Doripenem Injection (Doribax) Gets FDA Approval For Treating Complicated Urinary Tract and Intra-Abdominal Infections

The U.S. Food and Drug Administration has approved doripenem injection, 500 mg intravenous infusion, for the treatment of complicated urinary tract and intra-abdominal infections. Doripenem injection, sold under the trade name Doribax, has been shown to be active against several strains of bacteria.

“This is a significant new drug in the treatment of hospitalized patients with serious bacterial infections,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.

In several multi-center, multinational studies, doripenem was shown to have a cure rate comparable to the currently prescribed medications levofloxacin, for complicated urinary tract infections, and meropenem, for complicated intra-abdominal infections.

The most common adverse reactions reported were headache, nausea, diarrhea, rash, and phlebitis. In addition, allergic reactions have occurred and some may require immediate treatment.

The safety and effectiveness of doripenem injection in pediatric patients have not been established. Doripenem has not been studied in pregnant women, and the drug should be used during pregnancy only if clearly needed.

Doripenem injection is manufactured by Johnson and Johnson Pharmaceutical Research and Development, LLC, Raritan, N.J.

However it is beneficial to know symptoms of Urinary Tract infections before they become complicated or if one has a clean slate prevent it.

UTI-bladder-Urinary tract infection symptoms:

* Burning sensation when urinating
* Persistent strong urge to urinate
* Going frequently on bathroom passing small amounts of urine
* Strong smelling urine , blood in the urine or cloudy
Prevention of urinary tract infection:
You can take action to prevent urinary tract infection:

* Drink a lot of liquid Cranberry juice(not if you are taking the blood-thinning medication warfarin) and especially water. Cranberry juice is known as good natural remedy for urinary tract infection.
* Urinate promptly, when urge arises. Don't retain urine for a long time after you feel urge to urinate.
* Wipe from front to back after urinating and after bowel movement. It helps bacteria in the anal region from spreading to the vagina and urethra.
* Clean your genital area before sex intercourse
* Empty your bladder as soon as possible after sex intercourse
* Avoid using feminine products that could be potentially irritable, such as deodorant sprays for genital areas.
* Take showers instead of tub baths

Sphere: Related Content

FDA,s Approved Source Of Puffer Fish

The Food and Drug Administration (FDA) is advising consumers only to eat puffer fish (also known as fugu, bok, blowfish, globefish, swellfish, balloonfish, or sea squab) from two known safe sources. The safe sources are 1) imported puffer fish that have been processed and prepared by specially trained and certified fish cutters in the city of Shimonoseki, Japan, and 2) puffer fish caught in the mid-Atlantic coastal waters of the United States, typically between Virginia and New York. Puffer fish from all other sources potentially contain deadly toxins and therefore are not considered safe.

The liver, gonads (ovaries and testes), intestines, and skin of some puffer fish contain the toxins tetrodotoxin and/or saxitoxin. These toxins are 1,200 times more deadly than the poison cyanide and can affect a person's central nervous system. There are no known antidotes for these toxins. Puffer fish must be cleaned and prepared properly so the organs containing the toxins are carefully removed and do not cross-contaminate the flesh of the fish. These toxins cannot be destroyed by cooking or freezing.

Symptoms resulting from ingesting either of the toxins include tingling of the lips and mouth, followed by dizziness, tingling in the extremities, problems with speaking, balance, muscle weakness and paralysis, vomiting, and diarrhea. These symptoms can begin anywhere from 20 minutes to 2 hours after eating the toxic fish. In extreme cases death can result from respiratory paralysis.

The Japanese government licenses specially trained fish cutters to process and prepare puffer fish. These fish are imported into the United States two to three times per year for special occasions, by only one approved New York importer, Wako International, under an FDA/Japanese government agreement. This is the only acceptable source of imported puffer fish. They are sold only to restaurants and dishes containing the fish are often very expensive, sometimes costing hundreds of dollars for a full meal.

