Archive for the ‘FDA’ Category

Child Health: Labels Urged for Food That Can Choke

May 27, 2010

Earlier this year, we posted a blog on our website in regard to the American Academy of Pediatrics (AAP) policy statement in regard to the prevention of choking among children.  Earlier this week, the New York Times featured an in-depth story on an issue that is very much a part of this policy statement:  food choking hazards among small children.  The article discusses the advocacy efforts to place warning labels on foods, which pose a choking hazard to small children, as well as the proposition that small children should not be allowed to eat certain foods at all.  The article starts with an all too familiar setting that ended in tragedy:

On a July afternoon in 2006, Patrick Hale microwaved a bag of popcorn for his two young children and sat down with them to watch television. When he got up to change the channel, he heard a strange noise behind him, and turned to see his 23-month-old daughter, Allison, turning purple and unable to breathe.

As a Marine, he was certified in CPR, but he could not dislodge the popcorn with blows to her back and finger swipes down her throat. He called 911, but it was too late: by the time Allison arrived at the hospital, her heart had stopped beating. An autopsy found that she had inhaled pieces of popcorn into her vocal cords, her bronchial tubes and a lung.

Does this story make you think twice before giving your little ones popcorn?  On a personal note, I called my wife immediately after reading this story, and we discussed the fact that we should no longer allow our son, who is now two and a half, to have any popcorn. Ironically, she was on her way to take him to a movie that was going to be serving….you guessed it, popcorn.

Now, some of you may say “Well, little kids can choke on anything.”  Well, that is true.  However, there are some foods that pose an increased risk of choking.  Consider the dynamics of how a small child eats, as well as the size of their airway:

Children under 4 are at the highest risk, not only because their airways are small (the back of a toddler’s throat narrows to the diameter of a straw) but also because of the way their eating abilities develop. Front teeth usually come in at 6 or 7 months — so babies can bite off a piece of food — but the first molars, which grind food down, do not arrive until about 15 months, and second molars around 26 months.

“Between the ages of 3 and 4, they’re developing their ability to chew adequately and prepare for swallowing,” said Dr. Nisha Kapadia, a pediatric resident at Johns Hopkins Children’s Center.

When young children chew foods like peanuts, raw carrots and popcorn, some is ground down and some is not, and they tend to swallow unchewed bits of food that can block the airway or be inhaled into the bronchial tubes and lungs.

This concern and the tragic deaths associated with this concern have prompted several organizations to propose various options to attempt to prevent these injuries and deaths.  One such organization is the Center for Science in the Public Interest:

Some advocates say the government should put hazardous foods off limits to young children.

“The F.D.A. needs to set a uniform standard for cautionary information on food that should not be consumed by children under 5,” said Bruce Silverglade, legal director of the Center for Science in the Public Interest, an advocacy group that lobbied unsuccessfully in 2003 for a bill to require the Food and Drug Administration to develop food labeling regulations.

Where this debate will end up, we don’t know.  However, to think that in 2001 there were 17,500 children 14 years old and younger treated in emergency rooms for choking, with 60% of those events caused by food, there must be a way to create a safer environment for our children when they are eating.  Any suggestions?

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Allergic to Dairy? Read Before Eating Those Sunflower Seeds!

May 19, 2010

Ryt-Way Industries, LLC, a food packaging company, is immediately recalling some of the sunflower seed products that they have packaged, as they contain undeclared dairy ingredients.  The recall, which includes products that have been distributed nationwide, is a voluntary recall, and is being done in conjunction with the FDA:

Ryt-way Industries LLC of Lakeville, MN is voluntarily recalling select BIGS ® Original Salted & Roasted Sunflower Seeds because they may contain dairy ingredients that were not declared on the packaging.  The product is packaged in 5.35oz plastic bags with BEST BY Dates of 30MAY2011 and 31MAY2011 with an individual bag UPC code 896887002196.  People who have an allergy or severe sensitivity to dairy run the risk of serious or life-threatening allergic reaction if they consume these products.

It was discovered that the sunflower seed packages at issue, as manufactured by BiGS, do not disclose the presence of dairy within them.  Ryt-Way goes on in their announcement to instruct consumers that are allergic to dairy how to handle this situation, should they be in possession of these recalled items:

Consumers who are allergic to dairy and who have purchased the recalled products are advised not to consume the product and are urged to return it to the place of purchase for a full refund.  Consumers with questions may contact 1-877-722-7556

So, if you are allergic to dairy and/or have a sensitivity to dairy products, and love those sunflower seeds, please check your home for these recalled products.  As the weather gets warmer and we try to snack on “healthier” items to get that “younger figure back for summer”, don’t let this recall pass you by!

