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Food and Drug Administration 233 articles

E-cigarettes found to contain carcinogens, toxic chemicals

Battery operated cigarette devices marketed toward and sold to young people have been found to contain carcinogens and toxic chemicals such as diethyele glycol, an ingredient used in antifreeze that could be harmful to humans, according to the Food and Drug Administration (FDA). The FDA issue a warning this week to pediatric health care professionals and consumers about the electronic cigarettes, also known as “e-cigarettes,” following a laboratory analysis on a sample of the e-cigarettes. E-cigarettes generally contain cartridges filled with nicotine and other chemicals that are converted into a vapor that is inhaled by the user. The FDA’s analysis detected ... Read More

FDA evaluating adverse events associated with Xolair asthma meds

The Food and Drug Administration (FDA) has announced it is evaluating interim safety findings from an ongoing study of the asthma treatment Xolair (omalizumab), which suggest those who use Xolair experience a disproportionate increase in ischemic heart disease, arrhythmias, cardiomyopathy and cardiac failure, pulmonary hypertension, cerebrovascular disorders, and embolic, thrombotic and thrombophlebitic events compared to those not treated with the drug. Xolair is approved for use by adults and adolescents (12 years of age and older) with moderate to severe persistent asthma who test positive for reactivity to a perennial airborne allergen, and whose symptoms are inadequately controlled with inhaled ... Read More

California grower recalls salmonella contaminated lettuce

A California produce grower has recalled romaine lettuce that was distributed throughout 29 states, Canada, and Puerto Rico because of salmonella contamination. Tanimura & Antle, Inc. of Salinas, Calif., issued the recall after the Wisconsin Department of Agriculture detected salmonella on the lettuce in a randomized test. Cartons of the lettuce were shipped in bulk “naked” (without packaging), tied with a printed twist tie, or bagged. The lot code on the suspected lettuce is 531380. The lettuce was provided to retail stores, food service companies, and wholesale customers. According to Tanimura & Antle, the lettuce was harvested between June 25 ... Read More

FDA announces recall of contaminated gravy and sauce mixes

Another salmonella-related recall was announced by the U.S. Food and Drug Administration, this time for a brand of sauce and gravy mixes manufactured by the C.F. Sauer Company of Richmond, Virginia. The recalled products include brown gravy, brown gravy with mushrooms, brown gravy with onions, turkey gravy, pork gravy, country sausage gravy, country style gravy, Alfredo sauce mix, Cajun gumbo mix, and Hollandaise sauce mix manufactured by Sauer under the Sauer’s, Gold Medal, and Piggly Wiggly brand names. According to the FDA, the recalled products include non-fat dry milk made by the Plainview Products Cooperative, which recently recalled its instant ... Read More

More lawsuits filed against maker of shoulder pain pumps

Four complaints have been filed in federal court in Philadelphia against Stryker Corp., maker of medical devices including postoperative pain pumps, for causing serious arthritis. The Kalamazoo, Michigan-based company is accused of actively concealing or misrepresenting information about the safety and efficacy of its pain pumps. One of the complainants, Glen Gore, says a Stryker pain pump was implanted in his shoulder after repair surgery in December 2002. After using the pain pump, he was had lost almost all of the cartilage in his shoulder joint, is unable to raise his arm above shoulder level, and now needs replacement surgery. ... Read More

FDA now requiring stronger warnings on Chantix labels

The U.S. Food and Drug Administration announced today that it will require drug manufacturers to put boxed warnings on the product labeling for Chantix (varenicline) and Zyban (bupropion hydrochloride, otherwise called Wellbutrin when prescribed as an antidepressant). Both Chantix and Zyban, commonly prescribed to patients as smoking cessation aids, have been linked to serious behavioral changes and other symptoms. Agitation, hostility, depression, and suicidal thoughts and actions are possible side effects that users should be keenly aware of, the FDA warns. “People who are taking Chantix or Zyban and experience any serious and unusual changes in mood or behavior or ... Read More

Pain pump makers may be liable for injury after shoulder surgery

For a long time, physicians didn’t know why patients who had shoulder surgery began suffering from a painful condition known as chondrolysis, in which the patient loses the cartilage in the shoulder. “This goes all the way back to about the year 2000. People who had surgery seven or eight years ago who thought they would recover are now seeing that they have lost their cartilage and they don’t know why,” says Frank Woodson, shareholder with Beasley Allen Law Firm. “However, now that the literature is expanding and more and more doctors are finding out about this and they’re telling ... Read More

Investigators still baffled over cookie dough contamination

Food safety authorities and microbiologists arrived at Nestle’s Danville, Virginia plant to investigate the likely presence of E. coli bacteria in refrigerated cookie dough products. The Food and Drug Administration and the Centers for Disease Control and Prevention have been baffled by the bacteria’s presence in the cookie dough because it is a type of food unlikely to contain E. coli. The E. coli outbreak has sickened 70 people in 30 states since March 2009. Thirty of the reported illnesses led to hospitalization. While some of the E. coli infections have led to serious kidney damage, no deaths from renal ... Read More

Royals’ Crisp may need shoulder surgery

Kansas City Royals outfielder Coco Crisp could be out for the rest of the season if the injury to his right shoulder turns out to be a torn labrum. He is getting second opinion from the renowned surgeon Dr. James Andrews. If it is torn, Crisp will have to decide whether to undergo immediate season-ending surgery or to put off surgery in hopes he can play again this season, according to The Kansas City Star. Crisp, who has not played since June 12, was put on the disabled list and restricted from all swinging and throwing activities. “Obviously, that’s not ... Read More

Nestle cookie dough products recalled after E. coli outbreak

The Food and Drug Administration and Centers for Disease Control and Prevention are investigating reports of E. coli illness caused by consumption of Nestle’s Toll House refrigerated cookie dough products. Nestle’s U.S. operations announced today that it was voluntarily recalling the Toll House products. According to the FDA, Nestle is cooperating fully with an ongoing epidemiological study being conducted by the CDC and several state health departments. Authorities say there have been 66 reports of E. coli food poisoning linked to the cookie dough products. The reported illnesses span 28 states. Of the reported illnesses, 25 people have been hospitalized. ... Read More