FDA Panel: Little Use for Metal on Metal Hips

Government health experts said Thursday there are few reasons to continue using metal-on-metal hip implants, amid growing evidence that the devices can break down early and expose patients to dangerous metallic particles.

The Food and Drug Administration asked its 18-member panel to recommend guidelines for monitoring more than a half-million U.S. patients with metal hip replacements. The devices were originally marketed as a longer-lasting alternative to older ceramic and plastic models. But recent data from the U.K. and other foreign countries suggests they are more likely to deteriorate, exposing patients to higher levels of cobalt, chromium and other metals.

http://finance.yahoo.com/news/fda-panel-sees-little-metal-225602426.html

Recent Food Recalls

News to report on several food recalls this month:

California Firm Recalls Raw Stuffed Chicken Product Due To Misbranding and Undeclared Allergens:
This one regarding chicken. The product subject to recall is: 

• Approx. 1-lb. trays of "TRADER JOE'S CRANBERRY APPLE STUFFED CHICKEN BREAST," with a Use By date of 06/13/12 through 06/23/12 located on a sticker in the top right corner of the package.

The product subject to recall bears the establishment number "P-22018" inside the USDA mark of inspection. The product was packaged between June 1, 2012, and June 11, 2012, and was distributed to retail establishments in Arizona, California, Nevada, New Mexico, Oregon and Washington.

The problem was discovered by FSIS personnel during a label review and may have occurred as a result of a change in an ingredient used in the product. FSIS and the company have not received reports of adverse reactions due to consumption of this product. MSG is not classified as an allergen, but can cause a brief reaction in people with a sensitivity to MSG. Anyone concerned about a reaction should contact a healthcare provider. 

Illinois Firm Recalls Meat Lasagna Products Due to Misbranding and Undeclared Allergens

The products subject to recall are:

• Retail cartons of “Safeway Select Five Cheese Lasagna” with a package code of April 4, 2013.
• Shipping cases of “Safeway Select Meat Lasagna” with a Best By date of April 4, 2013.

The products subject to recall were produced on April 4, 2012, and were shipped to retail establishments in Alaska, California, Delaware, the District of Columbia, Hawaii, Idaho, Maryland, Montana, Nevada, Oregon, Texas, Washington, and Virginia.

The problem was discovered when the company received two consumer complaints. The problem may have occurred as a result of the meat lasagna product being inadvertently packaged in a cheese lasagna carton. FSIS and the company have received no reports of adverse reactions associated with consumption of these products. Individuals concerned about a reaction should contact a healthcare provider.

Dole recalls some bagged salads

Dole Food Co.'s fresh vegetable unit has recalled more than 1,000 cases of bagged salads sold at Kroger and Walmart stores in six states because of the possibility of listeria contamination.

The bagged salads included in the recall are:

-- Kroger Fresh Selections Greener Supreme coded N158 211B 1613 KR04 with a use-by date of June 19 and UPC 11110 91039

-- Kroger Fresh Selections Leafy Romaine coded N158 111B KR11 with a use-by date of June 19 and UPC 11110 91046

-- Wal-Mart Marketside Leafy Romaine coded N158111B with a use-by date of June 19 and UPC code 81131 02781

http://www.aikenstandard.com/story/m1028-BC-US-Dole-Recall-06-26-0658

Covidien Recall Duet TRS units

The U.S. Food and Drug Administration said the company had received numerous complaints related to the use of the product since May 2009.

Covidien, however, did not initiate a corrective and preventative action until later in January of 2012. It was that month when an  FDA inspection team sought to review data related to the complaints, the regulator said in a warning letter.

http://www.chicagotribune.com/health/sns-rt-us-covidienbre85p1a0-20120626,0,2286860.story

Here's the letter from June 14:

• orcement, and Criminal Investigations
 
• Enforcement Actions
 
• Warning Letters

Enforcement Actions

• Warning Letters
• 2012

-

Covidien LP 6/14/12

Department of Health and Human Services	Public Health Service Food and Drug Administration
	New England District One Montvale Avenue Stoneham, Massachusetts 02180 Phone: (781) 587-7500 FAX: (781) 587-7556

WARNING LETTER
CMS#282277

VIA UPS

June 14, 2012
 

Mr. Jose E. Almeida
President and CEO
Covidien, Inc.
15 Hampshire Street
Mansfield, Massachusetts 02048 

Dear Mr. Almeida,

During an inspection of Covidien, LP, located in North Haven, Connecticut, on January 13, 2012, through February 09, 2012, investigators from the United States Food and Drug Administration (FDA) determined that your firm manufactures surgical staples and single-use loading units, such as the DUET Tissue Reinforcement System (TRS) Reload (Staple, Implantable). Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or any function of the body.