McNeil Consumer Healthcare Announces Voluntary Recall of Certain OTC Infants’ and Children’s Products

May 8, 2010

Last week, the FDA and McNeil Consumer Healthcare launched a massive voluntary recall of certain medications for infants and children.  There is a dedicated McNeil website that addresses the recalls.  In addition, the FDA has published a press release that has some of the important information regarding the recall

The following is some basic information concerning the recall, as published by McNeil under the Product Recall Information:

McNeil Consumer Healthcare is initiating this voluntary recall because some of these products may not meet required quality standards. This recall is not being undertaken on the basis of adverse medical events. However, as a precautionary measure, parents and caregivers should not administer these products to their children. 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. While the potential for serious medical events is remote, the company advises consumers who have purchased these recalled products to discontinue use.

The investigation into these products, which include, but are not limited to, Infants’ and Children’s Tylenol and Motrin (Please click here for a complete listing) is ongoing.  The Commissioner of Food and Drugs, Dr. Margaret A. Hamburg, states:  “While the potential for serious health problems is remote, Americans deserve medications that are safe, effective and of the highest quality. We are investigating the products and facilities associated with this recall and will provide updates as we learn more.”

We will continue to monitor this massive recall.  Please immediately check your homes for the recalled products. We strongly recommend that you read and follow the FDA’s instructions.

Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

April 12, 2010

The FDA has recently launched a comprehensive new study regarding ways to reduce radiation exposure as a result of medical imaging.  The on-line article sets the background for the study, then provides comprehensive scientific and medical information for support:

Like all medical procedures, computed tomography (CT), fluoroscopy, and nuclear medicine imaging exams present both benefits and risks.  These types of imaging procedures have led to improvements in the diagnosis and treatment of numerous medical conditions.  At the same time, these types of exams expose patients to ionizing radiation, which may elevate a person’s lifetime risk of developing cancer.  As part of a balanced public health approach, the U.S. Food and Drug Administration (FDA) seeks to support the benefits of these medical imaging exams while minimizing the risks.

Through the Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging, FDA is advocating the universal adoption of two principles of radiation protection: appropriate justification for ordering each procedure, and careful optimization of the radiation dose used during each procedure.  Each patient should get the right imaging exam, at the right time, with the right radiation dose.

The related White Paper discusses types of medical imaging procedures,  factors causing the unnecessary exposure, and proposes possible solutions.  The factors include: Issues relating to Device Use, as well as Issues Relating to Clinical Decision Making.  Solutions include: Promoting Safe Use of Medical Imaging Devices, supporting informed clinical decision making, as well as increasing patient awareness.

Fat-Melting Injections (a.k.a. Lipodissolve) May Not Be As Safe As You Think

April 9, 2010

According to an article published by WebMD, the FDA reprimanded six U.S. spas (Monarch Medspa in King of Prussia, Pa., Spa 35 in Boise, Idaho, Medical Cosmetic Enhancements in Chevy Chase, Md., Innovative Directions in Health in Edina, Minn., PURE Med Spa in Boca Raton, Fla., All About You Med Spa in Madison, Ind.) and one Brazilian company for making misleading statements about the safety and side-effects of fat-melting therapy (a.k.a. mesotherapy, lipodissolve, lipozap, lipotherapy, or injection lipolysis).

FDA’s Deputy Director of the Division of New Drugs and Labeling Compliance noted:

They make it sound so good and so safe. … [They claim] it dissolves fat — melts it away with no side effects — and they have done thousands of procedures, and it really sells well. … We are really concerned because we have had reports of complications, and we have no good data that say this is safe and this is effective.

Lipodissolve is a process whereby a series of subcutaneous injections are administered (usually injections of phosphatidylcholine and deoxycholate) to a specific part of the body in an attempt to melt the subcutaneous fat. According to the article, some of the reported side-effects of this therapy have been scaring of the skin and the developments of painful subcutaneous knots.

If you are considering Lipodissolve, be aware that this treatment is yet to be approved by the FDA, and there is no medical data or scientific research demonstrating that Lipodissolve is safe for consumers.

