Tag Archives: FDA

Social media, health and drug marketing

13 May

I recently wrote about social media and prescription drug marketing for Nature Biotechnology. The policy issues balance precariously on a number of fulcrum points: free speech, public health and safety, and the sense of online community that can grow out of social media interactions. How do you regulate how companies can talk about prescription drugs in these settings? Space is often limited, so companies can’t include the fine print that discusses the risks and benefits of particular products. At the same time, if a company can’t participate, it also isn’t in a position to correct misinformation that might be circulating among consumers. The FDA held hearings in November to discuss the issues and will be advising pharmaceutical companies about how they can interact with the public in the world of Web 2.0.

If you’re interested in following this topic, check out the following links

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MotW: Acetaminophen (and House’s Vicodin habit)

2 Jul
Acetaminophen structure via Wikipedia (benjah-bmm27)

Acetaminophen structure via Wikipedia (benjah-bmm27)

More FDA warnings for cold sufferers– and really anyone who takes pain relievers– to keep in mind. Acetaminophen– the molecule at the left– is found in Tylenol and a whole host of other pain relievers, cold medicines and prescription drugs. At lower doses, it’s safe, but at higher doses can cause liver damage and even liver failure. The tricky thing? The molecule is included in so many different medications that it’s possible to take too much without realizing it. If you’re sick and have a headache, that Tylenol combined with acetaminophen in a cold remedy might have just tipped the dose over the recommended levels.

An FDA advisory committee issued the warnings, but  it will be interesting to see what the agency decides to do to help prevent further problems. It’s possible that some prescription painkillers such as Percocet and Vicodin, which mix acetaminophen with narcotics, might be taken off the market.

I must admit that the Vicodin tidbit led me to more frivolous thoughts about Gregory House, the fictional doctor from the TV series. Considering everything else that has managed to go wrong with him, I’m a little surprised that the  producers haven’t written liver failure into the plot line considering his Vicodin problem. Or did I miss it? Will the writers have to find a new painkiller addiction? Will he finally kick the habit?

So– I guess I’m wondering out loud– could the FDA wind up changing both our pharmacy shelves and the plot lines of TV? My brain is lurking somewhere in that nebulous space between pop culture and medicine today.

The practical stuff, news stories and FDA info:

The fun stuff: I couldn’t find a good video clip about House’s Vicodin habit, but this video/song montage was the next best thing. Enjoy!

Molecule of the Week: Zinc gluconate

20 Jun

The Molecule of the Week is the active ingredient in Zicam, the nasal gel cold remedy that the FDA warned consumers to stop using this week. What’s the problem? Some users have reported losing their sense of smell after using the gel. On Tuesday, the FDA stepped in and issued a warning letter to Matrixx Initiatives about Zicam:

According to the labeling accompanying the Zicam Cold Remedy intranasal products, each of these products “reduces” the “duration of the common cold” and the “severity of cold symptoms,” including specifically “sore throat • stuffy nose •sneezing • coughing • congestion.” These claims make these products drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals.

The FDA has urged consumers to stop using zinc gluconate products that involve application inside the nose. Zinc lozenges are not part of the warning. It’s a healthy reminder: just because a remedy is “homeopathic” doesn’t mean that it’s also safe. Chemical activity comes with the molecule itself– it doesn’t matter whether it was made by a living organism or synthesized in a lab.

Zinc gluconate structure from Wikimedia Commons

Zinc gluconate structure from Wikimedia Commons

The molecule itself is interesting– like two sugar-like wings around a central zinc ion. The gluconate “wings” are oxidized forms of the sugar glucose, in case that name looked familiar. Zinc ions bind to electron-rich atoms (like those oxygens) on many types of biological molecules.

I’ll be interested in the follow-up investigation into Zicam and further scientific evidence. I’m not willing to put my sense of smell on the line until researchers know more.

Reuters Health: US tells Zicam maker to stop selling some products