Vitamin Information Center

MINNEAPOLIS, Dec 03, 2008 /PRNewswire via COMTEX/ — Upsher-Smith Laboratories, Inc. announced its plans to market PreNexa(TM), the first and only single gel capsule prenatal vitamin with the most plant-based Docosahexaenoic acid (DHA, 265 mg) for women considering pregnancy, pregnant women and new mothers who are breastfeeding.(1-6)
“Martek’s life’sDHA(TM), the DHA in PreNexa(TM), is derived from a natural plant source grown outside the ocean.(1,7) It is also the same DHA source used in infant formulas and has been granted Generally Recognized As Safe (GRAS) status for use in infant formulas by the United States Food and Drug Administration,” said Steve Dubin, CEO of Martek.(8) The availability of PreNexa(TM) avoids the potential of being exposed to oceanborne pollutants like mercury because it derives its DHA from microalgae, a direct plant source. In addition, for women with an allergic sensitivity to fish, PreNexa(TM) offers healthcare professionals the first single-capsule prenatal vitamin with plant-based DHA.
DHA is a key omega-3 fatty acid used throughout the body. It works to support fetal and infant brain and eye development.(9,10) The source of DHA for many other prenatal vitamins is fish oil, which can leave patients with a fishy smell, taste and after taste.
The plant-based DHA in PreNexa(TM) is derived from algae grown in fermentation tanks and processed in a closed and controlled manufacturing process. Whereas, fish-based DHA is obtained by extracting DHA after the fish have eaten algae and the oil has been processed through varying filtration methods.(7) “PreNexa(TM) represents an advancement in delivery by being the first single-capsule prenatal vitamin with the most plant-based DHA for women, before and after the birth of their child,” said Mark Evenstad, Vice Chairman/President of Upsher-Smith Laboratories, Inc.
DHA is polyunsaturated and contains 22 carbon fatty acids which are predominantly found in fish and marine animal oils. Since many women do not consume the amount of DHA recommended by many experts in diet alone, a prescription prenatal vitamin with DHA can be just what a mother and her baby need to help ensure her DHA intake is greater than or equal to 200-300 mg per day during pregnancy and while breastfeeding.(10,12,13)
Developing infants cannot efficiently produce their own DHA, they must obtain this vital nutrient through the placenta during pregnancy or from an outside source such as breast milk after birth.(14) Mothers continuously lose their omega-3 fatty acid stores during pregnancy.(15) Furthermore, it takes an average of six months to recover from the loss, so a daily source of DHA is recommended by many health experts.(10,12)
PreNexa(TM) is a once daily single gel capsule that includes: Folic Acid (1.2 mg), Vitamin C (25 mg), Vitamin D3 (170 IU), Vitamin E (30 IU), Iron (30 mg), Calcium (160 mg) and Vitamin B6 (25 mg).(1) It also contains a gentle stool softener known as docusate sodium, which is an added benefit for approximately 50 percent of pregnant women who suffer from irregularity at some point in their pregnancy.(1,11)
PreNexa(TM) is available nationwide, by prescription only, in bottles containing a 30 day supply. This once-daily, single gel capsule with the most plant-based DHA, can be conveniently taken at anytime, day or night.
Upsher-Smith is pursuing drug therapies to improve people’s lives. The company is driven by the ever-changing needs of patients, physicians, pharmacists and healthcare organizations. Focused on market expansion in women’s health, dermatology, cardiology and in developing products for neurology, their perspective is not “more products” but the “right products” to improve lives. For additional information about PreNexa(TM), visit http://www.prenexa.com, or to learn more about Upsher-Smith, visit http://www.upsher-smith.com.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six years of age. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In the case of accidental overdose, call a doctor or poison control center immediately. Please see accompanying full Prescribing Information for a complete list of warnings and precautions.
References: 1. PreNexa (package insert). Minneapolis, MN: Upsher-Smith Laboratories, Inc; 2008. 2. CitraNatal DHA (package insert). San Antonio, TX: Mission Pharmacal Company; 2007. 3. Duet DHA(ec) (package insert). Newport, KY: Xanodyne Pharmaceuticals, Inc; 2007. 4. Prenate DHA (package insert). Atlanta, GA: Sciele Pharma, Inc; 2007. 5. PrimaCare Advantage (package insert). St. Louis, MO: Ther-Rx Corporation; 2008. 6. PrimaCare One (package insert). St. Louis, MO: Ther-Rx Corporation; 2007. 7. Martek Biosciences Corporation. Data on file. 8. U.S. FDA GRAS Notice No. GRN 000041. 9. Medline Plus. http://www.nlm.nih.gov/medlineplus/druginfo/natural/patient-fishoil.html. Accessed September 9, 2008. 10. Koletzko, et al. The roles of long-chain polyunsaturated fatty acids in pregnancy, lactation and infancy; review of current knowledge and consensus recommendations. J Perinat Med 36 (2008) 5-14. 11. American Pregnancy Association. Pregnancy and Constipation. http://www.americanpregnancy.org/pregnancyhealth/constipation.html. Accessed August 21, 2008. 12. Simopoulos AP, Leaf A, Salem N Jr. Workshop on the essentiality of and recommended dietary intakes for omega-6 and omega-3 fatty acids. J Am Coll Nutr. 1999;61:57-62. 13. Arterburn LM, Oken HA, Bailey Hall E, et al. Algal-oil capsules and cooked salmon: nutritionally equivalent sources of docosahexaenoic acid. J Am Diet Assoc. (2008);108:1204-1209. 14. Szajewska, et al. Effect on n-3 long-chain polyunsaturated fatty acid supplementation of women with low-risk pregnancies on pregnancy outcomes and growth measures at birth: a meta-analysis of randomized controlled trials. American Journal Clinical Nutrition, (2006);83:1337-44. 15. Hornsta G, AI MD, van Houwelingen AC, Forman-van Drongelen MM. Essential fatty acids in pregnancy and early human development. Eur J Obstet Gynecol Reprod Biol. (1995);61:57-62.
SOURCE Upsher-Smith Laboratories, Inc.

