Public Citizen Sues FDA to Force Agency to Act on Petition Seeking Stricter Antibiotic Warnings


Public Citizen Sues FDA to Force Agency to Act on Petition Seeking Stricter Antibiotic Warnings

Fuente: Public Citizen
Despite long-standing evidence that fluoroquinolone antibiotics such as CIPRO and LEVAQUIN can cause tendon ruptures, the Food and Drug Administration (FDA) has failed to increase its warnings to patients and physicians about the dangers of the medicines, Public Citizen told a federal court Thursday.

Public Citizen, the authors of WorstPills.org, sued in the U.S. District Court for the District of Columbia, asking the court to force the FDA to act upon a petition the consumer group filed with the agency 16 months ago. The FDA has failed to respond to the petition, which Public Citizen contends is a violation of the Administrative Procedure Act.

The petition. asked the agency to put a “black box” warning on fluoroquinolone antibiotics to make doctors and patients more aware of the risk of serious tendon injury before tendons actually rupture. A “black box” is the strongest type of warning the FDA can request.

The petition also urged the FDA to send a warning letter to physicians, as well as require an FDA-approved medication guide to be dispensed when prescriptions are filled.

Stronger warnings could lead to earlier intervention and prevent needless injuries by allowing doctors to switch patients to other antibiotics, according to Dr. Sidney Wolfe, editor of WorstPills.org.

“While the FDA sits idly by and ignores the problem, more people will suffer serious tendon ruptures that could have been prevented,” Wolfe said. “The current warning is buried in a long list of possible side effects and is far too easy to miss.”

From November 1997 through December 2005, the FDA received 262 reports of tendon ruptures, mainly of the Achilles tendon, 258 cases of tendinitis and 274 cases of other tendon disorders in patients using fluoroquinolone antibiotics. An additional 74 tendon ruptures have subsequently been reported to the FDA for a total of 336. Because only a small fraction of cases are typically reported to the FDA, the actual number of ruptures and other tendon injuries attributable to the antibiotic is much higher.

LEARN more
VIEW the legal documents

Public Citizen y Rosiglitazona (Avandia).


Recibido de Worst Pills, Best Pills Drug Alert

In May, a study in the New England Journal of Medicine linked the diabetes drug rosiglitazone (AVANDIA, AVANDAMET and AVANDARYL) to heart attacks and heart-related deaths. But the heart risks of this drug should not have been a surprise.

Public Citizen has long warned about the dangers of using the glitazone class of diabetes drugs, beginning with our petition to the Food and Drug Administration (FDA) in 2000 for better warnings. We have classified rosiglitazone as a Do Not Use drug for the past three years.

Since the release of the New England Journal of Medicine study, the following actions have been taken:

1/ In October, the Department of Veterans Affairs, after conducting its own review, removed rosiglitazone from its formulary (the drugs that its doctors may prescribe), concluding that, “for some patients, rosiglitazone may not afford the same margin of safety as alternative drug therapies.”

2/  On November 6, 2007, Health Canada, the Canadian equivalent of the  U.S. FDA, issued broad new restrictions on the use of rosiglitazone. In Canada, rosiglitazone is now no longer approved either as a single treatment for diabetes (except for patients unable to take metformin), or for use in combination with a sulfonylurea* except when patients are unable to take metformin.
Furthermore, Health Canada warns that rosiglitazone should not be used in any of these situations: in patients taking insulin, in combination with metformin and a sulfonylurea drug, or in patients diagnosed with any degree of heart failure, either past or current, even that which is very mild (NYHA Classes I, II, III, or IV).

Health Canada advises patients to talk to their doctors about the benefits and risks of continuing therapy, especially those with heart disease or at a high risk for a heart attack or heart failure.

3/ Shortly after the Canadian warning, on November 14, the FDA modified its black box warning for rosiglitazone concerning heart attacks, but in a most confusing fashion: it cites four analyses. One of the four is a meta-analysis of 42 studies which showed an increased risk of heart attacks; the results of the three others “have not confirmed or  excluded this risk,” according to the FDA. This is inaccurate and provides no useful guidance to patients or their physicians.

The FDA needs to immediately publish an alert similar to that of Health Canada to warn U.S. citizens who are at increased risk from heart attacks and heart failure not to take rosiglitazone. Until then, Health Canada remains the sole source of this vital information.

We continue to label Avandia as a Do Not Use drug.

Learn more:
Read our July 2007 article about the risk of heart problems with
rosiglitazone: https://www.worstpills.org/member/newsletter.cfm?n_id=538

See the new Health Canada restrictions on rosiglitazone here:
http://www.hc-sc.gc.ca/dhp-mps/medeff/advisories-avis/public/2007/avandia_pc-cp_4_e.html.

*Examples of sulfonylurea drugs are glyburide, glimepiride, and
tolbutamide. Ask your doctor if you are taking these or any other drugs
in this class.

En Argentina:

AVANDIA • GlaxoSmithKline

Rosiglitazona mas metformina:

AVANDAMET • GlaxoSmithKline

Fuente: Alfabeta