Children's Tylenol nationwide recall due to packag ing that may lead to improper dosing
June 4, 2005 07:50

Date: Fri, 3 Jun 2005 15:27:48 -0400 From: CDER MEDWATCH LISTSERV Subject: FDA MedWatch - Children's Tylenol nationwide recall due to packag ing that may lead to improper dosing

MedWatch - The FDA Safety Information and Adverse Event Reporting Program McNeil Specialty Pharmaceuticals and FDA notified consumers and healthcare professionals about a nationwide recall of all lots and all flavors of Children's TYLENOL Meltaways 80 mg, Children's TYLENOL SoftChews 80mg, and Junior TYLENOL Meltaways 160mg. The recall addresses issues regarding the design of the blister package, information on the package, and bottle cartons for the products that may be confusing and lead to improper dosing, including overdosing.

Read the complete MedWatch 2005 Safety summary, including a link to the firm press release, at: http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Tylenol

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It concluded that any benefits offered by estrogen therapy are outweighed by the treatment's potentially harmful effects. The task force recommendation also reaffirmed earlier advice against the routine use of combined estrogen and progestin (hormone replacement therapy) for preventing chronic conditions in postmenopausal women. "The available studies have shown that hormone replacement therapy should not be used to prevent heart disease, cancer and bone fractures," task force Chairman Dr. Ned Calonge, chief medical officer and state epidemiologist of the Colorado Department of Public Health and Environment, said in a prepared statement. "Women should use a shared decision-making approach with their clinicians to decide how best to prevent these conditions." The task force is an independent panel of prevention and primary-care experts.

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Science Daily, Thu, 02 Jun 2005 9:03 PM PDT Dartmouth Professor Finds Prescription Drug Advertising 'Walks A Communications Tightrope' http://www.sciencedaily.com/releases/2005/06/050602012251.htm Dartmouth linguistics expert Lewis Glinert studies how people use and interpret language, and two of his studies appear in the June issue of the journal Research in Social and Administrative Pharmacy. Both aim to understand how effectively and efficiently drug ads convey their messages. Glinert says that this line of research was prompted when the Food and Drug Administration (FDA) called for

NWCN, Fri, 03 Jun 2005 8:48 AM PDT Nationwide recall of Children's Tylenol http://www.nwcn.com/perl/common/rssredir.pl?page=http://www.nwcn.com/topstories/stories/NW_060305HEBtylenol_recallJM.2da138d62.html Tylenol is issuing a voluntary recall of the 80-milligram variety of Children's Tylenol Meltaways and Tylenol SoftChews (not shown) as well as the 160-milligram Junior Tylenol Meltaways.

Detroit News, Thu, 02 Jun 2005 11:28 PM PDT Viagra alert unlikely to lead to recall http://www.detnews.com/2005/health/0506/03/healt-196421.htm WASHINGTON -- An investigation into whether Viagra and other popular impotence drugs may cause permanent eye damage is unlikely to lead to a recall, federal officials and medical experts said Friday, but could prompt new warnings.

PR Newswire via Yahoo! Finance, Fri, 03 Jun 2005 7:00 AM PDT McNeil Consumer & Specialty Pharmaceuticals Announces Nationwide Recall of Children's TYLENOL(R) Meltaways - 80 mg, http://biz.yahoo.com/prnews/050603/phf005.html?.v=12 McNeil Consumer & Specialty Pharmaceuticals is voluntarily recalling all lots and all flavors of Children's TYLENOL® Meltaways 80 mg packaged in bottles and blisters, Children's TYLENOL® SoftChews 80 mg packaged in blisters, and Jr.

Bloomberg.com, Thu, 02 Jun 2005 6:15 PM PDT Elan, Biogen Decline on Report of New Tysabri Illness (Update6) http://www.bloomberg.com/apps/news?pid=10000085&sid=aUulMFoEfnig June 2 (Bloomberg) -- Shares of Elan Corp. and Biogen Idec Inc. tumbled after a fourth possible case of a rare and often fatal nerve disorder was reported in a patient taking the companies' withdrawn Tysabri multiple-sclerosis drug.

1010wins.com, Fri, 03 Jun 2005 8:38 AM PDT Some Children's Tylenol Products Recalled http://1010wins.com/topstories/local_story_154112438.html (1010 WINS) (WASHINGTON) The maker of Tylenol says it is recalling some products intended for children, citing concerns about potential confusing information on the correct doses.

New Ratings, Fri, 03 Jun 2005 9:44 AM PDT J&J unit recalls certain Tylenol painkillers for children http://www.newratings.com/analyst_news/article_856551.html NEW YORK, June 3 (newratings.com) McNeil Consumer & Specialty Pharmaceuticals, a unit of Johnson & Johnson (JNJ.NYS), has recalled certain variants of its Tylenol painkiller for children, due to improper packaging information.

Duluth News Tribune, Fri, 03 Jun 2005 1:26 AM PDT Guidant sold faulty defibrillators after new ones were available http://www.duluthsuperior.com/mld/duluthsuperior/news/local/11804854.htm The fallout from Guidant Corp.'s handling of its potentially defective Prizm 2 defibrillator intensified Thursday.