This inspection revealed that these devices are adulterated within the meaning of section 501 (h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820.

We received a response from Mr. Garrett B. Raymond, Vice President Global Quality Assurance and Regulatory, dated February 24, 2012, concerning our investigators' observations noted on the Form FDA 483 (FDA 483) List of inspectional Observations that was issued to your firm. We address this response below, in relation to each of the noted violations. These violations include, but are not limited to, the following:
 

1. Failure to implement your firm's procedures for implementing corrective and preventive actions, as required by 21 CFR 820.100(a). Specifically, your firm failed to initiate a corrective and preventative action (CAPA) after the review of quality data based on trend, criticality, recurrence, and correlation obtained from complaints and adverse events to ensure the proper course of action would be undertaken as described in your firm's procedure, (b)(4). Despite receiving numerous complaint, adverse event, and serious adverse event information since May of 2009 regarding use of the DUET TRS, a CAPA investigation was not initiated until January 19, 2012 and after the FDA inspection team requested to review the CAPA file related to these complaints and adverse events.
 

The response dated February 24, 2012, is not adequate.

Here's the letter from earlier in the year:

January 16, 2012 -Covidien (NYSE: COV), a leading global provider of healthcare products, today announced that it is conducting a voluntary recall of all production lots for the Duet TRS Universal Straight and Articulating Single Use Loading Units, with respect to the use of this product family in the thoracic cavity.

“After receiving reports connecting the use of the Duet TRS with patient deaths after thoracic surgery, we have made the decision that the product should not be used in such procedures,” said Bryan Hanson, Group President, Surgical Solutions, Covidien. “Accordingly, we are advising our customers that the Duet TRS should not be used in thoracic surgery.”

Covidien has received reports of 13 serious injuries and three fatalities, following the application of Duet TRS in the thoracic cavity. The Company has concluded that Duet TRS has the potential to injure adjacent anatomical structures within the thorax, which may result in life-threatening, post-operative complications.

The affected product codes and descriptions are as follows:

DUET4535
DUET4535A
DUET4548
DUET4548A
DUET6035
DUET6035A
DUET6048
DUET6048A

DUET TRS 45 3.5MM STRAIGHT SULU
DUET TRS 45 3.5MM ARTICULATING SULU
DUET TRS 45 4.8MM STRAIGHT SULU
DUET TRS 45 4.8MM ARTICULATING SULU
DUET TRS 60 3.5MM STRAIGHT SULU
DUET TRS 60 3.5MM ARTICULATING SULU
DUET TRS 60 4.8MM STRAIGHT SULU
DUET TRS 60 4.8MM ARTICULATING SULU

Covidien is working with the United States Food and Drug Administration (FDA) and other worldwide regulatory authorities to modify instructions for use to contraindicate the device in thoracic procedures in both adult and pediatric populations. Further, the Company placed a hold on its Duet TRS inventory globally to allow for the relabeling with new instructions for use.  Additionally, it is providing information to its customers on alternative tissue reinforcement products that may be used in conjunction with Covidien endoscopic staplers for thoracic surgery.

“These steps are consistent with our belief that patient safety is a commitment that cannot be compromised,” said Hanson.  “Patient safety is our first obligation.”

Launched in 2009, the Duet TRS is a single-use loading unit with a fully integrated tissue reinforcement system to support staple lines in tissues. To date, the Company has sold more than 500,000 units worldwide. Covidien believes approximately one-third of global procedures using Duet TRS are for thoracic indications.  The Duet TRS will continue to be used for other indications, including abdominal procedures. 

