Strollerderby : FDA

Federal Agent* Seizes Oat-Based Contraband

Madeline Holler — Thu, 14 May 2009 23:02:00 GMT

By now you know that the Food and Drug Administration has deemed Cheerios, that favorite O-shaped toddler snackfood, a drug. Big time!

General Mills' claim that the pincher-grasp fortifying num-nums also lower cholesterol "4 percent" puts it in the drug category. The company must, therefore, submit to testing and apply for approval before it can be sold.

So what of that box sitting on top of the fridge? As this family learned, look out for federal agents.

Cheerios. Total gateway to the hard stuff -- Cocoa Pebbles, Cookie Crisp, trail mix with chocolate chips.

* Or not.

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Salmonella Might Be In Second Peanut Plant

Brett Singer — Wed, 11 Feb 2009 04:26:00 GMT

The AP is reporting that samples from a second Texas plant owned by The Peanut Corp. of America have a "presumptive positive" result. What'd they find? Salmonella.

This just keeps getting worse.

The news is currently being reported as a "maybe," and the AP story says that no products from the plant were shipped to consumers. Personally I have a hard time believing that. Not that I have any knowledge of the situation beyond what I've read. I'm just suspicious.

This line made me furious: the plant in Plainview, Texas "had operated unlicensed and uninspected for nearly four years." How exactly does something like that happen?

Are you still giving your kids peanut butter and jelly? Or have you switched to cream cheese or some other sandwich spread?

Source: AP via Yahoo! News

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Poisoned Teething Gel Kills 84 Children in Nigeria

Kate Tuttle — Mon, 09 Feb 2009 18:33:00 GMT

An over-the-counter teething medication commonly used in Nigeria has killed more than 80 babies and young children, according to health officials, due to a batch that mistakenly contained a poisonous chemical.

Sold under the brand name My Pikin Baby Teething Mixture ("pikin" means child in West African pidgin), was found to contain diethyline glycol, a chemical found in antifreeze, most likely in place of glycerin, the sweet syrup used to flavor children's medicines and toothpastes. According to the New York Times, counterfeiters regularly replace glycerin with the less expensive (and often deadly) glycol to boost profits. The poison attacks the liver, kidneys, and central nervous system. Health officials say three-quarters of the children sickened by the bad batch have died, all of them between the ages of two months and seven years.

It's impossible for most of us to imagine the pain these parents face. But it's a valuable reminder of how important good consumer-protection laws are, and how useless they are in the absence of enforcement. If you ever find yourself in an argument with someone who wants to cut funding for the FDA, ask them if they're ever wondered how it would feel to have to wonder, when giving their child some soothing medicine, whether it was truly safe.

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Web Index of Recalled Peanut Butter Products Available

JeanneSager — Sun, 25 Jan 2009 21:52:00 GMT

If yours is one of those households that depends on peanuty goodness to get through the day, the salmonella scandal of '09 has probably sent you rushing to the cabinets each time a new product has been added to the list.

Take heart - you're not the only one!

To make things a little easier on us, the Food and Drug Administration (FDA) has set up a searchable index of recalled peanut butter products.

Broken down into brand name, product name, lot and/or stock numbers, labels and packaging size, the list puts all of the information you need in one place. But you do have to do a thorough check. The initial page lists "peanut butter product recalls" in a long list, making you think that's where you need to go to get all the peanut butter-related products. Not so. Other sections on the page link to lists of crackers that were recalled because of peanut butter or nutrition bars recalled for the same reason.

The overall list includes the pet foods recalled too - so it hits the whole family. And if you're as freaked out by all these food frenzies as I have become, at least you can get all your stress out in one place!

Image: Costco

FDA Asked to Approve Gardasil for Boys

JeanneSager — Thu, 08 Jan 2009 15:25:00 GMT

If you thought parenting boys meant you were off the hook on having to decide whether or not to go with the Gardasil shot, listen up.

Gardasil, the HPV prevention shot aimed girls nine to twenty-six, has been submitted to the Food and Drug Administration (FDA) by maker Merck for consideration as a vaccine for boys.

Obviously, we're not talking about cervical cancer here (please, tell me that was obvious), but a Merck study tracked four thousand boys ages sixteen to twenty-six who were given Gardasil and found it prevented ninety percent of cases of penile cancer and genital warts caused by the four common virus strains targeted by the vaccine.

The proposal calls for the vaccine to be approved for boys in the same age group as that already approved for girls - nine to twenty-six - and all report indicate it would come at a similar cost.

