Archives for August 2015

FDA Warning Letters: Facility Problems, Unsafe Ingredients, Drug Residues

The latest batch of warning letters posted by the U.S. Food and Drug Administration (FDA) included one addressed to Frito-Lay Inc. of Plano, TX, concerning the “poor state of repair” of the company’s snack food manufacturing facility in Pulaski, TN.

FDA extends use of Promacta in young children with rare blood disorder

The U.S. Food and Drug Administration today approved Promacta (eltrombopag) to treat low blood platelet count in pediatric patients – ages one year and older – with a rare blood disorder called chronic immune thrombocytopenic purpura (ITP). Promacta can be used in these children when they have not achieved an appropriate response using other ITP medicines or surgery to remove the spleen.
ITP is a disorder that results in an abnormally low number of platelets, the cells that help your blood clot. Without enough platelets, bleeding can occur under the skin, in mucous membranes (such as in the mouth) or in other parts of the body.

FDA Releases 18 Years of Isolate-Level Data for Common Gut Bacteria

In a move to make its data more transparent and promote scientific research, the US Food and Drug Administration (FDA) is releasing 18 years of data on several bacteria, collected as part of the National Antimicrobial Resistance Monitoring System (NARMS).

Merck recalls Temodar and Temozolomide bottles

Merck Sharp & Dohme of Whitehouse Station, N.J., is recalling about 276,000 bottles with cracked caps containing Temodar (Temozolomide) and Temozolomide (generic) capsules

The cracked bottle can cause the child-resistant closure to be ineffective, allowing young children to gain unintended access to the capsules, posing a risk of poisoning.

Women May Have an FDA-Approved Drug to Treat the Most Common Sexual Dysfunction

That’s been my credo over 40+ years of fighting for gender equity. And trust me, I’ve been outraged for nearly every minute of the past four decades. With all the basic rights women have had to fight tooth and nail to win and hang on to over that tumultuous period, how could I not?

FDA: We’re working to reduce the risks

The FDA’s first priority is patient safety.

The FDA has been working for several years to reduce the risk of patient infections associated with reusable endoscopes — small, flexible lighted tubes that allow doctors to see inside patients and treat certain medical conditions in a less invasive manner than traditional surgery. The devices, which include duodenoscopes, are reprocessed, or cleaned and disinfected, for use between patients.

Deadly harm: The result of regulatory failure by FDA

On Monday, August 10, 2015 a young mother, Viviana Ruscitto, lay dying at a New York Hospital – her abdominal cavity filled with inoperable cancerous tumors blocking her intestines. Her toddler’s life was forever changed. You can read her account here.

Court sides against FDA in “off-label” drug promotion case

The maker of a prescription fish-oil pill won an early victory Friday against the Food and Drug Administration over its right to publicize unapproved uses of its drug.

Cuba’s medical breakthroughs have caught U.S. attention

TAMPA — As relations with Cuba improve, many people in Tampa are hoping for easier access to one export item the island nation has made famous — premium cigars.

But there’s far more at stake with another product developed in Cuba — a treatment for lung cancer, the disease most commonly caused by tobacco smoking.