Drug safety
terrasig | March 1, 2008DrugMonkey just had an interesting post about the potential influence of cocaine use trends following the 1986 death of Maryland college basketball player, Len Bias, just days after his being selected in the NBA draft by the Boston Celtics. DM's post and the ensuing discussion got me thinking tonight about a variety of issues in substance abuse, realistic assessment of risk and, ultimately, parenting.
In the comments, I mentioned that Heath Ledger's recent death might be a trigger for pop culture to pay more attention to the risks of recreational use of prescription and over-the-counter…
terrasig | February 25, 2008[Note: I originally posted this last Thursday under another title but it got lost in other events of that day. As I find it ironic that Mr Comarow has been attacked by an alternative medicine practitioner and advocate, I find this story worthy of reposting.]
A few weeks ago the skeptical blogosphere was up in arms about an article in US News & World Report by Avery Comarow on alternative medicine services in US academic medical centers. Mr Comarow is a senior medical writer for USN&WR and best known as editor for the last 18 years of the magazine's annual feature, America's Best…
terrasig | February 19, 2008For more details on this story, you can go to Mark Chu-Carroll, Orac, Mike the Mad Biologist, or the Autism Blog. I just wanted to share my personal views on the need for childhood vaccinations and support a public information campaign from the AAP.
Until I started medical blogging, I had not realized quite how vocal was the community of individuals refusing to vaccinate their children, mostly at the urging of those who claimed that vaccines and related components caused illness in their own children. I will first say that no drug product, natural or otherwise, is completely and absolutely…
terrasig | February 6, 2008I'll leave my neuropharmacology and neuroscience colleagues to comment in greater detail on this story (see earlier DrugMonkey post), but this report is just in from AP on Heath Ledger's toxicology report:
The cause of death was "acute intoxication by the combined effects of oxycodone, hydrocodone, diazepam, temazepam, alprazolam and doxylamine," spokeswoman Ellen Borakove said in a statement.
I haven't seen a copy of the report itself (maybe Smoking Gun will have it soon) but plasma concentrations of each were not noted. However, this was the statement from the family:
In a statement…
terrasig | February 3, 2008
Yesterday was the 1st anniversary of Blogroll Amnesty Day, originally proposed by a reasonably prominent blogger who used the occasion to relieve himself of guilt when purging his blogroll and building back up only a list of those he reads regularly.
I learned via my new homies, PhysioProf and DrugMonkey that Jon Swift and Skippy have proposed this day instead as an opportunity for low-traffic bloggers to blogroll even lower-traffic bloggers to help everyone rise up in notoriety.
Despite being here at ScienceBlogs for 20 months, I have managed to keep my readership to a small but select…
terrasig | January 17, 2008Yesterday, the FDA released a warning statement on an increasingly common mistake in the medically-unsupported practice of "chelation therapy" for autism:
FDA notified healthcare professionals and patients about important safety information concerning Edetate Disodium. There have been cases where children and adults have died when they were mistakenly given Edetate Disodium instead of Edetate Calcium Disodium (Calcium Disodium Versenate) or when Edetate Disodium was used for "chelation therapies" and other uses that are not approved by the FDA. Edetate Disodium was approved as an emergency…
terrasig | January 1, 2008...there is a very colorful discussion thread of hangover remedies over at the WSJ Health Blog.
Yesterday, Health Blog's Jacob Goldstein briefly discussed a 2000 Annals of Internal Medicine paper on alcohol hangovers and remedies/prophylactic approaches. Despite all of the discussion, Goldstein also cites a 2005 systematic review in BMJ by Max Pittler and Edzard Enrst at Exeter that concluded,
No compelling evidence exists to suggest that any conventional or complementary intervention is effective for preventing or treating alcohol hangover. The most effective way to avoid the symptoms of…
terrasig | December 5, 2007Yet another example in today's press about dietary supplements contaminated, intentionally or accidentally, with prescription or unapproved drugs - in this case, anabolic steroids showing up in about 20% of supplements tested.
I was asked by a major news organization if this is the first time that anabolic steroids have been found in supplements. Nope, look at this FDA action from March 2004 or March 2006.
Ugggh, this is a very old story that I've discussed here many times, mostly relative to erectile dysfunction supplements:
Potentially life-threatening adulteration of erectile dysfunction…
terrasig | November 27, 2007Compounds in grapefruit juice inhibits an enzyme required for metabolism of nearly half of prescription drugs on the market. If you inhibit drug metabolism, would that allow you to take a lower (and cheaper) dose of one of those drugs, especially an expensive drug?
That is the proposition of a company called Bioavailability Systems, featured in today's Wall Street Journal and alluded to on the WSJ Health Blog (yes, I cite the WSJ very often but only because they have some of the best medical and health reporting on topics well ahead of the MSM curve).
The intestines and the liver contain…
terrasig | November 25, 2007As I sat to write a post this morning, I became more engaged in a story in the New York Times magazine by Dr Daniel Carlat entitled, "Dr. Drug Rep." Joseph of Corpus Callosum recently commented here about being solicited to recommend fellow physicians in the local area and nationally who he perceived as "thought leaders" in his specialty.
