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Weekly Drug News Round-Up: May 11, 2016

FDA Warns of Rare But Possibly Fatal Olanzapine Drug Reaction

Patients should seek immediate medical care if they notice these symptoms while taking any olanzapine-containing product Read More...

Olanzapine is an antipsychotic available under the brand names Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax, and also as generics. FDA is updating a label warning for all olanzapine products that describes a severe condition known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS). DRESS is rare event and FDA has identified 23 cases worldwide since 1996. Symptoms may start as a rash that can spread to all parts of the body, with fever, swollen lymph nodes, swollen face, and end-organ injury. DRESS is a potentially fatal drug reaction with a mortality rate of up to 10 percent.

Antibiotic Use for Vibativ is Expanded 

In its most serious form, bacteremia can be fatal Read More...

Bacteremia is the presence of bacteria in the bloodstream and can occur spontaneously or in the presence of other infections. In response, the FDA has approved expansion of Vibativ (telavancin) injection for the treatment of patients with concurrent Staphylococcus aureus (S. aureus) bacteremia in both approved indications in the U.S. Approved uses include treatment of adults with hospital-acquired and ventilator-associated bacterial pneumonia caused by S. aureus when alternative treatments are not suitable and treatment of adults with complicated skin & skin structure infections caused by susceptible isolates of Gram-positive bacteria, including S. aureus, both methicillin-susceptible (MSSA) and methicillin-resistant (MRSA) strains.

FDA Approves Ameluz for Actinic Keratosis

Actinic keratosis affects more than 58 million people in the U.S. alone Read More...

FDA has granted approval of Biofrontera’s combination topical prescription drug Ameluz (BF-200 ALA) and medical device BF-RhodoLED for photodynamic therapy (PDT) treatment of mild to moderate actinic keratosis (AK) on the face and scalp. In clinical trials, 779 patients with four to eight mild to moderate AK lesions demonstrated a complete patient response rate of 91% when paired with BF-RhodoLED PDT lamp. AK, if left untreated, can develop into squamous cell carcinoma, a potentially fatal skin disease with rapidly growing incidence. Ameluz is already approved and marketed in Europe and U.S. launch is expected in September 2016.

A Penicillin Allergy May Not Be All It Seems

A skin test can determine the existence of a true penicillin allergy Read More...

Penicillin allergies are not as common as you might believe. While many people tell their doctor they are allergic to penicillin, a Mayo Clinic study found that over 80 percent of people who list a penicillin allergy have no evidence of a true reaction and avoid the drug unnecessarily. A true penicillin allergy can cause symptoms that include hives, nausea, diarrhea, vomiting, swelling of the lips, tongue and throat, and asthma-like symptoms. A true allergic reaction can result in anaphylaxis -- a life-threatening reaction that usually occurs within minutes or an hour or two of taking the drug. Stomach upset is not usually due to a penicillin allergy.

Live Malaria Vaccine Showing Promise: Study

The experimental vaccine is known as PfSPZ Vaccine, produced by Sanaria Inc. from Maryland Read More...

More than 500,000 people worldwide die from the malaria parasite each year, but most fatal cases of malaria involve children under the age of 5. A small, phase 1 clinical trial published this week is showing promise in the development of a vaccine to prevent malaria. The investigational malaria vaccine contains a live but weakened form of the malaria parasite, Plasmodium falciparum. In a group of 101 healthy adult volunteers, 59 people received the vaccine and effectiveness was determined by analyzing the levels of malaria parasite in the blood. The vaccine was shown to protect a majority of adults against the mosquito-borne parasite for up to one year.

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