FDA: Amylin Pharma Concealed Heart Safety Risks of Key Diabetes Drug

Amylin Pharmaceuticals concealed a study from the U.S. Food and Drug Administration that raised heart safety concerns about its diabetes drug Byetta and then hindered FDA access to the data when the agency discovered its existence according to a recent report.


The review and approval of Bydureon was a "long and complicated process, in part due to Amylin's withholding of information on Byetta that FDA deemed to be important to its evaluation of the safety and effectiveness of Bydureon," according to a memo written by Mary Parks, division director of the FDA responsible for the review and oversight of diabetes drugs. Parks wrote the memo in January 2012 after Bydureon was approved 


Source:  http://www.thestreet.com/story/11595037/1/fda-amylin-pharma-concealed-heart-safety-risks-of-key-diabetes-drug.html?puc=yahoo&cm_ven=YAHOO

Digestive 3 in 1 Health Liquid Dietary Supplement: Recall

News on another dietary supplement recall from the FDA.

Botanical Laboratories Inc. and FDA notified consumers and healthcare professionals of a recall of Wellesse Digestive 3 in 1 Health liquid dietary supplement. A supplier of one of the ingredients indicated the ingredient 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 (which may be bloody), 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.

BACKGROUND: Product lots affected by this recall include: 16 oz. size with "LOT 34441C (followed by a four digit time code) A EXP 03/2014" jet coded on the bottom of the bottle. 33.8 oz. size has "LOT 34552C (followed by a four digit time code) A EXP 03/2014" jet coded on the bottom of the bottle.

Both 33.8 oz. and 16 oz "Digestive 3 in 1 Health" were distributed nationwide through retail stores, and online retailers. The product was distributed after 05/01/2012.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm307260.htm

Dietary Supplement Reumofan Plus May Contain Harmful Drugs

The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product. 

The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning). 

An FDA laboratory analysis of Reumofan Plus found that it contains:

• diclofenac sodium – a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines. 
• methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.   

These ingredients also may interact with other medications and result in serious adverse events.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm306348.htm

FDA issues warning about counterfeit Adderall purchased online

The U.S. Food and Drug Administration has issued a warning about counterfeit generic Adderall tablets being sold on the Internet. Adderall is approved by the FDA to treat attention-deficit hyperactivity disorder and narcolepsy.

The FDA became aware of the problem when Teva Pharmaceutical Industries reported that a consumer alerted them about purchasing a fake version of Teva's Adderall 30-milligram tablets from an illegal Internet pharmaceutical site.

http://www.ketknbc.com/news/fda-issues-warning-about-counterfeit-adderall-purchased-online-0

Risk for Sulfonylureas Use with Diabetes Meds

Three diabetes  drugs are associated with a greater risk of death when compared to a drug from a different class, metformin, according to a recently published study.

Researchers analyzed data from nearly 24,000 patients with type 2 diabetes, average age 62, who were treated with one of three drugs called sulfonylureas (glipizide, glyburide, and glimepiride) or with another type of drug called metformin.

Sulfonylureas help decrease blood sugar levels by stimulating the pancreas to produce insulin. Metformin also helps reduce blood sugar levels.

Overall, all three sulfonylureas were associated with a more than 50 percent greater risk of death compared to metformin, according to the study, which was funded by drug company Astra Zeneca.

The researchers also found that, among diabetes patients with heart disease, glipizide was associated with a 41 percent greater risk of death and glyburide was associated with a 38 percent greater risk of death, compared with glimepiride and metformin.

According to one expert not connected to the study, the new data could provide some guidance for patients.

"Patients taking sulfonylureas should be made aware of this increased risk of death and other oral options for glycemic [blood sugar] control should be discussed," said Dr. Spyros Mezitis, an endocrinologist. 

Read more here. http://news.yahoo.com/metformin-outperforms-common-class-diabetes-drugs-study-160405357.html

DMAA/Oxyelite Pro Wrongful Death Lawsuit Filed in PA

Our office, with local counsel Steve Wigrizer from Philadephia, PA filed a civil action this week. The complaint is below. The life of a young lady was taken from her because (it's alleged) of the use of DMAA in  a dietary supplement. The product is Oxyelite Pro. Read more about DMAA below the Complaint. 


