Another McNeil OTC drug recall: quality control issues not just for generic drugs

Let me just say at the outset that I generally pay extra to purchase brand name medications, prescription or over-the-counter (OTC), because of concerns I have about federal oversight of generic drug manufacturers.
On April 30, McNeil Consumer Products issued a voluntary recall of a litany of children’s cold products under the Tylenol, Motrin, Zyrtec and Benadryl brand names.

McNeil Consumer Healthcare, Division of McNEIL-PPC, Inc., in consultation with the U.S. Food and Drug Administration (FDA), is voluntarily recalling all lots that have not yet expired of certain over-the-counter (OTC) Children’s and Infants’ liquid products manufactured in the United States [in Fort Washington, PA] and distributed in the United States, Canada, Dominican Republic, Dubai (UAE), Fiji, Guam, Guatemala, Jamaica, Puerto Rico, Panama, Trinidad & Tobago, and Kuwait.

The complete product list can be found at the bottom of the press release (here) from which the above quote was derived.
McNeil noted that “some of the products included in the recall may contain a higher concentration of active ingredient than is specified; others may contain inactive ingredients that may not meet internal testing requirements; and others may contain tiny particles.”
However, an ABC News story on the recall provides an FDA report (PDF) indicating that some of the remedies contained as-yet unidentified gram-negative bacteria.
Your humble blogger was contacted for this story and quoted therein but I had not known at the time of the bacterial contamination. All reports suggest that these problems are unlikely to present any risks to infants and children, pending identification of the bacteria, but this cannot be good – especially since this is the third recall by the manufacturer in the last eight months.
ABC News quoted a statement released Tuesday from Johnson & Johnson, the parent company of McNeil Consumer Healthcare:

“The quality issues that the FDA has observed, many of which we had recently identified in our own quality reviews and communicated to the FDA, are unacceptable to us, and not indicative of how McNeil Consumer Healthcare intends to operate,” the Johnson and Johnson statement read.

This recall is also yet another blow to the widely-held belief in the higher-quality of a brand name drug product over generic drugs, at least in the case of over-the-counter products:
“This recall provides compelling evidence that quality assurance is an issue for all drugmakers, and is not specific to generic products, as many have implied,” said Dr. Jerry Avorn, professor of medicine at Harvard Medical School and chief of the Division of Pharmacoepidemiology and Pharmacoeconomics, Brigham and Women’s Hospital.
What struck me was the report from the Associated Press and the FDA’s own Q&A site that until these products are back on the market, parents use alternative products with the same ingredients on the labels – i.e., generic versions of the McNeil products – rather than trying to calculate how much of an adult-strength product to use in an infant or child.
I wonder how many parents might switch to the generics, see the incredible price savings, and switch permanently to one of these products.
Commenters at several of the news site also note that there has been much ado about quality control issues at drug plants outside the US; that excuse can’t be invoked in this case.

Conservative author David Frum: “Repeal DSHEA”

David Frum.jpgBy most metrics, those of us at Terra Sig World Headquarters are liberals. Nevertheless, we often enjoy reading conservative writer, attorney, and American Enterprise Institute fellow, David Frum. Perhaps I have a soft spot for him because he’s Canadian and he also writes for my favorite print newsmagazine, The Week.
Well, Frum chose this week to write, “Herbal remedies need real scrutiny,” at his FrumForum and the post was subsequently published as a special commentary at The latter version has accumulated about ten times as many comments. The thesis of his essay is that the differential regulation of drugs and dietary supplements is flawed and ends with this paragraph:

Improving and rationalizing this costly and dysfunctional system is a gigantic, maybe impossible, task. But one small reform could strike a meaningful blow for reason and cost-effectiveness: Apply the rules governing the advertising of aspirin to the advertising of oregano tablets. Repeal the DSHEA law and give the Food and Drug Administration full authority over every manufactured substance that purports to promote health or relieve illness.

DSHEA is the Dietary Supplement and Health Education Act of 1994 that governs, among other things, the claims that may be made for herbal and non-botanical products not subjected to conventional and rigorous preclinical and clinical studies.
But it gets better.

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Oriental Trading Co. Face Paint Recall – Colors Expanded

face paint.jpgThe US Food and Drug Administration is usually the first federal authority to take action on adverse event reports for any health product. But few appreciate that the FDA is also responsible for regulation of cosmetic products: pretty much anything applied to the skin.
So, it was no surprise when I was trolling the FDA adverse event reports and news releases to find their announcement of a recall of a number of children’s face paints due to rashes and undue skin irritation. The products are manufactured by Shanghai Color Art Stationery Company Limited, Shanghai, China.
The original recall was issued on 12 May but two additional colors were added yesterday.
While you may not recognize the name of the Chinese manufacturer, parents may recognize the name of the US distributor of these products: Oriental Trading Company of Omaha, Nebraska. (I’d add that they were the ones who issued a voluntary recall and did not require FDA action to do so).