The three-series shot has drawn controversy for its $360 pricetag in the past, and its not the only one. Parents have had mixed reactions to the vaccine, some rushing out to have it administered to be on the safe side. As reported on Babble last month, however, others parents say Gardasil has caused paralysis in their daughters. I'm still undecided, myself, and hoping more conclusive research on the risks and benefits is available six years down the line when my daughter would first be "of age" for Gardasil.

But if the Merck study results are to be believed, this could save little boys lives. What do you think parents, would you take your sons in for the shot?

Image: Jezebel

Source: USA Today Via Jezebel

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They Say: Maybe You Should Eat Fish During Pregnancy?

Jen Chaney — Mon, 15 Dec 2008 20:32:00 GMT

In addition to avoiding booze and taking it easy on the caffeine, most pregnant women are told to be careful about eating fish. Just four years ago, the Food and Drug Administration and the Environmental Protection Agency issued a statement advising women of childbearing age, pregnant and nursing women and infants and children to limit their consumption of fish that might contain mercury because of potential health risks.

Well, apparently the FDA has changed its mind. Late last week, The Washington Post reported that the FDA has drafted a report asking the federal government to backpedal on the fish warning because the benefits of eating tuna and its ilk outweigh the potential hazards of consuming mercury. Apparently folks at the EPA are kinda ticked; their memos say the FDA's findings are "scientifically flawed and inadequate."

Other medical professionals and advocates seem to be siding with the EPA on this one. This Market Watch story reports that several have joined the chorus against these new recommendations. The director of the Mercury Policy Project is apparently so incensed that he has developed an insatiable need to inject fish metaphors into everything he says, as quoted in the Market Watch piece:

"'Talk about getting hooked on fish stories,' said Michael Bender, Director of the Mercury Policy Project. 'FDA has really gone overboard this time by casting out the science and reeling in the industry 'line' instead.'"

Would it be wrong if I said that only the most clueless person on Earth wouldn't be able to "catch" his meaning?

Meanwhile, know who's super-happy? The National Fisheries Institute. "This is a science-based approach," a spokesman for the group tells the Washington Post. "And you start to see a picture emerge that shows the clear benefits of eating seafood outweigh the risks of a trace amount of mercury in fish."

In other words, the bickering will continue. In the meantime, what's a childbearing/pregnant woman or nursing mother to do? My OB always told me I could eat fish in moderation. So I personally never had more than a couple servings per week. Whether I needed to limit myself that much, I don't know, but it seemed like the logical thing to do. If you're concerned, it's probably best to consult your doctor about what makes the most sense.

As with most health issues, I suspect the honest answer lies in the middle: That it's okay to consume some fish, as long as you do so responsibly and in careful moderation. But Lord knows how long it will take for our federal agencies to feel in synch enough to issue that sort of statement.

Image: MSNBC.com

FDA Sets Standard For Melamine in Formula

Amy Kuras — Mon, 01 Dec 2008 21:31:00 GMT

Well, well, WELL.

After some public outcry over trace amounts of melamine found in infant formula here in the US, the Food and Drug Administration has finally decided that they can, in fact, set a safety standard for melamine. Previous to the agency’s releasing tests it had done which revealed the presence of the chemical in baby formula, they had said it was impossible to set a safety standard, indicating that any level of melamine was of concern.

The new level is 1 part per million for both melamine and its chemical relative cyanuric acid.

According to the Associated Press, which broke the story, “Dr. Stephen Sundlof, the FDA's director of food safety, said Friday the agency was confident in the 1 part per million level for either of the chemicals alone, even though there have been no new scientific studies since October that would give regulators more safety data. He had no ready explanation for why the level was not set earlier.

The standard is the same as the one public health officials have set in Canada and China, but is 20 times higher than the most stringent level in Taiwan.”

According to Sundlof, it’s the lack of both chemicals being present that is key to safety, because studies show danger from melamine only when both chemicals are present.

It should be noted that the melamine found in the US formula is far below the level that killed three babies in China and sickened thousands of others.

Melamine Found in US Formula

Amy Kuras — Wed, 26 Nov 2008 22:01:00 GMT

Thought your baby was safe from melamine-tainted formual because he or she isn't in China? Think again!!

Yes, tests by the Food and Drug Administration revealed that formula made by the three biggest formula manufacturers – Abbot Labs, makers of Similac, Mead Johnson, makers of Enfamil, and Nestle, makers of Good Start – has either trace levels of melamine or a chemical by-product of melamine. Together, these formulas make up 90 percent of all formula sold in the US.

