FDA Warns Consumers About Potential Health Risk With Juices Incorporated Juice Products

The U.S. Food and Drug Administration is warning consumers not to consume any juice products or other beverages from Juices Incorporated (aka Juices International and Juices Enterprises) of Brooklyn, N.Y. The company's carrot and beet juice products have the potential to be contaminated with Clostridium botulinum, a bacterium which can cause botulism, a serious and potentially fatal foodborne illness. Consumers are warned not to consume these products even if they do not look or smell spoiled.

Botulism can cause the following symptoms: general weakness; dizziness; double-vision; and trouble with speaking or swallowing. Difficulty in breathing, weakness of other muscles, abdominal distension and constipation may also be common symptoms. People experiencing these symptoms after consuming carrot or beet juice products from Juices Incorporated should seek immediate medical attention.

Although previously distributed in New York, New Jersey, Connecticut and Pennsylvania, Juices Incorporated products were recently found in retail establishments and restaurants in the New York City area, and consumers may have moved the products beyond this region.

The following Juices Incorporated juice products pose a particular concern for Clostridium botulinum contamination:

Carrot Juice DrinkCarrot & Beet Juice DrinkCarrot & Ginger DrinkDouble Trouble Carrot PunchGinger Beet JuiceBeet Juice Drink

The products are packaged under the following brand names:

Juices IncorporatedJuices InternationalJuices Enterprises

On October 7, 2010, the U.S. Department of Justice filed a complaint for permanent injunction against the owners of Juices Incorporated after FDA inspections revealed continuing violations of the Federal Food, Drug and Cosmetic Act, including insanitary conditions at the Juices Incorporated facility. Under a January 3, 2011 Consent Decree of Permanent Injunction (Consent Decree), the owners of Juices Incorporated are required to stop manufacturing and distributing any articles of food, including all juice products and other beverages, until they correct the food safety deficiencies and insanitary conditions at their facility.

Subsequently, on June 21, 2012, U.S. District Court Judge Sandra L. Townes for the Eastern District of New York issued an Order to Enforce Consent Decree after the owners of Juices Incorporated failed to comply with the requirements of the Consent Decree. FDA investigators recently confirmed that Juices Incorporated and its owners continue to manufacture and distribute juice products and other beverages in violation of the Consent Decree and the Court's Order to Enforce Consent Decree.

Although Clostridium botulinum has never been found inJuices Incorporated's juice products, FDA is concerned about the firm's continuing production of potentially hazardous juice products despite the requirements of the Consent Decree and Order to Enforce Consent Decree. Because the company was ordered not to manufacture or distribute any food, FDA is also warning consumers not to consume other Juices Incorporated beverages, including but not limited to: Ginger Beer Drink, Agony Peanut Punch, Front End Lifter Magnum Punch, Irish Sea Moss, Cashew Punch, Sorrel Drink, Pineapple Twist, Soursop Juice, and Corn Punch. The Federal Food, Drug and Cosmetic Act refers to unsanitary conditions as insanitary.

SOURCE: FDA, May 10, 2013

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FDA Warns Pregnant Women About Migraine Drugs

Medicines containing valproate linked to lower IQs in children, agency says

By Robert Preidt

HealthDay Reporter

MONDAY, May 6 (HealthDay News) -- Pregnant women who struggle with migraine headaches should never use medicines containing the ingredient valproate because they can lower the IQ scores of their children, the U.S. Food and Drug Administration said Monday.

The new warning will be included on the labels of medicines that contain valproate. These medicines already carry a boxed warning about fetal risk, including birth defects. Valproate products include valproate sodium (Depacon); divalproex sodium (Depakote, Depakote CP, and Depakote ER); valproic acid (Depakene and Stavzor); and their generic versions.

"Valproate medications should never be used in pregnant women for the prevention of migraine headaches because we have even more data now that show the risks to the children outweigh any treatment benefits for this use," Dr. Russell Katz, director of the division of neurology products in the FDA's Center for Drug Evaluation and Research, said in an agency news release.

Valproate medicines have several FDA-approved uses including: prevention of migraines, treatment of epileptic seizures and treatment of bipolar disorder.

This new warning was issued after a study found that children whose mothers took valproate drugs to protect against epilepsy during pregnancy scored eight to 11 points lower on IQ tests at age 6 than children who were exposed to other antiepileptic drugs in the womb.

It's not known if there's a specific time during pregnancy when valproate can result in decreased IQ in children. The women in the study took the antiepileptic valproate drugs throughout their pregnancies, the FDA said.

Valproate may have some value in treating bipolar disorder and epileptic seizures in pregnant women, but should only be taken if other medications have failed to control the symptoms or are otherwise unacceptable, according to the agency.

The FDA also said that:

Women who can become pregnant should not use valproate unless it is essential to managing their medical condition.Women of childbearing age taking valproate products should use effective birth control.Women who are pregnant or who become pregnant while taking valproate medications should talk to their health-care professional immediately. Women should not stop taking their medication without talking to their health-care professional because stopping treatment suddenly can cause serious and life-threatening medical problems for the woman or the fetus.

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Tattoos Can Pose Health Hazards, Doctor Warns

By Robert Preidt

HealthDay Reporter

FRIDAY, March 1 (HealthDay News) -- Tattoos have become increasingly popular in the United States in recent years, but along with that comes a rise in problems such as allergic reactions and infections, an expert says.

More than one-third of Americans aged 18 to 25 report getting a tattoo, according to the Pew Research Center. But if you're thinking about getting "inked," there are some things to consider before you head to the tattoo parlor.