Contributing author: Jon Stefanuca

St. Joseph Medical Center Stent Patients Now Face Another Risk: The FDA Requires a Black-Box Warning on Anti-Clotting Drug Plavix

March 13, 2010

For those of you who have been following the St. Joseph Medical Center stent fiasco, a story in the Los Angeles Times regarding the anti-clotting drug Plavix brings home a new concern for the patients who received this drug as part of the post-procedure therapy. Plavix is used “to prevent clotting of blood in patients who have stents or other prostheses or conditions that predispose them to clotting, and thus strokes and heart attacks.”

The Food and Drug Administration said Friday that it will require a new black-box warning on the label of   the popular anti-clotting drug Plavix to indicate that some patients do not metabolize the drug properly and may receive little benefit from it. The warning indicates that the drug is dangerous only in the sense that it doesn’t work in those patients and thus may leave them unprotected against heart attacks and strokes.

“The new warning appears on the label of the drug in a black box — hence the name — which is considered the most severe form of warning.”  A black box warning is the strongest warning required by the FDA.  The intent of requiring such a warning is to alert physicians and help them treat their patients correctly. “The FDA says between 2% and 14% of Plavix users don’t respond well to the drug and might benefit from alternative treatment.”

According to the FDA press release:

Plavix reduces the risk of heart attack, unstable angina, stroke, and cardiovascular death in patients with cardiovascular disease by making platelets less likely to form blood clots. Plavix does not have its anti-platelet effects until it is metabolized into its active form by the liver enzyme, CYP2C19.

People who have reduced functioning of their CYP2C19 liver enzyme cannot effectively convert Plavix to its active form. As a result, Plavix may be less effective in altering platelet activity in those people. These “poor metabolizers” may not receive the full benefit of Plavix treatment and may remain at risk for heart attack, stroke, and cardiovascular death.

A Wall Street Journal Blog suggests that this situation may actually make the physicians’ job more difficult.

Genetic testing could identify the poor responders. But most doctors aren’t well equipped to do genetic testing. They don’t have quick access to the tests. Even if they did, they might not have time in the cases of many patients to wait for results to come back.

Only one genetic test has been approved by the FDA,  Roche’s AmpliChip, “to look for the variation, but not specifically for determining treatment with Plavix. Many laboratories offer other tests, whose quality the FDA says doctors will have to assess before using. Doctors should make sure the tests are at least 98% accurate, FDA officials told reporters.”

According to Christopher Cannon, a Harvard Medical School associate professor and editor-in-chief of Cardiosource, associations involved with the cardiac-related specialties and sub-specialties “will need to develop protocols for testing and treatment. The alternatives include increasing the dose of Plavix or switching to bloodthinner Prasugrel from Lilly and Daiichi Sankyo, but Cannon says neither has been tested for that purpose.”

“Thus a real conundrum” for patients and their physicians, Cannon said. “I expect mass confusion in response to this FDA warning,” he added.

As we reported in “Eye Opener” on March 13, 2010, St. Joseph Medical Center this past week added another 169 patients to the list of those notified by letter that they had received unnecessary, expensive and potentially dangerous stent procedures.  This brought the number notified to a whopping 538 patients – at least to date.

One has to wonder in all of this, was there a single moment of thought given to the potential risks to the patients at St. Joseph Medical Center when these unnecessary stents were put in hundreds of patients?  Maybe those involved in this tragic story of despicable care were not fully versed in the genetic complication of Plavix (or maybe they were); however, they were most assuredly aware that they were exposing these unwitting patients to a risk of hemorrhage, not to mention the risks associated with having a foreign body unnecessarily placed in their coronary vessels.

FDA Orders Widespread Food Additive Recall

March 9, 2010

The FDA has ordered a recall of over 90 products, as manufactured by Basic Food Flavors, Inc.  The ingredient in question is hydrolyzed vegetable protein, and the recall covers multiple products.

As of this writing, there have been no reported illnesses to the FDA, based on the contamination.  For a listing of the recalled products, click on this link.    Jeffrey Farrar, associate commissioner for food protection at the FDA, was recently quoted in an article as stating:  “At this time we believe the risk to consumers is very low.”

The FDA states that this product is used in thousands of food products.  However, the article states the following, as it relates to the risk.  Again, Jeffrey Farrar:

Jeffrey Farrar, associate commissioner for food protection at the FDA, said Thursday that many of the products that contain the product are not dangerous because the risk of salmonella is eliminated after the food has been cooked. Many of the foods involved in the recall are ready-to-eat items that are not cooked by the consumer.

This recall continues to evolve with time.  Please continually check the FDA website for updates as to the status of what products are in the recall.