Melamine is the chemical found in Chinese infant formula that has been blamed for killing at least three babies and making at least 50,000 others ill. Of course, the melamine in the Chinese formula was intentionally added to make it look like it had higher protein than it actually did. At the small amounts found in the American formula, the nutritional profile would not be affected. The tainted Chinese formula also had melamine added in much, much higher concentrations than that found in the American formula.

Previously undisclosed tests, obtained by The Associated Press under the Freedom of Information Act, show the FDA has detected melamine in a sample of Enfamil Lipil and the presence of cyanuric acid, a chemical relative of melamine, in Nestle Good Start.

The Food and Drug Administration said last month it was unable to identify any melamine exposure level as safe for infants, but a top official said it would be a "dangerous overreaction" for parents to stop feeding infant formula to babies who depend on it.

"The levels that we are detecting are extremely low," said Dr. Stephen Sundlof, director of the FDA's Center for Food Safety and Applied Nutrition. "They should not be changing the diet. If they've been feeding a particular product, they should continue to feed that product. That's in the best interest of the baby."

The levels detected by the FDA tests are well below the standards set for melamine in other parts of the developed world, and are equivalent to one drop in a 64-gallon trash can.

But still. Yikes. Somehow I think this is the tip of a very big iceberg.

They Say: "Microwave Safe" Ain't

Miriam Axel-Lute — Mon, 17 Nov 2008 17:00:00 GMT

If you're the type to be suspicious of chemicals and corporations, and especially their mixture, this will likely not surprise you:

A team of investigative journalists from the Milwaukee Journal-Sentinel did one of those surprisingly simple things that we love real, honest-to-god investigative journalists for: an experiment. Specifically, they took 10 items marked with the comforting phrase "microwave safe" that were likely to be ingested by children or used for children's food (several were actually baby food, one was formula), heated them (in both a microwave and an oven), and had the contents tested for bisphenol-A (BPA).

(If you've been under a rock, BPA is the hormone-like substance that everyone from the Canadian government to Wal-Mart have been all freaked out about getting out of baby bottles recently, on account of it's been shown to do nasty things to neurological development and also cause pre-cancerous changes to mammary glands and other fun stuff at super low levels.)

I think you can tell where this is headed: All of the food had levels of BPA that were shown in lab tests to be problematic. The food in the Rubbermaid all-purpose container and the infant formula had the highest levels. So much for worrying about the bottles themselves. The article estimates how much an average kid might be ingesting per day, and it ain't pretty.

The manufacturers' response, of course, is to say it's just a tiny amount and won't hurt you. The FDA says "What they said" and goes back to buffing up an 8-year-old resume. There are (prepare to be shocked now) apparently no standards whatsoever behind the designation "microwave safe." If the container doesn't blow up, which would presumably generate complaints if not any regulatory action, then it can be labeled zappable.

This was one of those stories I almost didn't read, because I am (1) predisposed by my environmental studies background to be veeeerrrry skeptical of claims that strange chemicals are harmless and (2) completely and utterly dependent on my microwave. I'm sure as hell not going to put a pan on the stove every time I need to heat up a quarter cup of frozen peas or leftover lentil soup for my daughter.

I had been comforting myself with the vapid mneumonic that Real Money readers came up with a while back about the better and worse plastics ("1, 2, 4, 5 will keep you alive; 3, 6, 7 will send you straight to heaven." Yes, I am embarrassed that I remember it), but the infuriatingly thorough MSJ notes that BSA was leaching from no.s 1, 2, and 5 as well. Great.

I guess this is where I consider dropping the plastic bowls when microwaving is needed and hoping my toddler doesn't shatter enough of our motley assortment of ceramic ones to constitute its own safety hazard. The plastic is still going in the dishwasher though. I know my limits.

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More Bad News For Bottled Water

Amy S.F. Lutz — Tue, 21 Oct 2008 12:29:00 GMT

Boy, it's not a great time to be Joe Bottled Water, is it? First, a 2007 taste test sponsored by Decanter magazine awarded top honors to London tap water, which experts determined tasted better than 20 bottled competitors. Then, environmentalists started yammering about how bad all those discarded bottles were for the environment. Now, a new study has concluded that tap water is actually safer to drink than many bottled waters.

