November 8 Week in Review: FDA Releases Information Regarding Impurities in Nizatidine and Ranitidine; Stephan Hahn to be Nominated as FDA Commissioner


This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings, and more. Our Week in Review is a can't miss for the busy pharmacy professional.

This weekly video program provides our readers with an in-depth review of the latest news, product approvals, FDA rulings, and more. Our Week in Review is a can't miss for the busy pharmacy professional.

Nicole Grassano, Host:Hello and welcome to the Pharmacy Times News Network. I’m Nicole Grassano your host for our Pharmacy Week in Review.

The FDA has released new information regarding impurities in nizatidine and ranitidine products, stating that the levels of NDMA are much lower than third-party investigators have claimed,Pharmacy Timesreported.

The FDA’s letter follows a recent report of slight traces of the impurity, NDMA, in ranitidine products, which are approved for intestinal and stomach ulcers. NDMA is classified as a probable human carcinogen and is a known environmental contaminant found in water and some foods.

However, the recent updated information stated that the amount of NDMA is lower than previously reported. The FDA said that its recommendation has not changed: Consumers can consider other OTC ranitidine products if they so choose.

The FDA is recommending recalls to manufacturers with products containing NDMA levels above the acceptable daily intake limit of .096 micrograms. The agency is also asking manufacturers to continue conducting their own laboratory testing to examine the levels of NDMA in these products as well as to send samples to the FDA to be tested by its scientists.

Sesame allergy is common among children with other food allergies, occurring in an estimated 17% of the population,Contemporary Clinicreported.

About 120 children with food allergies whose sesame-allergic status was unknown were evaluated using a standard skin-prick test and the allergen-specific antibody test.

The study found that 15 of the 119 children were sesame-allergic, 73 were sesame-tolerant, and sesame-allergic status could not be determined for 31 children. Seventeen percent of the 88 children whose sesame-allergic status was definitive had a sesame allergy.

Sesame-specific immunoglobulin E was used to develop a mathematical model for predicting the probability that a child with food allergies is allergic to sesame. With this model, children with more than 29.4 kilo of sesame-specific immunoglobulin E per liter of serum have a greater-than-50% chance of being allergic to sesame. The authors noted that this model will need to be validated by additional studies before it can be used in clinical practice.

Texas oncologist Stephen Hahn, chief medical executive of MD Anderson Cancer Center, is expected to be nominated as FDA commissioner,Specialty Pharmacy Timesreported.

The intent to nominate Hahn was announced Friday by sources that include US Secretary of Health and Human Services Alex Azar.

If appointed to the permanent position, Hahn would replace former FDA Commissioner Scott Gottlieb, who left the agency in April. Acting Commissioner Norman “Ned” Sharpless, filled the role on an interim basis until his tenure expired on November 1, 2019.

A graduate of the medical school at Temple University in Philadelphia, Hahn spent nearly 2 decades with the University of Pennsylvania health system. Among his roles at UPenn, Hahn served for nearly a decade as chairman of the Department of Radiation Oncology at the university’s School of Medicine in Philadelphia.

Pharmacists may get more questions about Cosentyx, if patients have seen a recent commercial for the prescription medication.

In the spot, called “Kind of a Shock: LauraLee,” a patient explains that she suffered with psoriasis for so long that it was almost shocking when Cosentyx helped alleviate her symptoms and kept her psoriasis-free for 5 years

According to the commercial, Cosentyx is used to treat psoriasis when taken as directed by a dermatologist.

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Thanks for watching our Pharmacy Week in Review. I’m Nicole Grassano at the Pharmacy Times News Network.

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