New York City Personal Injury Lawyer - FDA & Prescription Drugs

FDA - New Seasonal Flu Vaccine Approved

Chrissie Cole — Fri, 27 Nov 2009 22:32:00 GMT

Agriflu, a new seasonal flu vaccine by Novartis’, was approved for sale by the U.S. Food and Drug Administration (FDA) on Friday. Agriflu is not intended to fight the H1-N1 virus, also known as swine flu.

The vaccine, approved to prevent influenza subtypes A and B in people 18 or older, is administered as a single injection in the upper arm. The agency used an accelerated approval process but the company is required to conduct more tests to show Agriflu's effectiveness.

Common side effects of Agriflu found during clinical trials include: headache, muscle aches, pain, swelling, redness at the injection site and tiredness.

Novartis is also the maker of Fluvirin, another licensed vaccine for seasonal influenza, which is approved for people 4 and older.

While no vaccine is 100 percent effective in preventing the flu, vaccination is the key to prevention, the FDA said.

Originally posted at InjuryBoard by Chrissie Cole

Brooklyn's BEST Smoked Nova Salmon Recalled Due to Potentially Deadly Bacterium

Paul Napoli — Sun, 22 Nov 2009 09:10:30 GMT

November 20, 2009

Service Smoked Fish Corp. of Brooklyn, NY, is recalling specific "Use-By" dates and lot codes of Brooklyn's BEST brand Smoked Nova Salmon because they have the potential to be contaminated with the organism Listeria monocytogenes.

The U.S. Food and Drug Administration (FDA) found Listeria monocytogenes in samplings of finished products, prompting this recall. Service Smoked Fish Corp. has ceased production and distribution of the product while the company and the FDA investigate the cause of the contamination. No illnesses have been reported to date.

Brooklyn’s BEST brand Smoked Nova Salmon was distributed in the greater New York area, New Jersey, Connecticut and the areas of Baltimore, MD, Los Angeles, CA, and Portland, OR. Consumers may have purchased the product from retail food stores.

The Smoked Nova Salmon was vacuum-packed in clear, plastic bags of various size packages including 3 oz., 4 oz., 8 oz., 12 oz., 16 oz. and random weight sides with the brand name "Brooklyn's BEST" appearing on a circular label inside the vacuum bag. A "Use-By" date appears on the bottom of the gold board. Units with "Use-By" dates of 12/03/09 through 12/19/09 are being recalled. The product was also air-packed in bulk boxes. Air-packed units with lot numbers 060 through 043 are being recalled. No other use-by dates or lots numbers are involved in this recall.

Listeriosis, a serious and sometimes fatal infection caused by eating food contaminated with the bacterium Listeria monocytogenes, is recognized as an important public health problem in the United States. People suffering from listeriosis may suffer gastrointestinal symptoms such as nausea, vomiting and diarrhea. The most serious manifestations of listeriosis include septicemia, meningitis (or meningoencephalitis), encephalitis, and intrauterine or cervical infections in pregnant women, which may result in spontaneous abortion or stillbirth. These disorders are usually preceded by influenza-like symptoms including persistent fever.

While healthy people may also be at risk, people most susceptible to the disease are children, frail or elderly people, pregnant women and people with immune systems weakened by corticosteroids, anticancer drugs, graft suppression therapy or AIDS.

L. monocytogenes has been associated with such foods as raw milk, supposedly pasteurized fluid milk, cheeses (particularly soft-ripened varieties), ice cream, raw vegetables, fermented raw-meat sausages, raw and cooked poultry, raw meats (all types) and raw and smoked fish. It is quite hardy and resists the deleterious effects of freezing, drying and heat and its ability to grow at temperatures as low as 3°C permits multiplication in refrigerated foods.

Listeriosis has an extremely variable incubation period. It can range from three to 70 days, but symptoms usually appear within a month. Specific laboratory tests are the only way to identify this disease. People who are experiencing symptoms and fear they may have contracted Listeriosis, especially those people most at risk, should contact their physician.

