April 30, 2013 News: Lipitor Linked to Type 2 Diabetes Risk in Women

News this week about Lipitor:

More than 20 million Americans take cholesterol-lowering drugs known as statins. These drugs, including the brand name Lipitor, have been linked to a high risk of Type 2 diabetes, especially in middle-aged and older women.

A study conducted by the Women’s Health Initiative of 150,000 postmenopausal women found that those taking a statin such as Lipitor were almost twice as likely to get a diabetes diagnosis. Studies published in the Journal of the American College of Cardiology and the Journal of the American Medical Association also reported a higher risk of diabetes for people taking statins.

The FDA has issued a warning about side effects of Lipitor, including the risk of diabetes. Data from large clinical trials reveal the danger of developing Type 2 diabetes from Lipitor is particularly high in women with existing risk factors including:

High blood sugar

Elevated triglycerides (a type of blood fat)

High blood pressure

Airtran Airways Sues Its Own Injured Employee for Over $250,000

Airtran Airways, a large domestic airline, has recently sued and obtained a judgment in excess of $280,000 against its longtime employee Brenda Elem, after she was severely injured in a car wreck.

Ms. Elem began working in 2002 for Atlanta based Airtran Airways, a billion dollar airline which is owned by Southwest Airlines.  The entire time Elem worked for Airtran, she always paid health insurance premiums to Aetna through the airline’s employee benefit program.  In 2007, Elem was injured in a car wreck and suffered significant injuries for which Aetna paid $134,000 in related medical expenses.  Airtran sued Ms.

Elem to recover the full $134,000 paid by Aetna and now  amazingly stands to collect over $280,000, an amount that almost exceeds the entire amount Elem personally received in her settlement with the driver that caused her injuries.  While many regular Americans have had their rights to recover damages for their personal injuries curtailed as a reaction to frivolous lawsuits, the system in this case has rewarded a billion dollar corporation for pursuing money from its own employee for medical expenses paid by an insurance company.  

The judgment obtained against Elem stems from a March 2007 car wreck which occurred when Elem was driving her car in Marietta, Georgia, and another driver lost control of his vehicle and slammed into her.  She was taken to an Atlanta hospital and treated for serious injuries.  Elem underwent years of medical treatment, numerous surgeries and lengthy physical therapy.  Elem will never completely recover from her injuries and will have difficulty walking for the rest of her life.  At the time of the wreck, Elem had worked for Airtran for many years and paid into the employee benefit program for her Aetna health insurance coverage.  Elem turned to the law firm of Link & Smith to file a lawsuit against the driver that caused the wreck.  Eventually her case against the driver was settled, and Elem thought the worst was behind her.

Shockingly, after her settlement with the driver that slammed into her, Elem and her lawyers were then sued by her own employer, Airtran, to recover the full amount of her medical expenses that Aetna had already paid.   Incredibly,  Airtran, a billion dollar airline, also sued Elem for money to pay for its own attorneys that brought the case in the first place.    Elem did not think that Airtran’s suit was fair, and fought Airtran in Federal Court in Atlanta for two years.

According to court documents, Airtran’s lawyers racked up over $204,000 in fees to recover $134,000 of medical costs.  It is astounding that a billion dollar corporation like Airtran can hire lawyers and spend over $204,000 to recover $134,000.  Ultimately, Judge Orinda Evans ruled that Elem and her attorneys should pay Airtran $281,120.08, an amount that nearly exceeds what Elem personally received in her  own lawsuit against the at-fault driver.

Airtran now stands to collect more than twice of what was paid out for Elem’s medical bills which  will leave Ms. Elem with nothing, despite her debilitating injuries.  In these tough economic times, it is appalling that a huge corporation like Airtran is not only willing, but is able to sue a valued employee like Elem to recoup medical expenses paid by Aetna.

If you disagree with this, call Airtran.

This article submitted for an attorney in Atlanta.