The study, done by the Environmental Working Group, found "pain medication, fertilizer residue and other various chemicals," in some major brands of bottled water. Cancer-causing contaminants - exceeding the self-imposed limits of the bottled water industry - were bought in California, Delaware, Maryland, North Carolina, Virginia and the District of Columbia.

It's not really that surprising, given that tap water is under FDA control, whereas the bottled water industry is primarily self-regulated. Tap water suppliers are required to release test results of contaminants in their water supply, but bottled water companies refuse to do so.

So what should a concerned consumer do? Hmmmm. Many tap waters taste better (except South Florida tap water, which is truly disgusting) and have fewer contaminants than bottled water. Plus, it's free! Why not give it a try? You can always attach a carbon filter to your faucet if you're concerned about what chemicals might be in your water - a list of which can be found at EWG’s National Tap Water Atlas.

BPA Bottles to Be Banned in Canada

Jen Chaney — Sun, 19 Oct 2008 19:03:00 GMT

They don't mess around with their baby bottles in the Great White North. The Canadian government announced Friday that it plans to ban bottles that contain bisphenol A, or BPA, the controversial chemical found in many plastic products. As we've all heard umpteen times by now, there is evidence that exposure to BPA may cause health problems, including possible hormonal and reproductive disorders in infants.

Here in the U.S., the federal government has not proposed banning baby bottles that contain BPA. But, as the AP reports, several state goverments are considering ways to restrict its use. Some major retailers also have pulled BPA-containing products from their shelves.

If there is a reason that U.S officials haven't issued a ban, it's probably because the scientific community at large can't seem to agree on whether BPA is really harmful. The FDA still says it's safe, although an independent panel is in the process of reviewing that claim. But that panel's effectiveness recently has been called into question because its chairman, Martin Philbert, headed a research center that received a donation from Charles Gelman, a well known critic of the BPA backlash.Lawmakers are investigating that potential conflict of interest. In other words, this whole thing has turned into one hot, baby bottle mess, which means that getting a clear answer about the potential hazards of the chemical may take a while.

What do you think? Is Canada doing the right thing by swfitly banning BPA bottles and erring on the side of caution? Or is the U.S. taking appropriate action by evaluating more evidence before considering a nationwide ban?

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Samples of Medicines Not Getting to Poor Kids

JeanneSager — Wed, 08 Oct 2008 18:04:00 GMT

I was all set to object to this piece on a study published in the Journal of Pediatrics that essentially advises pediatricians NOT to give parents free samples of prescriptions. What about all the uninsured parents out there? What about the insured who have crappy coverage? What about poor starving writers' kids? Apparently, 80 percent aren't getting the loot anyway.

The study by the CDC found more than half a million kids received samples of drugs the FDA later issued safety warnings for. That included 38,000 parents of kids under 2 who received an eczema treatment the FDA later said was not recommended for children under 2 anyway. That's bad, yes, but I don't see how a sample handed to a family was any worse than a prescription. The child is still being exposed to potentially dangerous pharmaceuticals. Without the samples, they'd just be PAYING for that exposure. Thanks FDA!

What the study also uncovered was that 80 percent of the kids receiving samples had insurance. So a measly 20 percent of the samples were given to parents of kids who would have to cough up the entire cost of a prescription? Isn't the point of samples to give to people who can't afford the drug? Technically, no. A look at any release issued by the Pharmaceutical Research and Manufacturers of America defending the use of samples shows the benefits to the uninsured are third on the list. The other benefits are supposed to be for the physician and patients as a whole - by giving doctors a chance to see what medicine works for what patients.

Sadly, I'm not surprised to see few uninsured kids are getting samples. Because I know more than a few uninsured who don't take their kids to the pediatrician. Ever. My own physician and my daughter's pediatrican - regularly ask, how is your insurance? When I tell the truth - it sucks - they usually pony up. And I'm not afraid to ask for the prescription cards that some pharmaceutical companies are putting out these days to cover a portion of the copay. Which gives me hope that the figures are a little off - 80 percent of those kids may have had insurance, but how good was that insurance?

Image: ABC News

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They Say: no cold medicine for kids 4 and under

Brett Singer — Wed, 08 Oct 2008 15:30:00 GMT

Kid has a stuffy nose? Suck it up. Well, not literally. But don't give them over the counter cold medicine. That's the word from the FDA, who are now saying that you shouldn’t give cold meds to any child under 4 years old.