The administration of cholecalciferol boosts serum levels of vitamin D in women with osteoporosis, allowing them sufficient vitamin D levels to enter an osteoporosis clinical trial, according to research presented here at the American Society for Bone and Mineral Research (ASBMR) 30th Annual Meeting.

The US Food and Drug Administration has recently modified the lower acceptable limit of 25-hydroxy vitamin D (25-OH vitamin D) for subjects participating in a clinical trial to 60 nmol/L, explained lead investigator Hans Christian Hoeck, MD, PhD, Center for Clinical and Basic Research, Aalborg, Denmark.

Dr. Hoeck and co-investigators enrolled 433 postmenopausal women who were treatment-naïve in an osteoporosis study; at the point of screening, they identified 152 subjects (35.1%) who had 25-OH vitamin D levels <60 nmol/L.

"The objective of the study was to reach the acceptable level of 25-OH vitamin D from the time of screening to inclusion [in] the study," said Dr. Hoeck in an interview at a poster session here on September 14.

Investigators assessed 21 subjects who were ineligible to undergo vitamin D3 supplementation, leaving 131 subjects to receive doses of vitamin D3. Study subjects were administered various dosages per day of 25-OH vitamin D3 for 10 days, including 25, 50, 75, 100, and 200 mcg.

Investigators measured 25-OH vitamin D with an enzyme-linked immunosorbent assay (ELISA) specifically for 25-OH vitamin D3; the assay had no cross reactivity to 25-OH vitamin D2.

After 10 days of supplementation, investigators observed statistically significant increases (P < .001) in the mean value of 25-OH vitamin D in subjects across all 5 dosing arms, but they found that 10 days of treatment did not ensure that all subjects met the threshold limit. Investigators acknowledged that extended treatment beyond 10 days is necessary for all subjects to reach the threshold.

