FDA Holds Hearing on Arthritis Drug Safety
February 16, 2005 06:13

WASHINGTON
Wednesday, February 16, 2005

A Merck & Co. official said Wednesday that all painkillers in the same class as the company's Vioxx (search) may cause heart problems or strokes, a change from the drug-maker's earlier position that such health issues appeared limited to its drug...

Wednesday, February 16, 2005

A new study has linked painkillers Vioxx (search), Celebrex (search) and Bextra (search) to increased cardiovascular risk, reinforcing findings of other trials that have already sparked concern over the safety of a popular category of drugs.

Vioxx and Celebrex increased patients' risk of heart attack and stroke by about 20 percent while Bextra increased the risk by 50 percent, according to a study by WellPoint Inc. (search), the nation's largest provider of health benefits which is based in Indianapolis.

Subject: FDA MedWatch - Recall of one lot of Similac Advance with Iron po wdered infant formula in 12.9-ounce cans, Lot Number 20307RB

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and the Ross Products Division of Abbott Laboratories announced a recall of one lot of Similac Advance with Iron powdered infant formula in 12.9-ounce cans, Lot Number 20307RB due to the presence of black plastic particles reported in a small number of cans. The particles are the result of an isolated manufacturing event that has already been corrected. No serious health or safety reports have been received that are attributed to this situation. This formula was distributed between September 15, 2004 and October 18, 2004 primarily in the Eastern half of the United States and in Iowa, Kansas, and Missouri.

Read the complete MedWatch 2005 Safety Summary, including a link to the Firm Press Release:

http://www.fda.gov/medwatch/SAFETY/2005/safety05.htm#Similac

Subject: FDA MedWatch: Phenergan (promethazine) contraindicated in childre n < 2 y.o due to fatal respiratory depression

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA and Wyeth notified healthcare professionals of revisions to the CONTRAINDICATIONS, WARNINGS/Use in Pediatric Patients, and DOSAGE AND ADMINISTRATION sections of the prescribing information for Phenergan. Phenergan is contraindicated for use in pediatric patients less than two years of age because of the potential for fatal respiratory depression. Postmarketing cases of respiratory depression including fatalities, have been reported with use of Phenergan in pediatric patients less than two years of age. Caution should also be exercised when administering Phenergan to pediatric patients two years of age and older.

Read the complete MedWatch 2005 Safety Summary, with links to the Dear Healthcare Professional letter and revised label, at:

www.fda.gov/medwatch/SAFETY/2005/safety05.htm#phenergan

"[W]ord that the U.S. Senate voted for tort deform...came just a few days after the news that seven executives of W.R. Grace and Co. were indicted on criminal charges for knowingly putting their workers and the public in danger by exposing them to asbestosore.... (Read Article)

"When supporters of class-action 'reform'...talk about the alleged horrors of class-action litigation,they frequently hold up the tiny, impoverished, and mostly black Jefferson County, Mississippi, as Exhibit A. 'Reformers' allege that current state lawsallow... (Read Article)

Few people are caught more tightly in the vortex of the controversy swirling over drug safety than DebbyDemaree and her family. Her three teenage children take Adderall, the attention-deficit drug Canadian regulators banned from the market there. Her son alsotakes... (Read Article)

A prescription cream and an ointment that millions ofAmericans use to control eczema should carry strong warnings to alert consumers that the drugs may increase the risk of some forms of cancer, especiallyamong children, a federal panel concluded. Although... (Read Article)

NY TIMES Responding to widespread criticism of the government's handling of drug safety problems, the Food and Drug Administration announced Tuesday that it was creating a board to advise it on drug complications and to warn patients about unsafe drugs....... (Read Article)

"FDA understands that the public expects better and more prompt information about the medicines they take every day," says acting commissioner Lester Crawford. "Our goal is to prepare the agency for these new demands by improving the way we monitor and respond to possible adverse health consequences that may arise regarding drugs that have been approved for sale to US consumers."
http://www.newscientist.com/article.ns?id=dn7017

http://www.newscientist.com/article.ns?id=dn7017


A prescription cream and an ointment that millions of Americans use to control eczema should carry strong new warnings to alert consumers that the drugs might increase the risk of some forms of cancer, especially among children, a federal panel concluded Tuesday.

While the risks posed by Elidel and Protopic remain far from clear, the Food and Drug Administration advisory panel said the agency should take a variety of steps to aggressively caution consumers and monitor the drugs' safety, including adding a prominent "black box" to the labels.