I missed the Weekly Roundup last week while on vacay and took this week off from blogging because let’s face it, everyone is gone. We are at that special cusp when the calendar really does coincide with a noticeable change in the environment. September – just before the chill comes – the growing season is tired. You can see it in the leaves, brown and curling at the edges. They are anxious to turn colors and fall off. Everything has an overly dry look. The season is a bit tired. Soon the barbeque grill will be left in favor of the fireplace. Sweaters will come out. Linens will go away.
In spite of the fact that the nation is away, a few interesting things did happen these past few weeks and here they are.
- Kardashian Reposts On Morning Sickness – Everyone is aware of the hoopla that resulted when a spokesperson for a morning sickness medication, Kim Kardashian, posted on Instagram commentary about the morning sickeness drug DICLEGIS which got FDA’s attention and response in the form of a warning letter due to the lack of risk information in the posting. FDA provided a link to images of the original material here. This past week, there was a re-posting of the material, this time with risk information included.
- Caffeine Warnings – FDA issued a round of Warning Letters dated August 27 to supplement manufacturers over the marketing of powdered caffeine products. The packaging of the product was such that consumers were many times instructed to measure out very small amounts of the powder (e.g., 1/14th of a teaspoon) which would require the use of equipment not often found in the possession of a typical consumer. FDA points out that an entire teaspoon of the powdered product could have harmful effects as it would offer the equivalent of 28 cups of coffee.
- E&C Letter to FDA on Blood Thinner Warfarin – Congress may be on recess, but a letter went out this week from the House Energy and Commerce Committee to Acting FDA Commissioner Dr. Stephen Ostroff following a report on adverse events often experienced in association with the use of the drug in nursing homes. Recognizing the fact that FDA did not have jurisdiction over nursing homes, the committee was nevertheless seeking to understand FDA’s awareness of the issue and whether or not any steps could be taken to mitigate the adverse events.
Enjoy the last “summer” weekend. We will be back next week and I will be providing some more updates on the database of pharma use of social media. Until then, take care.