The Food and Drug Administration warned consumers last week to stop using six paint colors distributed by Oriental Trading Co. of Omaha, Neb., after reports of rashes and skin irritations. The products were found to have yeast and mold counts above industry guidelines, FDA said.
Oriental Trading Co. subsidiary Fun Express announced Friday it was adding white and yellow face paints to the colors already recalled, which were blue, purple, red, orange, black and green.

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The separation of church and state supplements

I just started receiving a bunch of Google referral hits from readers searching for a story about the US Federal Trade Commission apparently taking regulatory action against a church that is selling supplements claimed to exhibit anti-cancer activities.
The article in question, “Tyrannical FTC Threatens Christian Church with Imprisonment for Selling Dietary Supplements,” was written by a gentleman named Mike Adams, an editor at I’m not exactly certain at this point what the specific FTC actions are today since the article is rife with rantings and rhetoric:

The FTC has unleashed a new assault against both dietary supplements and religious freedoms by targeting a Christian church for termination. Through exclusive interviews and conversations with health freedom attorney Jim Turner (…), NaturalNews has learned that the church Daniel Chapter One ( has been targeted by the FTC for destruction.

While the US Food and Drug Administration (FDA) is largely responsible for regulating foods, drugs, and medical devices for safety and approved claims, the FTC has often stepped in on dietary supplement sales where claims being made might be considered fraudulent, deceptive, or otherwise untrue.
The FTC action on Daniel Chapter One cited today was actually released back on 18 September 2008 as part of 11 actions against companies marketing bogus cancer “cures”:

Daniel Chapter One – This company markets several herbal formulations as well as shark cartilage. According to the complaint, in addition to making deceptive and false claims that these products effectively prevent, treat, and cure cancer, the respondents also claim that one of their herbal formulations mitigates the side effects of radiation and chemotherapy. In addition to the FTC action announced today, this company received a warning letter from FDA.

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Not industry, not academia – how about the FDA?

I see you – I’ve been there.
You’re sitting in the lab the day before New Year’s Eve looking at what you’ve done over the last year – or last six years – and thinking about how you’re ever going to turn this postdoc or extended grad school period into some gainful career. The economy is for hell no matter where you live and you’re wondering if this is all worth it.
Well, as I’ve said before, don’t limit your options until you explore them. The US drug, medical device, food, cosmetic regulatory and safety agency, the Food and Drug Administration (FDA), can provide a really satisfying career where you actually use an amazingly diverse amount of your interdisciplinary knowledge. In fact, FDA announced in April 2008 that it would be hiring as many as 1,300 scientists this year.
I’ve also been compassionate toward my FDA colleagues because of the agency is expected to approve new drugs as quickly as possible but then also be responsible for optimizing safety when drugs are released to a genetically-diverse population of millions. This is an ongoing challenge that requires the incorporation of pharmacology, physiology, and genetics in refining policy and review criteria.
And keep in mind that no matter how bad things get in academia or industry, drug approval and drug safety monitoring marches on.
This job in particular caught my eye:

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Recommended post: How could Amy Winehouse have emphysema?

When I first heard that 24-year-old British singer-songwriter Amy Winehouse was hospitalized with early stage emphysema I said “what?” DrugMonkey, a drug-abuse research colleague, has a terrific post up now on the link between Winehouse’s crack cocaine use, possible genetic predisposition, and the emergence of early-onset emphysema.
While sad to see a very young person so afflicted, I tend to be fascinated scientifically by these odd medical cases involving natural products – often drugs of abuse.
I’m also particularly impressed by Amy Winehouse’s tremendous vocal talents and songwriting abilities. Her jazz and soul vocal style has been described as reminiscent of legends like Sara Vaughn and I find it striking that her songs are considered pop music in 2008. But like many incredible musicians before her, Winehouse at 24 has more legal problems, drug abuse issues and violent, self-destructive behaviors than most people might accumulate in several dozen lives. I echo DrugMonkey’s call to Winehouse and her dad that she avail herself ofserious acute and long-term medical intervention, and soon.
So, while my personal output here is a bit slow, mosey on over to DrugMonkey for a lovely medical discussion of the Winehouse emphysema case.