4/23/13: Stimulant Potentially Dangerous to Health, FDA Warns

The Food and Drug Administration (FDA) is using all available tools at its disposal to ensure that dietary supplements containing a stimulant called dimethylamylamine (DMAA) are no longer distributed and available for sale to consumers in the marketplace.

The ingredient, DMAA, is most commonly used in supplements promising weight loss, muscle building and performance enhancement; it can elevate blood pressure and could lead to cardiovascular problems, including heart attack, shortness of breath and tightening of the chest. Given the known biological activity of DMAA, the ingredient may be particularly dangerous when used with caffeine.

As of April 11, 2013, FDA had received 86 reports of illnesses and death associated with supplements containing DMAA. The majority are voluntary reports from consumers and healthcare practitioners. The illnesses reported include heart problems and nervous system or psychiatric disorders. Note, however, that a report is not proof that the product actually caused the problem.

FDA has warned companies known to be using DMAA in dietary supplements that those products containing this ingredient are illegal. Such warnings offer the quickest way at FDA's disposal to halt the further distribution of dietary supplements containing DMAA in the marketplace. In fact, all but one of the companies sent a Warning Letter have agreed to stop using DMAA as an ingredient in their dietary supplements. The one company that has yet to agree to such action, USPLabs, has responded to FDA's warning by submitting published studies that purport to challenge FDA's conclusions.

However, after reviewing the studies provided by USPLabs, FDA has found the information insufficient to defend the use of DMAA as an ingredient in dietary supplements. FDA is finalizing a formal response to the firm to reflect its findings, according to Daniel Fabricant, Ph.D., director of FDA's Division of Dietary Supplement Program.

FDA's authority over dietary supplements is very different from its authority over drugs and other medical products. FDA is required to undertake what are usually lengthy scientific and legal steps in order to force the removal of dietary supplements that may be unsafe or are otherwise illegal if companies don't voluntarily comply.

As FDA continues the process needed to get DMAA off the market, the agency is urging consumers to check labels and avoid any dietary supplements containing DMAA, which is referred to on different product labels by 10 possible names. The alternatives are listed at FDA's DMAA web page.

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The Challenge

FDA's response to the use of DMAA illustrates the challenges that the agency faces in addressing incidents involving potentially dangerous dietary supplements. The effort is increasingly important as the use of dietary supplements increases worldwide. A 2011 study found that more than half of U.S. adults used a dietary supplement between 2003 and 2006, compared to 40% between 1988 and 1994.

In recent years, FDA has alerted consumers to hundreds of tainted products marketed as dietary supplements. Consumers should be aware that dietary supplements are subject to different oversight than drugs and other medical products.

"Consumers may mistakenly look at a capsule and think that FDA has signed off on that product as safe and effective prior to that product appearing on the market, as we do with drugs and other medical products," says Fabricant. "In contrast, with dietary supplements, there is no pre-market approval, and once a product is on the market, the burden is on the FDA to prove that a product is unsafe."

FDA's role in overseeing dietary supplements is laid out in a 1994 law and subsequent amendments. FDA's enforcement capabilities range from issuing warning letters seeking voluntary cooperation—the quickest way to get a product off the market—to bringing criminal charges. In recent years, FDA enforcement actions involving dietary supplements have included banning products, executing injunctions, working with U.S. marshals to seize products, and issuing safety alerts and consent decrees—which are agreements approved and enforced by a federal court.

In many cases, FDA has acted when dietary supplements were found to contain ingredients approved for use in prescription drugs. DMAA was approved in 1948 for use as a nasal decongestant, but the approval was withdrawn in 1983.

The products cited in the warning letter to USPLabs are Oxy Elite Pro and Jack3D. These products claim, among other things, to be fat-burning and performance-enhancing supplements, respectively. While action in that case in pending, FDA is following up to ensure that other companies which promised to cease using DMAA as an ingredient in their dietary supplements are actually doing so. FDA is also looking to see if there are other dietary supplement products containing DMAA in the marketplace, and will continue to act to ensure that such products, when identified, are no longer distributed and available for sale to consumers.

