Andrx Corporation has announced that the FDA has approved the marketing of its Abbreviated New Drug Application for TaztiaTM (diltiazem HCl). The extended-release capsules are bioequivalent to Tiazac® (Biovail). This product, a calcium-channel blocker, is indicated to treat hypertension and chronic stable angina. The capsules will be available in strengths of 120, 180, 240, 300, and 360 mg.
Giving antibiotics to help prevent inflammation in patients with coronary disease is an attractive idea to clinical researchers for a number of reasons. Many studies have focused on whether antibiotics can help change the course of coronary artery syndromes. Results have been mixed, with smaller studies tending to show benefits but larger trials showing no advantages.
One large study, Antibiotic Therapy after an Acute Myocardial Infarction (ANTIBIO), monitored 868 patients for 12 months. Patients who were given roxithromycin (e.g., Generic Rulid®, Aventis) 300 mg/day for six weeks fared no better and no worse than patients given placebo. Of 431 patients in the drug group, 28 died (6.5%); of 437 placebo patients, 26 died (6%).
The ANTIBIO researchers noted that the type of macrolide ( generic roxithromycin or azithromycin drug [Zithromax tablet, Pfizer]), the type coronary artery disease (unstable or stable), the duration of therapy, and whether or not patients had C. pneumo-niae infection did not seem to have a major impact on the effect of antibiotic treatment. Because smaller trials have been more likely to show benefits, the researchers suggest that the effect of antibiotics, when added to standard therapy, might be very small and perhaps limited to certain patient subgroups, such as patients with high antibody titers. They add that their findings challenge the hypothesis that C. pneumoniae plays a major role in the pathogenesis of arteriosclerosis.
Neurologists at Thomas Jefferson University Hospital in Philadelphia, Pennsylvania, may have found a long-acting drug to stop monthly migraines that occur in some women around the time of their menstrual periods—before the headaches start.
Frovatriptan succinate (Frova®, Elan), was found in a nationwide study to prevent migraines associated with menstruation in as many as 50% of the women evaluated. Frovatriptan is in a class of drugs called triptans, which reduce inflammation of certain blood vessels in the brain that are thought to cause pain.
Participants had an average 12-year history of migraine, which affects more than five million American women. In the U.S. alone, approximately nine million women suffer from migraines; about 60% of them, or 5.4 million, report an increased number of headaches in association with their menstrual periods.
Liver-function tests might not be all that helpful in determining which patients with sarcoidosis should discontinue taking methotrexate. Researchers from the University of Cincinnati performed 100 liver biopsies in 68 patients with chronic sarcoidosis who had been treated for up to eight years with methotrexate. (To their knowledge, this study represented the largest series of liver-biopsy results in this patient population.)
Toxic drug effects were observed in 14 cases. After examining all the abnormal liver-function test results during the year before the biopsy, however, the researchers found no pattern that might predict toxicity. Patients with hepatic sarcoidosis already had higher levels of various liver enzymes, which meant that the predictive value of the liver-function tests was lost; in addition, more than half of the patients in the methotrexate toxicity group did not have elevated aspartate transami-nase levels in the year before biopsy.
canadian antibiotics
Methotrexate has become a standard second-line agent for the treatment of sarcoidosis, and hepatotoxicity is a well-known side effect of the drug. Using a liver biopsy to look for a toxic reaction to methotrexate has been controversial, the researchers note, and they point out that rheumatologists have relied on serial liver-function tests to identify at-risk patients with rheumatoid arthritis, based on the relatively low rate of metho-trexate-related liver damage. For patients with sarcoidosis, the policy at the researchers’ institution is to perform a liver biopsy in patients who receive metho-trexate for more than two years.
Johnson & Johnson plans to contact thousands of U.S. physicians advising them of a possible increased risk of stroke among elderly patients taking its well-known antipsychotic drug risperi-done (Risperdal®). The company might also change the package insert label of the medication, which has annual global sales of $2.1 billion, to note a possible risk of stroke.
In October 2002, the company had sent a similar warning letter to Canadian physicians and pharmacists citing 37 reports of stroke or related events such as blood clots and hemorrhages, including 16 deaths, among patients who had taken Generic Risperdal.
Is the antibiotic that was administered as a protective measure in the U.S. during the anthrax scare in 2001 becoming less effective against other bacteria because of overuse?
In 1994, ciprofloxacin (Cipro canadian, Bayer) was found to be efficacious against 86% of bacterial samples analyzed; by the year 2000, the rate had declined to 76%.
In a multicenter study, researchers examined data on infections in hospitalized patients in 43 states, including Washington, DC, from 1994 to 2000. Ailments included respiratory and urinary infections caused by various bacteria.
Many organisms had grown resistant to fluoroquinolones, a class of antibiotics that includes ciprofloxacin. The anthrax bacterium was not studied, and the researchers noted that their findings did not mean that the drug was becoming less effective against anthrax, which often affects animals but rarely humans.
Bacteria that became increasingly resistant during the study were all common causes of infections and included Escherichia coli.
When a drug is used repeatedly against the same organism, it has the potential to mutate into drug-resistant forms. The greater resistance came at a time when physicians were increasingly prescribing generic ciprofloxacin and similar drugs for common ailments such as respiratory infections caused by viruses, which are unaffected by antibiotics, the researchers noted. They urged more judicious use of the floroquinolones to limit the downward trend.
In theory, clinicians who treat patients with advanced colorectal cancer can extend treatment indefinitely because of the low cumulative toxicity associated with therapy. However, researchers from the Medical Research Council Colorectal Cancer Group advise that it is safe to stop chemotherapy and then restart the treatment. In fact, doing so can enhance quality of life without compromising survival.
In a study of 354 patients with chemo-sensitive, advanced colorectal cancer, chemotherapy was safely stopped after 12 weeks and restarted if the disease progressed. The researchers found no clear evidence of a benefit with continuous chemotherapy.
