label has been eliminated.
Ferrlecit was originally approved in 1999. It is indicated for use as a first-line treatment of iron deficient anemia in chronic hemodialysis patients who are receiving supplemental erythropoietin therapy. The company states that physicians should carefully review the labeling of Ferrlecit to understand the risks associated with the use of the product.
Watson notes that the its supplemental new drug application approval was based on "interim data from a single dose, placebo-controlled, crossover, post-marketing study, reporting safety result on 1,097 patients."
February 7, 2001
ST. LOUIS (MD Consult) - Indications for Astra Zeneca's drug Toprol-XL (metoprolol extended release) now include treatment of chronic and congestive heart failure, according to the US Food and Drug Administration (FDA).
Previous indications approved for the drug in the US and Europe included hypertension, angina, and post-MI. After review of data showing that Toprol-XL, a beta-blocker, reduced mortality rates in patients with chronic and congestive heart failure by 34%, the FDA granted the new indication.
Toprol-XL was initially approved for treatment of heart failure in Denmark in April of 2000 under the name of Seloken ZOK. An AstraZeneca spokesperson stated that Toprol-XL is only the second beta-blocker to gain approval for a heart failure indication. The first was GlaxoSmithKline's Coreg (carvedilol).
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