Consumers are urged to report any problems associated with supplement use to the company or the agency, and to always consult with their health care professional before using a supplement.

FDA Recalls 'Sunchang Ssamjang' Product Containing Undeclared Peanuts

Fda (Photo credit: Wikipedia)

Daesang America Inc. is recalling  packages of sesame- and garlic-flavored mixed soy bean paste because they may contain undeclared peanuts, according to the U.S. Food and Drug Administration.

People who are allergic to peanuts run the risk of a serious or life-threatening allergic reaction if they consume these products, according to the FDA. The packages were sold in stores nationwide, and online.

No injury or illness has yet been reported.

"The product comes in a 500 gram (17.64 ounce), Sage Green plastic package marked with Sunchang Ssamjang (Sesame & Garlic Seasoned Bean Paste) on the top & front of the package," the alert said. "All dates of expiration fall under this recall coverage for this particular item. It is a product of Korea and was distributed from June 2012 through February 2013. UPC for the product is 880152435671."

http://www.latimes.com/health/boostershots/la-heb-allergy-alert-20130320,0,4627875.story

FDA Issues Insulin Pump Recall

English: Logo of the U.S. Food and Drug Administration (2006) (Photo credit: Wikipedia)

The FDA has issued a class I recall for the Animas 2020 insulin infusion pump due to false alarms that may trigger, cease device function, and cause serious adverse events.

All lots of the pump manufactured from March 1, 2012 to Nov. 30, 2012 may contain a malfunctioning component that can trigger a false alarm or warning, which requires the user to "complete the rewind, load, and prime sequence to clear this alarm," according to the agency.

Patients who do not disconnect the pump from their body before undertaking these steps risk an unintended delivery of insulin, which can lead to hypoglycemia or other serious adverse events and death, the FDA stated.

The false warnings indicate "loss of prime," "occlusion," or "no cartridge detected" and may require the user to rewind the motor, load the cartridge, and prime the infusion set to clear the alarm.

http://www.medpagetoday.com/PublicHealthPolicy/FDAGeneral/38293

FDA Warning: 'Ninja Mojo,' 'Love Rider' Contain Hidden Drugs

News from the FDA on an enhancement supplement:

The Food and Drug Administration (FDA) is advising consumers not to purchase or use “Love Rider,” a product promoted and sold for sexual enhancement on various websites, and in some retail stores.

FDA laboratory analysis confirmed that “Love Rider” contains tadalafil, the active ingredient in the FDA approved prescription drug Cialis, used to treat erectile dysfunction (ED).  This undeclared ingredient may interact with nitrates, which are found in some prescription drugs, such as nitroglycerin.  This interaction may lower blood pressure to dangerous levels.  Men with diabetes, high blood pressure, high cholesterol, or heart disease often take prescription drugs that contain nitrates. 

Consumers should stop using this product immediately and throw it away.  Consumers who have experienced any negative side effects should consult a health care professional as soon as possible. 

Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

http://www.fda.gov/Drugs/ResourcesForYou/Consumers/BuyingUsingMedicineSafely/MedicationHealthFraud/ucm346326.htm

FDA: Food Recall of Farm Rich Products

The U.S. Food and Drug Administration is expanding a recall Friday after linking it to cases of E-coli.

The recall includes all Farm Rich products made at the company's Waycross, Ga., plant with “best by dates” ranging from Jan. 1, 2013 to Sept. 29, 2014, according to the FDA.

The Centers for Disease Control and Prevention said 10 patients with E-coli reported eating Farm Rich products.

Rich Products Corporation, a Buffalo, N.Y. firm, is expanding its recall of various heat treated, not fully cooked frozen mini meals and snack items to more than 10.5 million pounds because they may be contaminated with E. coli O121, the U.S. Department of Agriculture's Food Safety and Inspection Service (FSIS) announced today. The expanded recall covers all products produced at the company's Waycross, Ga. plant with "Best by" dates ranging from January 1, 2013 to September 29, 2014.

