FDA's Medwatch announced a recall today of 18 lots of Complete (R) MoisturePLUS multipurpose contact lens care solution and Active Packs which were distributed in the U.S. Certain lots were contaminated with bacteria that compromised sterility, which can carry serious health consequences, including eye infection and microbial keratitis.

If you have the recalled product, you should discontinue using it immediately. Individuals who experience symptoms of an eye infection such as redness, pain, tearing, increased light sensitivity, blurry vision, discharge or swelling, should remove their lenses and consult their eye care provider immediately.

Posted by Seth A. Katz at 02:10 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA has recommended that the label of Roche's popular flu drug, Tamiflu, be updated to carry warnings about possible "neuropsychiatric adverse events," particularly in pediatric patients. The recommendation follows a 10-month review of 103 cases of unsafe behavior, 67 percent of which occurred in pediatric patients. Most of the events, 95 percent, occurred in Japan, which is Tamiflu's largest consumer. The reports include two deaths, a 14-year old boy who fell after climbing on his condominium balcony railing, and an adult who left a suicide note.

Japan's labeling already carries warnings about behavioral events, and the FDA said "it would be prudent to update the U.S. labeling to be similar in scope."

Posted by Peter W. Burg at 09:20 PM | Permalink | Comments (0) | TrackBacks (0)

The FDA and CDC have updated an alert issued last year after receiving more reports of a rare neurological disorder, Guillain Barre Syndrome (GBS) following administration of a vaccine (trade name Menactra) designed to prevent meningococcal disease, a major cause of bacterial meningitis and blood stream infections.

To date, a total of 15 confirmed cases of GBS have been reported among individuals aged 11-19, and two additional cases have been reported in persons aged 20+. All of the individuals are reported to have recovered or are recovering.

GBS is a serious, rare neurological disorder that can occur, often in healthy individuals, either spontaneously or after certain infections. GBS typically causes increasing weakness in leg, arm and other muscles that can be severe and require hospitalization. GBS usually resolves on its own, but some people may have residual neurological deficits.

Posted by Peter W. Burg at 09:18 PM | Permalink | Comments (0) | TrackBacks (0)