The cough and cold medicine industry, in the wake of intensifying criticism from consumer groups, lawmakers and pediatricians, agreed Tuesday to add "do not use" warnings to pediatric cough and cold medicines.

Taken literally, this would mean that they will sell you the product, but add a label that says not to use it. I know that's not exactly what they mean, but it's funny to think about anyway. It's sort of what cigarette companies have to do, right? They can sell you the cigs, but they have to include a label that says YOU WILL DIE IF YOU SMOKE THESE. Of course, it doesn't say, "do not use." Just that if you DO use them, you'll get emphysema.

The real problem, according to the FDA, is misuse of the meds. "[Parents] should follow very carefully the directions on the package," said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. "The No. 1 cause of problems is children getting into medicine for accidental ingestion."

The American Academy of Pediatrics wanted the FDA to tell people that the meds didn't work for kids aged 6 and under, but the FDA was concerned "that parents would give adult doses if it instituted a ban of products for children under age 6." Well, duh. If I can't give them their own drugs, I'll just cut mine in half.

Now look. I'm being obnoxious here, and I apologize. But as I understand it, no one is saying that over the counter cold medicine is unsafe when the recommended dosages are used. They do seem to be saying that the medicines are ineffective, which I can believe. In my own experience, I have more success treating my old colds with Ginger Tea, Vitamin C and sleep. (Those three things even rhyme, sort of.) The best thing in the world, for me, is acupuncture. Two needles in the right spots on my nose and poof – no more snot. That's not going to work for everyone, and on the rare occasion when I have severe sinus pain, I'll take something stronger (an over the counter sinus pill usually does it for me). Again, this is only my own experience, your mileage may vary, and I'm not a doctor nor have I played one on TV. I don't even watch "Grey's Anatomy." So don't take this as advice.

Bottom line: the FDA says don't give your kids cold medicine if they are under 4 years of age. They would say under 6, but they're afraid that if they did, you'd give them your drugs. Thanks guys.

Source: Chicago Tribune

image: webmd

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Breaking News: Cadbury chocolate made in China recalled

Brett Singer — Tue, 30 Sep 2008 03:15:00 GMT

The AP is reporting that Cadbury is "recalling 11 types of Chinese-made chocolates after tests found they contained the industrial chemical melamine." This follows the recall of tainted milk powder in China.

AND, according to Newsinferno.com, a specific candy made by Cadbury called "White Rabbit" has been found to contain Melamine, the substance that cause more than 50,000 children to fall ill in China. The candy has been "distributed to California, Georgia, Hawaii, Illinois, Minnesota, New York, Oregon, Texas, and Washington state through wholesale distributors to retail stores."

Before you say what I said ("Newsinferno? What's that?"), here's a link to the FDA's press release about the recall.

Newsinferno also reports that, "Pizza Hut suspended supplying cheese powder found to be contaminated by melamine in Pizza Hut’s Taiwan branch." Unless you happen to be in Taiwan, this one is pretty easy to avoid, but the White Rabbit stuff sounds like it could be in your local candy shoppe. Plus there are 11 other varieties, such as Eclairs (sold in Australia). So be careful.

But wait! There's more! According to Wikipedia, this White Rabbit stuff was recalled last year in the Philippines because it contained formaldehyde. Yum!

Anyone else in the mood for some good news? Like, "Field of unicorns found frolicking in Central Park, film at 11"? Sorry, I made that one up. Sounds good though, right?

Sources: CBS News/AP, Newsinferno.com, Sydney Morning Herald, Wikipedia (also image)

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Chinese Milk Scandal Heads to Europe. Is the U.S. Next? Yes!

Madeline Holler — Fri, 26 Sep 2008 18:59:00 GMT

The Chinese milk powder scandal has gone international. European Union regulators have ordered testing of imported food products that contain at least 15 percent milk powder. They are worried that some imported food products containing the tainted milk powder may be making their way around Europe. In particular, the regulators are worried about cookies, chocolates and toffees.

From the NY Times:

In 2007, the European Union imported from China about 19,500 tons of confectionary products, including pastries, cake and cookies, and about 1,250 tons of chocolate and other prepared foods containing cocoa.

Consumer groups in the U.S. have called on the FDA to take similar action and restrict food imports from China that contain any dairy until this whole mess gets sorted out.

The United States has imported two million pounds of a milk protein called casein this year, along with other powdered milk proteins that are used as ingredients in many processed foods, according to figures from the United States Department of Agriculture. This includes 293,000 pounds that were imported in July.