"Since tattoos are not regulated in any way, there are many unknowns that could pose potential problems for consumers in terms of the inks and tools used," Dr. Michi Shinohara, a clinical assistant professor of dermatology at the University of Washington in Seattle, said in an American Academy of Dermatology news release.

"It is especially important for consumers to be aware of the potential risks, report any problem that develops to the tattoo artist and see a board-certified dermatologist for proper diagnosis and treatment," Shinohara added.

Tattooing inks have changed a great deal over the years and many modern tattoo inks contain organic azo dyes with plastic-based pigments that are also used industrially in printing, textiles and car paint. Many unknowns exist about how these new tattoo inks interact with the skin and within the body.

Allergic reaction to the tattoo pigments is one of the most common problems associated with tattooing. Infections also can pose a serious threat to health. Along with localized bacterial infections, there have been reports of people being infected with syphilis and hepatitis B and C due to non-sterile tattooing practices, Shinohara said.

Skin cancer is another potential risk associated with tattoos because they can make it hard to detect cancer-related changes in moles. If you get a tattoo, make sure it's not placed over an existing mole.

A tattoo can also cause a reaction that creates a bump that resembles a type of skin cancer called squamous cell carcinoma. Because it is hard to distinguish from skin cancer, the bump could lead to potentially unnecessary and expensive skin cancer treatment, including surgery, Shinohara said.

She offered the following advice for people who want to get a tattoo:

Go to a professional tattoo parlor and to a tattoo artist who is licensed according to state requirements. Insist on seeing tattoo equipment in sterile packaging.Tell the tattoo artist if you have a reaction. If a problem lasts more than one to two weeks, see a dermatologist.People with a chronic skin condition such as psoriasis, eczema or a tendency toward keloid scarring should check with a dermatologist before getting a tattoo.Do not get a tattoo over a mole. Doing so will make it more difficult to diagnose a problem if the mole changes in the future.

More information

The U.S. Food and Drug Administration has more about tattoos and permanent makeup.

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Don't Overlook Eating Issues Tied to Autism, Study Warns

By Robert Preidt

HealthDay Reporter

SATURDAY, Feb. 9 (HealthDay News) -- Children with autism are five times more likely than other kids to have feeding issues, such as being especially picky eaters or having ritualistic behaviors or extreme tantrums during meals, new research finds.

These problems can lead to deficiencies in calcium, protein and other nutrients, according to the study, which was published online this month in the Journal of Autism and Developmental Disorders.

Healthy eating promotes a child's growth and development, and mealtimes provide important opportunities for children to socialize, the researchers noted. Chronic feeding troubles increase a child's risk for problems such as malnutrition, poor growth, social difficulties and poor school performance.

The researchers added that there is growing evidence that feeding problems and dietary patterns among children with autism may put them at increased risk for long-term health problems such as poor bone growth, obesity and cardiovascular disease.

"The results of this study have broad implications for children with autism," study author William Sharp, an assistant professor at Emory University School of Medicine in Atlanta, said in a university news release.

"It not only highlights the importance of assessing mealtime concerns as part of routine health care screenings, but also suggests the need for greater focus on diet and nutrition in the autism community," added Sharp, who also is a behavioral pediatric psychologist in the Pediatric Feeding Disorders Program at Marcus Autism Center in Atlanta.

Sharp said that despite the risk of long-term medical issues, feeding problems often are overlooked in relation to other areas of concern in the autism population.

"Our findings have immediate and important implications for the work of practitioners serving children and families with autism, who in the absence of such information may struggle to address parents' concerns, or, worse, may fill the void with alternative treatments that may be ill-conceived or even harmful to children and families," Sharp explained.

More information

The U.S. National Institute of Neurological Disorders and Stroke has more about autism.

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FDA Warns of Fatal Rash From Hep C Drug Incivek

By Cari Nierenberg
WebMD Health News

Dec. 19, 2012 -- The FDA warned people taking the hepatitis C drug Incivek (telaprevir) that it has received reports of a serious skin rash from the medication, which has led to several deaths.

The deaths occurred in people taking Incivek combination treatment. This antiviral treatment includes the drug Incivek in combination with the drugs peginterferon alfa and ribavirin.

This combination treatment is most commonly used for genotype 1 chronic hepatitis C in adults with compensated liver disease (meaning the liver has some damage but still works), including those who have cirrhosis (scarring of the liver) or those who have previously received interferon-based treatment.

The FDA says some people had developed a serious skin rash while on the combination drug treatment, yet they continued to take the three medications despite the rash worsening and leading to life-threatening symptoms.

The FDA advises people receiving Incivek combination treatment to be aware of the potential for developing a rash as a side effect of drug treatment. It recommends that anyone who gets a serious skin reaction after taking these drugs stop them immediately and seek emergency medical care.

The FDA will be adding a boxed warning about these potential problems to the Incivek drug label. The warning will instruct people receiving Incivek combination treatment to immediately discontinue all three medications if they develop a rash.

In a news release from Vertex Pharmaceuticals, makers of Incivek, the company said that less than 1% of people who received Incivek combination treatment had a serious skin reaction to it when the treatment was tested in a late-stage clinical trial. These patients required hospitalization for the skin reaction, yet all recovered from it.

The FDA also encourages patients and health care professionals to report any serious or harmful side effects to its MedWatch Safety Information and Adverse Event Reporting Program. This report can be submitted online. Forms can also be obtained by calling 800-332-1088, and then faxing to 800-FDA-0178. 

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