An FDA review published in The New England Journal of Medicine online led to concerns over how long women should continue using the drugs, known as bisphosphonates, which are sold as generic versions of brands like Fosamax and Boniva, as well as Novartis’s Reclast.

The concern is “rare but serious adverse events,” after prolonged use.  This includes unusual femur fractures, esophageal cancer and osteonecrosis of the jaw, a painful and disfiguring crumbling of the jaw bone.

The FDA’s analysis found little, if any, benefit from the drugs after three to five years of use.

The FDA report offered little specific guidance about long-term use.  It said that the decision to continue or stop treatment should be based on an individual assessment of risks, benefits and preferences discussed between a patient and her doctor. The agency did say that women at low risk for fracture or with a bone density near normal may be good candidates to stop therapy after three to five years, but older patients at higher fracture risk and bone density “in the osteoporotic range” may benefit from continued therapy.

Using Danish national registries, researchers studied over 1.5 million women without prior thrombotic disease or cancer, who were not pregnant. Overall, the incidence of venous thrombosis was 6.2 events per 10,000 exposure-years with combination oral contraceptives, 9.7 per 10,000 with the patch, and 7.8 per 10,000 with the ring.

Basically, when compared with women who used oral contraceptives, those who used the patch or ring had about twice the thrombosis risk. Compared to the women who didn’t use any hormonal method, the patch and ring users had eightfold and sixfold increases in risk, respectively.

The use of these contraceptive were not significantly associated with thrombosis risk.

The authors conclude that “women are generally advised to use combined oral contraceptives … rather than to use transdermal patches or vaginal rings.”

The infection, Clostridium difficile infection, also called C. difficile or CDI, is a hard-to-cure infection that causes severe diarrhea that has recently been linked to proton pump inhibitors (PPIs), the most powerful class of antacid drugs.

CDI is a spore forming bacteria which can be part of the normal intestinal flora without causing disease. The trouble starts when normal intestinal flora is altered, allowing CDI to flourish in the intestinal tract and produce a toxin that causes a watery diarrhea. Mild cases have frequent watery stools with a foul smell. The more severe cases develop painful colitis with accompanying abdominal cramps as well as prolonged diarrhea with blood and mucous. Severe cases may require hospitalization and quarantine.

So in other words, natural stomach acids do a great job of keeping CDI down.  However, because PPIs keep stomach acid below the levels that protect against this bad bug, it increased the risk in getting the infection.

Results from the new study show the use of acid-suppression therapy was associated with a significantly increased risk for the infection in a systematic review and meta-analysis of data from 30 studies.

According to PharmaGossip, although the tendering strategy was piloted in five Chinese provinces, it is generally referred to as the “Anhui model.” This is because in Anhui, the country’s fourth-poorest province, it has been shown to reduce prices of essential drugs by an average of 53% below their officially-set maximum retail prices, with some price levels being slashed as much as 90%. Currently, the tendering system covers 307 essential drugs but Ministers want to increase this to around 800 products, and also to cover the procurement of more expensive drugs used in hospitals in the treatment of diseases such as cancer. Research-based drugmakers say that doing so would force them to compete on price with generics makers, but supporters of the proposal point out that most such drugs are expensive imports.

Thirty-three cases of a rare, but serious, fungal eye infection have been confirmed across seven states. Federal officials are announcing that the infection stemmed from products mixed in a Florida compounding pharmacy.

it seems the victims underwent some sort of an eye procedure, either a surgery or injections. Of these, 23 suffered vision loss and 24 needed repeat surgery, according to the AP, citing a report by the U.S. Centers for Disease Control and Prevention (CDC).

According to AP, many cases were traced by health officials to a dye and an injection that included triamcinolone and other products that came from Franck’s Compounding Lab in Ocala, Florida. The U.S. Food & Drug Administration (FDA) tested unopened bottles and unused syringes of the dye collected from Franck’s Compounding Lab and discovered multiple bacterial and fungal species.

CDC officials said the investigation to identify the root cause is ongoing and warned doctors and patients to stay away from “compounded products labeled as sterile from Franck’s,” according to the report.

The FDA is also investigating the matter and has advised that any Brilliant Blue G (BBG) product from Franck’s be quarantined and returned. The FDA stated it received reports of fungal endophthalmitis (eye infections) in patients given BBG supplied by Franck’s Pharmacy during eye surgeries. BBG is not an approved drug in the U.S., noted the FDA.

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However, this drug is known to sometimes make the heart problems worse – even resulting in death.

In 2011, the FDA terminated a clinical trial of Multaq before the trial was completed. The trial was supposed to test Multaq’s effectiveness as a drug for people whose hearts did not beat in a steady rhythm without stimulation. However, a significant number of participants in the trial suffered from a stroke or heart attack after taking Multaq, while people in a control group who took a placebo instead of Multaq did not have abnormally high rates of these diseases. The data in this clinical trial suggested that taking Multaq can double a patient’s risk of heart attack or stroke if he or she has an abnormal heart rhythm.

