DOs and DON’Ts in Managing GERD ( GastroEsophageal Reflux Disease ) :

DO eat a healthy diet, rich in fruits, vegetables, and low-fat dairy products. Lower your intake of saturated and total fats. DO raise the head of your bed 6 to 8 inches with wooden blocks. DO maintain a healthy body weight. DO take medicines recommended by your doctor. DON’T eat refl ux-inducing foods, such as citrus fruits and juices, coffee, peppermint, chocolate, and spicy foods. DON’T eat large meals. DON’T eat meals late in the day. DON’T lie down just after eating. DON’T wear tight-fi tting clothing. DON’T smoke or use tobacco products.

Restrictions on use of diabetes drug rosiglitazone lifted after FDA re-examines cardiovascular risk data

ST LOUIS - On November 25, 2013, the US Food and Drug Administration (FDA) issued a safety alert stating that it is requiring the removal of certain restrictions on prescribing and use of Avandia (rosiglitazone), a drug used in the treatment of diabetes. This new label information concerns cardiovascular risk. The FDA is also requiring the same modifications be made to the labels for any other drugs that contain rosiglitazone. The decision to remove the previous prescribing and dispensing restrictions for rosiglitazone-containing medicines was made on the basis of results from the FDA's review of data of a large, long-term clinical trial. Moreover, the decision to change the restrictions was supported by a comprehensive, outside, expert re-evaluation of the data conducted by the Duke Clinical Research Institute. In 2010, in response to data from a meta-analysis of placebo-controlled randomized trials that suggested an elevated risk of cardiovascular events in association with rosiglitazone use, the FDA announced it would restrict the drug to use in patients with type 2 diabetes who could not manage their disease with other medications. The FDA also required GlaxoSmithKline, the manufacturer of Avandia, to convene an independent group of scientists to readjudicate key aspects of the trial known as Rosiglitazone Evaluated for Cardiac Outcomes and Regulation of Glycemia in Diabetes (RECORD). This trial evaluated the cardiovascular safety of Avandia compared with standard diabetes drugs. The original evaluation of data from RECORD suggested an increase in myocardial infarctions (MIs) and decreases in the rates of death and stroke in patients treated with rosiglitazone. These results were not statistically significant. During the course of the FDA's original 2010 review of the RECORD trial, important questions had arisen about potential bias in the identification of cardiovascular events. The readjudicated results could not dismiss an increased risk of MI with rosiglitazone versus placebo, because the trial did not use a placebo. However, the readjudicated results did assess rosiglitazone versus the standard-of-care diabetes drugs metformin and sulfonylurea and confirmed the original RECORD finding that did not show an increased risk of MI associated with the use of rosiglitazone. In the trial, patients treated with rosiglitazone experienced fewer deaths from a cardiovascular cause, from a stroke, and from an MI; fewer nonfatal strokes; and fewer deaths from any cause compared with patients treated with metformin and sulfonylurea. Patients treated with metformin and sulfonylurea experienced fewer nonfatal MIs compared with patients treated with rosiglitazone. However, none of these results were statistically significant. On the basis of the results from the readjudicated RECORD trial, the FDA is requiring modifications to the rosiglitazone Risk Evaluation and Mitigation Strategy (REMS) program to remove the requirements for restricted distribution. After the changes to the REMS are finalized, health care professionals, pharmacists, and patients will no longer be required to enroll in the rosiglitazone REMS program to prescribe, dispense, or receive rosiglitazone medicines. Patients will also be able to receive rosiglitazone through regular retail pharmacies and mail order pharmacies.

FDA warns of risk of myocardial infarction and death with use of certain cardiac stress test drugs

On November 20, 2013, the US Food and Drug Administration (FDA) issued a warning concerning the rare risk of myocardial infarction (MI) and death with use of the cardiac nuclear stress test agents Lexiscan (regadenoson) and Adenoscan (adenosine). The FDA has approved changes to the drug labels to reflect these serious events and has updated its recommendations for use of these agents. The FDA has reviewed the FDA Adverse Event Reporting System (FAERS) database and the medical literature for cases of MI and death from all causes associated with the use of Lexiscan and Adenoscan. Information about Lexiscan included that dating from June 24, 2008, to April 10, 2013, and for Adenoscan, from May 18, 1995, to April 10, 2013. The beginning dates correlated with the start of marketing for each drug. The FAERS database contained 26 MI cases and 29 cases of death occurring after Lexiscan administration, and 6 cases of MI and 27 cases of death after Adenoscan administration. Reports did not always specify when deaths or MIs occurred. When reported, these adverse events tended to occur within 6 hours after Lexican or Adenoscan administration. A few deaths occurred when Lexiscan or Adenoscan was administered with exercise stress testing, which is not an FDA approved use of the drugs. With Lexiscan, the most common adverse events associated with death were cardiac arrest, MI, loss of consciousness, respiratory arrest, electrocardiography ST-segment depression, pulmonary edema, and ventricular fibrillation. With Adenoscan, the most common adverse events associated with death were cardiorespiratory arrest, dyspnea, cardiac arrest, respiratory arrest, and ventricular tachycardia. A review of the medical literature also identified 2 case reports of MI associated with Lexiscan use. However, published studies from the medical literature have not documented an increased incidence of cardiovascular adverse events with Lexiscan compared with Adenoscan. Lexiscan and Adenoscan are FDA approved for use during cardiac nuclear stress tests in patients who cannot exercise adequately. Both products help identify coronary artery disease by dilating these arteries and increasing blood flow to help identify obstructions. Lexiscan and Adenoscan cause blood to flow preferentially to the healthier, unblocked, or unobstructed arteries, which can reduce blood flow in obstructed arteries. In some cases, this reduced blood flow can lead to an MI, which can be fatal. The use of both drugs should be avoided in patients with signs or symptoms of unstable angina or cardiovascular instability because these patients may be at greater risk for serious cardiovascular adverse reactions. Cardiac resuscitation equipment and trained staff should be readily available before administering Lexiscan or Adenoscan.

High schoolers smoking more cigars, pipes, e-cigarettes

BY RICHARD FRANKI Overall use of tobacco among high school students decreased from 2011 to 2012, but cigar and pipe smoking went up, as did the use of some nonconventional products, the Centers for Disease Control and Prevention reported. In 2012, 23.3% of high school students surveyed reported current tobacco use, compared with 24.3% in 2011. Use of cigars, driven largely by a significant increase among non-Hispanic black students, went from 11.6% in 2011 to 12.6% in 2012, and pipe use rose from 4.0% to 4.5%, according to data from the National Youth Tobacco Survey. “Youths are known to have higher rates of cigar use than adults, which might be related to the lower price of some cigars (e.g., cigarillos and ‘little cigars’) relative to cigarettes, or the marketing of flavored cigars that might appeal to youths,” the report said (MMWR 2013;62;893-7). Significant increases in use were seen for electronic cigarettes (1.5% in 2011 to 2.8% in 2012) and hookahs (4.1% to 5.4%), but the use of other nonconventional products such as bidis (small brown cigarettes wrapped in a leaf), kreteks (clove cigarettes), and snus declined, the CDC noted.