Consumers who have purchased the above "Use-By" dates or lot codes of Brooklyn's BEST brand Smoked Nova Salmon are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 718-388-4067, Monday - Friday, 7 am - 3 pm.

Originally posted at InjuryBoard by Paul Napoli

Food Allergies Increasing Dramatically in Children

Paul Napoli — Sun, 22 Nov 2009 09:01:39 GMT

November 18, 2009

In a new study by researchers of the National Center for Health Statistics, food allergies in U.S. children under age 18 years increased dramatically by 18 percent between 1997 and 2007.

"People are more aware of food allergies today, and that could have something to do with it," said study author, Amy Branum. "But, when we looked at health-care surveys filled out by parents and those from the health-care sector, we saw the increase across the surveys so this may be more than just increased awareness."

The authors of the study, Amy M. Branum, MSPH and Susan L. Lukacs, MSPH, DO are with the Centers for Disease Control and Prevention's National Center for Health Statistics, Office of Analysis and Epidemiology, Infant, Child, and Women's Health Statistics Branch. Results of the study were published online November 16 and will appear in the December print issue of Pediatrics.

The study defined food allergy as a potentially serious immune response to eating specific foods or food additives. Eight types of food accounted for over 90% of allergic reactions in affected individuals: milk, eggs, peanuts, tree nuts, fish, shellfish, soy and wheat. Reactions to these foods by an allergic person can range from a tingling sensation around the mouth and lips and hives to death, depending on the severity of the allergy.

Other notable study findings:

· Four of every 100 children have a food allergy. In 2007, an estimated 3 million children under age 18 years (3.9%) had a reported food allergy.

· Children with food allergy are more likely to have asthma or other allergic conditions. In 2007, 29% of children with food allergy also had reported asthma compared with 12% of children without food allergy.

· Recent data show hospitalizations with diagnoses related to food allergies have increased among children. From 2004 to 2006, there was an average of 9,537 hospital discharges per year with a diagnosis related to food allergy among children 0 to 17 years.

"People should be aware that food allergy may really be increasing," Branum said. "If small children have symptoms when they eat a particular food, have that child checked out, particularly if they have co-occurring conditions like asthma and eczema."

Because food allergies can range from merely irritating to life threatening, the U.S. Food and Drug Administration (FDA) works to ensure that major allergenic ingredients in food are accurately labeled. The FDA, in cooperation with food manufacturers, issues recall notices on its website at http://www.fda.gov/Safety/Recalls/default.htm when a food product is found to contain allergens undeclared on the label and needs to be recalled for public safety. There have been five food product recalls so far this month and eleven last month in October due to undeclared allergens.

When a product causes serious injury or death, it is important to contact a personal injury attorney who has experience in handling product liability cases. Products liability is the branch of law that deals with the liability of parties involved in the manufacturing of a product for any damages caused by the product. If you or a loved one suffered an allergic reaction due to milk, eggs, peanuts, tree nuts, fish, shellfish, soy or wheat as the result of undeclared allergens on the food product label, call Napoli Bern Ripka LLP today at 888-529-4669 to discuss your case and determine if you are entitled to compensation for your injuries or a loved one’s wrongful death.

Originally posted at InjuryBoard by Paul Napoli

FDA Issues Letters To Web Sites For Selling Unapproved and Misbranded Drugs

Chrissie Cole — Fri, 20 Nov 2009 20:20:00 GMT

On Thursday, the Food and Drug Administration (FDA) issued 22 warning letters to Web site operators regarding illegal sales of misbranded drugs and/or unapproved drugs.

The move ends a weeklong international effort aimed at curbing illegal actions regarding medical products, including sales. In total, the agency and its partners in the program targeted 136 Web sites that appeared to be engaged in the illegal selling of medical products.

The involved pharmacies were not located in Canada or the U.S.