Puffer fish caught from the mid-Atlantic coastal waters of the United States do not contain these deadly toxins and are considered safe to eat. They are less expensive than imported puffer fish and may be found in markets or restaurants. However, puffer fish caught off the east coast of Florida should not be eaten because the entire fish is potentially toxic.

Before ordering or buying puffer fish, consumers should ask where it came from to ensure it is from a known safe source. Consumers who are unsure of the source should not eat puffer fish.

To Spanish Readers

Coma pez globo sólo de fuentes seguras conocidas

La Administración de Medicamentos y Alimentos (FDA, Food and Drug Administration) recomienda a los consumidores que coman pez globo (también conocido como, fugu, bok, botete diana, pez inflado o pez rechoncho) sólo de fuentes seguras conocidas. Las fuentes seguras son: 1) pez globo importado que se ha procesado y preparado por cortadores de pescado certificados y especialmente capacitados en la ciudad de Shimonoseki, Japón, y 2) pez globo que se pesca en las aguas costeras del Atlántico medio de los Estados Unidos, normalmente entre Virginia y Nueva York. Los peces globo de todas las demás fuentes pueden contener toxinas mortales, por lo que no se consideran seguros.

El hígado, las gónadas (ovarios y testículos), los intestinos y la piel de algunos peces globo contienen las toxinas tetrodotoxina o saxitoxina. Estas toxinas son 1,200 veces más mortales que el cianuro y pueden afectar el sistema nervioso central de una persona. No se conocen antídotos para estas toxinas. El pez globo se debe limpiar y preparar de manera adecuada para que los órganos que contienen las toxinas se retiren cuidadosamente y no se produzca la contaminación cruzada de la carne del pescado. Estas toxinas no se pueden destruir con la cocción o congelación.

Los síntomas que aparecen al ingerir cualquiera de las toxinas incluyen hormigueo en los labios y la boca, seguido de mareos, hormigueo en las extremidades, problemas para hablar, con el equilibrio, debilidad muscular y parálisis, vómitos y diarrea. Estos síntomas pueden comenzar desde 20 minutos hasta 2 horas después de comer el pescado tóxico. En casos extremos, se puede producir la muerte debido a una parálisis respiratoria.

El gobierno japonés autoriza a cortadores de pescado especialmente capacitados para procesar y preparar pez globo. Estados Unidos importa estos pescados dos a tres veces al año para ocasiones especiales, y lo hace a través de un sólo importador aprobado de Nueva York, Wako International, en virtud de un acuerdo entre la FDA y el gobierno japonés. Ésta es la única fuente aceptable de pez globo importado. Se vende sólo a restaurantes y los platos que contienen el pescado a menudo son muy costosos, en ocasiones llegando a costar cientos de dólares una comida completa.

El pez globo que se pesca en las aguas costeras del Atlántico medio de los Estados Unidos no contiene estas toxinas mortales y se considera seguro para comer. Cuesta menos que el importado y se puede encontrar en mercados o restaurantes. Sin embargo, el pez globo que se pesca en la costa este de Florida no se debe comer porque el pescado completo puede ser tóxico.

Antes de pedir o comprar pez globo, los consumidores deben preguntar por su origen para asegurarse de que proviene de una fuente segura conocida. Los consumidores que no están seguros de la fuente no deben comer pez globo.

Sphere: Related Content

The U.S. FDA Approves Raltegravir Tablets As New HIV Drug

The U.S. Food and Drug Administration (FDA) has approved raltegravir tablets for treatment of Human Immunodeficiency Virus (HIV)-1 infection in combination with other antiretroviral agents in treatment-experienced adult patients who have evidence of viral replication and HIV-1 strains resistant to multiple antiretroviral agents.

Raltegravir is the first agent of the pharmacological class known as HIV integrase strand transfer inhibitors, designed to interfere with the enzyme that HIV-1 needs to multiply. Raltegravir, sold under the trade name Isentress, received a priority review by the FDA.

