Medical News

FDA Approves Botox to Treat Spasticity in Flexor Muscles of the Elbow, Wrist and Fingers
The U.S. Food and Drug Administration today approved Botox (onabotulinumtoxin A) to treat spasticity in the flexor muscles of the elbow, wrist, and fingers in adults. Spasticity is common after stroke, traumatic brain injury, or the progression of multiple sclerosis.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - March 5, 2010
As part of the Salmonella Montevideo investigation, the Food and Drug Administration has been actively investigating the supply chain of black and red pepper supplied to Daniele International Inc., Pascoag, R.I.

FDA Investigation Reveals Salmonella Tennessee at Plant that Makes Flavor Enhancers for Food Processors and Other Distributors
The U.S. Food and Drug Administration is actively investigating positive findings of Salmonella Tennessee in hydrolyzed vegetable protein (HVP) manufactured by Basic Food Flavors Inc. in Las Vegas, Nev. HVP is a flavor enhancer used in a wide variety of processed food products such as soups, sauces, chilis, stews, hot dogs, gravies, seasoned snack foods, dips and dressings. It is often blended with other spices to make seasonings that are used in or on foods. There are no reports of consumer illness associated with this recall. Only HVP manufactured by Basic Food Flavors is involved in this recall.

FDA Approves Name Change for Heartburn Drug Kapidex
The U.S. Food and Drug Administration has approved a name change for the heartburn drug Kapidex Change to Dexilant is part of FDA effort to prevent medication errors(dexlansoprazole) to avoid confusion with two other medications – Casodex and Kadian. Effective in late April 2010, Takeda Pharmaceuticals North America Inc. will market Kapidex under the new name Dexilant.

La FDA advierte a los consumidores en Puerto Rico acerca de la presencia de una bacteria dañina en desinfectantes para manos
La Administración de Medicamentos y Alimentos (FDA por sus siglas en inglés) está advirtiendo a los consumidores en Puerto Rico acerca de un alto contenido de la bacteria Burkholderia cepacia en los desinfectantes para manos: "Bee-Shield Hand Sanitizer” con Aloe Vera ( botellas de 10 onzas o de un galón) y “MD Quality Hand Sanitizer” con Aloe Vera (botellas de 10 onzas). La bacteria Burkholderia cepacia puede causar infecciones graves en las personas.

FDA Warns Consumers in Puerto Rico of Harmful Bacteria in Hand Sanitizers
The U.S. Food and Drug Administration is warning consumers in Puerto Rico that two hand sanitizers – "Bee-Shield Hand Sanitizer” with Aloe Vera (10 fl. oz. or 1 gallon bottles) and “MD Quality Hand Sanitizer” with Aloe Vera (10 fl oz. bottles) – contain high levels of a bacteria, Burkholderia cepacia, that can cause serious infections in humans.

FDA, FSIS, CDC Collaborate on Methods to Measure Success of Food Safety Programs
The U.S. Food and Drug Administration, the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) will host a joint public workshop on how best to measure progress in reducing foodborne illnesses on March 30, in Washington, D.C.

FDA Calls on Food Companies to Correct Labeling Violations; FDA Commissioner Issues an Open Letter to the Industry
The U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.

FDA Survey Finds More Americans Read Information on Food Labels
A majority of consumers read food labels and are increasingly aware of the link between good nutrition and reducing the risk of disease, according to the latest survey of dietary habits released today by the U.S. Food and Drug Administration.

FDA Approves First Generic Tamsulosin to Treat Enlarged Prostate Gland
The U.S. Food and Drug Administration today approved the first generic version of Flomax Capsules 0.4 mg (tamsulosin hydrochloride) to treat benign prostatic hyperplasia (BPH), a condition in which an enlarged prostate gland causes problems with urination.

U.S. Attorney News Release: Boca Raton Man Sentenced for Nutritional Supplement Scam
Jeffrey H. Sloman, United States Attorney for the Southern District of Florida, David W. Bourne, Special Agent in Charge, Food and Drug Administration, Office of Criminal Investigations, Daniel W. Auer, Special Agent in Charge, Internal Revenue Service, Criminal Investigation Division, and Henry Gutierrez, Postal Inspector in Charge, U.S. Postal Inspection Service, announced the February 26, 2010 sentencing of defendant Frank Sarcona, a/k/a Frank Sarcone, a/k/a Dave Johnson, 58, of Boca Raton, FL. U.S. District Court Judge Kenneth A. Marra sentenced Sarcona to a term of 20 years’ imprisonment for conspiracy to commit mail and wire fraud, and criminal contempt of court; conspiracy to commit money laundering; and multiple counts of substantive mail fraud, wire fraud, money laundering, misbranding of a food, and criminal contempt of court.

FDA Announces Meeting Information and Voting Membership of the Tobacco Products Scientific Advisory Committee
The U.S. Food and Drug Administration today announced membership and meeting information for the Tobacco Products Scientific Advisory Committee (TPSAC). The Committee, required through the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), will provide advice, information, and recommendations to FDA on a wide range of tobacco-related issues.

International Collaboration: FDA and European Medicines Agency Agree to Accept a Single Orphan Drug Designation Annual Report
In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 26, 2010
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

FDA Approves Therapy to Treat Gaucher Disease
The U.S. Food and Drug Administration has approved velaglucerase alfa for injection (VPRIV) to treat children and adults with a form of the rare genetic disorder Gaucher disease.

U.S. Attorney News Release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety
U.S. Attorney News release: Medical Device Manufacturer Guidant Charged in Failure to Report Defibrillator Safety Problems to FDA

FDA Update on the Investigation into the Salmonella Montevideo Outbreak - February 25, 2010
The Food and Drug Administration, along with the Centers for Disease Control and Prevention and the U.S. Department of Agriculture’s Food Safety and Inspection Service, continues to work closely with the Rhode Island Department of Health and other states in the investigation of an outbreak of Salmonella Montevideo infections associated with certain Italian-style sausage products including salami/salame.

U.S. Attorney News Release: Medical Technician Sentenced to 30 Years
Statement by U.S. attorney David Gaouette regarding the sentencing of Kristen Parker

FDA Approves Pneumococcal Disease Vaccine with Broader Protection
The U.S. Food and Drug Administration today approved Prevnar 13, a pneumococcal 13-valent conjugate vaccine for infants and young children ages 6 weeks through 5 years. Prevnar 13 will be the successor to Prevnar, the pneumococcal 7-valent conjugate vaccine licensed by the FDA in 2000 to prevent invasive pneumococcal disease (IPD) and otitis media. The new vaccine extends the protection to six additional types of the disease causing bacteria.

NIH and FDA Announce Collaborative Initiative to Fast-track Innovations to the Public
The U.S. Food and Drug Administration and the National Institutes of Health today unveiled an initiative designed to accelerate the process from scientific breakthrough to the availability of new, innovative medical therapies for patients.