If you have questions about this lawsuit, reach us at 404-451-7781 or email me at mark(at)markzamora.com

DMAA WRONGFUL DEATH COMPLAINT OXYELITE PRO

View more documents from mzamoralaw

From the FDA:

Before marketing products containing DMAA, manufacturers and distributors have a responsibility under the law to provide evidence of the safety of their products. They haven’t done that and that makes the products adulterated," said Daniel Fabricant, Ph.D., Director of FDA’s Dietary Supplement Program. 

Specifically, the warning letters cite the companies for marketing products for which a notification had not been submitted for the use of DMAA as a New Dietary Ingredient (NDI). Under current law, dietary supplement manufacturers or distributors who use certain dietary ingredients not marketed in a dietary supplement prior to October 15, 1994, are responsible for notifying the FDA of evidence to support their conclusion that their dietary supplements containing NDIs are safe. Manufacturers or distributors must submit notification at least 75 days before marketing their products. The companies warned today were marketing products for which this requirement had not been met.

The FDA warning letters also advised the companies that the agency is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible for ensuring that they are marketing a safe product.

The FDA letters noted that DMAA is known to narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest to heart attack. The agency has received 42 adverse event reports on products containing DMAA. While the complaints do not establish that DMAA was the cause of the incidents, some of the reports have included cardiac disorders, nervous system disorders, psychiatric disorders, and death.

Pfizer Paid $896 Million In Prempro Settlements

Pfizer has now settled about 6,000 lawsuits that claim Prempro and other hormone-replacement drugs caused breast cancer, and it has set aside an additional $330 million to resolve the remaining 4,000 suits, according to a filing with the U.S. Securities and Exchange Commission.


More here. http://www.bloomberg.com/news/2012-06-19/pfizer-paid-896-million-in-prempro-accords-filing-shows-1-.html

Gfanuflo and NaturaLyte News

There is news about metabolic alkalosis with Fresenius Medical Care’s GranuFlo and NaturaLyte dialysis products , which can lead to heart problems and other potentially fatal complications. According to the New York Times, the company acknowledged the dangers in an internal memo last year, but failed to disclose the information to the FDA, its consumers or the public. [nytimes.com/2012/06/15/health/fda-investigates-fresenius-for-failure-to-warn-of-risk.html?emc=tnt&tntemail0=y]

Dialysis is a procedure that replaces the function of the kidneys by filtering toxic waste products out of the blood; a number of different solutes are used to maintain a healthy balance. One of these substances is bicarbonate, an alkaline chemical used to neutralize any excess acidity in the blood. According to the New York Times, the issue with GranuFlo and NaturaLyte is that they produce more bicarbonate than their competitors, which may lead to excessively high alkaline levels, or metabolic alkalosis. Metabolic alkalosis can increase the risk of serious complications, such as: 

•     Sudden Cardiac Arrest
•     Sudden Heart Attack
•     Hemodialysis cardiac arrest
•     Hemodialysis cardiopulmonary arrest
•     Stroke
•     Death
•     Arrhythmia
•     Altered mental status (confusion)
•     Low blood pressure

[medicinenet.com/hemodialysis/article.htm]

Fresenius Medical Care addressed these risks in an internal memo dated November 4, 2011, but did not warn its consumers or the public  about the issue until March, after it was questioned by the FDA. The memo stated that 941 patients experienced cardiac arrest in Fresenius clinics in 2010, and found that that elevated bicarbonate levels resulted in a six fold increased risk of cardiac arrest. “In light of these troubling findings” doctors should adjust blood alkalinity accordingly, the memo said.

http://www.prweb.com/releases/2012/6/prweb9611143.htm

Vicodin-Type Pain Pills May Face Stricter U.S. Regulation

Vicodin and other hydrocodone- combination painkillers may face tighter U.S. oversight following repeated reports of misuse and addiction that have been cited by the Drug Enforcement Administration.