The following FSIS-regulated products are subject to the expanded recall:

Retail products--

• 21-oz. bags of Farm Rich mini bacon cheeseburgers, UPC code 0 41322 35622 2
• 1-lb. bags of Schwan's mini meatball sandwiches, UPC code 0 72180 55312 6
• 18-oz. bags of Farm Rich mini quesadillas, UPC code 0 41322 35611 6, case code 1 00 41322 35631 1
• 18-oz. bags of Farm Rich mini quesadillas, UPC code 0 41322 35635 2, case code 1 00 41322 35635 9
• 20-oz. bags of Farm Rich mini quesadillas, UPC code 0 41322 35611 6, case code 1 00 41322 35611 3
• 21-oz. bags of Farm Rich Philly Cheese Steaks, UPC code 0 41322 35618 5, case code 1 00 41322 35618 2

Foodservice products--

• 25-lb. cases containing 2.5-lb. foodservice paks of BBQ Chicken Sandwich Melt, UPC code 00041322653024, Product code 65302
• 25-lb. cases containing 2.5-lb. foodservice paks of Meatball Marinara Sandwich Melt, UPC code 00041322653031, Product 65303
• 25-lb. cases containing 2.5-lb. foodservice paks of Farm Rich Whole Grain Rich Pepperoni Pizzata, UPC code 10041322652321, Product code 65232
• 27-lb. cases containing 3-lb. foodservice paks of Farm Rich Turkey Pizzata, UPC code 00041322652348, Product code 65234
• 24.75-lb. foodservice paks of Pepperoni Pizzata, UPC code 00041322652829 , Product code 65282
• 25.7-lb. cases of 2.57-lb. foodservice paks of Farm Rich Handheld Stuffed Pepperoni Pleezer, UPC code 10041322652925, Product code 65292.

http://www.fsis.usda.gov/News_&_Events/Recall_025_2013_Expanded/index.asp

Ad-Tech Medical Instrument Corporation Issues Global Recall of Macro Micro Subdural Electrodes

On December 18, 2012 Ad-Tech Medical Instrument Corporation initiated a recall of 115 Macro Micro Subdural Electrodes. There is a concern the microelectrodes are not flush with the silastic surface. As a result, there is the potential for abrasion of cortical brain tissue and the existence of fractured pieces remaining in the cortical tissue when the electrode is explanted, which may result in hemorrhage or damage to cortical fibers, leading to infarct or seizure activity.

Recalled Product(s) were manufactured from June 2006 to March 2012, and distributed from June 8, 2006 to March 14, 2012.

The following Macro Micro Subdural Electrodes have been recalled:

