Wednesday, October 27, 2021

The new label for the FDA. Don’t overdo it

Diabetes, high blood pressure, heart disease and stroke cannot be prevented by a lack of eating healthily and taking up regular exercise. If you have any concerns about these areas of your health, talk to your doctor.

That’s a message the Federal Drug Administration just wanted to get out, because millions of people have had the same message for decades. Then, on 27 September, the FDA approved Pfizer’s innovative Prilosec® Suppressant Arthritis Treatment Booster Shots For Adults and Older People. These are administered intramuscularly and are part of a popular, existing health regimen (read the FDA brand name out there for your local pharmacies), which helps prevent and treat certain life-threatening diseases, such as Type 2 diabetes and high blood pressure.

The FDA advises it in several details not to share with anyone that there’s really nothing new here, but given that people who have had these shots in the past are already taking them, it’s much easier to warn current and future recipients. Plus, the boxes mentioning how the approved product, like some others mentioned in this post, is safe, effective and only one of many treatment options often mean someone’s been using it for years, not just a few weeks. The FDA explains:

These preventive medications are approved for use to prevent or delay the development of diabetes and high blood pressure. They are similar to existing drugs but have fewer side effects.

These meds, called pump dose or glucometer-activated products, are used by patients with type 2 diabetes and uncontrolled high blood pressure. Other drugs often prescribed for these conditions are commonly used as well, such as metformin, and can provide similar benefits. However, the risk of serious side effects, such as low blood sugar levels and dangerous bleeding, has discouraged many physicians from prescribing metformin in favor of the approved Pump dose tablets. Most patients with these conditions will benefit from taking these regulated medications as well as they always have.

Although the purpose of this announcement is not to tell people “don’t take the pill or dipole” it’s important that people who have access to these drugs know what to expect. It’s an important, important reminder to familiarize yourself with the approved drug-label when writing your prescriptions and considering the use of these shots.

Questions? Comments? Tell us what you think is relevant for medical professionals, patients and the public.

This post is part of a collaborative series. A live chat by Jacqueline Gerber discussing how we can use data to help improve health and care delivery takes place on Monday, 12 September, in the comments below.

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