Drug safety
terrasig | February 18, 2007Lack of health insurance, or selective lack of drug coverage by some insurance companies, has created a large, Internet-based market for cheaper prescription drugs. There have been many warnings about the risks of buying one's drugs on-line from such sources from the FDA and the pharmaceutical industry but those warnings, especially from drug makers, are often viewed as self-serving.
This week, however, saw two examples of Internet drug-buying gone wrong that highlight the risks of purchasing medicines on-line.
On Friday, the US FDA released a warning to consumers that some who purchased…
terrasig | February 9, 2007My apologies to those regular readers who may have noticed my recent case of blogger's malaise. A combination of family sicknesses and having to write a fair bit for the day job seems to have interfered with this week's blogging.
So, what to do? Link to other worthy blogs!
This gives me an opportunity to introduce our fairly-recent addition to the ScienceBlogs corral, Karen Ventii and ScienceToLife. Karen is a late-stage biochemistry Ph.D. student down the road apiece at Emory University and posted earlier this morning on the FDA decision to reclassify the prescription diet pill, Xenical (…
terrasig | February 1, 2007Between the news offices for New England Journal of Medicine and NIH's National Institute for Environmental Health Sciences (NIEHS), you have no doubt already heard the report that topical application of lavender and tea tree oil-containing products has been linked with gynecomastia in three boys.
Yes, imagine being a private practice pediatrician whose 10-year-old male patient presents with "firm, tender breast buds measuring 3.5 cm by 4.0 cm in length and width and 3.5 cm in depth, with stretching of the areolae." In fact, imagine being the parent...or the boy himself.
In all three cases,…
terrasig | January 25, 2007In an insult to dietary supplement companies who at least try to play by the rules, a company has agreed with the US FDA to recall its product because it might work too well:
FDA and Ebek, Inc. notified healthcare professionals and consumers of a voluntary nationwide recall of the company's dietary supplement because the product contains tadalafil, a drug used to treat erectile dysfunction.
Yes, you read correctly: if the herbal product doesn't work, just add an actual prescription drug to the concoction. Tadalafil is better known in the US as Cialis. In fact, this adulteration of herbal "…
terrasig | January 19, 2007Now this is bloody lovely: supplement consumer watchdog ConsumerLab.com reports that some multivitamin supplements are contaminated with lead, with one at concentrations 10 times above acceptable California exposure limits. Jacqueline Stenson at MSNBC does a good job of putting this all in perspective:
Of 21 brands of multivitamins on the market in the United States and Canada selected by ConsumerLab.com and tested by independent laboratories, just 10 met the stated claims on their labels or satisfied other quality standards.
Most worrisome, according to ConsumerLab.com president Dr. Tod…
terrasig | January 17, 2007While I wait for my copy of Dan Hurley's book, "Natural Causes: Death, Lies and Politics in America's Vitamin and Herbal Supplement Industry," it is interesting to read the media reports on his interviews and the responses from the dietary supplement industry.
While the Natural Products Association has simply responded with a measured, educational piece that does not mention Hurley by name, the Council for Responsible Nutrition was all over the wires today dismissing the book as, "not credible."
Some of the most thoughtful discussion today came from CBS News's Public Eye site and a post by…
terrasig | January 16, 2007Dan Hurley's new book, "Natural Causes: Death, Lies and Politics in America's Vitamin and Herbal Supplement Industry," has the industry on the defensive.
Cited by Katie Couric's two-part CBS News series on dietary supplements and excerpted today in the New York Times, Hurley seems to have created a buzz reminiscent of Marcia Angell's similar indictment of the prescription pharmaceutical industry.
Hurley's book is already #953 on Amazon and had been picking up heat from supplement advocate bloggers since before it was even released on 26 December.
Unfortunately, I was not privy to the…
terrasig | January 3, 2007It's been over two years since I saw a notice for a conference entitled, "Developing an Adverse Event Reporting (AER) System for the Dietary Supplement Industry," in St. Paul, MN, sponsored by the Center for Dietary Supplement Safety at the University of Minnesota and the Utah Natural Products Alliance. At this conference, I first heard of the support of the dietary supplement industry for an adverse event reporting system similar to the MedWatch program for prescription drugs.
In general, industry representatives I spoke with justified their support with the expectation that herbal products…
terrasig | December 6, 2006In a note of sad irony, I am finishing a chapter in Thomas Hager's excellent, The Demon Under The Microscope, on the elixir of sulfanilamide deaths in the US in 1937. A specific formulation of this truly miraculous antibiotic at the time was associated with over 100 deaths from renal failure.
This formulation had used as a vehicle the solvent diethylene glycol, a relative of ethylene glycol used in antifreeze - a great solvent, but one that is metabolized to insoluble oxalate crystals that accumulate in the kidneys, causing virtually-irreversible renal failure and death.
In this oft-told…
terrasig | November 28, 2006My subscription to US Food and Drug Administration missives usually returns horrific or, at least, disturbing cases of food or drug recalls.
However, I never knew 1) that processed, prepackaged turkey and cheese sandwiches normally contain anchovy flavoring and, more surprisingly, 2) that some people are allergic to anchovies.
Fresh Grill Recalls Smoked Turkey & Jack Cheese Sandwiches Due to Undeclared Anchovies
Contact:
Fresh Grill
714-444-2126
FOR IMMEDIATE RELEASE -- Santa Ana, CA -- November 21, 2006 -- On 10-12-2006 Fresh Grill of Santa Ana, California recalled 2056 units of SMOKED…
terrasig | August 17, 2006Just cleaning out the day job e-mail account early this morning and came across something, I should've posted this a month ago when FDA sent me this release.
There are obvious problems with US federal regulation of dietary supplements related to lack of proven efficacy, bioavailability of purported active constitutents, and thinly-veiled medical marketing.
However, few people are aware of the fact that adulteration of dietary supplements is a real problem and, in the case below, potentially life-threatening:
From the FDA MedWatch adverse drug reaction (ADR) reporting program:
MedWatch - The…
terrasig | July 24, 2006There was really nothing more I could add last week regarding all of the turmoil at/about the US Food and Drug Administration in the aftermath of the much-debated survey results, as covered by my SiBlings and elsewhere last week. A good many of us have colleagues and former classmates who work at FDA and are busting their humps to serve the public good despite the lack of scientific support and the abundance of political pressure.
As evidence in defense of the folks at the front line at FDA, here is a very nice public-service education and drug safety program developed by FDA for kids…
terrasig | July 20, 2006Being part of a family with a high penetrance for both depression/anxiety and migraines, I can't tell you how many times I've asked docs and pharmacists whether it is safe to take a "triptan" class migraine drug (e.g. Imitrex, Zomig) while taking maintenance doses of a SSRI or SNRI class antidepressant (e.g. Prozac, Lexapro, Effexor).
Well, the US Food and Drug Administration today released a warning on the potential for interaction between these two classes of agents. This risks are real, although very, very low for a condition called "serotonin syndrome."
The FDA statement would scare the…