"If we treat subjects with 50 mcg of vitamin D3 for 10 days, followed by 2 weeks treatment with 200 mcg of vitamin D3 daily, it would ensure concentrations of 25-OH [vitamin] D3 greater than 60 nmol/L in all subjects," explained Dr. Hoeck. This regimen would permit patients to reach the necessary 25-OH vitamin D threshold without developing adverse events such as hypercalcaemia, he noted.

Investigators observed no adverse events during the vitamin D supplementation period. They recorded that serum calcium rose within the reference range (P < .006) among subjects taking 25-, 100-, and 200-mcg doses of cholecalciferol. Parathyroid hormone levels only fell in the 25-mcg group (P = .004). Investigators also noted a significant rise in alkaline phosphatase levels in the 50-mcg group (P = .003) and in creatinine levels in the 200-mcg arm (P = .023). There were no variations in AP or creatinine levels observed in any of the other treatment arms (P > .1).

Dr. Hoeck noted that it would be extremely challenging to achieve the revised acceptable limit of 25-OH vitamin D through diet alone.

Funding for this study was provided by Nordic Bioscience A/S.

[Presentation title: The Efficacy and Safety of Short Term Treatment With Different Doses of Cholecalciferol on 25-Hydroxy Vitamin D Levels in Postmenopausal Females With Osteoporosis. Abstract Su434]

WASHINGTON (Reuters) - Two U.S. lawmakers are investigating advertising claims by Wyeth that promote its Centrum Cardio vitamin as a cholesterol-lowering product, according to a letter to the company released on Friday.

Michigan Reps. John Dingell and Bart Stupak are seeking related company documents following television commercials that tout the vitamin as “the only complete multivitamin that can lower cholesterol,” according to the lawmakers’ letter.

“We are concerned that these statements may be misleading to the general public and that patients with high cholesterol may erroneously substitute Centrum Cardio for a treatment plan prescribed by their physician,” the lawmakers wrote.

As Democrats, the two men chair the U.S. House of Representatives Committee on Energy and Commerce and its Subcommittee on Oversight and Investigations, respectively.

Representatives for the company could not be immediately reached for comment.

Centrum Cardio, launched in October 2007, is part of Wyeth’s Centrum line of multivitamin products.

On Wyeth’s website, the company cites a 2000 U.S. Food and Drug Administration interim rule that allows dietary supplements or foods that provide of 800 milligrams of free phytosterols to claim a possible reduction in heart disease.

A daily serving of Centrum Cardio, or 2 tablets, contains 800 milligrams of phytosterols, it said.

(Reporting by Susan Heavey; Editing by Andre Grenon)

Nearly 200 people across the country have been sickened after taking the vitamin supplement Total Body Formula, United Press International reported Sunday.

The Centers for Disease Control and Prevention found that users of the supplement suffered loss of hair and fingernails, as well as nausea, joint pain, and diarrhea among other symptoms.

The liquid supplement is one of more than 12 supplements that have been recalled in the past year by the U.S. Food and Drug Administration.

Some batches of Total Body Formula and Total Body Mega Formula contained excessive amounts of the minerals selenium and chromium.

Selenium, a trace mineral, is only needed in small amounts for good health, the FDA said, and too much of it can cause the symptoms listed above. Chromium, also a trace mineral, can cause anemia, kidney failure, and liver damage if too much is ingested.

The company now faces lawsuits from former customers who allege they were poisoned by the product and face long-term side effects.

In March, the FDA warned consumers in 15 states about the link between the dietary supplement and adverse side effects including “significant hair loss” after 23 individuals suffered “serious reactions” within seven to 10 days of ingesting the liquid supplements.

At that time the distributor of the supplements voluntarily recalled the products, which were distributed by Total Body Essential Nutrition of Atlanta.

