Wegovy available?

The FDA has listed both of Novo Nordisk’s versions of semaglutide — Ozempic and Wegovy — as “available” on its shortage site. But it’s still officially in shortage.

That last part is kind of important, because you know the company will be saying “Ozempic is available now.” It might even take a page from Lilly’s playbook and threaten compounding pharmacists. And news media will be confused, making the whole thing more complicated.

But, once again: Ozempic and Wegovy are still officially in shortage, although the FDA now lists them as “available.” (Yes, it’s a weird system the FDA has, where a drug can be both “Available” and “Currently in shortage.”) But the fact that semaglutide injections are still in shortage means that compounding pharmacists can still compound it.

But are Novo’s drugs safe?

The FDA cited Novo Nordisk for “quality lapses” at the second of the company’s two Ozempic manufacturing plants. This facility, in Denmark, was dinged for potential contamination issues — the other is in North Carolina, which got a similar rebuke from the FDA earlier this year. The Denmark issue is bad enough that the company doesn’t expect it to be resolved in 2024.

More meds, more apps

In case you don’t have enough apps on your phone, drug makers are starting to roll out more of them to go with prescriptions.

The idea is that the apps will “prod patients to take pills as directed, manage side effects, or track how well a treatment works.” They couldn’t possibly be used to collect more information on patients or share that data with third parties. No sirree^*.

This adds a headache for the FDA because the whole app-with-drugs marketplace (they’re called PDURS, or prescription drug use-related software) is still evolving. The agency is working on guidance that will update its 7-year-old “Digital Health Innovation Action Plan.” One question it will grapple with is when an app is promotional and when it’s therapeutic.

^* If you want a shock, download the DuckDuckGo Private Browser for your phone (Android)(iPhone). You don’t need to use the browser, but it includes a feature that blocks apps from sending your data to third parties — and shows you what it blocked. It’s frankly terrifying. Click the pic below to enlarge it to see some of mine.

Congrats to Raquibul!

Mercer pharma prof Raquibul Hasan has received his third grant from the American Heart Association for studying how statins might also relax blood vessels and thus lower blood pressure.

That idea isn’t new, but there’s been conflicting evidence as to whether the effect is real. Hasan’s research is focused on how some statins affect a particular (newly discovered) target, which might explain their effects — and could lead to better-targeted therapies.

FDA wants interactions flagged

The FDA wants to make drug interactions clearer on labels, so it’s issued some draft guidance with the changes it wants to see. Essentially, it’s suggesting, the label…

… must document clinically significant observed or predicted drug interactions in the Drug Interactions section, including interactions with over-the-counter drugs, prescription drugs, drug classes, and foods as well as interference with laboratory tests.

It also needs to give “specific practical instructions” to prevent and manage those interactions, and all in language that’s clear to healthcare practitioners who aren’t pharmacists.

Short Takes

Georgia lacks healthcare access

A new survey out of Forbes Advisor looked at how accessible healthcare is across the country, and Georgia … well, Georgia didn’t do so well, ranking #45 out of the 50 states.

Georgia’s population has the second highest percentage of people who don’t have health insurance, accompanied by a high number of residents who cannot afford a visit to the doctor.

The pigs have it

The USDA has detected the first case of the H5N1 flu virus in a pig — it’s in Oregon, and it lived with poultry that had become infected. This is a little worrying because pigs are one of those animals particularly good at mixing human and animal viruses. The good news: It was a small, non-commercial farm so the risk of further spread is limited.

More drugs in shortage

Here are the latest additions to the list compiled by the FDA and the American Society of Health-System Pharmacists:

• Linezolid injection. Shortages primarily due to manufacturing delays; Piramal Critical Care and Sun Pharma have the injection available.
• Droperidol injection. Only limited supplies available
• 0.9% sodium chloride small-volume bags. Baxter is facing supply issues due to damage at its North Carolina plant.
• 23.4% sodium chloride injection. Estimated release dates for Fresenius Kabi’s products range from early November to mid-December. No word on Pfizer versions.
• Technetium Tc-99m sodium pertechnetate generator. Shortages of both active and inactive ingredient components.
• Micardis (brand name). Discontinued for business reasons; no longer available.
• Strattera (brand name). Discontinued for business reasons; no longer available.
• Byetta (brand name). Discontinued for business reasons; no longer available.