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Letter on Liprotamase (Sollpura) (HRG Publication #1930)
These comments from Public Citizen Health Research Group are being submitted in follow-up to our testimony presented at the January 12, 2011 meeting of the Food and Drug Administration (FDA) Gastrointestinal Drug Advisory Committee regarding the drug liprotamase (Sollpura).
[Created on: 01/28/2011]
Statement: FDA’s Response to Preventable Acetaminophen Toxicity Problem is Dangerously Inadequate (HRG Publication #1927)
The measures announced today by the Food and Drug Administration (FDA) concerning acetaminophen in prescription drug products are certainly a step forward, but they entirely fail to address the greater issue of over-the-counter (OTC) use of this drug and to implement strong recommendations made by three FDA advisory committees in June 2009 about this problem.
[Created on: 01/13/2011]
Testimony on Liprotamase (HRG Publication #1926)
Liprotamase, a new drug proposed to treat patients with cystic fibrosis who have problems digesting food should not be approved by the Food and Drug Administration (FDA), and further trials to determine the effectiveness of liprotamase would be unethical.
[Created on: 01/12/2011]
Rapidly Increasing Criminal and Civil Monetary Penalties Against the Pharmaceutical Industry: 1991 to 2010 (HRG Publication #1924)
Over the past two decades, especially during the past 10 years, there has been a marked increase in both the number of government settlements with pharmaceutical companies and the size of the accompanying financial penalties.
[Created on: 12/16/2010]
Statement: FDA Must Not Approve Another Dangerous Weight Loss Drug (HRG Publication #1923)
The diet pill Contrave is the latest in a long line of dangerous and, ultimately, failed weight loss drugs
[Created on: 12/14/2010]
Position Statement: Delayed FDA Removal of Painkiller Propoxyphene (Darvon, Darvocet) From U.S. Market Has Cost More Than 1,000 U.S. Lives (HRG Publication #1921)
The announcement by the U.S. Food and Drug Administration (FDA) that propoxyphene-containing products are finally going to be taken off the market – because of dangers previously known and acted upon, with bans announced in the UK almost six years ago, and in Europe, almost 1½ years ago – is a serious indictment of the FDA’s long-lasting unwillingness to protect people in this country from a deadly but barely effective painkiller.
[Created on: 11/24/2010]
FDA’s Decision to Pull Diet Pill Meridia Commendable, But Took Too Long for Drug’s Victims (HRG Publication #1920)
The FDA’s decision to ask pharmaceutical maker Abbott to withdraw the drug is commendable, but dangerously too late for all of the victims of its unacceptable risks.
[Created on: 10/13/2010]
Study Reinforces Long-Known Dangers of Weight-Loss Drug Meridia (HRG Publication #1917A)
It is no surprise that a study published in the New England Journal of Medicine shows that the weight loss drug sibutramine (Meridia) increases the risk of strokes and heart attacks.
[Created on: 09/20/2010]
Testimony on Sibutramine (Meridia) Safety (HRG Publication #1918)
Sidney Wolfe, M.D. testified that the risks of sibutramine (Meridia) outweigh the benefits and that the drug should be removed from the market.
[Created on: 09/20/2010]
FDA’s Partial Hold on Unethical Diabetes Drug Trial Does Not Do Enough to Protect Patients (HRG Publication #1916)
The Food and Drug Administration (FDA) has gone only half-way in stopping the unethical TIDE study by halting the recruitment of any new patients. To allow the experiment to continue at all is a major breach in the FDA’s obligation to protect people in clinical trials.
[Created on: 08/17/2010]