According to the letters, the sites sold powerful controlled substances including Valium and Xanax and also Viagra. Some sites also offered prescription drugs that are not yet approved for distribution or sale in the U.S.

Many of the Web sites listed in the complaint, such as 24-7meds.com and Wellknowndrugs.com have already been taken offline, according to Karen Riley and FDA spokeswoman.

More information can be found on the FDA Web site.

Originally posted at InjuryBoard by Chrissie Cole

FDA Warns of Dangerous Drug Interactions for Clopidogrel (Plavix) Patients

Paul Napoli — Tue, 17 Nov 2009 16:56:50 GMT

November 17, 2009

The U.S. Food and Drug Administration (FDA) released a public health advisory today warning the public of the dangerous drug interaction between clopidogrel (marketed as Plavix) and omeprazole (marketed as Prilosec and Prilosec OTC).

Clopidogrel is an anti-clotting medication prescribed for patients at risk for heart attacks or strokes. It may also cause bleeding in the stomach and medications like omeprazole may be used in combination with clopidogrel to reduce the production of stomach acid and prevent stomach bleeding. The FDA has new data showing that omeprazole, when used in conjunction with clopidogrel, reduces the anti-blood clotting effects by blocking the conversion of clopidogrel into its active form.

The FDA warns patients using clopidogrel to consult with their healthcare provider if they are currently taking or considering taking omeprazole, including Prilosec OTC. Both clopidogrel and omeprazole can provide significant benefits to patients, and patients should always consult with their healthcare professional before starting or stopping any medication. It is very important that patients talk with their healthcare professional about any over-the-counter (OTC) drugs they are taking before starting or while using clopidogrel.

The FDA advised in the agency’s Drug Safety Information for Healthcare Professionals, “The concomitant use of omeprazole and clopidogrel should be avoided because of the effect on clopidogrel's active metabolite levels and anti-clotting activity.”

Patients who use clopidogrel and need a medication to reduce stomach acid can use antacids such as Maalox or Mylanta and most acid reducers, such as Zantac (ranitidine), Pepcid (famotidine), or Axid (nizatidine), because the FDA does not believe that these medicines will interfere with the anti-clotting activity of clopidogrel.

The FDA warned that these other drugs should also be avoided in combination with clopidogrel because they may have a similar interaction include: esomeprazole (Nexium), cimetidine (which is available by prescription Tagamet and OTC as Tagamet HB), fluconazole (Diflucan), ketoconazole (Nizoral), voriconazole (VFEND), etravirine (Intelence), felbamate (Felbatol), fluoxetine (Prozac, Serafem, Symbyax), fluvoxamine (Luvox), and ticlopidine (Ticlid).

If you or a loved one has suffered a dangerous drug interaction or harmful side effects of over-the-counter or prescription medication, contact Napoli Bern Ripka, LLP at 888-529-4669 to discuss your options for filing a claim and recovering compensation for your medical expenses, lost wages and pain and suffering.

Originally posted at InjuryBoard by Paul Napoli

Blue Bonnet Spread Recalled Due To An Undeclared Allergen

Chrissie Cole — Sun, 15 Nov 2009 12:41:00 GMT

ConAgra Foods, in conjunction with the FDA, announced a voluntary recall of certain 15 oz. tubs of Blue Bonnet Spread due to an undeclared allergen. The recalled product contains whey, which is not listed on the label.

People, who have an allergy or sensitivity to milk, run the risk of serious or life-threatening allergic reaction if the recalled product is consumed. To this date, there have been no reports of allergic reaction associated with the recall.

The recall affects 1,120 cases of a single lot and has product UPC 27000-00930 on the tub.

The rim of the lid will list the batch code 2247923200 and a "Sell By" date of March 18, 2010.

The company issued an alert through the Food Allergy & Anaphylaxis Network (FAAN) (www.foodallergy.org), in an effort to notify potentially affected consumers.