Carlat was such a physician who was cultivated by Wyeth to discuss their antidepressant, Effexor XR, to fellow physicians at conferences and in doctors' offices. His piece in the NYT magazine chronicles his development by Wyeth as a drug spokesperson and…
terrasig | November 20, 2007I wrote about the general issue of eyelash-enriching "cosmeceuticals" on my Terra Sigillata back in July. Increasing the number and thickness of eyelashes is not some hokey magical wish - it is a known side effect buried in the prescribing information for the prescription glaucoma drugs, bimatoprost (Lumigan®) and latanoprost (Xalatan®).
Last Friday, the US FDA seized a product called Age Intervention Eyelash at the San Jose facility of Jan Marini Skin Research, Inc., citing that the product contained an unapproved drug and could be harmful to the user's vision.
When composing my post in…
terrasig | October 29, 2007Perhaps you've stumbled on this post late at night while tending to a child suffering from a cold.
Well, I've been reading a fair bit lately about the 18-19 October meeting of the FDA's joint meeting of their Nonprescription Drug and Pediatric Advisory Committees, trying to make sense about calls to restrict or prohibit the use of cough and cold medicines in children under age 6. There is so much material on the subject that I have hesitated to post on the issue until I received the following e-mail from an old friend, fellow scientist and parent, North of 49:
Okay, so I'm writing to you to…
terrasig | October 6, 2007I've got to admit that I've really enjoyed reading Health Blog from the Wall Street Journal. Short, pithy, and great bites about health/pharma stories that make it into one of the best sources for news in the US (its op-ed page notwithstanding).
So, I was tickled on Friday to see Health Blog interview AggravatedDocSurg. Little did I know that the Aggravated One was a general surgeon in APB's former stomping grounds of The Centennial State.
Here was the quote that made the interview from one of his public service announcements.
We've got advertisements on TV continuously for Plavix. It's not…
terrasig | September 20, 2007You read correctly. If the US Senate does not pass an FDA funding bill today, 2,000 employees, nearly one-quarter of the FDA staff, will be relieved of their duties. (There were 8,157 FDA employees in 2006 - source). The House has already passed the bill but there are concerns:
Senate staffers were poring over the bill's 400-page text, and leaders were hoping to be able to pass it by voice vote. But some Senate Republicans raised concerns. "We're getting a bill that has been mashed together at the last minute," said a GOP aide involved in negotiations with the House. "It's very worrisome…
terrasig | September 16, 2007Leukemia Drug Adulteration
Chinese generic versions of the anticancer drugs, methotrexate and cytarabine hydrochloride, have been reported to be contaminated with an undisclosed substance according to several wire reports this morning.
Several children in a Shanghai hospital were reported to suffer leg pain and difficulty walking after being injected with methotrexate. A common drug used in many chemotherapy regimens for leukemia, methotrexate is not normally associated with these side effects.
The Xinhua news agency reported that the drugs had been traced to one manufacturer, Shanghai…
terrasig | September 9, 2007Yes, you have heard this before: another company selling erectile dysfunction dietary supplements has been nailed by the US FDA for adulteration of their product with prescription drugs used for erectile dysfunction.
From the FDA (full press release here):
Bodee LLC, Inc., issued a nationwide recall of Zencore Tabs, a product marketed as a dietary supplement, because it contains undeclared ingredients. FDA laboratory analysis of Zencore Tabs found that the product contains aminotadalafil, an analog of tadalafil, and sildenafil, both of which are active ingredients of FDA-approved drugs used…
terrasig | September 1, 2007Like any regulatory agency standing between industry and the public, the US FDA has its fair share of detractors. So, it's always a pleasure to draw attention to their programs that serve public and professional welfare.
Since February, 2002, FDA's MedWatch Drug Safety Program has produced short videos every month called FDA Patient Safety News (PSN). While these videos are generally prepared for the health professional community (such as, "Importance of Using Aseptic Technique with propofol (Diprivan)"), there are three videos this month that are of particular interest to patients…
terrasig | August 22, 2007...if they contrain sibutramine.
Sold under the trade name of Meridia in the US and Reductil in Europe, this prescription appetite suppressant for weight loss was recently detected in an apple cider vinegar supplement called MetaboSlim sold by Confidence, Inc. An alert by the FDA notes that the affected lot was only sold in Canada but we are fortunate to have a good number of Canadian readers.
This episode is yet another in a long string of reports of dietary supplements being adulterated with prescription drugs, intentionally or accidentally. Interestingly, Confidence Inc. was also the…
terrasig | August 19, 2007Late last week saw two announcements from the US FDA on genetic issues in drug safety. The first of these addresses the prescribing guidelines for Coumadin, or warfarin. Coumadin is a "blood-thinner" (or anticoagulant) prescribed for conditions from heart valve and hip/knee joint replacements to pulmonary hypertension and following strokes due to inappropriate blood clotting.
The reasons for this warning relate to data that has accumulated whereby individual patients respond quite differently to the same dose of Coumadin. Two genetic markers have been identified to account for much of…
terrasig | August 12, 2007This may at first seem to be an esoteric development but scientists at the Oregon Health & Science University have succeeded in propagating human liver cells in severely immunocompromised mice. The full report appears in Nature Biotechnology. The work was done in collaboration with colleagues at Stanford University, the University of Pittsburgh, and Texas Children's Hospital at Baylor.
Human liver cells, or hepatocytes, have become an important part of preclinical drug safety testing since the liver is the primary source of drug metabolizing enzymes. These are generally split into the…