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List of Withdrawn Pediatric Cold Medicines

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The following medicines are among those that have been withdrawn from the market by their manufacturers for treatment of coughs and colds in infants. If you have any of these medicines at home, it would be wise to discard them to avoid accidental administration.

If you wish to use any of these medications for children between the ages of 2 -6, please contact your pediatrician for additional information. Be advised that their use in the 2-6 age group, while not covered by the current voluntary withdrawal, remains controversial.

Manufactured by Johnson & Johnson:

  • Concentrated Infants’ Tylenol Drops Plus Cold
  • Concentrated Infants’ Tylenol Drops Plus Cold & Cough
  • Pediacare Infant Drops Decongestant (PSE)
  • Pediacare Infant Drops Decongestant & Cough (PSE)
  • Pediacare Infant Dropper Decongestant (PE)
  • Pediacare Infant Dropper Long-Acting Cough
  • Pediacare Infant Dropper Decongestant & Cough (PE)

Manufactured by Novartis:

  • Triaminic Infant & Toddler Thin Strips Decongestant
  • Triaminic Infant & Toddler Thin Strips Decongestant Plus Cough

Manufactured by Prestige Brands Holding

  • Little Colds Decongestant Plus Cough
  • Little Colds Multi-Symptom Cold Formula

Manufactured by Wyeth Labs

  • Dimetapp Decongestant Infant Drops
  • Dimetapp Decongestant Plus Cough Infant Drops
  • Robitussin Infant Cough DM Drops

Source: FDA

Baby Cold Medicines Withdrawn

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In a voluntary drug withdrawal initiated by the FDA, major manufacturers of over-the-counter cold and cough medicine targeted to infants have withdrawn their products.

The stated reason was to avoid misuse by misinformed parents. The withdrawal only affects products for infants, leaving products for use in children 2 and older on the market.

Further research, and further negotiations between pharmaceutical companies and the FDA will decide the fate of cold medicines marketed to the 2 – 6 year old population.

In the New York Times, Dr. Daniel Fratarelli, a pediatrician on the American Academy of Pediatric’s committee on drugs stated in regard to pediatric cough and cold medicines, "I don’t recommend their use in any child… These medicines don’t help, they may hurt, so don’t use them."

Obesity linked to increased risk of esophageal cancer

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Writing in the aptly named online journal Gut, Australian researchers have discovered a disproportionate incidence of increased esophageal cancers in overweight individuals.

According to the researchers, those with a "body mass index (BMI) of 40 or more, were six times as likely than those with a BMI of between 18.25 and 25."

Gastric reflux increased the incidence of this cancer 5X, and combined with obesity, the risk increased 15X.

Men 50 years old and younger were particularly vulnerable.

When Yoga and Pilates Go Bad

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LJK, a New York businessman and former movie studio executive had just assumed his normal pilates position when he felt and heard a distinct "pop" in his lower back. This was accompanied, he said, "by some of the worst pain I’ve ever had in my life."

It took four ambulance attendants to carry him down a flight of stairs from the upper East Side pilates studio to the waiting ambulance.

The diagnosis? A ruptured lumbar disc. The treatment? Surgery to remove disc fragments impinging on LJK’s spinal cord.

He joined one of over 13,000 Americans treated in ERs during just the last year alone for yoga and pilates-related injuries.

His lesson, and the lesson for other yoga/pilates devotees is that your body isn’t a pretzel, and the effects of aging on joints and spinal columns doesn’t magically disappear through the ministrations of yoga. You must slowly learn these disciplines, and you must find a well-trained instructor. And even with all of these precautions, one wrong move can spell disaster.

Don’t necessarily trust the perfectly-sculpted instructor at your health club for instruction. And, by the way, don’t expect yoga or pilates to peel off the inches or pounds. For that you’ll need to hit the cardio machines or spinning classes.

Epilepsy Drug Topamax Helps Alcoholism Treatment

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A drug called Topamax (topiramate) has been found to help alcoholics quit drinking excessively, according to a University of Virginia study. The drug is not FDA approved for treatment of alcoholism, but has been prescribed off-label by doctors to treat the condition.

Topiramate (brand name Topamax) is an anticonvulsant drug produced by Ortho-McNeil Neurologics, a division of Johnson & Johnson. The drug is FDA-approved for treatment of epilepsy and for the prevention of migraines.

To test the drug’s efficacy in treating alcoholism, researchers conducted a 14-week study of 317 alcoholics. Half of the participants were given a placebo and the other half were given Topamax.

The study found that participants on Topamax reduced their alcohol intake from 11 drinks per day on average, to just 3.5 drinks per day. Furthermore, while only abstaining from drinking 3 days per month at the start of the study, by the end of the study they were abstaining from drinking about 15 days per month.

The placebo group also drank less during the study. However, by the end of the study, they abstained from drinking 10 days per month and consumed six drinks per day on average.