Consumers may return the recalled product to the place of purchase for a full refund. For more information, consumers can call 866-518-4177 or visit www.bluebonnet.com

Originally posted at InjuryBoard by Chrissie Cole

Overdoses Prompt FDA to Suggest Conformity of Dosage Delivery Devices in OTC Liquid Drug Products

Paul Napoli — Mon, 09 Nov 2009 14:10:50 GMT

November 9, 2009

The U.S. Food and Drug Administration (FDA) had released a Guidance for Industry regarding the dosage delivery devices included in the packaging of over-the-counter (OTC) liquid drug products.

The Guidance, intended for companies manufacturing, marketing or distributing OTC liquid drug products such as elixirs, suspensions, solutions and syrups recommends that markings on the included dosage delivery devices such as calibrated cups, droppers, syringes and spoons must not be false or misleading and must be clear and consistent with the drug product’s directions for use. The delivery device packaged with these drug products has calibrated units of measure marked on the device intended to facilitate proper product dose dispensing by the patient, parent or caregiver.

The FDA has received numerous reports of accidental overdose attributed, in part, to markings on measured dosage cups for OTC liquid drug products that were misleading or incompatible with the labeled dosage directions for use and has issued this Guidance because of ongoing safety concerns about the serious potential for accidental drug overdoses, especially in children.

The FDA considers any written, printed or graphic matter, including measurements on dosage delivery devices packaged with OTC liquid drug products to be labeling and therefore must conform to the Federal Food, Drug and Cosmetic Act. Products found to be in violation of the Act are considered misbranded and the FDA issues a Warning Letter to the manufacturer. Despite these efforts, through routine monitoring and surveillance programs, the FDA has become aware that an increasing number of liquid drug products have dosage delivery devices that are incompatible with labeled product dosage directions.

This Guidance for Industry does not establish legally enforceable responsibilities. Instead, Guidance documents describe the Agency's current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited.

If you or your child has suffered adverse effects or overdose of an over-the-counter (OTC) liquid drug because the dosage delivery device contained markings that were false, misleading or inconsistent with the drug product’s directions for use, please contact the attorneys of Napoli Bern Ripka Law Firm LLP at 1-888-529-4669.

Originally posted at InjuryBoard by Paul Napoli

FDA Warns Consumers about the Sexual Enhancement Dietary Supplement Stiff Nights

Paul Napoli — Sun, 08 Nov 2009 22:49:40 GMT

November 8, 2009

The U.S. Food and Drug Administration (FDA) is warning consumers that Stiff Nights, distributed by Impulsaria LLC of Grand Rapids, MI as a dietary supplement for male sexual enhancement, contains an illegal ingredient that can dangerously lower blood pressure.

The FDA determined, while investigating a consumer complaint, that Stiff Night contains sulfoaildenafil, which is a chemical similar to sildenafil, the active ingredient in Viagra. Sulfoaildenafil may cause dangerously low blood pressure by interacting with prescription drugs known as nitrates, including nitroglycerin.

"Because this product is labeled as an ‘all natural dietary supplement,’ consumers may assume it is harmless and poses no health risk," said Deborah M. Autor, director of FDA’s Center for Drug Evaluation and Research Office of Compliance. "In fact, this product is illegally marketed and can cause serious complications.”

The official website for Stiff Nights by Impulsaria LLC markets the product as a special blend of herbs, mushrooms and greens that is 100% natural and 100% safe. The sale of Stiff Nights is currently wide spread on the Internet and in retail stores. It is sold in bottles containing 6, 12 or 30 red capsules or in blister packs containing one or two capsules.

In February of 2009, The FDA released a Consumer Update warning the public about dietary supplements sold to treat erectile dysfunction. These supplements are often sold with labeling suggesting that they are all-natural alternatives to prescription drug products that have been approved by FDA for treating ED, leading consumers perceive these products as completely safe while they may be laced with potentially hazardous ingredients that aren't noted on the label.