Ew and yuck! Is there any way to tell whether the ingredients in your Oreo are domestic or imported and if imported, from where? No.

Again, the Times:

In an increasingly globalized food economy, manufacturers use raw ingredients from all over the world, often making it difficult to track the origins.

For example, Kraft Foods, the maker of Oreo cookies, recently moved one of its large cookie factories from Australia to China. But Claire Regan, a spokeswoman for the company, said that most of the products Kraft made in China were distributed within China, although a limited number were exported. Most do not contain milk products from China, she said, and, when they do, the levels of such ingredients are very low. The Oreo product line does not contain milk ingredients from China, Ms. Regan said.

The milk products which have caused nearly 50,000 Chinese kids to become sick -- and several have died -- contained melamine, an ingredient that diluted the milk but maintained its level of protein. Oh, and tends to cause kidney stones in babies who eat too much of it.

THIS JUST IN -- Now recalls over the melamine tainted milk product include Heinz baby cereal sold in China and Hong Kong and a bunch of cookie products sold in Japan.

AND THIS TOO! -- You might want to give up your Mr. Brown instant coffee habit. And if you're a fan of milk tea products from China, which are widely available in the U.S. The FDA is warning the two products may contain some of the tainted milk powder from China.

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They Say: That Thing About BPA Bottles Being Safe? Uh, Kidding!

Madeline Holler — Fri, 05 Sep 2008 19:01:00 GMT

On behalf of plastic-pushing parents everywhere, I'd like to say to government scientists: make up your damn minds!

The latest out of Washington is that, yes, once again, there is cause for concern about baby's brain development in children who consume food and drink through plastics containing BPA (bisphenol-A for those raising their children under a rock).

Just weeks ago, the FDA announced there's nothing to be worried about; there, there, silly mamas, those studies were done on rats, you're not raising rats, a little BPA never hurt no one. Well! A report that came out this week now says there is some conern that BPA exposure can cause developmental problems in brains and hormonal systems of infants and children.

From MSNBC:

Program repeats initial findings issued in April. The group — which includes scientists from the National Institutes of Health and other agencies — said bisphenol's risks to humans cannot be ruled out, but acknowledged its concerns are based on the findings of studies on animals.

A final report from the FDA is expected later this year. At this point, though, who do you even believe?

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High Fructose Corn Syrup Is the Same As Honey?

Adrienne Martini — Sun, 06 Jul 2008 19:00:00 GMT

Some of my best friends are honest PR professionals. I know such critters exist. But honest PR professionals must not work for the high fructose corn syrup industry. How do I know this?

Witness their recent campaign to rescue HFCS from consumers who would rather their sweeteners didn't require a complex chemical process. Their argument? The FDA says HFCS is natural; therefore it is. If memory serves, the FDA also attempted to declare ketchup a vegetable.

This PR campaign has been unleashed because more American parents are reading the labels of the foods they buy and rejecting those that list HFCS as an ingredient. If nothing else, it's heartening to know that consumer choice is having an impact on the corn industry.

What's disheartening is the lengths that said industry will go to in order to convince that same consumer of a correlation (honey and maple syrup are the same as HFCS) that is only vaguely true in a very limited set of definitions.

Walgreens Sued Over Infant Death Caused by Cold Medicine

Jen Chaney — Mon, 09 Jun 2008 12:03:00 GMT

Natural News.com reports that an Illinois woman has filed a lawsuit against both Walgreens and McNeil PPC Inc., parent company of Tylenol, because her son died after consuming cold medicines made by both companies.

Devon Mehlberg-Alvarez died Oct. 8 -- three days before various infant and children's cold medications were pulled from store shelves -- due to dextromethorphan intoxication. The boy had taken both Infant Tylenol Cold and Decongestant Plus and Walgreen Pediatric Drops-Cough Plus Cold in the days preceding his death. His mother, Dimitria Alvarez, insists she never gave him the medications simultaneously and believes the two companies are responsible for selling a product without adequately warning of its risks.

Alvarez's attorney claims this may be the first suit of its kind. Which, if true, could open the flood gates for even more lawsuits.

It's unclear whether this case has legs since the FDA began to suggest that such medications could be hazardous to infants in August of last year, and the -- in January of last year. No matter what happens, the loss of Alvarez's son is certainly a sad reminder that all of us should read those product labels carefully and check with our pediatricians -- no matter how stupid we might feel for making the call -- if we have any doubt about which remedies are right for our kids.