The most common side effects of Topamax include a change in taste (carbonated beverages, especially diet sodas and beer, taste particularly bad) and feelings of pins and needles in the head and extremities. Less common side effects include cognitive deficiency (particularly word-finding difficulty); grogginess; lethargy; renal stones, impairment of fine motor skills; vision abnormality and transient or permanent vision loss; weight loss; breast pain; abdominal pain; intense sweating; menstrual disorder; taste changes; pharyngitis; sinusitis; diplopia; rash; leukopenia; fatigue; dizziness; insomnia; anxiety; depression; paresthesia; diarrhea; nausea; dyspepsia; constipation; dry-mouth; dysmenorrhea.

Sources:

  • New Scientist October 10, 2007
  • FDA

Lidocaine Derivative (QX-314) with Capasicin Key to Pain-Specific Local Anesthesia Technique

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Researchers from Massachusetts General Hospital and Harvard Medical School have found a way to target only pain-sensing neurons when injecting a local anesthetic. The technique blocks pain without affecting motor function or sensitivity to non-pain stimulus.

While current local and general anesthetics work well for controlling pain, since they work by interfering with the excitability of all neurons and not just pain-sensing neurons, they produce dramatic side effects—loss of consciousness for general anesthetics, and loss of motor function for local anesthetics.

The experimental results were achieved in rats by combining a normally inactive lidocaine derivative (QX-314) with capasicin, the "hot" ingredient in chili peppers.

According to the researchers, the results of their new technique were achieved by taking advantage of a membrane-spanning protein called TRPV1, which is unique to pain-sensing neurons. TRPV1 forms a large channel, where molecules can enter and exit the cell. But a "gate" typically blocks this opening. In this case, that gate is opened when the cells are exposed to the heat of the capsaicin. Non-pain sensing neurons are unaffected because they do not possess TRPV1.

The lidocaine derivative QX-314 is not used clinically because it can’t penetrate cell membranes to block the excitability of the cell, so it typically remains outside the neurons. In this case, that property is a benefit to the new pain management technique. When pain-sensing neurons are exposed to capsaicin, however, QX-314 can enter the cells and shut them down. But the drug remains outside other types of neurons that do not contain these channels so they retain their ability to send and receive signals.

"We’re optimistic that this method will eventually be applied to humans and change our experience during procedures ranging from knee surgery to tooth extractions," says the study’s senior author, Professor Clifford Woolf of Massachusetts General Hospital. "Eventually this method could completely transform surgical and post-surgical analgesia, allowing patients to remain fully alert without experiencing pain or paralysis."

The study appears in the October 4, 2007 issue of Nature.

Source: Harvard Medical School

Low Level Lead Exposure Leads to Chronic Renal Disease in Animal Study

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While lead exposure has long been associated with hypertension, arteriolosclerosis and kidney disease, a new animal study from the University of Florida, Gainesville indicates that even low level exposure to lead accelerates chronic renal disease–primarily by raising blood pressure and accelerating injury to kidney tissues and blood vessels.

The study used male rats which were fed a standard diet. In addition, 16 of the rats were given water with lead acetate at a dosage resulting in similar or slightly lower than the levels observed in subjects with occupational lead exposure. Thereafter they underwent remnant kidney (RK) surgery and afterwards continued on the lead acetate for 12 more weeks.

A control group also underwent RK surgery but without lead acetate. At eight and 12 weeks after surgery, the body weight of all the rats was measured and systolic blood pressure was assessed. Twelve weeks after RK surgery, kidney tissue was collected for histologic and molecular biologic studies from both groups.

Study Results
Lead treatment was well tolerated and resulted in modest elevations in whole blood lead levels. However, the lead exposure reduced body weight, increased blood pressure and worsened renal dysfunction.

Specifically, lead exposure:

  • was associated with higher systolic blood pressure and worse renal function, and with a tendency for greater urinary protein; and
  • while scarring in the renal capillary system tended to be worse in lead treated rats, the most striking finding was that kidney tissue disease (arteriolar disease, peritubular capillary loss, tubulointerstitial damage and macrophage infiltration) worsened with lead exposure. These developments were associated with the significantly increased renal expression of monocyte chemoattractant protein-1 mRNA.

According to Dr. Richard J. Johnson, the seior researcher, "This study examined the effect of mild, chronic lead intoxication in an experimental model of chronic renal disease. The dose of lead administered resulted in mild toxicity. This degree of lead poisoning was sufficient to cause higher blood pressures and accelerate the progression of renal failure."

Source: American Journal of Physiology—Renal Physiology (Online Edition)

Prostate Cancer Mortality Rate Lower with Surgery Than Other Treatment Options

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Prostate cancer patients who opt for radiation treatment, hormone therapy, observation, or other forms of treatment for localized prostate cancer have a higher rate of death within 10 years than patients who have undergone surgery for prostate cancer, according to a recent Swiss study, published in the Archives of Internal Medicine.

As there have not yet been any notable randomized trials for prostate cancer treatments, treatment decisions are currently strongly influenced by the patient and physicians’ personal perferences and experiences, say the study’s authors.

Researchers used data from the Geneva Cancer Registry to assess all 844 patients diagnosed with localized (not yet spread) prostate cancer in Geneva between 1989 and 1998.