The FDA found the following products sold online as "dietary supplements" for treating erectile dysfunction and enhancing sexual performance to contain potentially harmful, undeclared ingredients:

· Actra-Rx
· Actra-Sx
· Libidus
· Nasutra
· Neophase
· Vigor-25
· Yilishen
· Zimaxx
· 4EVERON
· Liviro3
· Lycium Barbarum L.
· Adam Free
· Rhino V Max
· V.Max
· True Man
· Energy Max
· HS Joy of Love
· NaturalUp
· Blue Steel
· Erextra
· Super Shangai
· Strong Testis
· Shangai Ultra
· Shangai Ultra X
· Lady Shangai
· Shangai Regular, also marketed as Shangai Chaojimengnan
· Hero
· Naturalë Super Plus
· Xiadafil VIP tablets (Lots 6K029 and 6K209-SEI only)

The FDA advises consumers who have experienced any adverse events from sexual enhancement products to consult a health care professional. Consumers and health care professionals should report adverse events to the FDA's MedWatch program at 800-FDA-1088 or online at www.fda.gov/medwatch/report.htm

If you or someone in your family has suffered adverse reactions resulting from the use of dietary supplement products, please contact the experienced attorneys here at Napoli Bern Ripka, LLP. You may be entitled for compensation for your injury, medical expenses or a loved one’s death. Our law firm has helped many people who have become victims of recalled medications. The consultation is free; just call 1-888-529-4669.

Originally posted at InjuryBoard by Paul Napoli

Certain Pet Carousel Treats Recalled

Chrissie Cole — Fri, 06 Nov 2009 18:37:00 GMT

The FDA is warning consumers not to feed their pets Pig Ears and Beef Hooves pet treats manufactured by Pet Carousel due to a possible Salmonella contamination.

The tainted pet products were distributed nationwide in bulk and retail packaging for sale in pet food and retail stores.

To this date there have been no reports of illness associated with the recalled pet treats, but the agency is advising consumers to not handle or feed these treats to their pets.

The recalled pig ear treats were packaged under the brand names Doggie Delight and Pet Carousel. And the recalled beef hooves treats were sold under the brand names Choo Hooves, Dentley’s, Doggie Delight, and Pet Carousel. All sizes and all lots of these products made by Pet Carousel are included in this alert.

Salmonella is harmful to humans and animals. The products should be disposed of in a safe manner by securing them in a trash bag.

The single most important measure to avoiding contamination is washing hands with hot soapy water for 20 seconds immediately after contact with dry pet foods, treats and supplements and after handling pets.

If your pet has consumed any of the recalled pet products or is experiencing any of symptoms of illness, you should contact your veterinarian immediately.

Originally posted at InjuryBoard by Chrissie Cole

BodyBuilding.com Recall Products May Contain Steroids Known to Cause Serious Side Effects and Death

Paul Napoli — Fri, 06 Nov 2009 10:45:11 GMT

November 5, 2009

Bodybuilding.com, LLC announced today that it is conducting a voluntary nationwide and international recall of all lots and expiration dates of 65 dietary supplement products that were sold through the Company's website, www.BodyBuilding.com, because the U.S. Food and Drug Administration (FDA) believes that the Recalled Products contain ingredients that are steroids.

The FDA has advised BodyBuilding.com LLC, of Boise, ID, that it believes the Recalled Products may contain the following ingredients that are currently classified, or the FDA believes should be classified, as steroids: "Superdrol," "Madol," "Tren," "Androstenedione," and/or "Turinabol."

The BodyBuilding.com, LLC press release says, “While the Company has not had an opportunity to independently confirm the FDA's concerns that the Recalled Products in fact contain these ingredients, the Company is undertaking this voluntary recall in an abundance of caution.” The Company denied they had received any reports of adverse events in connection with the Recalled Products.

The BodyBuilding.com Recall Press Release was available on the FDA website, but notice of the recall could not be found on BodyBuilding.com’s home page or elsewhere on the company website.

