Posts Tagged ‘FDA’

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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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

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.

FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging

February 10, 2010

Ostensibly in the wake of recent reporting on catastrophic injuries resulting from use and misuse of radiation emitting diagnostic tests such as CT scans and other nuclear medicine studies (e.g. MRI’s) and fluroscopy, the FDA announced yesterday a new three-prong initiative for patient safety in the design and use of these devices.   See the announcement posted on their website for complete details.

While recognizing the value of such testing for diagnostic purposes, the FDA formally acknowledged that these imagining procedures “expose patients to ionizing radiation, a type of radiation that can increase a person’s lifetime cancer risk. Accidental exposure to very high amounts of radiation also can cause injuries…”  The agency urges patients and their physicians to discuss “the medical need and associated risk for each procedure.”  In legal parlance – health care providers should obtain the patient’s informed consent when using these studies.

“The amount of radiation Americans are exposed to from medical imaging has dramatically increased over the past 20 years,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The goal of FDA’s initiative is to support the benefits associated with medical imaging while minimizing the risks.”

The announcement emphasizes two express principles of radiation protection for patients: “appropriate justification of the radiation procedure and optimization of the radiation dose used during each procedure.”

Were you aware that a CT scan of the abdomen involves the use of  approximately 400 times the radiation dose of a chest x-ray?  By comparison, perhaps, the FDA references the fact that a dental x-ray is approximately one-half the dose of the chest x-ray.

The FDA intends to issue targeted requirements for manufacturers of CT and fluoroscopic devices to incorporate important safeguards into the design of their machines to develop safer technologies and to provide appropriate training to support safe use by practitioners.

The agency intends to hold hearings on March 30 – 31, 2010 to “solicit input on what requirements to establish.”

Examples could include a requirement that these devices display, record, and report equipment settings and radiation dose, an alert for users when the dose exceeds a diagnostic reference level (the optimal dose for most patients), training for users, and a requirement that devices be able to capture and transmit radiation dose information to a patient’s electronic medical record and to national dose registries.

For those of you who stay current with “Eye Opener,” you will recall that we recently posted on steps being taken through an independent initiative by the National Institute of Health for reporting in the electronic medical records just how much radiation its patients receive from CT scans and other procedures.

Other aspects of the FDA’s initiative would include matters such as a dose registry for establishing nationwide benchmark doses for such therapeutic tests; the development and dissemination of a patient medical imaging history card (think NIH) and a collaborative effort with the Center for Medicare and Medicaid Services  “to incorporate key quality assurance practices into the mandatory accreditation and conditions of participation survey processes for imaging facilities and hospitals.”

From my very limited vantage point of following stories on horrific events associated with these devices and the use of them by apparently under-qualified personnel, it would seem that the power of the press has once again brought about an awakening on the federal level of the need to control the use and users of these wonderful yet potentially injurious diagnostic machines.  Kudos to those who have reported on the need to gain such control.

Boston Anesthesiologist Charged with Fraud: The United States Department of Justice – United States Attorney’s Office – District of Massachusetts

January 18, 2010

This past Friday, January 15, 2010, the FDA issued an announcement regarding a criminal information/charge being filed by the United States Department of Justice against Dr. Scott Reuben.  The details of the charge are contained in the official announcement of the DOJ – The United States Department of Justice – United States Attorney’s Office – District of Massachusetts.

In essence, here is the nature of the charge:

The Information alleges that REUBEN solicited and obtained research grants from pharmaceutical companies to perform research studies on pain management, often associated with various surgical procedures, but that he did not actually perform the research studies. Instead he made up patient data, submitted it to medical journals and caused false articles to appear in a number of medical journals.

If convicted on this charge, REUBEN faces up to 10 years imprisonment, to be followed by 3 years of supervised release and a $250,000 fine.

As the DOJ correctly notes, this is only a charge against Dr. Reuben.  To use its words, “The details contained in the Information are allegations. The defendant is presumed to be innocent unless and until proven guilty beyond a reasonable doubt in a court of law.”

It does make you wonder, however, just how carefuly so-called ‘peer reviewed’ articles and research papers ARE scrutinized and ‘reviewed.’

FDA announces research program for prescription drugs in pregnancy

January 2, 2010

On December 30, 2009, the FDA announced that a new collaborative research program to study the effects of prescription medications taken by women during pregnancy.  This program is called the Medication Exposure in Pregnancy Risk Evaluation Program (MEPREP) and will be a collaborative effort among the FDA, and researchers at the HMO Research Network Center for Education and Research in Therapeutics (CERT), Kaiser Permanente’s multiple research centers and Vanderbilt University.

The FDA references in its announcement an article in the American Journal of Obstetrics and Gynecology, which states  that it estimates that two-thirds of women who are pregnant take at least one prescription medication during their pregnancy.

One might think that there had been a number of clinical trials relating to medications taken during pregnancy prior to this collaborative effort; however, this appears not to be the case since there were too many concerns about the health of the mother and fetus preventing such a study in the past.

For more details  on this long-overdue research study, see the FDA’s announcement.