New Report Shows FDA Failed to Adequately Address Opioid Crisis

A new report by researchers at Johns Hopkins University shows that the Food and Drug Administration (FDA) failed to adequately address the opioid epidemic that has caused enormous suffering throughout the United States. The documents show the FDA failed to appropriately conduct oversight of the pharmaceutical industry and did not adequately train doctors to handle opioids and the associated risk of addiction. These failures contributed to the rise of opioid addiction in the United States, which kills around 72,000 people per year.… Read the rest

Michael Moores CAPITALISM: A LOVE STORY in Action: The FDA’s Approval of Menaflex

Last week, just one week before the opening of Michael Moores new movie, Capitalism: A Love Story, the U.S. Food and Drug Administration (FDA) admitted what has been known for a while that its approval of the Menaflex device in December 2008, came after intense political pressure from politicians made just months after they received significant campaign contributions from the manufacturer of Menaflex.

In issuing its approval, the FDA overrode the agency’s scientific reviewers who repeatedly and unanimously over many years decided that the device was unsafe because the device often failed, forcing patients to get another operation. This was … Read the rest

Is Nothing Sacred Anymore? FDA Warns Bar-B-Q and Dessert Lovers to Guard Against E. coli

On June 19, 2009, the U.S. Food and Drug Administration (FDA) and the U.S. Centers for Disease Control and Prevention warned consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7. As of June 25, the CDC reported that 69 persons from 29 states have been infected with the outbreak strain. Thirty-four persons have been hospitalized, nine with a severe complication called hemolytic uremic syndrome. No one has died.

On June 25, 2009, the FDA found E. coli O157:H7 (a bacterium that can cause serious food … Read the rest

FDA Requires Boxed Warning on Serious Neuropsychiatric Events for Chantix and Zyban. Is a Ban Next?

The U.S. Food and Drug Administration (FDA) announced on July 1, 2009, that it is requiring manufacturers to put a Boxed Warning on the prescribing information for the smoking cessation drugs Chantix (varenicline) and Zyban (bupropion) and to update the Medication Guides for patients that further discuss the risk of mental health events when using these products. The warning will highlight the risk of serious mental health events including changes in behavior, depressed mood, hostility, and suicidal ideation and behaviors when taking these drugs.

The FDA has received additional information bolstering the suggestion of a possible association between both varenicline … Read the rest

FDA Advises Consumers to Stop Using Zicam; Active Ingredient Can Cause Loss of Smell

In a press release dated June 16, 2009, the U.S. Food and Drug Administration (FDA) advised consumers to stop use of three over-the-counter Zicam Cold Remedy products: nasal gel, nasal swabs and the discontinued “kids size” swabs. The FDA’s advisory stated that the products are associated with the loss of sense of smell, called anosmia.

Anosmia may be long-lasting or permanent. In addition to a loss of the sense of smell, patients have also complained of a loss of the sense of taste. The FDA has received more than 130 reports of loss of sense of smell associated with the … Read the rest

Fallout from Salmonella in Tainted Peanuts Continues Unabated as President Obama Announces Creation of Food Safety Working Group

Recall after recall has resulted from the U.S. Food and Drug Administration (FDA) expansion of the Peanut Corporation of America’s (PCA) Salmonella related recall to include all peanut ingredient products produced in PCA’s Plainview, Texas facility since January 1, 2007. Just last week, the FDA announced recalls of 18 peanut-containing products because the products have the potential to be contaminated with Salmonella.

Salmonella is an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems. The government fails to inspect 95 percent of food processing plants. Referring to … Read the rest

Don’t Be So Sure That Dietary Supplements Are Safe; The F.D.A. Isn’t

In the first 10 months of 2008 the U.S. Food and Drug Administration (F.D.A.) received 948 reports of health problems associated with dietary supplements, but not necessarily directly caused by them, according to a report from the federal Government Accountability Office (G.A.O.). Those included 9 deaths, 64 life-threatening illnesses and 234 hospitalizations. The F.D.A. recently estimated that there are more than 50,000 minor and serious health problems a year related to dietary supplements.

For purposes of the G.A.O. report, dietary ingredient means an ingredient that is included in the dietary supplement definition in the Dietary Supplement Health and Education Act … Read the rest

FDA Approves Tapentadol Hydrochloride, The First New Drug In Its Class In More Than 25 Years for the Relief of Moderate to Severe Acute Pain

According to the American Pain Foundation, more than 25 million Americans experience acute pain each year as a result of injuries or surgeries, and a recent study estimated that 42 percent of U.S. hospital emergency department visits were due to pain-related problems. Acute pain is a symptom of many medical conditions and can significantly interfere with a person’s quality of life and general functioning. Arthritis is the most common chronic debilitating disease in the United States (more than 43 million people or 1 in 6). Osteoarthritis of the knee is a very common and a major cause of disability.

The … Read the rest

Ovarian Cancer Test OvaSure Being Marketed Without Necessary FDA Approval

The U.S. Food and Drug Administration warned clinical test giant Laboratory Corp. of America Holdings that it was marketing OvaSure, an ovarian cancer test, in violation of the law in that it did not have marketing clearance or approval from the FDA.

OvaSure measures six proteins in blood samples and calculates the chances that the woman has ovarian cancer. LabCorp made the $220 test available in June, under a provision that exempts tests developed and offered by a single lab from the usual FDA review. Thus OvaSure did not go through an FDA review.

But in a letter dated September … Read the rest

Danger: Unapproved Ophthalmic Balanced Salt Solution Drug Products and Topical Drug Products Containing Papain

The U.S. Food and Drug Administration (FDA) today announced that companies marketing unapproved ophthalmic balanced salt solutions (BSS) and unapproved topical drugs containing papain must stop manufacturing these products on or before November 24, 2008, and must stop shipping such unapproved products on or before January 21, 2009, or risk enforcement action. FDA is taking these actions because it has received reports of serious adverse events associated with their uses, including eye inflammation, cloudy vision, permanent loss of visual acuity, a serious drop in blood pressure and increased heart rate.

Ophthalmic balanced salt solutions are used to irrigate the eye … Read the rest