CATALOG NUMBERS	LOT NUMBER	BATCH NUMBER	QTY
QGC8A-SP10N-OOO	G608060002	0020161	1
QGC8D-SP10N-OOO	C704040001	0025418	1
QGC8A-SP10N-OOO	G704150001	0026119	1
QGC8A-SP10N-OOO	C703160006	0026358	2
EGE4A-SP10N-OOO	C702201001	0029304	1
QGC8A-SP10N-OOO	C805210003	0030815	1
QG36A-SP10N-000	C805210004	0030819	2
QG36A-SP10N-OOO	C802220003	0031061	1
QGC8A-SP10N-OOO	C802220005	0031035	1
EGE4A-SP10N-OOO	C802220006	0031104 0031094	2
EGE4A-SP10N-OOO	C801240003	0032308	2
EGE4A-SP10N-OOO	C800250002	0033276	1
EGE4A-SP10N-OOO	C800350004	0033277	1
EGE4A-SP10N-OOO	G805270001	0034692	1
QGC8B-SP10X-OOO	208140314	0038610	1
EGE4A-SP10X-OOO	208140314	0038520 0038521 0038522	3
QGC8A-SP10N-OOO	G903080003	0041526	1
QG36A-SP10N-OOO	5903080004	0041659	1
QS20A-SP10N-OOO	5905280003	0042295	1
QGC8C-SP10X-OOO	208140343	0043004	1
QGC8B-SP10X-OOO	208140344	0043076	1
EGD7A-MP12N-OOO	G903011001	0043905	1
EGD7A-MP12N-OOO	G900211002	0044215	1
QG18A-SP10N-OOO	C908221002	0044840	2
QG16A-SP10X-OOO	208140353	0044772	2
QG18A-SP10X-OOO	208140353	0044835	2
QGC8B-SP10X-OOO	208140354	0044932	1
QGC8A-SP10N-OOO	G015020002	0045573	1
QG20B-SP10N-OOO	019020	0045227	3
QG53A-SP10X-OOO	208140362	0046112	1
QG96A-SP10N-OOO	G012140002	0047160	1
QG66A-SP85N-OOO	G016240001	0047248	1
QG96A-SP10X-OOO	208140369	0047159	1
QGC8D-SP10N-OOO	G019150003	0048115	1
QG26A-SP10N-OOO	G017250004	0048221	1
QG36B-SP10N-OOO	G0172S0005	0048224	1
EG10A-SP10N-OOO	G017250006	0048181	1
QG96A-SP10X-OOO	208140374	0047724	1
EG34B-SP10X-OOO	208140381	0048753	1
QG20E-SP10X-OOO	208140382	0048898	1
QG20D-SP10X-200	208140382	0048899	1
QGC8E-SP10X-OOO	208140382	0048901	1
QG36A-SP10N-OOO	C010180001	0050030	2
QG36A-SP10X-OOO	208140387	0050031	2
QG17A-SP10X-OOO	208140390	0050218	1
QG18A-SP10X-OOO	208140395	0051090	2
QG20F-SP10X-OOO	208140398	0051181	1
QG10B-SP10X-OOO	208140398	0051442	1
QG18A-SP10N-OOO	G012111001	0051906	1
QG18A-SP10N-OOO	G018011001	0051663	1
QG10C-SP10N-OOO	G018011003	0051667	2
QG10D-SP10N-OOO	G018011002	0051675	2
QG11A-SP10X-OOO	208140399	0051598	2
QG10C-SP10N-OOO	G019021002	0052519	2
QG10D-SP10N-OOO	G019021003	0052260	2
QGC8B-SP10X-OOO	208140356R	0044932	1
QGC6A-SP07N-OOO	G119020004	0053503	1
QG20B-SP10X-OOO	208140357R	0045319	1
QG16A-SP10X-OOO	208140414	0054443	3
QG16A-SP10X-OOO	208140417	0055275	1
QGC8F-SP10X-OOO	208140421	0055934	1
QG36A-SP10N-OOO	G114160002	0056510	1
QG10C-SP10N-OOO	G114160001	0056441	1
QG36A-SP10N-OOO	G115170004	0057159	1
QG20C-SP10N-OOO	G112270004	0057110	2
QG96C-SP10X-OOO	208140431	0057422	1
QS40B-SP10X-OOO	208140431	0057284	1
QG36A-SP10N-OOO	G115080002	0057839	1
QG24A-SP10N-OOO	G115280005	0058246	2
QG20B-SP10X-OOO	208140357R	0045319	1
QG20B-SP10X-OOO	208140357R	0045319	1
QG20C-SP10X-OOO	208140443	0059392	1
QGC8A-SP10X-OOO	208140443	0059234	1
QG18A-SP10X-OOO	208140443	0059248	1
QG11A-SP10X-OOO	208140445	0059777	1
QG32A-SP10X-OOO	208140450	0060750	1
QG32B-SP10X-OOO	208140450	0060751	2
QG96C-SP10X-OOO	208140450	0060500	1
QG96D-SP10X-OOO	208140450	0060740	2
QG16A-SP10X-OOO	208140452	0060830 0060878	2
QG18A-SP10X-OOO	208140452	0060879	2
QG88A-SP10X-OOO	208140452R	0060885	1
QG44A-SP10X-OOO	208140453	0061307	2
QG69A-SP10N-OOO	G211220001	0062673	1
QG36A-SP10X-OOO	208140450	0059620	2
QG36A-SP10X-OOO	208140458	0061050	1

Product(s) can be identified by the label provided on the packaging.

