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Unique Pharmaceuticals Sterile Drugs Recalled Due to Unsanitary Conditions

Healthcare professionals and consumers should not use sterile drug products manufactured by Texas-based Unique Pharmaceuticals, the U.S. Food and Drug Administration (FDA) warned. Furthermore, the agency is instructing consumers to voluntarily recall the products. The warnings are prompted by an inspection showing that the facility had unsanitary conditions that could contaminate the products. More Unique Pharmaceuticals Sterile Drugs Recalled Due to Unsanitary Conditions

9/11 Zadroga Act Deadlines are Fast Approaching

Patients who are suffering from certain types of recognized World Trade Center-related cancers are running out of time to register for the James Zadroga September 11 Victim Compensation Fund (VCF).

Members who were diagnosed on or before October 12, 2012 with one of the cancers first recognized by the VCF on that date have until October 12, 2014 to register. More 9/11 Zadroga Act Deadlines are Fast Approaching

Pradaxa-maker Kept FDA in Dark about Bleeding Risks

Regulators were kept in the dark about important data Boehringer Ingelheim had about the safety of its oral direct thrombin inhibitor dabigatran (Pradaxa) while the drug was under review for approval in nonvalvular atrial fibrillation (AF), according to several documents published Wednesday in the British Medical Journal (BMJ).

The four documents indicate that Boehringer Ingelheim didn’t share its own analysis with U.S. or European regulators suggesting a severe reduction in bleeding risk when Pradaxa was dosed with guidance from anticoagulation monitoring. It is likely this information was withheld because if it made its way to the regulators, it would have undermined the key Pradaxa marketing message that no such monitoring would be required, reported. One of alleged benefits of Pradaxa was that unlike warfarin, routine monitoring was not required. More Pradaxa-maker Kept FDA in Dark about Bleeding Risks

FDA Plans August Meeting to Discuss the Confidentiality of Cardiovascular Outcomes Trials

The U.S. Food and Drug Administration (FDA) announced Monday that it will hold a public meeting in August on ways to keep cardiovascular outcomes trials (CVOTs) confidential until they are completed.

Drug manufacturers have typically been required to conduct extensive clinical trials to assess the cardiovascular risks associated with their products to the tune of upwards of tens of thousands of dollars. Since the mid-2000s, the FDA has approved many drugs on the condition that drug companies complete mandatory trials by pre-specified dates, according to More FDA Plans August Meeting to Discuss the Confidentiality of Cardiovascular Outcomes Trials

California Halts Fracking Waste Injections amid Contamination Concerns

An emergency shutdown of 11 oil and gas waste injection sites has been ordered by California officials due to concerns companies may have been pumping fracking liquids and other waste into drinking water aquifers.

California’s Division of Oil and Gas and Geothermal Resources (DOGGR) distributed cease and desist orders to seven energy companies warning that they may be injecting flacking fluids into aquifers that could be a source of drinking water. The DOGGR said that their waste disposal “poses danger to life, health, property, and natural resources,” reported. The state has confirmed that its investigation has been expanded to look at additional wells.

The order comes at a time when central California has been enduring a lengthy drought that has emptied reservoirs and cost the state $2.2 billion this year alone, according to The drought has forced many farmers across the state to supplement their water supply from underground aquifers, which is where the dangers of the fracking liquid come into play.

According to, at least 100 of California’s aquifers were believed to be useless for drinking and farming due to poor quality, or because the aquifers were too deep underground to easily access. Several years ago California exempted those aquifers from environmental protection, which permitted the oil and gas industry to intentionally pollute them. However not all aquifers are exempted, which causes the system to be a mixture of protected and unprotected water resources deep underground.

According to the cease and desist orders, it looks likely that at least seven injection wells have been pumping fracking waste into fresh water aquifers protected by the law, and not other aquifers sacrificed by the state long ago, reported.

“The aquifers in question with respect to the orders that have been issued are not exempt,” Ed Wilson, a spokesperson for the California Department of Conservation told via email.

A 2012 investigation by ProPublica into more than 700,000 injection wells across the U.S. revealed wells were often poorly regulated and experienced high rates of failure. This information indicated that fracking practices were likely polluting underground water supplies that are supposed to be protected by federal law. Several of those water supplies are at the heart of this issue. The exempted aquifers were poorly defined and vaguely outlined, according to documents the state filed with the U.S. Environmental Protection Agency (EPA) in’81.

This is not the first time California has expressed concern over fracking practices. In September 2013 the California Coastal Commission raised questions about the potential impact of offshore fracking by the federal government.

The commission, which oversees part of the coast’s development, also asked both the EPA and Department of the Interior to investigate what the federal government is doing, the Wall Street Journal reported. The commission’s biggest concern is that such offshore oil-rig fracking will increase the possibility of oil spilling into the ocean.

Hysterectomy Procedure may Spread Cancer

A new study has provided more evidence that a hysterectomy procedure known as power morcellation may spread cancer.

The procedure, performed on about 50,000 women a year, uses a device to cut uterine tissue into pieces before removing them through small incisions made during minimally invasive surgery, the New York Times reported. The procedure is also used to remove fibroid tumors. More Hysterectomy Procedure may Spread Cancer

Tylenol no Better than Placebo for Back Pain

A large extensive trial has found that when it comes to treating back pain, acetaminophen works no better than a placebo.

The findings go against what consumers have been told for years. Advertisement after advertisement has included claims that acetaminophen, sold under brand names like Tylenol and Panadol, is the best option to treat back pain. Even medical guidelines around the world recommend acetaminophen as a go-to treatment. More Tylenol no Better than Placebo for Back Pain

Health Canada Warns of Dangers of Testosterone Products

Testosterone hormone replacement products carry a risk of serious and possibly life-threatening cardiovascular (heart and blood vessel) problems, according to a new health advisory released by Health Canada.

Testosterone hormone replacement products are intended to be taken by men who are experiencing medical conditions because their body cannot make enough testosterone. However, many of the products are also marketed to improve sex drive and end up being taken by men who do not have a medical condition. More Health Canada Warns of Dangers of Testosterone Products

FDA Warns of Tainted Weight Loss Supplements

The U.S. Food and Drug Administration (FDA) is warning consumers to not buy or use several tainted supplements promoted for weight loss or body building. Included in the FDA’s warning are: Mix Fruit Slimming; Trim-Fast Slimming Softgel; Lingzhi Cleansed Slim Tea; Sliming (sic) Diet By Pretty White; Lipo 8 Burn Slim; and 24 Ince.

The warning was issued after FDA lab analyses confirmed that sitbutramine, a controlled substance withdrawn from the market, was an active ingredient in Mix Fruit Slimming, Trim-Fast Slimming Softgel, Lingzhi Cleansed Slim Tea, Sliming (sic) Diet By Pretty White, Lipo 8 Burn Slim, and 24 Ince. More FDA Warns of Tainted Weight Loss Supplements

FDA Cites HeatWare for Controller Failures Linked to Two Deaths

The U.S. Food and Drug Administration (FDA) has published a letter that accuses HeartWare International of design and software malfunctions that may have led to serious injuries and death.

In the letter, the FDA said it was notified that HeartWare received 27 complaints about controller failure for its ventricular assist device, of which electrostatic discharge was determined to be the most likely cause, the Worcester Business Journal reported. Included in the complaints are reports of two deaths and four serious injuries. More FDA Cites HeatWare for Controller Failures Linked to Two Deaths