The FDA warns that acute liver injury is known to be a possible harmful effect of using steroid-containing products. In addition, steroids may cause other serious long-term adverse health consequences in men, women and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, a higher predilection to misuse other drugs and alcohol, adverse effects on blood lipid levels, and increased risk of heart attack, stroke and death.

RECALLED PRODUCT LIST

4Ever Fit D-Drol

Advanced Muscle Science Dienedrone

Advanced Muscle Science Liquidrone UTT

Anabolic Xtreme Hyperdrol X2

APS (aka Advanced Muscle Science) Mastavol

APS (aka Advanced Muscle Science) Revamp

APS (aka Advanced Muscle Science) Ultra Mass Stack

APS (aka Advanced Muscle Science) Ripped Stack

Better Body Sports Finadex

Black China Labs Straight Drol

Black China Labs Straight Phlexed

Body Conditioning Solutions TestraFLEX

Bjorklund Methyldrostanolone

BOSC Enterprises Epi-Tren

BOSC Enterprises Magna Drol

Chaparral Labs Epivol

Chaparral Labs Pheravol-V

Competitive Edge Labs M-Drol

Competitive Edge Labs P-Plex

Competitive Edge Labs X-tren

Diabolic Labs Epio-Plex

Diabolic Labs Finabolic 50

Diabolic Labs Revenge

Ergopharm 6-OXO

Ergopharm 6-OXO Extreme

EST (aka Engineered Sports Technology) MethAnstance

Extreme Labs Susto-Test Depot

Fizogen ON Cycle II Hardcore

G.E.T/ (Genetic Edge Technologies) SUS-500

G.E.T/ (Genetic Edge Technologies) Tren-250

Hardcore Formulations T-Roid

I Force Nutrition 1,4 AD Bold 200

I Force Dymethazine/Reversitol Combo Pack

I Force Reversitol

I Force Nutrition 17a PheraFLEX

I Force Nutrition Dymethazine

I Force Nutrition Methadrol

IDS (aka Innovative Delivery Systems) Bromodrol

IDS (aka Innovative Delivery Systems) Grow Tabs TR

IDS (aka Innovative Delivery Systems) Mass Tabs

IDS (aka Innovative Delivery Systems) Oxodrol Pro

IDS (aka Innovative Delivery Systems) Ripped Tabs TR

IDS (aka Innovative Delivery Systems) Rapid Release

Ripped Tabs

Kilo Sports Massdrol

Kilo Sports Phera-Mass

Kilo Sports Trenadrol

Monster Caps Monster Caps

Myogenix Spawn

Nutra Coastal D-Stianozol

Nutra Coastal H-Drol

Nutra Coastal MDIT

Nutra Coastal S-Drol

Nutra Coastal Trena

Performance Anabolics Methastadrol

Performance Anabolics Tri-Methyl X

Purus Labs E-pol Inslinsified

Purus Labs Nasty Mass

Rage RV2

Rage RV3

Rage RV4

Rage RV5

Redefine Nutrition Finaflex 550-XD

Redefine Nutrition Finaflex Ripped

Transform Supplements Forged Extreme Mass

Transform Supplements Forged Lean Mass

Customers who have any of the Recalled Products in their possession should stop using them immediately and contact their physician if they have experienced any problems that may be related to taking one or more of the ingredients listed above. The FDA encourages the reporting of any adverse events related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program online at www.fda.gov/MedWatch/report.html or by phone at 1-800-332-1088.

If you or someone in your family have used any of these recalled dietary supplement products and suffered adverse reactions as a result, please contact the experienced attorneys here at Napoli Bern Ripka, LLP. You may be entitled for compensation for your injury, medical expenses or a loved one’s death. Our law firm has helped many people who have become victims of recalled medications. The consultation is free; just call 1-888-529-4669.

Originally posted at InjuryBoard by Paul Napoli