January 24th, 2010

FDA Adds Cardio Warnings to Weight-Loss Drug

By Cole Petrochko, Staff Writer, MedPage Today
Published: January 21, 2010

WASHINGTON — The FDA said the weight-loss drug sibutramine (Meridia) should not be taken by patients with history of cardiovascular disease following a review of additional data showing an increased risk of heart attack and stroke among that population.

The agency said the manufacturer, Abbott, has agreed to add the contraindication to its labeling, which will be expanded to include patients with a history of the following:

  • Coronary artery disease (i.e., heart attack, angina)
  • Stroke or transient ischemic attack
  • Heart arrhythmia
  • Congestive heart failure
  • Peripheral arterial disease
  • Uncontrolled hypertension (>145/90 mmHg)

The initial review of sibutramine began in November 2009 when the FDA received preliminary data from the SCOUT study suggesting patients using the drug had a higher risk for cardiovascular events. (See Early Data Link Diet Drug to MI, Stroke, and Cardiac Death)

Prior to review, the product label included a warning for patients with cardiovascular disease.

Healthcare professionals should monitor patients for increase in blood pressure and heart rate and should discontinue therapy if either increase is observed, an FDA statement said.

Patients should also discontinue use of sibutramine if they do not lose 5% of their baseline body weight within the first three to six months of treatment, as the drug may not be effective and puts the patient at unnecessary risk, the release said.

The FDA said its review of SCOUT study data, as well as other information related to the drug’s risks and benefits, is ongoing and will be followed by an open public advisory committee meeting to determine if it requires additional regulatory action.



November 4th, 2009

Two once-daily drugs may help clear HCV, trials indicate.


MedPage Today (11/3, Gever) reported, “Two investigational drugs targeting the hepatitis C virus (HCV) protease enzyme helped patients clear the virus with once-daily dosing, contrasting with the three-times-per-day schedule needed for similar drugs in development,” according to separate trials. Baylor College researchers found that “at least 85 percent of patients adding narlaprevir (formerly called SCH 900518) to pegylated interferon-alfa-2b (PEGIntron) and ribavirin (Rebetol) after four weeks achieved rapid virological responses, compared with no patients receiving only interferon and ribavirin.” The “investigational compound BI 201355″ produced “comparable results” in a study conducted by Johns Hopkins. Specifically, the “drug, also given once daily with interferon-ribavirin, led to HCV RNA becoming undetectable by week 12 in up to 90 percent of patients.” Notably, the aforementioned results are “from ongoing Phase II trials.”

appendicitis and air pollution

October 8th, 2009

The “Wellness” blog, hosted by Time (10/5, Sharples), reported that the scientific community has longed charted the commingling of industrialization and appendicitis incidence. “With the growth of industry in North America and Europe during the 1800s and early 1900s came the increased emission of pollutants such as ozone, nitrogen dioxide, and carbon monoxide.” This was paralleled by “an increase in cases of appendicitis.” But, “as clean air legislation emerged in the late 1900s, there was a noticeable drop in appendicitis.” Now, researchers in Canada are “offering several examples of this correlation, including the fact that…after the United States’ Clean Air Act was passed in 1970, the incidence of appendicitis decreased by 14.6 percent from 1970 to 1984.”

        The scientific community has “yet to identify how exactly pollution provokes appendicitis,” the Calgary Sun (10/5, Kaufman) pointed out. But, lead researcher Dr. Gilaad Kaplan, of the University of Calvary, “suspects it could be consistent with findings on other organs.” He added, “If you breathe in pollution, it can actually trigger an inflammatory response.”

        That, says Dr. Kaplan, may also explain why men appear to “be more susceptible to the effects of outdoor air pollution,” considering “they are more likely to be employed in outdoor occupations,” the UK’s Independent (10/6, von Radowitz) reported.

        Another “prevailing theory” revolves around the “opening of the appendix” being blocked, according to HealthDay (10/5, Gardner). According to speculation, that may be the result of “lower fiber intake among citizens of industrialized countries,” which “leads to obstruction of the appendix by the stool.” Such a theory, however, “doesn’t explain the decreased incidence of appendicitis in the second half of the 20th century.”

        So, University of Calgary researchers examined data on 5,200 adults hospitalized “for acute appendicitis” and pollution figures “collected by the Canadian government’s environment branch,” MedPage Today (10/5, Smith) reported. As expected, “high levels of ambient air pollutants such as ozone and nitrogen dioxide were associated with an increased risk of the condition.” And, “in the summer months of July and August,” researchers “found pronounced effects for” the increase, according to the paper published in the Canada Medical Association Journal.

CRC and Green Tea

October 7th, 2009

Green tea may reduce women’s gastric cancer risk, research suggests.


MedWire (9/30, Piper) reports, “A high consumption of green tea may decrease the risk for gastric cancer, particularly for the distal subsite, in women,” according to a Japanese study appearing in Gut in which investigators collected “data on…219,080 individuals.” After identifying “3,577 cases of gastric cancer,” the team also noted that, “among both men and women, 80 percent of individuals consumed green tea every day.” Notably, “women who consumed at least five cups of green tea a day were a significant 21 percent less likely to have gastric cancer compared with women drinking less than one cup a day.” The “protective effect of green tea in women was also evident for distal gastric cancer, with a 30 percent risk reduction.”

Milk Indigestion

April 23rd, 2009

We see a lot of people with chronic indigestions which they ascribe to a multitude of different foods.  One of the things we see with great frequency is lactose intolerance.  This is usually a straightforward condition which is identifiable by most individuals by just paying attention to what causes the problem.  The culprits are, of course, foods which contain milk (lactose).  The symptoms will vary from person to person, and the severity of these is also very variable.  Most people will complain of excessive gas, cramping and increased disconfort.  Some people will have a variable amounts of diarrhea.  In the elderly population, burdened with constipation, many times, this is a welcome side effect.  The treatment for this condition varies with the severity, and most of the time can be effectively controlled by avoiding lactose.  There are several over the counter supplements which will aid in the digestion of milk products, i.e., Lactaid.  Ramon A Garcia MD FACP.