Medication & Supplement Alert

Anesthesia
There are new concerns about an increased risk for learning problems in very young children exposed to general anesthesia during surgical procedures,,, according to a study published in the November issue of Pediatrics. The FDA requested and funded the study. About 37% of children who had had multiple surgeries requiring general anesthesia before age 2 had learning disabilities, compared to 24% of children who had just one surgery and 21% of children who had no surgeries.

Antibiotics
According to a recent editorial in Nature, entitled "Stop the killing of beneficial bacteria", experts hint that sometimes, our friendly flora never fully recover from antibiotic use. These long-term changes to the beneficial bacteria within people’s bodies may even increase our susceptibility to infections and disease. Overuse of antibiotics could be fueling the dramatic increase in conditions such as obesity, type 1 diabetes, inflammatory bowel disease, allergies and asthma, which have more than doubled in many populations.

Not surprisingly, an American Journal of Gastroenterology study found that people who are prescribed a large number of antibiotics tend to have a higher risk of inflammatory bowel disease (IBD), Researchers found 12 percent of people diagnosed with ulcerative colitis and crohn's diisease had been prescribed three or more antibiotics two years before compared to seven percent without the disease.

Antipsychotics
The antipsychotic drug asenapine maleate (Saphris) can cause life-threatening allergic reactions, even at the first dose, the FDA said. Label information for the drug will be updated to include a section about the risk, according to an FDA drug safety communication. Agency staff, searching the FDA's adverse event reporting system, discovered 52 reports of type I hypersensitivity reactions following asenapine dosing. These reactions can range from rashes and wheezing to full-blown anaphylaxis.

Aspirin
While many welcome the recent data showing aspirin's protective effect against bowel cancer in those with a family history, we must remind everyone that aspirin is not "one-size-fits-all". Case in point: frequent use of aspirin is associated with early aging macula disorder (AMD), as well as wet late AMD, especially in those who take aspirin daily, according to a new study in Ophthalmology.

Additionally, the risk of gastrointestinal (GI) bleeding needs to be considered when determining the potential preventive benefits associated with low-dose aspirin for cardiovascular disease and cancer. According to a new study in Clinical Gastroenterology and Hepatology, the use of low-dose aspirin increases the risk for GI bleeding, with the risk being increased further with accompanying use of cardiovascular disease-preventing therapies, such as clopidogrel and anticoagulants.

Diabetes Drugs
Two newer drugs used to treat Type 2 diabetes could be linked to a significantly increased risk of developing pancreatitis and pancreatic cancer, and one could also be linked to an increased risk of thyroid cancer. According to U.S. Food and Drug Administration's database for adverse events reported between 2004 and 2009 among patients using the drugs sitagliptin and exenatide, there was a six-fold increase in the odds ratio for reported cases of pancreatitis, compared with four other diabetes therapies they used as controls. Patients who took the two drugs were also more likely to have developed pancreatic cancer than those who were treated with the other therapies. The study is published in the journal Gastroenterology.

General Medication Use
Common medications may account for 10% of all lower urinary tract symptoms (LUTS) in men, but doctors may neglect to take the effects of these medications into account,according to a studies in Archives of Internal Medicine and British Journal of Urology International. Antihistamines, bronchodilators, sympathomimetics, anticholinergics, diuretics, and antidepressants were all indicated.

NSAIDs
Use of acetaminophen and nonaspirin nonsteroidal anti-inflammatory drugs was associated with a significantly increased risk for developing renal cell carcinoma, according to data presented at the 10th AACR International Conference on Frontiers in Cancer Prevention Research. The Harvard Medical School and Brigham and Women's Hospital in Boston demonstrated that any use of acetaminophen was associated with a 33 percent increased risk for RCC, and use of other NSAIDs was linked with a 26 percent increased risk. No significantly increased risk for RCC was found with the use of aspirin.

PPIs
Proton pump inhibitors may actually be aggravating damage in the small intestine caused by the nonsteroidal anti-inflammatory drugs, also known as NSAIDs. In a study published in the medical journal Gastroenterology, the extent of the hard-to-detect damage caused to the small intestine has only recently been discovered through use of small video cameras swallowed like pills. Suppressing acid secretion is effective for protecting the stomach from damage caused by NSAIDs, but these drugs appear to be shifting the damage from the stomach to the small intestine, where the ulcers may be more dangerous and more difficult to treat.