“This is an important new product for many HIV-infected patients whose infections are not being controlled by currently available medications,” said Janet Woodcock, M.D., FDA’s deputy commissioner for scientific and medical programs, chief medical officer and acting director, Center for Drug Evaluation and Research.

When used with other anti-HIV medicines, raltegravir may reduce the amount of HIV in the blood and may increase white blood cells, called CD4+ (T) cells, that help fight off other infections.

FDA’s approval of raltegravir is based on data from two double-blind, placebo-controlled studies in 699 HIV-1 infected adult patients with histories of extensive antiretroviral use. A greater proportion of the patients who received raltegravir in combination with other anti-HIV drugs experienced reductions in the amount of HIV in the blood, compared with patients who received placebo in combination with other anti-HIV drugs.

The most common adverse events reported with raltegravir were diarrhea, nausea, and headache. Blood tests also showed abnormal elevated levels of a muscle enzyme in some patients receiving raltegravir. Caution is advised when using raltegravir in patients at increased risk for certain types of muscle problems, including those who use other medications that can cause muscle problems.

Patients taking raltegravir may still develop infections, including opportunistic infections or other conditions that may develop in patients living with HIV-1 infection. The long-term effects of raltegravir are not known, and its safety and effectiveness in children less than 16 years of age has not been studied.

Raltegravir also has not been studied in pregnant women. Women who are taking HIV medications when they get pregnant are advised to talk with their physician or other health care professional about use of this drug during pregnancy, and about registering with the Antiviral Pregnancy Registry if they use raltegravir.

Raltegravir is distributed by New Jersey-based Merck & Co., Inc.

Sphere: Related Content

OTC Cough and Cold Oral infant Medicines Voluntarily Withdrawn Due To Abuse

The Consumer Healthcare Products Association (CHPA) on behalf of the leading makers of over-the-counter cough and cold medicines today announced voluntary market withdrawals of oral cough and cold medicines that refer to "infants." The voluntary withdrawal affects only these "infant" oral medicines, not those intended and labeled for use in children age two and older.

"It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately," said Linda A. Suydam, D.P.A, president of CHPA. "The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority."

The branded cough and cold medicines that are being voluntarily withdrawn are:

* Dimetapp® Decongestant Plus Cough Infant Drops
* Dimetapp® Decongestant Infant Drops
* Little Colds® Decongestant Plus Cough
* Little Colds® Multi-Symptom Cold Formula
* PEDIACARE® Infant Drops Decongestant (containing pseudoephedrine)
* PEDIACARE® Infant Drops Decongestant & Cough (containing pseudoephedrine)
* PEDIACARE® Infant Dropper Decongestant (containing phenylephrine)
* PEDIACARE® Infant Dropper Long-Acting Cough
* PEDIACARE® Infant Dropper Decongestant & Cough (containing phenylephrine)
* Robitussin® Infant Cough DM Drops
* Triaminic® Infant & Toddler Thin Strips® Decongestant
* Triaminic® Infant & Toddler Thin Strips® Decongestant Plus Cough
* TYLENOL® Concentrated Infants' Drops Plus Cold
* TYLENOL® Concentrated Infants' Drops Plus Cold & Cough

This voluntary withdrawal does not affect medicines intended for children age two and older. CHPA and its member companies have put forth recommendations to the U.S. Food and Drug Administration (FDA) to strengthen the labels on all oral OTC children’s cough and cold medicines from "ask a doctor" before using to "do not use" in children under two years.

CHPA made these recommendations to the FDA in preparation for a joint FDA advisory committee meeting on October 18 and 19. These recommendations, as well as several additional recommendations, including those proposed by FDA review staff, will be explored further at this meeting.

"These medicines are—and always have been—safe at recommended doses," Suydam said.

