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Weekly Drug News Round Up - December 24, 2013

REMS, Post-Marketing Studies Allow Iclusig to Return to Market

Patients currently receiving Iclusig should discuss the risks and benefits with their doctor Read More...

On October 31, 2103 the U.S. Food and Drug Administration (FDA) requested that Ariad Pharmaceuticals suspend marketing and sales of Iclusig (ponatinib), a leukemia chemotherapy drug, because of the risk of life-threatening blood clots and severe narrowing of blood vessels. After review, the FDA is requiring several new safety measures for Iclusig (ponatinib) to address these risks. Ariad can resume marketing and commercial distribution of Iclusig now that a revised package insert and Risk Evaluation and Mitigation Strategy (REMS) have been put into place. The new label includes a revised indication statement and boxed warning, updated safety information and recommendations regarding dosing considerations for prescribers.

Cancer Drug Shortages Often Involve Generic Products

FDA is working with manufacturers to identify possible production flaws to fend of shortages earlier Read More...

A survey published in the New England Journal of Medicine notes that drug shortages are commonplace for physicians. Drug shortages are often seen with colon cancer, breast cancer and leukemia medications. In the survey, four out of five cancer doctors were unable to prescribe their preferred medication at least once during a six-month period because of a drug shortage. When substitutions can be made, it's often a more expensive brand name drug replacing a generic in short supply. In addition, formal guidelines for making appropriate substitutions for cancer drugs in short supply do not exist at most institutions.

FDA Health Risk Warning: “Mass Destruction” Dietary Supplement

Mass Destruction is manufactured for Blunt Force Nutrition in Sims, N.C. and sold in retail stores, fitness gyms, and on the Internet Read More…

The U.S. Food and Drug Administration (FDA) is warning consumers and healthcare providers about the bodybuilding dietary supplement “Mass Destruction” that contains one or more anabolic steroids and may lead to liver failure. In general, anabolic steroids may cause other serious, long-term consequences including increased risk of heart attack and stroke, masculinization of women, testicle shrinkage, breast enlargement, infertility in males, and short stature in children. Consumers who have used “Mass Destruction” and experience unexplained fatigue, stomach or back pain, discolored urine, or other health changes should consult a doctor.

Orphan Drug Tretten Approved for Rare Blood Clotting Disorder

Reported side effects include headache, pain in the extremities and pain at injection site Read More...

The U.S. Food and Drug Administration (FDA) has approved Novo Nordisk’s Tretten (coagulation factor XIII A-Subunit recombinant) to treat an extremely rare, genetic blood clotting disorder called congenital Factor XIII A-Subunit deficiency. Patients with this deficiency do not produce enough Factor XIII, a blood protein that is important for normal clotting. Without treatment, people with Factor XIII A-Subunit deficiency are at risk for serious and life-threatening bleeding. In studies, Tretten given monthly was effective in preventing bleeding in 90 percent of the patients. No individual in the trial of 77 patients developed abnormal clots.

Recalled: One Lot of Gardasil Vaccine

If product from recalled lot has been administered, revaccination is not necessary Read More...

Merck Sharp & Dohme is initiating a voluntary recall of Gardasil (Human Papillomavirus Quadrivalent - Types 6, 11, 16, and 18 - Vaccine, Recombinant), Lot J0078354, due to the potential for glass particles in vials. Merck distributed this one lot between August 20, 2013 and October 9, 2013; no other lots are affected. Gardasil is administered via intramuscular injection to males and females 9 to 26 years of age for prevention of human papillomavirus (HPV). If a vaccine containing glass particles is administered to a patient, there is a remote risk of an injection site reaction. The sterility of the vaccine has not been impacted.