Multaq had formerly been approved for use in people with heart conditions, but not people who had the particular condition being studied in the clinical trial. The FDA therefore reviewed data from previous clinical trials and determined that Multaq is safe for its original use, but is not safe for use in patients that have abnormal heart rhythms requiring permanent use of pacemakers or other stimulation devices. Furthermore, all patients that are on Multaq should be closely monitored by their physicians. It’s particularly important to take EKG readings to ensure that the patient’s heart has not developed an abnormal rhythm, as this would indicate that the patient is at risk of stroke or heart attack if he continues on this medication.

One company MuscleMeds, which produces the popular pre-workout supplement Code Red, deleted the product from its Web site. A receptionist was informing consumers that the product was being reformulated.

A Web page for Fahrenheit Nutrition, another one of the 10 companies that received the FDA letter, reflected that its Lean EFX product no longer had DMAA on the nutritional label. A man answering the phone at the number given on the company’s Web site said he couldn’t comment.

The FDA warning letters have already prompted retailers, such as Amazon, to stop carrying the DMAA products.  They are going to still, however, allow third party vendors to do so.

Yet, one company does not agree with the FDA warnings, and is disputing that the agency has not cited medical or scientific evidence showing that DMAA us unsafe.  The company owns the GNC health and wellness stores.   They are disputing a recent U.S. Food & Drug Administration’s (FDA) warning questioning the safety of DMAA dietary supplements. In a statement just issued, GNC asserted that the agency has not cited medical or scientific evidence showing that DMAA is unsafe. The company maintains that, when used as directed, DMAA supplements have “the same effect on the body as drinking two cups of coffee.”

According to the FDA, DMAA can narrow the blood vessels and arteries, which can elevate blood pressure and may lead to cardiovascular events ranging from shortness of breath and tightening in the chest, to heart attack, according to the agency. The FDA said it had received had received 42 adverse reports on products containing DMAA, including psychiatric disorders and death.

According to a HealthDay News the Institute of Medicine has suggested the FDA work to create a publicly-accessible database tracking these reports concerning prescription drugs. The database should, according to the report, contain a “risk- and benefit-assessment plan for each drug” and that information should include data from the time the drug reaches the market until the time it is removed.

That data should also include known side effects of the drugs, including individual incident reports on the patients who suffered those complications. Additional side effects should be noted as they appear among patients taking the drug. In addition to those reports, the FDA should also include any regulatory action the agency has taken on a particular drug.

Institute of Medicine believes having such a database in place will hopefully avoid some of the catastrophic failures of prescription drugs in the past, particularly the painkiller Vioxx, the Type 2 diabetes drug Avandia, and the cholesterol drug Crestor. Each drug was widely available and prescribed by doctors to millions of patients unbeknownst to them each party of the risks each drug carried. Data on the side effects suffered by patients taking these drugs was not widely reported as they were occurring and hence, more doctors prescribed the drug because the only information that was readily available did not make mention of the dangerous and life-threatening side effects being suffered by people currently taking the drugs.

They have cited 10 companies that manufacture and distribute dietary supplements containing dimethylamylamine, known as DMAA, for marketing products for which evidence of the products’ safety was not submitted to the agency.

DMAA is also known as 1,3-dimethylamylamine, methylhexanamine, or geranium extract. The ingredient is often marketed as a “natural stimulant” in dietary supplements.

The following companies received warning from the FDA and were warned that they were marketing products for which this requirement had not been met:

• Exclusive Supplements: Biorhythm SSIN Juice
• Fahrenheit Nutrition: Lean Efx
• Gaspari Nutrition: Spirodex
• iSatori Global Technologies, LLC: PWR
• Muscle Warfare, Inc.: Napalm
• MuscleMeds Performance Technologies: Code Red
• Nutrex Research: Hemo Rage Black, Lipo-6 Black Ultra Concentrate, Lipo-6 Black, Lipo-6 Black Hers Ultra Concentrate, Lipo-6 Black Hers
• SEI Pharmaceuticals: MethylHex 4,2
• SNI LLC: Nitric Blast
• USP Labs, LLC: Oxy Elite Pro and Jack3D

The agency’s letters advised the companies that it is not aware of evidence or history of use to indicate that DMAA is safe. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), manufacturers, marketers and distributors of dietary supplements are responsible to ensure that they are marketing a safe product.

The FDA also warned the companies that synthetically produced DMAA is not a “dietary ingredient” and is ineligible as an active ingredient in a dietary supplement. DSHEA defines a dietary ingredient as a vitamin, mineral, amino acid, herb or other botanical, a dietary substance for use by man to supplement the diet, or a concentrate, metabolite, constituent, extract, or combination of these substances.

Health Canada, the FDA equivalent in Canada, already banned DMAA in July of last year after finding it was not in fact a dietary supplement and instead was a drug that needed further approval.