"These voluntary actions are being taken out of an abundance of caution. The vast majority of parents and caregivers safely use these medicines to help relieve their children’s symptoms. But as with all medicines, it’s important that parents read over-the-counter medicine labels carefully, use these medicines only as directed, and store them safely out of the reach of children."

CHPA will be launching a major, multi-year national campaign to educate parents and healthcare providers about the safe use of over-the-counter medicines in children, partnering with major physician, nurse, and pharmacist organizations.

Sphere: Related Content

Controversial Vaccine Drops Cases Of Meningococcal B In Rotorua And Taupo In News Zealand

Alison Brown

A drop in the number of cases of meningococcal B in Rotorua and Taupo is proof a controversial vaccine is working, health experts say.

There have been no cases of meningococcal B in Rotorua or Taupo this year. Nationally, 76 people have contracted the potentially deadly illness.

The figures are well down on the hundreds of cases reported at the height of the epidemic, which has swept the country for 16 years.

Bay of Plenty medical officer of health Phil Shoemack says there's no doubt the immunisation campaign has been effective.

"The vaccine has accelerated the natural decrease in the epidemic. When you look at how much of an impact it's had, we wish we could have had it earlier so fewer kids would have got the disease."

Since 1991 about 6000 New Zealanders - half of them under 6 - have been struck down by the disease and 245 people have died. At the height of the epidemic, Bay of Plenty was among the worst regions affected, recording double the rate of cases as the rest of the country.

In the two years before the vaccine became available in the Bay of Plenty, 107 cases were reported - 29 in 2004 and 78 in 2003. Two people died.

Meningococcal B is an infection of the fluid of the spinal cord and fluid surrounding the brain. It is caused by bacterium and can kill within 24 hours. Other strains of the disease are caused by a virus. Symptoms can be mistaken for influenza and include fever, severe headaches, vomiting, drowsiness, muscular aches and a stiff neck.

In an attempt to control the epidemic, the Ministry of Health launched a massive $220 million vaccination programme targeting babies and teenagers in 2004. Free but not mandatory, it became available in Rotorua and Taupo in February 2005. About 32,100 people under 20 in the Lakes district have been eligible for the vaccine - 82 per cent or 26,400 have completed the programme.

The figures are slightly less for Maori, with 78 per cent of eligible Maori receiving all their doses.

About 5800 out of 7629 preschoolers (76 per cent) have been immunised. Of the 4139 Maori under fives eligible for the vaccine, 2730 (66 per cent) have completed the programme.

Vaccination rates for school-aged children are higher. Of the 24,540 eligible for the vaccine, about 20,600 (84 per cent) have completed the programme. About 9600 out of 11,740 Maori school children and teenagers (82 per cent) have received their three doses.

The school-age immunisation campaign has finished but the health ministry has indicated vaccinations will continue to be available for under-5s until 2009.

Health Rotorua chief executive and Maori health manager Eugene Berryman-Kamp said Lakes has had more success reaching Maori in all age groups than other regions.

Sphere: Related Content

Massage Hurts, But Hurts So Good

Jo McCarroll

I am a bit of sadist when it comes to having a massage, which might sound like a non-sequitur but it isn't really. Because while there is a wide variety of massages on offer, in the end there are only really two - hard massage and soft massage.

Some people like those fluffy soft massages, all tinkling music and feathery stroking.

Me, I'd rather chew glass. If I'm having a massage, I like a bruising deep tissue massage right on that edge of pain.

I am already a fan of Thai massage, which is usually, in my experience, quite exquisitely agonising (don't be fooled by the often tiny therapist - they often have superhuman upper body strength). However, I had never tried a Thai herbal hot compress ($200 for 90 minutes), an ancient form of massage and one of the signature treatments at Senses Spa at the Westin Hotel.

It uses a "massage ball", a poultice stuffed with lemon grass, plai, soap pod, turmeric and kaffir lime (among other things), soaked in hot oil and then rubbed onto your skin, followed by a full body massage.

