Children's FDA Medical Research

 

The FDA is also investigating reports of several hundred serious side effects -- or "adverse events" -- and seven deaths since May 1, when McNeil recalled 50 children's versions of these non-prescription medicines because of serious quality and safety concerns.

The FDA's investigation into the recalls is ongoing and the agency would not comment on the matter.

Adverse event reports are consumer complaints of a serious side effect associated with the use of a medical product, according to the FDA. Adverse events could include death, hospitalization, disability and other health complications.

The House Committee on Oversight and Government Reform has scheduled a hearing on May 27 to examine the recall.

Following the most recent recall, Johnson & Johnson (Symbol :JNJ) has suspended production at McNeil's facility in Fort Washington, Penn., that manufactured the children's drugs.

McNeil's latest recall is its fourth in the past seven months:

In November 2009, five lots of Tylenol Arthritis Pain 100 count with the EZ-open cap were recalled for unusual odor leading to nausea, stomach pain, vomiting and diarrhea.

In December, the recall was expanded to include all product lots of Tylenol Arthritis Pain caplet 100 count bottles with the red EZ-open cap.

In January 2010, the recall was widened to an undisclosed number of Tylenol, Motrin and other Dilantin Cerebellar Atrophy Risks drugs after complaints of consumers feeling sick from an odor.

McNeil has maintained that its recall of the children's drugs was not "undertaken on the basis of adverse medical events" but as a precautionary measure.

"We track all adverse events and thoroughly investigate all serious adverse cases that are reported and, in turn, report these to the FDA, whether or not the event may be caused by our products," McNeil said in a statement Tuesday.


What is Stevens Johnson Syndrome?

Committee members also questioned the executive about other incidents cited by the FDA.

In 2008, for example, McNeil received several consumer complaints about ....

"It should not have taken a year," he said. "It should have taken three days."

After hearing Sharfstein's testimony, Rep. Eleanor Holmes Norton, D-D.C., asked Goggins whether the delay amounted to a "cover-up."

Goggins said that McNeil had initially tested the products for microbiological contamination and that the tests had come back negative. When the consumer complaints subsided, the company thought the problem had resolved itself, she said.

The consumer complaints picked up again in 2009. McNeil recalled products in November, December and in January after it determined that the odor was caused by contamination from a chemical, used to treat wooden transport pallets, that had leached into some products.

In an FDA inspection report last month about the Fort Washington plant, the agency cited McNeil for similar issues—failing to properly investigate 46 consumer complaints of foreign particles and unidentified black bits in some products. McNeil received that report on April 30 and announced the recall that evening. In her written testimony, Goggins said that McNeil takes each complaint and report seriously and seeks to investigate each one.

 

Congressional committee investigates J&J's Motrin 'phantom' recall

By Michael Johnsen

WASHINGTON (Jun. 4) Rep. Ed Towns, D-N.Y., on Thursday announced that the Committee on Government Oversight and Government Reform, which he chairs, has begun querying contracting companies on whether they were hired by Johnson & Johnson in late 2008 to execute a “phantom” recall of a certain SKU of Motrin available primarily through the convenience channel.

“Rather than doing the right thing and announcing a recall, we have learned that the drug company hired contractors to basically sneak into stores to purchase the products as if they were legitimate customers,” stated Towns.  “We need to better understand Johnson & Johnson’s relationship with the contractor and get to the bottom of the services the contractor was asked to provide.”

Towns had addressed the Motrin recall with Colleen Goggins, J&J worldwide chairman, consumer group, during last week’s hearing. Goggins testified that she did not know the specific language of the contract between J&J and the contractor, but that the Food and Drug Administration had knowledge of J&J’s particular actions in this situation at the time the contract was being executed.

The committee is examining an alleged attempt by J&J, parent company of McNeil Consumer Healthcare, to hire a contractor to go into retail stores and secretly purchase the suspect Motrin in order to avoid issuing a formal recall. Only when the FDA discovered this covert activity did J&J announce a recall of the affected medication, Towns asserted. “It wasn't until this caper was foiled by the Food and Drug Administration that McNeil did what it should have done in the first place and recalled the affected medication,” Towns said. “The company's motivation was apparently to save itself the embarrassment and potential financial loss associated with a recall.

According to a document obtained by the Committee, WIS of San Diego was recruited by Carolina Supply Chain Services, now a division of Inmar, "on behalf of Johnson & Johnson" to purchase the affected Motrin...


 

Causes of Stevens Johnson Syndrome (SJS / TEN)

High-dose intravenous immunoglobulins in the treatment of toxic epidermal necrolysis: an Asian series.

Authors:  Tan AW, Thong BY, Yip LW, Chng HH, Ng SK.

Tylenol Motrin Side Effects


 

Clinical & Experimental Dermatology

Epidemiological study of severe cutaneous adverse drug reactions in a city district of China

Authors: Li, L.-F.; Ma, C.

Volume 31, Number 5, September 2006, pp. 642-647(6)


 

Stevens Johnson Syndrome (SJS / TEN) Treatment and Outcomes

 

Risk estimates for drugs suspected of being associated with Stevens-Johnson syndrome and toxic epidermal necrolysis: a case-control study.

Authors:  Lin MS, Dai YS, Pwu RF, Chen YH, Chang NC.

Graduate Institute of Epidemiology, College of Public Health, National Taiwan University, Taipei, Taiwan.

PMID: 15737140

 

British Journal of Dermatology

The CD40/CD40 ligand system is expressed in the cutaneous lesions of erythema multiforme and Stevens-Johnson syndrome / Toxic Epidermal Necrolysis

Authors:  M. Caproni, D. Torchia, E. Schincaglia, W. Volpi, A. Frezzolini*, D. Schena�, A. Marzano�, P. Quaglino, C. De Simone, A. Parodi, E. Barletta�� and P. Fabbri


Volume 154 Issue 2 Page 319 - February 2006