Nipple Cream pulled from shelves; could harm nursing infants

Brett Singer — Sat, 24 May 2008 02:20:00 GMT

If you're using Mommy's Bliss Nipple Cream, stop. Now.

Not to be alarmist, but the FDA has issued a warning about the product, which is meant to nursing mothers "help soothe dry or cracked nipples." Problem is, two of the ingredients – chlorphenesin and phenoxyethanol – "may cause respiratory distress, vomiting and diarrhea in infants." Nice.

From CNN/AP: "FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, director of the Center for Drug Evaluation and Research. "Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants."

It needs to be stated that we have no information other than what has been reported by AP and numerous other media outlets.

A quick Google search of the two potentially offending ingredients shows that one of them, chlorphenesin, is listed as "not commercially available in the United States" on one of the first web sites to pop up in the search listing. Makes you wonder what exactly the company was thinking when they put out this stuff. Last year, MOM Enterprises recalled another product, Apple Flavored Baby's Bliss Gripewater, because it may have contained a parasite.

As of this writing, contrary to news reports that "the company has stopped selling the cream", the product is still for sale on MOM Enterprises' web site. Again, not wanting to be alarmist, but this sounds like potentially nasty stuff that mothers and their children really don't need.

image: Amazon.com

New LASIK Complication: Suicide?

Amy S.F. Lutz — Wed, 27 Feb 2008 14:27:00 GMT

I got LASIK over three years ago, and for me, it was the best thing I ever did. No glasses for the kids to grab, or to slide down my nose while I ran, or to have to wear at the beach or in the swimming pool (unless I wanted said kids to drown). I couldn't recommend it highly enough to my friends.

Now, in response to complaints from patients, the FDA is launching a study to examine whether complications from LASIK can lead to depression, and ultimately, suicide. At question is whether patients who experience botched LASIK procedures are more likely to be emotionally devastated than patients who experience complications during other types of surgeries. Because vision is so central to our quality of life, many experts believe the LASIK patients are more at risk.

Compounding the problem for the approximately 30,000 LASIK patients who experience complications every year is regret. As opposed to other patients who may have experienced problems with necessary surgeries, LASIK patients have to live with the knowledge that they asked for and paid someone to do this to them.

The despair was too much for Colin Dorrian, a 28-year-old Philadelphia attorney who killed himself after LASIK left him with permanently distorted vision. Laser eye surgeons argue that patients like Colin may have been depressed before undergoing LASIK in the first place. Hopefully, this is a question the FDA will soon be able to answer.

Surprise! Botox Can Kill You

Amy S.F. Lutz — Fri, 25 Jan 2008 16:36:00 GMT

To many people, it seemed suspicious from the beginning: inject botulinum toxin into my face? Paralyze my muscles? And this isn't, you know, dangerous?

Now, Public Citizen, a U.S. consumer group, is asking the FDA to order manufacturers of Botox and Myobloc, a similar medication, to put strong warnings on their labels, as well as to send out letters to doctors. Sixteen deaths and almost two hundred cases of botulinum toxin complications - including muscle weakness, difficulty swallowing and aspiration pneumonia - have been blamed on these drugs so far. Such complications occur when the botulinum toxin spreads from the face, where it was injected, into the esophagus. Partial paralysis of the esophagus can result.

Public Citizen believes that better educated patients and their doctors will more quickly recognize botulinum toxin complications when they occur, increasing the likelihood that they can be redressed before becoming fatal.

On a positive note, if you die following a Botox injection, you will doubtless look ravishing at your viewing.

It's Official: FDA Says No Cough Meds for Very Young

Madeline Holler — Fri, 18 Jan 2008 13:27:00 GMT

We've been expecting this for months. The FDA has finally, officially, issued a warning against giving over-the-counter cough and cold medicines to children under 2. This includes even those marketed to and labeled for infants and young children.

Since October, manufacturers quit selling many version of their remedies that were targeted at infants and toddlers. (Though you still see a lot on the shelves, no?)

In the report:

That month, the FDA's scientific advisers also voted that the drugs don't work in small children and shouldn't be used in preschoolers, either — anyone under age 6.

By Spring, the FDA expects to make a recommendation regarding use of decongestants and antihistamines and cough suppressants for older children.

An FDA panel looked into recommending the new FDA warning, after noting that about 1500 babies and toddlers wound up in the ER in two years after having been given these OTC cough and cold medicines. Furthermore, the medicines haven't actually been shown to be effective for kids with colds. Most alarming is that these medicines were approved for use in young children without ever having been studied. Drug makers operated under the notion that children are just smaller adults, and what works for grown-ups works for kids, just in smaller amounts. We now know this isn't the case.