The massage ball looks exactly like a larger version of one of those money balls you get as part of a mixed entree platter at a Thai restaurant - in fact, the waft of lemon grass that pervades the room is quite reminiscent of Thai restaurants as well (in the most pleasant way, I hasten to add).

Lemongrass, apparently, helps you relax - and the herbs that make up the compress all have healing or soothing properties. Plai, which is from the same plant family as ginger, combats joint and muscle problems; soap pod, a Thai herb similar to tamarind, improves the texture of the skin; turmeric is good for skin problems; and Kaffir lime works on skin tone.

The essential oils in the plants are released into the heated massage oil - devotees of this treatment claim it has a number of health benefits, in particular relieving muscle sprains and joint stiffness.

But the health benefits, for me, are not the point of having a massage, what I want is to de-stress and relax. And, my God, after an hour-and-a-half of being rubbed with this hot massage ball (and be warned it is hot, almost to the point where it's uncomfortable) I felt like I was practically liquid.

Having (rather swaggeringly) told the therapist I liked my massages fairly hard, she more than took me at my word: ow, ow, ow, ooo, ooo, ooo God yes.

At the end my arms barely had the strength to lift my cleansing ginger tea. Those of you who like your light ticklings and barely-there back rub, steer clear.

But for the rest of us it's best summed up in just three words: hurts so good.

Sphere: Related Content

Gordon McEwen, A Veteran Chef Allergic To Fish

Julie Jacobson

Gordon McEwen could be forgiven for wanting to cry into his kilt at times. The veteran chef, who has cooked for some of the diplomatic community's most powerful members, is acutely allergic to fish.

But the former Wellington restaurateur hasn't let what many would consider to be a major handicap get in the way of a stellar 40-year career in the kitchen.

Now at the Tauranga Club in the Bay of Plenty, McEwen spent the past 19 years as chef to five US ambassadors. During that time he catered for several world leaders and dozens of visiting dignitaries.

It was while working at the ambassador's Lower Hutt residence he had his first reaction to seafood.

"I'd been cooking fish for 25 years. I'd just had a meal when my eyes started falling out of my head and my lips began swelling up. It was not very pleasant."

Since then, he has used gloves to prepare the fish and shellfish meals for which he has become renowned.

At the same time, he "cooks" in his head - "I imagine the dish and the taste in my mind".

McEwen's wife, Elizabeth, and other kitchen staff are called on to check seasoning and taste any new dish he develops.

He says the allergy has had unexpected results - he believes his kitchen has some of the highest hygiene standards in the business.

"I take huge care in the kitchen not to cross-contaminate anything. I've had to become very aware of the implements I use, which means everyone else in the kitchen picks up on that."

While it doesn't hamper what goes on the menu - calamari in a soy-lime dressing; chilli, garlic and ginger prawns; and fresh fish with an Asian mustard sauce and balsamic vinegar drizzle are some of his dishes - it has occasionally put a dampener on McEwen's social life.

He has learned not to kiss his wife immediately after she has eaten seafood, and there have been several times when he's especially chosen steak at a restaurant only to suffer a reaction. "I've known straight away that whoever cooked that steak had been handling fish."

Despite that, McEwen still loves fish. He waxes lyrical when describing the preparation that goes into his dishes, and says he remembers distinctly what fish tastes like; "the texture on my tongue, Akaroa smoked salmon ... it sometimes drives me insane that I can't taste it".

He admits to being so tempted by a nice piece of fresh fish that he ate several small pieces "just in case I'd got over it.

"Unfortunately, I learned the hard way that I hadn't."

Ironically, Thai fish sauce, tinned salmon and tuna, and marinated mussels, are four things that don't trigger a reaction.

Nor does smelling seafood. "Like any- one else, I can tell what's fresh and what isn't," he laughs.

Sphere: Related Content