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Weekly News Round Up - September 21, 2011

Adverse Drug Interaction: Politics and Vaccines

Political backlash leads to rumors, fears surrounding safety of human papillomavirus (HPV) vaccine for pre-teen girls; experts chime in Read More...

According to the Centers for Disease Control and Prevention, roughly 4,000 women die each year from cervical cancer. Gardasil and Cervarix are vaccines that target the two types of HPV that lead to roughly 70% of cervical cancers. These vaccines are approved for use in girls and young women to ward off the sexually-transmitted HPV virus. After a US political debate last week, additional concerns over the safety of the vaccine arose due to an unfounded report of mental retardation as a reaction to the vaccine. Multiple experts, including those from the American Academy of Pediatrics, confirm that the HPV vaccine is safe and has greater benefit than risk.

Zofran Drug Safety Communication: Risk of QT Prolongation, Torsades de Pointes

Zofran (ondansetron) label update for increased risk of abnormal heart rhythms; avoid use in patients with congenital long QT syndrome Read More...

Even old drugs can get new warnings. Zofran (ondansetron), a 5-HT3 receptor antagonist approved over 2 decades ago and used for prevention of nausea and vomiting associated with chemotherapy, surgery, or radiation treatment has important new safety warnings. Updated labels will reflect an increased risk of QT prolongation, which may lead to fatal heart rhythms, including Torsades de Pointes. Patients with congenital long QT syndrome are at particular risk for these abnormal heart rhythms, and should avoid using ondansetron. Patients with low levels of potassium or magnesium, congestive heart failure, slow heart rhythms, or taking other drugs that may also lead to QT prolongation may need to have their electrocardiogram followed.

Prolia Approved To Treat Bone Loss Due to Hormone Ablation Therapy

Prolia indicated to increase bone mass in prostate and breast cancer patients receiving hormone-reducing treatment Read More...

Hormone ablation treatments, such as those used in breast and prostate cancer, can result in bone loss and subsequent bone fractures. Prolia (denosumab), already approved for treatment of postmenopausal osteoporosis, was given two new indications this week: to increase bone mass in women at high risk of fracture also receiving adjuvant aromatase inhibitor therapy for breast cancer, and for men at high risk of fracture receiving androgen deprivation therapy for non-metastatic prostate cancer. Two Phase 3 clinical trials demonstrated significant bone mineral density increase in both groups of patients when compared to placebo. Prolia is a RANKL inhibitor and prevents osteoclast formation thus reducing bone resorption (break down).

Packaging Error Leads to Nationwide Recall of Oral Birth Control Tablets

Qualitest Pharmaceuticals issues contraceptive tablet recall; packaging error reverses pill orientation on blister card Read More...

Women using certain lots of Cyclafem 7/7/7, Cyclafem 1/35, Emoquette, Gildess FE 1.5/30,Gildess FE 1/20, Orsythia, Previfem, and Tri-Previfem oral contraceptives should be aware of a packaging error which resulted in select blisters being rotated 180 degrees within the card, reversing the weekly tablet orientation and obscuring the lot number and expiration date. The daily regimen of the pills may be incorrect and could leave women without adequate contraception. Women using recalled packages should start a non-hormonal form of birth control immediately and consult with their health care provider. The pills themselves do not pose a health risk. The Qualitest press release and affected lot numbers can be found here.

Study: Rates of Unintentional Drug Poisonings in Kids Continue to Rise

Ninety-five percent of poisoned children found to accidentally take prescription medications themselves Read More...

Parents with small children may need to rethink how and where they store prescriptions. A new study reports that 95 percent of children admitted to an emergency department (ED) for accidental drug poisonings ingested the medication themselves. Prescription drugs accounted for 55 percent of the ED visits, and for greater than 70% of the significant injuries and hospitalizations. More concerning was the drugs involved: opioids for pain, such as morphine, codeine and oxycodone, muscle relaxants, sleeping pills and heart medications. The researchers suggest parents keep medicines locked up or out of reach. They also propose critically needed package design changes for prescription and over-the-counter medications. New packaging could reduce the quantity of drug a child can swallow if they do get their hands on a potent prescription medication.