So what's a parent to do? Well, shortly after these reports came out, an interesting study showed honey to be the most effective cough suppressant and we reported it here. Over the holidays, both the kids developed some kind of night cough (dry air?). I decided to give it a try, and it worked! Just last night when I was coughing up my own pair of lungs after a short but intense cold/flu earlier this week, I took a huge spoonful of honey and didn't cough again until morning. So ... just putting that out there.

Photo: AP

Attack of the Clones: It's What's For Dinner

Karen Murphy — Fri, 18 Jan 2008 12:28:00 GMT

Hey! Yep, our friends over at the Food and Drug Administration (the FDA to their closest friends) have done it again! Yay for them! Because they've cleared the way for us all to someday be eating cloned meat. Mmm, mmm, mmm!

Yes indeed, the FDA says that "The data show that healthy adult clones are virtually indistinguishable." Tasty! But opponents have this to say: "If you ask what's for dinner, it means just about anything you can cook up in a laboratory," which is closer to my thoughts about it.

Sure, it could be years before cloned meat hits our tables, since the cost is thus far prohibitive, but I'm thinking we might as well go vegetarian now anyway. Just in case. I know, I know, if a clone is "virtually indistinguishable" from it's parent animal, what's the big deal, right? The big deal is that some previously undetected problems in said parent animal could be reproduced over and over, spreading some Cloned Cow Disease to everyone's tables before anyone knows what happened.

And, well, the whole thing just makes me go "ew." I'm already dubious about genetically-modified foods (which are in SO many foods it's scary) and irradiated foods, etc etc, so I don't see the need to clone animals to kill and eat them (not that I'm a fan of factory farming to begin with, but there's the whole extra "ew" factor in clone farming).

I can't be way off base here, can I? This is creepy, right?

Photo: pump.tuthill.com

Asthma Drugs Under FDA Scrutiny

Madeline Holler — Thu, 29 Nov 2007 20:29:00 GMT

On the one hand, I should feel relieved that the FDA is cracking down on medications marketed for children, as they did in the recent crackdown on ineffective and potentially life-threatening children’s cough and cold medicines.

On the other hand, what else are parents dosing their kids up with right now – at a doctor’s behest – that could someday warrant closer scrutiny? Like the latest treatment that millions of kids use to, uh, stay alive.

Asthma drugs. The FDA wants a child-specific warning – that these drugs carry an increased risk of asthma-related death and/or hospitalization in children, and that these should be used with other asthma drugs and not alone -- stamped on each and every Serevent and Advair inhaler and are considering the same recommendation for Foradil. They also want a panel to consider whether the benefits of these drugs outweigh the risks. Yikes!

FDA reviewers found five deaths among nine adverse-event reports in children during its 13-month review period for Serevent. Such reports don't mean a drug caused a problem. They said there was evidence that inhaled steroid therapy was "not protective" in young people taking Foradil.

I’ve been lucky enough, so far, to not yet have a child diagnosed with asthma, though, in truth, I’m waiting for it to happen. I live in one of the dirtiest cities in the country and saying your kid has asthma here is about as common as saying she has dance classes too. (Excuse me, how sad is that?).

How many of your kids have one of those inhalers stashed in your purse or your school’s nurses office? Would you oppose a recall? Do you read warning labels or discuss them with your doctor?

Surviving Colds Without Cherry-Flavored Syrups

Madeline Holler — Fri, 02 Nov 2007 16:29:00 GMT

My 2-year-old woke up with a runny nose this morning and I instinctively went for the cold medicine. All gone. In a fit of responsible consumerism last month, I threw out the dregs of our cough and cold medicines, left over from intense use last winter.

We’re not in crisis mode, but I do wonder what we’ll do if, tonight for example, these sniffles keep my daughter (and me) from getting some sleep. I might try some of these old-fashioned sounding home remedies. The round-up of doctors recommend music and massage, tea and a bath, or Vitamin C and vabor rub. Can I get all of that in a bubble gum flavored syrup?

Do you have your own favorite remedies? Last year, one of my naturopathic mom friends said to tuck a sock dotted with eucalyptus oil under my congested kids’ pillows. I did. Didn’t work.

How are you dealing with the recall? And who has THE solution for clogged noses?

Photo: Redbook magazine