Advisers to the Food and Drug Administration, which regulates pharmaceutical sales, will meet in October to discuss the risks and benefits of hydrocodone preparations used as pain relievers or cough suppressants.

http://www.bloomberg.com/news/2012-06-07/vicodin-type-pain-pills-may-face-stricter-u-s-regulation.html

Use of Pradaxa/Dabigatran Leads To Increased Complications

In 2011 the FDA received more safety reports about dabigatran than any other drug. The data notes that since the bleeding complications of dabigatran are well known and physicians are more likely to report adverse events associated with new drugs, there may be more safety reports. 


 Dabigatran was the subject of  3,781 serious adverse events reported to the FDA in 2011. This included 542 patient deaths and 2,367 hemorrhages. Warfarin  was the subject of  1,106 serious adverse events, including 72 deaths.


Read more here: http://www.forbes.com/sites/larryhusten/2012/06/07/dashboard-store-posts-all-posts-add-new-categories-tags-copy-a-post-media-links-pages-comments-feedbacks-polls-ratings-appearance-users-tools-settings-collapse-menu-help-screen-options-ed/

Smith & Nephew Recalls Hip Device Component

Smith & Nephew is voluntarily taking the metal liner component of its R3 Acetabular System off the market. The company claimed that it was “not satisfied with the clinical results” of the liner, with one spokeswoman reportedly stating that an uptick in revisionary surgeries prompted the recall. 

According to reports, approximately 7700 of the liners were implanted in patients since their introduction into the marketplace. It has been reported that the liner was associated with infections, performance issues and fractures, among other problems. According to a company spokeswoman, metallosis, a type of poisoning linked to metal-on-metal implants, was not among the issues that necessitated the recall. 

Over the past several years, a number of metal-on-metal hip implants, including the recalled DePuy ASR devices, have been linked to metal poisoning and premature failure. A recent study from the National Joint Registry of England and Wales revealed that 6% of patients implanted with metal-on-metal hip implants required further surgery to replace or repair the devices after five years, compared with 1.7 to 2.3% of those implanted with a plastic or ceramic device. It has also been reported that patients implanted with metal-on-metal hips have shown high levels of metal ions in their bloodstream, which are released when the metal components move against each other. Excessive levels of cobalt have been linked to a number of health problems, while muscles and soft tissue damaged by the body’s inflammatory response to the metallic debris may compromise revision surgery.  

http://www.cbsnews.com/8301-505245_162-57445552/smith-nephew-recalls-hip-device-component/

June 2012 Mesh Recall News: Ethicon Mesh Recalled

Johnson & Johnson's subsidiary and pelvic mesh manufacturer, Ethicon, Inc., informed the FDA yesterday that it is recalling four of its Pelvic Floor Repair Systems and is asking for 120 days to “cease commercialization” of its products, notify customers and allow physicians and hospitals time to choose different treatments for patients. Ethicon plans to discontinue or change its marketing materials as needed and revise product labeling limiting the use of certain products to abdominal procedures.

Here is the letter from the company's reps:

Ethicon has advised FDA that it will stop commercializing the GYNECARE TVT SECUR™ system, GYNECARE PROSIMA™ Pelvic Floor Repair System, GYNECARE PROLIFT™ Pelvic Floor Repair System, and
GYNECARE PROLIFT+M™ Pelvic Floor Repair System in the United States.
 
Ethicon has no present intention to commercialize these products in the future, but it has
requested that FDA allow it 120 days to cease commercialization. This time period would
permit Ethicon to notify its customers, and provide those hospitals and surgeons with sufficient
time to select alternative treatment options for their patients. Ethicon will also discontinue or
revise, as appropriate, all marketing materials during this time. 

Ethicon will continue to report
adverse events and provide medical communications for these products, consistent with
applicable regulations; however, Ethicon has requested that FDA’s Office of Surveillance and
Biometrics place the existing 522 orders requiring additional studies for these products on hold.
Ethicon is awaiting written confirmation of that plan.

Ethicon also plans to update the product labeling for GYNECARE GYNEMESH® PS,
including the Indication for Use, to restrict the indication for use to the abdominal
sacrocolpopexy procedure for the treatment of pelvic organ prolapse. In order to allow
customers continued access to this product for patient treatment, Ethicon has requested that it be
allowed to continue the sale of GYNECARE GYNEMESH® PS using the current Instructions
for Use until FDA responds to this proposed plan.

