Prescription drugs should be safe if approved by the Food and Drug Administration. Unfortunately, many are not and the result could be debilitating injury or death for the patient. Same goes for over the counter products. This makes Americas Watchdog barking mad! Huge profits over safety is criminal.

Bausch + Lomb is conducting a voluntary recall of its PreserVision® Eye Vitamin AREDS 2 Formula with Omega 3 Soft Gels, available solely in the United States, announced the U.S. Food and Drug Administration (FDA).

Two weeks ago, as a “precautionary” measure, the company pulled specific lots of its ReNu Multi-Purpose Solution and ReNu MultiPlus multi-purpose solution in Europe and the Middle East.

Continue Reading »

The U.S. Food and Drug Administration (FDA) has said psychiatric side effects among Chantix users included 98 reports of suicide and 188 reports of attempted suicide. Although some psychiatric problems could have resulted from nicotine withdrawal, the agency affirmed that incidents occurred while Chantix users were still smoking.

Now, there is additional evidence linking aggressive behavior and violence to the stop-smoking drug, said WebMD. The medication is so potentially dangerous that its use should be restricted to exclude police, military, and similar jobs in which workers carry weapons, says Thomas J. Moore, senior scientist for drug safety and policy at the Institute for Safe Medication Practices in Horsham, Pa. Moore is one of three authors who wrote the new report just published in Annals of Pharmacotherapy, said WebMD.

Continue Reading »

Mega-company GlaxoSmithKline has admitted it wasn’t up-front about divulging its involvement in a paid medical journal supplement last year. According to The Wall Street Journal, the firm also admitted the piece, which appeared in the May 2009 edition of  Urology, improperly discussed unapproved uses of its prostate-shrinking drug Avodart.

The disclosure comes as drug makers are under fire for their roles in spinning favorable articles about their wares in medical journals, which can sway doctors’ prescribing decisions. Also, accusations of gorilla marketing and improper research procedures have been at the crux of legal wrangling, which has forced the industry to unwillingly shell out billions of dollars these past years.

Continue Reading »

Airgas South, Inc., a distributor of industrial, medical, and specialty gases, has expanded a voluntary recall of medical gas products filled at its Chattanooga, Tennessee facility, announced the U.S. Food and Drug Administration. The call back is a precautionary measure because these products might have been manufactured under conditions that did not sufficiently comply with current Good Manufacturing Practices (cGMPs).

The potential for serious medical problems is remote. Other than one initial complaint of a contaminated cylinder which triggered the initial recall, Airgas South is not aware of any other confirmed events involving cylinder contamination.

Continue Reading »

J & H Besta Corp. of Hicksville, NY, has been informed by the Food and Drug Administration (FDA) that lab analysis of Joyful Slim Herb Supplement distributed by the company was found to contain undeclared Desmethyl Sibutramine.

Sibutramine is an FDA-approved drug used as a weight loss appetite suppressant; however, this herb supplement is not approved so the safety and effectiveness is unknown.

Continue Reading »

The U.S. Food and Drug Administration (FDA) announced that Cook has voluntarily recalled certain lots of its Ciaglia Blue Rhino and Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays that contain a Covidien 6PERC or 8PERC Shiley™ Tracheostomy Tube.

Covidien has initiated this recall of certain lots of cuffed Shiley™ tracheostomy tubes due to the product’s cuff not holding air because of leaks in the pilot balloon inflation assembly. If a cuff does not hold air, ventilation will be adversely affected since the ability to generate positive pressure in the airway could be compromised by lack of cuff seal.

Continue Reading »

Chinese authorities neglected to investigate their country’s adulterated heparin ingredients, despite US Food & Drug Administration (FDA) officials repeatedly requesting them to do so, according to a US congressional probe. Between 2007 and 2008, contaminated heparin using a raw ingredient manufactured in China, was associated with 81 US deaths and hundreds of illnesses.

Texas Reps. Joe Barton and Michael Burgess said FDA officials told them the tainted heparin investigation has been “severely hampered” by China not cooperating in finding those responsible, wrote The Wall Street Journal.

Continue Reading »

GlaxoSmithKline has been ordered to stop recruiting patients for its Avandia trail called TIDE (Thiazolidinedione Intervention With Vitamin D Evaluation), which compares the drug’s long-term effects with Actos, a competing diabetes drug.

The Food & Drug Administration (FDA) decision comes on the heels of an advisory panel vote–20 to12–to keep Avandia on the market. Ten voted that its sales be restricted and label warnings stronger; 7 wanted solely to support enhanced warnings; and 3 said that the drug should continue as is without any warning changes. Nineteen panelists said TIDE should continue, while 11 opposed.

Continue Reading »

No to Avastin is the recommendation by a U.S. Food & Drug Administration (FDA) advisory panel. The group voted 12-1 to revoke the controversial breast cancer treatment after follow-up studies failed to reveal significant benefits for breast cancer patients, wrote the Associated Press (AP).

Although the FDA is not mandated to follow recommendations of advisory panels, it usually does. But when the agency first approved Avastin for breast cancer treatment, it did so against the advice of such a panel. Avastin is now the world’s best selling cancer drug.

Continue Reading »

Zinc nasal sprays such as Zicam have been associated with loss of smell, known as anosmia, before. Now a new study involving 25 patients at a nasal dysfunction clinic indicates that over-the-counter (OTC) homeopathic nasal remedies containing zinc support those claims, according to WebMD.

University of California, San Diego professor and clinic director Terence M. Davidson, MD affirms the analysis supports the hypothesis. And he says that the effectiveness of zinc-containing products for preventing or shortening cold spans has never been proven.

Continue Reading »