Big Surprise! Drug Industry caught in web of deceit |
Johnson & Johnson and risks associated with Topomax |
CHICAGO (Reuters) - U.S. regulators said certain promotional materials for Johnson & Johnson's epilepsy drug Topamax fail to disclose serious risks linked to the medicine and asked the company to immediately cease using them.
In a warning letter to J&J unit Ortho-McNeil dated Sept. 15 and posted on the Food and Drug Administration Web site on Wednesday, the agency said the promotional material was missing information about serious side effects associated with Topamax, including hyperthermia and insufficient sweat production.
The materials encourage unsafe use of the drug, especially for children, the FDA said.
The agency asked for a written response to its charges by Sept. 29.
"Because the violations described are serious, we request further that your submission include a plan of action to disseminate truthful, non-misleading and complete information to the audiences that received the violative promotional materials," Thomas Abrams, the FDA's director for the division of drug marketing, advertising and communications, wrote in the warning letter.
Topamax is an important drug for New Brunswick, New Jersey-based Johnson & Johnson with annual global sales in excess of $1 billion.
"We take this matter very seriously and we are working closely with the FDA to address their concerns as quickly as possible," said Leslie Fishman, a spokeswoman for Ortho-McNeil.
Fishman said the company would not speculate on possible actions.
Thanks to Stefan Kruszewski
posted by Will Brady @ 03:59
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