FDA notified healthcare professionals and cystic fibrosis patients in U.S that the Agency is investigating the possible connection between the use of a liquid solution of Colistimethate that was premixed for inhalation with a nebulizer and the death of a patient with cystic fibrosis (CF).

FDA notified healthcare professionals and consumers of important information from two recent studies that should be considered when making treatment decisions in pregnant women who take antidepressants. The studies included pregnant women who were treated with selective serotonin reuptake inhibitors (SSRIs), or in a few cases, other antidepressant medications.

The U.S. Food and Drug Administration (FDA) is warning consumers not to purchase or consume Zimaxx, Libidus, Neophase, Nasutra, Vigor-25, Actra-Rx, or 4EVERON. These products are promoted and sold on web sites as "dietary supplements" for treating erectile dysfunction (ED) and enhancing sexual performance, but they are in fact illegal drugs that contain potentially harmful undeclared ingredients. These products have not been approved by FDA, and there is no guarantee of their safety and effectiveness, or of the purity of their ingredients.

The French Health Products Safety Agency (AFSSAPS) has announced a temporary ban on all cosmetic products containing vitamin K1 (INCI name: phytonadione; common name: phylloquinone; CAS: 84-80-0).

European regulators have banned 22 hair dye chemicals as part of a safety investigation prompted by a study linking dyes to bladder cancer.
But cosmetics industry officials tell WebMD consumers have little cause for concern, because the chemicals are virtually nonexistent in commercial hair products sold in Europe and the United States.
The ban, which takes effect Dec. 1, came as part of an overall safety review of hair dyes being conducted by the European Union's regulatory agency, the European Commission.

The findings of a new case controlled study has been published in the August issue of the journal Birth Defects Research Part B, which is published by John Wiley & Sons, states that congenital birth defects especially cardiac septal defects, could be associated with the use of NSAID by women in their first trimester.

Women who took first-trimester NSAIDs also had more than three times the risk of anomalies related to cardiac septal closure, mainly ventricular and atrial septal defects, the investigators found.

A CDC survey found three infant deaths in 2005 associated with cough and cold medicines.
According to the report, in the latest MMWR, the infants ranged in age from 1 to 6 months, and all had high blood levels of what appeared to be pseudoephedrine. The survey was based on e-mail queries to medical examiners and a review of news and journal reports, and because the response was low, the CDC cautioned that the total might have underestimated the true number of cases.