Ad-Tech Medical Instrument Corporation voluntarily recalled the Macro Micro Subdural Electrodes after becoming aware of potential harm to the patient. Ad-Tech Medical Instrument Corporation has notified the FDA of this action.

There has been one reported serious injury that may have been related to the use of the device.

http://www.fda.gov/Safety/Recalls/ucm341680.htm

Pallimed Solutions, Inc. Nationwide Recall of All Sterile Compounded Products

Pallimed Solutions, Inc. of Woburn, MA, doing business as Pallimed Pharmacy, is voluntarily recalling all sterile compound products dispensed since January 1, 2013 to the user level.

The recall resulted from a recent inspection conducted by the U.S. Food and Drug Administration and the Massachusetts Board of Registration in Pharmacy where visible particulates (filaments) were observed in vials of sterile compounded products: TRIMIX, BIMIX (Lot 02252013@3), ALPROSTADIL, DMSO 50 PERCENT – IRRIGATION (Lot 03122013@19), and BACTERIOSTATIC WATER FOR INJECTION (Lot 01072013@28). The potential public health risks are unknown as the particulate matter has not yet been identified.  However, particulate matter has the potential to damage or obstruct blood vessels, which could induce emboli, cause systemic allergic reaction, or cause tissue responses to the foreign material.

At this time a total of 5 affected vials were discovered.  To date, no injuries or illnesses have been reported.  In an abundance of caution, the pharmacy included all sterile compounded products dispensed since January 1, 2013, in the voluntary recall.  The company took the precautionary recall measure to ensure patient safety.

The products are used for a wide range of therapeutic uses, including for treatment of erectile dysfunction, testosterone replacement therapy, vitamin injections, and ophthalmic preparations. All products are packaged in glass vials. All products were distributed to patients and/or physicians’ offices through Friday, March 22, 2013, from Woburn, Massachusetts.

The recall applies to the following sterile compound products dispensed since January 1, 2013, including all strengths, all dose forms, and all products within expiry date:

ACETYLCYSTEINE OPHTHALMIC SOLUTION
ALPROSTADIL IN NS INJECTION
ATROPINE INJECTION
BACTERIOSTATIC WATER FOR INJECTION BIMIX INJECTION
BUPRENORPHINE HCL, VETERINARY INJECTION
CIDOFOVIR OPH SOLUTION
CYCLOSPORINE OPHTHALMIC
DIAZEPAM INJECTIBLE
DEXAMETHASONE PF
DMSO AQUEOUS IRRIGATION 50%
GENTAMICIN SULFATE IRRIGATION
HCG CHORIONIC GONADOTROPIN
HYDROXYPROGESTERONE CAPR. (G.S.)
METHYLCOBALAMIN - PF
MIC WITH B6 & B12
NANDROLONE DECANOATE INJECTIBLE
QUADMIX INJECTION
TACROLIMUS OPHTHALMIC
TESTOSTERONE CYPIONATE/TESTOSTERONE ENANTHATE INJECTION
TESTOSTERONE CYPIONATE/PROPIONATE INJECTION
TESTOSTERONE CYPIONATE INJECTION
TRIMIX INJECTION
VANCOMYCIN OPTHALMIC P.F.
VERAPAMIL INJECTION

Products were distributed directly to patients and/or physicians’ offices located in some or all of the following states: California, Connecticut, Florida, Georgia, Illinois, Louisiana, Maine, Maryland, Massachusetts, Michigan, Nevada, New Hampshire, New Jersey, New York, Pennsylvania, Rhode Island, Tennessee, Texas, Vermont, Virginia, and Wisconsin.

http://www.fda.gov/Safety/Recalls/ucm345468.htm