Of those men, 158 received prostatectomy, or surgery to remove all or part of the prostate; 205 had radiation treatment (radiotherapy); 378 chose watchful waiting, which entails active follow-up and treatment if the disease progresses; 72 underwent hormone therapy; and 31 had another type of therapy.

After 10 years, survival rates were 83 percent for those who underwent surgery to remove the prostate (prostatectomy), 75 percent for radiation therapy, 72 percent for watchful waiting, 41 percent for hormone therapy and 71 percent for other treatments.

"At 10 years, patients treated with radiotherapy or watchful waiting had a significantly increased risk of death from prostate cancer compared with patients who underwent prostatectomy," the authors wrote.

The increased mortality associated with radiotherapy and watchful waiting was primarily observed in patients under 70 years of age and in patients with poorly differentiated tumors, or tumors that have certain cellular characteristics and are more likely to spread aggressively.

While the authors recognize that their study can be improved through randomized clinical trials, they noted that "until clinical trials provide conclusive evidence, physicians and patients should be informed of these results and their limitations."

Source: Archives of Internal Medicine  2007;167(18):1944-1950.

HAART Drug Cocktail May Halt HIV-Related Brain Damage

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A combination of antiretroviral drugs, known as Highly Active Anti-Retroviral Therapy (HAART), shows promise in halting brain damange caused by HIV, according to a Swedish research study published in the journal Neurology.

Participants were given the drug combination for a period of 12 months, and Researchers tested the subjects’ cerebrospinal fluid for the neurofilament light protein before, during and after treatment. The protein is a biomark for brain injury.

The researchers found that, of the 53 people in the study, approximately 40 percent had high levels of the protein at the commencement of treatment. After one year of treatment, only four of the participants still showed high levels of neurofilament light, suggesting that the drug combination not only treats the infections caused by HIV, but also appears to halt brain damage caused by the virus.

According to Åsa Mellgren, MD, PhD, an author of the study, HAART treatment "appears to halt the neurodegenerative process caused by HIV. This study confirms that neurofilament light protein serves as a useful marker in monitoring brain injury in people with HIV and in evaluating the effectiveness of HAART." He added that further study of the protein is needed that includes more extensive neurological measures, including cognitive testing.

Dr. Mellgren is from the Clinic of Infectious Diseases SÄS in Borås, Sweden, and the Sahlgrenska Academy at Göteborg University in Göteborg, Sweden. The study was supported by grants from the National Institutes of Health, Göteborg University, and Research Foundation of Swedish Physicians against AIDS.

Source: Neurology (October 9, 2007)

New Breast Cancer Gene HMMR Found

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Researchers have found a new gene called HMMR that, when mutated, may lead to a significantly greater chance of developing breast cancer. The study was a collaboration of international researchers from Spain, Israel, and several U.S. organizations.

The HMMR gene is mutated in about 10% of the population, while two other genes related to breast cancer, BRCA1 and CRCA2, are mutated in only about 0.3% of the popuation. According to the study’s authors, it’s important to identify more common breast cancer-related genes so that targeting the gene for early detection will have a greater impact.

The method of identifying the HMMR gene began with computer modeling to identify genes that impact cancer development and to see how they interact with other genes. Starting with four known breast cancer-related genes (BRCA1, BRCA2, ATM and CHEK2), researchers then showed that alterations of either BRCA1 or HMMR can lead to genetic instability and interfere with cell division.

To specifically understand whether variations in HMMR increased breast cancer risk, 923 women with breast cancer and similar women without breast cancer were analyzed in a study led by Gadi Rennert, M.D., director of the CHS National Cancer Control Center in Haifa, Israel. The results indicated that women in the study under 40 years of age with the HMMR variant (even after accounting for mutations in the BRCA1 or BRCA2 genes), had a 2.7 times greater risk of developing breast cancer than women without the variation.

The study was conducted among a population of Ashkenazi Jewish women, who have a higher risk of breast cancer than other groups.

The findings were verified in two other studies conducted in New York–one among another group of Ashkenazi Jewish women with a family history of breast cancer but no identified BRCA1 or BRCA2 mutations, and a third study of Jewish women with and without breast cancer in New York. Overall, 2,475 women with breast cancer and 1,918 healthy women were studied in Israel and New York.

The findings indicated that incidence of breast cancer was 23% higher in women who had one copy of the genetic variant, and 46% higher in women who had two copies of the variant. Researchers also concluded that HMMR may be associated with early-onset breast cancer, as the women with the HMMR variant were diagnosed about one year earlier than the control group.

"Identifying genes involved in cancer in the general population is important, because not all of the causes of breast cancer have been found. Through discoveries such as this, someday we might be able to more precisely estimate a person’s risk of cancer based on their genes," says study author Laura Rozek, Ph.D., a postdoctoral research fellow at the University of Medical School.

The study was funded by the National Cancer Institute, the National Institutes of Health, the Breast Cancer Research Foundation, the Niehaus, Southworth, Weissenbach Foundation, and the Koodish Foundation.

Sources: Nature Genetics, doi:10.1038/ngxxxx and University of Michigan