Litigants Claim Talcum Powder Causes Cancer

Talcum powder is a hydrated magnesium silicate and most often seen in its popular baby powder form.  Women also use talcum powder for personal hygiene and cosmetic purposes. Recently, there have been claims that talcum powder causes ovarian cancer, and that manufacturers have looked the other way.

Recently, the household brand name of Johnson & Johnson has come under attack. Johnson & Johnson (J&J) manufactures a diverse line of products ranging from baby powder to antipsychotic drugs.  With so many varied products, J&J has been sued multiple times in the past for product defects and personal injuries. According to Bloomberg.com, … Read the rest

SimplyThick Manufacturer Changes Product Warnings in Light of Potential Catastrophic Infant Injury or Death

Last month, SimplyThick, LLC, the manufacturer of SimplyThick, announced online a major change to its product warnings. The new warning will state that SimplyThick is “NOT intended for use with preterm or infants under 12 months of age. Or children under the age of 12 years with a history of NEC.” This action follows two advisories by the U.S. Federal Drug Administration (“FDA”) that infant’s fed SimplyThick may develop necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, which if not catastrophic, can be fatal.

In May 2011, the FDA advised against feeding SimplyThick … Read the rest

Should Television Ads for Chantix Be Required to State That Its Side Effects are the Subject of an FDA Black Box?

Yesterday morning an advertisement for smoking cessation drug Chantix came on my television. The ad featured a man extolling how much better his life is now that Chantix (and support, slips in the ad) has helped him kick his smoking habit. Then an announcer came on and read, for what seemed like an extraordinary time for the disclaimers usually heard on drug commercials, a litany of side-effects and warnings. These warnings included suicidal thoughts, personality changes, and skin rashes. The announcer did not state, however, that many of the side-effects announced are the subject of a FDA-mandated black box … 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