Product News and Recalls

Firm advertised willingness to approve dangerous implant

Reporters with the U.K. newspaper The Daily Telegraph and the British Medical Journal visited a Slovakian firm as part of an undercover investigation into the European Union’s approval process for medical devices. The firm, EVPU, is one of the private companies authorized to license medical implants for the EU.

Posing as representatives of a fictitious Chinese company, the reporters presented plans for an all-metal artificial hip joint. Those plans were overtly ...

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Diabetes drugs Januvia and Byetta linked to cancer

A study suggests that two diabetes drugs – Januvia and Byetta – may raise the risk of pancreatitis and pancreatic cancer, according to a story in USA Today. The study found that Byetta may also carry an increased risk of thyroid cancer.

Lopez McHugh is reviewing cases involving pancreatic cancer with Januvia and Byetta. If you or a loved one received this diagnosis while on either of these drugs, call or ...

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Editorial: FDA justified in energy drink concerns

An editorial in the Pittsburgh Post Gazette praises the U.S. Food and Drug Administration for investigating highly caffeinated energy drinks, in light of agency documents suggesting they may be linked to a number of health problems and deaths.

The editorial specifically mentions 5-Hour Energy Shots. FDA reports link the product with 92 adverse events, including 33 hospitalizations and 13 deaths. Other FDA reports have linked Monster Energy with five deaths and one heart attack since 2004. And Rockstar Inc.’s energy drinks, ...

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Doctor weighs in on energy drink concerns

In an opinion piece for CBS 4 out of Denver, medical editor Dr. Dave Hnida weighs in on the recent concerns that the U.S. Food and Drug Administration has been issuing about high-caffeine energy drinks.

According to Hnida, the biggest concerns have been about four drinks in particular — Red Bull, RockStar, 5 Hour Energy, and Monster.

Recently released FDA reports have linked Monster Energy with five deaths and one heart attack ...

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Jurisdiction questions may have prevented action on bed rails

Questions about jurisdiction may have held federal regulators back from investigating potential hazards that bed rails in hospitals and nursing homes present for seniors, the New York Times reports.

The rails are metal bars that assist patients in pulling themselves up and prevent them from rolling out of bed. They can be hazardous when patients, especially those with Alzheimer’s, get confused and trapped between a bed rail and a mattress.

According to the New York Times, the U.S. Food and Drug Administration ...

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FDA issues recall for defibrillators

The U.S. Food and Drug Administration has issued a Class 1 recall for certain models of the HeartSine Samaritan 300/300P Public Access Defibrillator.

According to the FDA, the problematic models were manufactured and distributed from August, 2004, through January, 2011.

The problems with the devices are twofold.

Some of the devices have been found to intermittently turn on and off, which may eventually deplete the battery. Also, certain devices that contain early versions of the battery management software may misinterpret a temporary drop ...

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