See also:

 http://www.reuters.com/article/2012/06/05/us-jj-mesh-idUSBRE85410Q20120605

Reumofan Plus Recall and Health Alert

The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).

An FDA laboratory analysis of Reumofan Plus found that it contains:

diclofenac sodium - a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines.

methocarbamol - a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.


http://www.infozine.com/news/stories/op/storiesView/sid/52022/
 

FDA Issues Class I Recall on Other-Sonic Ultrasound Gel

A Class I Recall was issued due to possible microbial contamination that included organisms such as Pseudomonas aeruginosa and Klebsiella oxytoca. Although this product is not labeled as either sterile or non-sterile, it is NOT sterile. The use of Other-Sonic Generic Ultrasound Transmission Gel may cause serious adverse health consequences, including death.

Customers are instructed to STOP using Other-Sonic Generic Ultrasound Transmission Gel from lot numbers 060111, 080111, 090111, 100811, and 120111. Although lot 120111 was not voluntarily recalled by the firm, it has been added to the STOP using list because FDA testing revealed that this lot also containedPseudomonas aeruginosa and Klebsiella oxytoca.

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm300873.htm

FDA: Health Warning against Using Teething Gels for Infants and Children

In a recent release the Food and Drug Administration issued a warning regarding potential health risks associated with the use of many brand name teething gels like Anbesol, Hurricaine, Orajel, Baby Orajel, and Orabase. The advisory, short of a product recall, is over concerns with the ingredient benzocaine used in the oral pain gels. Children under 2 years old appear to be at particular risk says the FDA.

Benzocaine is a local anesthetic found in the over-the-counter products like those previously listed in the gel and liquid pain relievers.

http://thechart.blogs.cnn.com/2012/06/01/fda-warns-about-benzocaine-in-baby-pain-gels/

http://newstaar.com/fda-issues-severe-health-warning-against-using-teething-gels-for-infants-and-children/355877/

FDA Issues Warning About Counterfeit Adderall

The FDA has issued a warning about counterfeit generic Adderall tablets being sold on the web. Adderall is approved by the FDA to treat attention-deficit hyperactivity disorder and narcolepsy.

The FDA became aware of the problem when Teva Pharmaceutical Industries reported that a consumer alerted them about purchasing a fake version of Teva's Adderall 30-milligram tablets from an illegal Internet pharmaceutical site.

The bogus version was discovered "by a consumer, who noticed misspellings on on the fake product packaging," according to Denise Bradley, Teva Pharmacautical's vice president of corporate communications. Bradley said two incidents have been reported to the FDA, and Teva Pharmaceuticals continues to work with the FDA on the investigation.


http://www.krdo.com/health/31134307/detail.html

June 2012 Mesh News: FDA Didn’t Approve Vaginal Mesh Products?

It's being reported that  vidence has surfaced that indicates that device manufacturer Johnson & Johnson did not have Food and Drug Administration approval for the transvaginal mesh product they were selling for three years.

men have already been wounded by vaginal mesh devices that have caused serious complications for them. According to a report by Bloomberg.com, the device manufacturer began selling the Gynecare Prolift vaginal mesh device in March of 2005, which was 3 years  before the device was approved by theFDA. Between the time it was released on the market until it was approved, the FDA received 123 reports of complications associated with the Gynecare Prolift device.




Vaginal mesh devices are ways of treating stress urinary incontinence and pelvic organ prolapse, which are both conditions dealing with the weakening of pelvic organs. Complications associated with the devices, however, can cause even further problems, including recurrence of the original problems, urinary tract infections, and mesh erosion. Hundreds of women—more than 550—have filed lawsuits after suffering from transvaginal mesh complications. They are hoping to gain compensation that would help cover medical bills they have incurred due to their side effects.

The Food and Drug Administration reported a fivefold increase in complications associated with vaginal mesh devices, including deaths and malfunctions, in July of 2011. This decision resulted in an advisory panel for the organization recommending that such devices should be reclassified as “high risk” devices that are in need of human testing before it can be determined whether or not they are safe.
FDA process questioned.

Read more here:  http://www.fda.gov/downloads/MedicalDevices/Safety/AlertsandNotices/UCM262760.pdf