Product Recalls: Granola bars – Trader Joe’s Chocolate Chip Chewy Granola Bars

February 22, 2010

I suspect that many of you love to grab that ‘healthy’ and ‘quick fix’ granola bar.  Well before you do, you may want to   check which one it is you are getting ready to bite into.  This notification just in from the FDA of a voluntary recall by Trader Joe’s on it’s product – Chocolate Chip Chewy Coated Granola BarsProduct Recalls: Granola bars.

[I]t has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. Healthy persons infected with Salmonella often experience fever, diarrhea, nausea, vomiting and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

The FDA’s press release advises that there have been “no illnesses . . . reported to date in connection with this product.” Forewarned is a good policy – so be  forewarned!

For details on contact information on the product’s recall, see the FDA announcement.

FDA reports says Avandia can hurt heart: NY Times investigative report

February 20, 2010

From a report in Yahoo News, which is the source for this posting  – FDA reports says Avandia can hurt heart: report:

According to a report by the NY Times yesterday, February 19, 2010, Confidential U.S. government reports recommend that GlaxoSmithKline Plc’s diabetes drug Avandia be pulled from the market because it can hurt the heart.

Two authors of the report, Dr. David Graham and Dr. Kate Gelperin of the FDA, both concluded that it should be removed from the market.

According to Yahoo News, Sales of Avandia, once Glaxo’s second biggest-selling product, plummeted two years ago after a U.S. study linked it to an increased risk of heart attack in a conclusion disputed by Glaxo.

According to the Times reporter, Gardiner Harris, an FDA advisory board voted, 8-7, in 2007 to accept the advice of an independent committee that while Avandia might increase the risk of heart attack, it should stay on the market.

A U.S. Senate investigation into the product “said Glaxo failed to warn patients earlier that Avandia was potentially deadly” – according to the Times report.

The Times said the internal FDA findings reflected a fierce debate inside the agency about Avandia. The newspaper quoted Glaxo as saying it had studied Avandia extensively and that “scientific evidence simply does not establish that Avandia increases” heart attack risk.

At the end of last year, Dr. Janet Woodcock, director of the FDA’s drug center, wrote an internal memorandum that “there are multiple conflicting opinions” about Avandia and ordered officials to assemble another advisory committee to reconsider if the drug should be sold.

The Times quoted FDA Commissioner Margaret Hamburg as saying on Friday, “I await the recommendations of the advisory committee.”

FDA and International Serious Adverse Events Consortium Complete Third Data Release

February 20, 2010

Do you know what ‘adverse event reporting’ is all about?  Well, in case you don’t, here it is – as defined by the Food and Drug Administration (FDA):

The Adverse Event Reporting System (AERS) is a computerized information database designed to support the FDA’s post-marketing safety surveillance program for all approved drug and therapeutic biologic products. The FDA uses AERS to monitor for new adverse events and medication errors that might occur with these marketed products.

Yesterday, February 19, 2010, the FDA issued a news release –Regulatory Science Update: FDA and International Serious Adverse Events Consortium Complete Third Data Release – concerning data on the genetic basis of drug-induced liver injury (DILI) and serious skin reactions (SSRs).  This consortium report was the product of the combined efforts of the U.S. Food and Drug Administration and the International Serious Adverse Event Consortium (SAEC).

The concept behind their efforts is the identification of genetic factors  in a subset of patients and thereby assist researchers to better predict an individual’s risk of developing these serious complications.

Drug-induced liver injury occurs in a small subset of patients and is often associated with a drug that is an unpredictable liver toxin, and may be the cause of acute liver failure in some patients. Although the exact mechanism behind drug-induced liver injury is unknown, research suggests that a person’s genes contribute to their likelihood of developing this injury.                                                                                    

Drug-induced SSRs, such as Stevens-Johnson, present as allergic-like skin reactions (blistering and peeling of the skin) and are considered serious enough to discontinue treatment with the medication. These reactions can be fatal if the signs and symptoms are not quickly recognized.

“FDA is pleased with the Consortium’s progress,” said ShaAvhree Buckman, M.D., Ph.D., director of the Office of Translational Sciences in the FDA’s Center for Drug Evaluation and Research. “The continued accumulation of scientific information on the genetic basis of adverse drug events provides researchers with invaluable tools for understanding why some people respond to medicines differently than others.”

If you have ever seen or read about a person suffering from a condition such as Stevens-Johnson Syndrome (SJS), you can well appreciate the significance of this research project.