US FDA: 125 Fake Cancer ‘Cures’ Consumers Should Avoid

This link is just to quickly follow up on yesterday’s post, “FDA Warns Individuals and Firms to Stop Selling Fake Cancer ‘Cures’.” The US FDA has specifically listed those companies and individuals as well as their specific products that were cited in yesterday’s action:
125 Fake Cancer “Cures” Consumers Should Avoid
And for more information to share with your family, friends, patients, colleagues, etc:
Beware of Online Cancer Fraud
This latter post is of great general value for the lay public to detect red flags for fraudulent cancer treatment or prevention products as well as some general guidelines for detecting health fraud in general.
Concise yet informative – perfect examples of how to communicate truthful information to the general public in the face of far greater volumes of fraudulent online marketing.

Today’s side effects are tomorrow’s therapy*

This whole “cosmeceutical” thing probably shouldn’t be in “Medicine & Health” but we did call your attention to today’s news item back on 27 July 2007: Drug maker Allergan announced at a stock analyst’s meeting this afternoon that it is filing a New Drug Application (NDA) for a cosmetic form of its anti-glaucoma drug bimatoprost (Lumigan®) as a result of it side effect in increasing the number and thickness of eyelashes.

Allergan (nyse: AGN) has completed its clinical trial program demonstrating that its patented formulation of bimatoprost, when applied directly to the base of the eyelashes, results in significant eyelash growth, the company said.

Too bad for the cosmeceutical/supplement companies that have been selling knockoffs of this prostaglandin analog, at prices in the range of US$150-160 for a month’s supply. We noted in November that the US FDA seized the inventory of one such company for selling an unapproved drug . Then, we saw action by Allergan’s itself back in January against the Jan Marini.

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Natural carcinogen and kidney toxin found in 12 dietary supplements

Apologies in advance for just this quick link, but the topic is very timely given our highly-read post last week suggesting the repeal/modification of DSHEA, the primary US legislation directing the weak oversight of the dietary supplement industry.

Herbal Science International, Inc. and FDA informed consumers and healthcare professionals of a nationwide recall of twelve dietary supplements that contain ephedra, aristolochic acid or human placenta because they may present a serious health hazard to consumers [press release]. FDA has long regarded dietary supplements containing ephedra, a botanical that contains ephedrine alkaloids, as a potential health hazards because the alkaloid raises blood pressure and otherwise stress the circulatory system. These effects are linked to adverse health effects like heart attacks and stroke. FDA issued a rule in February 2004 prohibiting the sale of dietary supplements containing ephedrine alkaloids because they present an unreasonable risk of illness or injury.
Two of the recalled products contain aristolochic acid which is a potent carcinogen and nephrotoxin. This chemical can cause serious kidney damage and has been associated with several occurrences of kidney failure. The twelfth recalled product contains human placenta, an ingredient which may transmit disease. Dietary supplements that contain human placenta may not be lawfully marketed in the United States. No illnesses have been reported in connection with the recalled products and distribution of all of the products has ceased. Consumers should immediately discontinue use of the recalled products and return the product(s) to their place of purchase.

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“You got lead in my marijuana. . .”

“. . .you got marijuana in my lead.”
Two great tastes that do not go great together (with apologies).
[Welcome readers on 12 Oct 2008 – I comment on the recent story here and you can read our other posts on drugs of abuse here. Thanks for stopping by – APB]
ResearchBlogging.orgA concise but fascinating medical detective story appears in the letters of this week’s (10 Apr 2008) issue of the New England Journal of Medicine (free full text at the time of this posting.).
An astute group of physicians at Leipzig Hospital in Germany noted a local surge of young people presenting with classic symptoms of lead poisoning – 29 patients aged 16 to 33 over the course of 3-4 months. Patients exhibited symptoms ranging from abdominal cramps, nausea, and “Burton’s line” to hematologic pathologies such as anemia and basophilic stippling (overview). Burton’s line, illustrated here in another NEJM image from a lead poisoning case, results from “the reaction of circulating lead with sulfur ions released by oral microbial activity [that] may cause the deposition of lead sulfide at the interface of the teeth and gums.”
In another hospital in Leipzig, one patient was so severely poisoned that they had severe encephalopathy with hallucinations and permanent palsy in one forearm.
None of the patients were in any industry, such as lead-smelting, where today’s rare cases of lead poisoning still occur. Instead, they were young smokers with body piercings, either students or unemployed.

The diagnosis was quickly established, and chelation therapy was effective, but despite great efforts by health authorities and police, the source of lead could not be identified.

Yes, this is the one evidence-based indication for chelation therapy, usually with aminocarboxylate (calcium EDTA) or sulfur-containing compounds (2,3-dimercaptosuccinic acid; DMSA; succimer; Chemet®) to complex the lead with very high affinity and enhance its urinary excretion.
What else was common to these patients?

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