AccessMyLibrary provides FREE access to over 30 million articles from top publications available through your library.
Create a link to this page
Copy and paste this link tag into your Web page or blog:
Severe IBS drug available with restrictions. (Risk Management Plan).
ROCKVILLE MD. -- Physicians who wish to prescribe Lotronex will be enrolled in a risk management program.
The Food and Drug Administration and GlaxoSmithKline (GSK), the manufacturer of Lotronex, described elements of the plan when they announced earlier this summer the approval of a supplemental new drug application that permits marketing of Lotronex "under modified conditions of use and with restrictions imposed by a risk management plan" for women with severe diarrhea-predominant irritable bowel syndrome.
During a telephone press briefing, officials at the FDA in Rockville, Md., said that this program would make the drug available to debilitated irritable bowel syndrome (IBS) patients who have no therapeutic alternative. Lotronex is the trade name for alosetron, a drug that blocks serotonin activity at 5-HT3 receptor sites in the enteric nervous system. The drug has been associated with severe constipation and ischemic colitis as well as fatal cases of bowel obstructions.
GSK voluntarily withdrew the drug from the market in November 2000 because of the safety issues. After the withdrawal, however, the FDA and the company received calls from desperate patients who had benefitted from the drug and had no therapeutic alternative. "The FDA and we clearly heard from patients that we needed to find a way to make it available," Dr. Eric Carter, vice president of clinical development and medical affairs, gastroenterology, at GSK in Research Triangle Park, N.C., said in an interview.
Under the plan, physicians who want to prescribe Lotronex will have to sign a "self-attestation" form, saying that they are qualified to prescribe the drug and accept a range of responsibilities described in the form. The list includes attesting that they are familiar with the diagnosis and treatment of IBS and of ...
- Risk management and the FDA.
- Newspaper article from: Research Practitioner Paracandola, Mark November 1, 2003 700+ words
...pharmaceutical products. FDA is developing risk management guidance, and...and the efforts FDA is taking te strengthen its risk management programs. Key...Administration (FDA), FDA Modernization...User Fee Act, risk management In the past 2...
- Final FDA safety regulations may flood IRBs and, sponsors, do little for 'risk...
- Newspaper article from: Bioresearch Monitoring Alert Ludwig, Elisa Reid, Ken August 1, 2003 700+ words
...the lack of knowledge about risk management, my guess is that when FDA develops its final guidance...market safety. encourage FDA to elevate the science of risk management and safety, is giving FDA money to double its post-marketing...
- United BioSource Scientists, FDA, and Other Industry Leaders Present to Risk...
- Press release article from: PR Newswire November 19, 2008 700+ words
...Policy, CDER, FDA; Claudia Karwoski...director, Division of Risk Management Team, Office of...effective global risk management and drug safety...response to the FDA Amendments Act of...Epidemiology and Risk Management, UBC, co-moderated...called "How Does the FDA ...
- PAREXEL Consulting Expands Risk Management Expertise, Appoints FDA Investigator...
- Press release article from: PR Newswire September 6, 2006 700+ words
...brings 29 years of FDA pharmaceutical inspection...the full range of risk management challenges facing...by consultants with FDA crisis management and risk management backgrounds, with...clients respond to FDA actions but also to...
- 'Real time' QA is goal of FDA's efforts for 'quality by design'.(Risk...
- Newspaper article from: Validation Times Pitman, Mary March 1, 2004 700+ words
...Parexel, and former FDA field investigator...the meeting that "risk management challenges are not...opportunity while FDA is receptive...Properly applied, risk management tools can yield...key component of risk management is risk analysis...biologics centers at ...
- FDA risk management "too cumbersome".(drug risk management)(Brief Article)
- Magazine article from: Medical Marketing & Media Dickinson, James G. June 1, 2001 700+ words
* Recent FDA drug risk management approaches have been...prescribers. Woodcock said the FDA'S recent risk management programs, like those for...she said, adding that FDA is now trying to shift risk management from a "blame model...
- FDA panel hears update on alosetron risk management: no deaths linked to...
- Magazine article from: Family Practice News Mechcatie, Elizabeth June 1, 2004 700+ words
...Administration's safety and risk management advisory panel agreed...GSK) and the FDA provided an update on the risk management program for alosetron...June 2002, the FDA approved the drug...starting dose, and a risk management program. A main...
- FDA Approves Isotretinoin Pregnancy Risk Management Program.
- Press release article from: PR Newswire August 12, 2005 700+ words
...Administration (FDA) has approved iPLEDGE...an enhanced risk management program designed...approved by the FDA. The program strives...replace the existing risk management programs for each...and an evolving risk management program has been...collaboration with the ...
- As FDA moves to efficient risk management, pharma "must make similar reforms".
- Newspaper article from: Pharma Marketletter April 7, 2003 700+ words
...they pay for, so anything which the FDA can do to reduce the cost of developing...Marketletter February 10) is efficient risk management. "In all our major policies and...possible," he told the meeting. The FDA is doing this to fulfil its mission...
- Drug Safety Reform and Risk Management Plans - A Test Case? Senior FDA...
- Press release article from: Business Wire November 14, 2006 700+ words
...midterm elections. For the building FDA reform effort, that just means more...the agency's evolving policies on risk management and safety evaluation from senior FDA policymakers and experts at Windhover's FDA/CMS Summit for BioPharma Executives...
Source: HighBeam Research, Severe IBS drug available with restrictions. (Risk Management Plan).