The products have been distributed in Alabama, California, Florida, Georgia, Kentucky, Louisiana, Michigan, Missouri, New Jersey, North Carolina, Ohio, Pennsylvania, Tennessee, Texas and Virginia.

Vitamin D kills prostate cancer cells in the laboratory. Now, specialists at the Hollings Cancer Center at the Medical University of South Carolina are studying whether vitamin D will halt the cancer’s progression in early-stage patients.

Drs. Sebastiano Gattoni-Celli and David Marshall hope to add a large dosage of vitamin D to “watchful waiting.”

Watchful waiting is an approach some men with slow-growing prostate cancer choose. Doctors monitor the disease for signs of growth. If and when that occurs, treatment may be sought.

“We offer something more than monitoring,” said Gattoni-Celli, principal investigator.

That “something more” is vitamin D — a nutrient mainly absorbed through sun exposure and long touted as a cancer-prevention agent.

The prostate is a walnut-sized gland below the bladder responsible for making and storing fluid that transports sperm. The gland is known to sequester vitamin D, which helps it function.

The recommended daily dose of vitamin D for men ages 51 to 70 is 400 International Units, or IUs. Study participants take 4,000 IUs of vitamin D daily.

The Food and Drug Administration approved the study-prescribed dosage as having minimal to no toxicity, said Gattoni-Celli, who has taken 4,000 IUs of vitamin D daily for three years.

“A good number of people may be deficient in vitamin D because we live and work indoors,” he said.

Participants in the watchful waiting and vitamin D study are monitored every eight weeks. If their levels of prostate-specific antigen — a protein found in blood that correlates with prostate cancer — rise twice consecutively, they will be counseled to reassess their treatment options.

Vitamin D is found in fortified milk, eggs and fatty fish, but people absorb most of what they need through ultraviolet rays. Fifteen minutes of sun exposure twice a week to the face, arms, hands or back without sunscreen is sufficient for most people to produce enough vitamin D, according to the National Institutes of Health.

People with dark skin might have difficulty getting enough vitamin D from the sun. Increased melanin, which gives dark skin its color, reduces the skin’s ability to synthesize the vitamin from sunlight.

Gattoni-Celli said he is not surprised by the fact that prostate cancer affects black men disproportionately. “The hunch is there,” he said about a link between vitamin D and prostate cancer, but the reality of collecting scientific evidence requires patience.

Patients can opt out of the study any time to pursue treatment, said Marshall, the study’s co- investigator. The only risk of watchful waiting is that treatment later might prove more complex than if used earlier, he said.

Watchful waiting is advisable because some forms of prostate cancer can proceed very slowly, Gattoni-Celli said.

Autopsies of older men who died of causes other than prostate cancer revealed that 50 percent of them had the disease, Gattoni-Celli said.

Some experts now worry that prostate cancer might be overdiagnosed and overtreated with the increased availability of prostate-specific antigen screening in the last 25 years. Men who otherwise might have lived the rest of their lives without suffering symptoms of the disease now could be receiving aggressive treatment.

Some prostate cancer patient advocates are critical of the watchful waiting approach, however.

Bob Strobel leads the Charleston chapter of Us TOO, a prostate cancer education and support group. “Anytime someone mentions watchful waiting to someone with prostate cancer, you’ll see them get irate,” he said.

Strobel pointed to advances in treatments. “The things that are happening now with medical treatment, it’s astounding,” he said.

Treatments include the surgical removal of the gland, radiation and hormone therapy. Doctors also can implant radioactive seeds into the gland or freeze the cancer. All treatment options can cause problems such as incontinence and erectile dysfunction.

Packaging companies have simplified the act of dispensing nutritional supplements every day across the nation. Some people have chosen a certain method of taking nutritional supplements because that method is faster and easier than all the others on the market today. A nutritional supplement cannot do a body good if it is not taken orally as directed on the packaging. Continue Reading…