Reclast
Zoledronic acid (Reclast, Novartis Pharmaceuticals), an injectable bisphosphonate used to prevent and treat osteoporosis, is now contraindicated for patients with creatinine clearance below 35 mL/min or evidence of acute renal impairment, according to a label change announced recently by the US Food and Drug Administration (FDA). The revision, which also includes an updated warning on kidney impairment, comes in the wake of continued cases of fatal acute renal failure associated with the drug.

Statins
A Journal of Neurochemistry study recently explained why some experience neurological dysfunction when on statin medication: "cholesterol is highly enriched in the brain, and plays a key role in synapse formation and function. The brain does not derive cholesterol from the circulation; instead, the majority of cholesterol is made in glia and secreted in form of lipoproteins. Neurons can synthesize cholesterol, but the extent of neuronal cholesterol biosynthesis in the adult brain is unknown. Cholesterol biosynthesis inhibitors of the statin family are widely used to lower circulating cholesterol and cardiovascular risk. Lipophilic statins can cross the blood brain barrier and inhibit brain cholesterol biosynthesis with possible consequences for synaptic cholesterol homeostasis. We have investigated the effects of lovastatin on synapse maturation and synaptic vesicle release. Treatment of primary hippocampal neurons with low levels of lovastatin for one week reduced synapse density and impaired synaptic vesicle release. Neither lipoproteins nor geranylgeraniol fully counteracted the lovastatin-induced decrease of synaptic vesicle exocytosis, even when cholesterol depletion was prevented. In contrast, restoration of neuronal cholesterol synthesis with mevalonate prevented defects in vesicle exocytosis without fully normalizing neuronal cholesterol content. These results raise the possibility that chronic exposure of neurons to lipophilic statins may affect synaptic transmission, and indicate that hippocampal neurons need a certain level of endogenous cholesterol biosynthesis."

Steroids
People taking oral steroids are twice as likely as the general population to have severe vitamin D deficiency, according to a study in Journal of Clinical Endocrinology and Metabolism. Physicians should more diligently monitor vitamin D levels in patients being treated with oral steroids.

Thyroid OTC Supplements
People who use over-the-counter "thyroid support'' supplements should only do so through a licensed health professional. These supplements contain varying amounts of thyroid hormones and without supervision, can adversely effect thyroid levels, according to the American Thyroid Association.

TNF-Alpha Inhibitors
The boxed warning on the labels of all tumor necrosis factor alpha (TNF-alpha) inhibitors will be updated to warn about the risk for serious and sometimes fatal infection from 2 bacterial pathogens, Legionella and Listeria, the US Food and Drug Administration (FDA) announced recently. TNF-alpha blockers are used to treat rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, plaque psoriasis, and juvenile idiopathic arthritis, as well as Crohn's disease and ulcerative colitis. Because they suppress the immune system, these drugs come with a known risk for serious, life-threatening, opportunistic infections, which is a risk previously highlighted in the boxed warning on their labels.

Vitamin D
Inaccurate labeling and composition of dietary supplements led two patients to take massive overdoses of vitamin D -- and in neither case was it easy to identify the source of the patient's vitamin D Intoxication, according to the Journal of Clinical Endocrinology & Metabolism. After repeated questioning, the patient said they'd been taking multiple dietary supplements for two months, which had been prescribed for them by physicians. Ultraviolet spectrophotometry and high-performance liquid chromatography revealed that one supplement contained 186,400 IU of vitamin D3, instead of the 1600 IU that was the stated dose on the label. On top of that, the instructions mistakenly recommended 10 capsules a day, instead of one. In other words, the patients took more than 1.8 million IU of vitamin D3 daily for two months, more than a thousand times what the manufacturer had led the patient to believe he was ingesting. While they complained of malaise and their calcium levels were tremendously high, both patients were back to normal health quickly after stopping the supplements and no long-term effects occurred. Bonnie - this is why you must know or trust someone who knows supplement manufacturers!

Yaz
There are new safety concerns about the popular birth-control pill Yaz. Government scientists say the Bayer drug and other newer birth-control pills that contain the synthetic hormone drospirenone appear to increase the risk of dangerous blood clots. A new study released by the Food and Drug Administration reviewed the medical history of more than 800,000 American women taking different forms of birth control between 2001 and 2007. On average, women taking Yaz had a 75 percent greater chance of experiencing a blood clot than women taking older birth-control drugs. Yaz contains estrogen along with drospirenone, a next-generation synthetic hormone known to increase potassium levels in the blood.