FDA refuses to recall Crestor
The FDA has once again failed to act in the interests of American people. If readers may recall, Dr. David Graham, the world-renowned expert at the FDA has charged that apart from Vioxx (and sister drugs like Celebrex and Bextra), there were four other dangerous drugs on the market. Crestor was one of them. Crestor, a member of a class of cholesterol-lowering drugs commonly referred to as 'statins', was approved in the U.S. in August 2003. Many consumer rights group have demanded a Crestor recall.
FDA has simply issued a health advisory against Crestor to re-emphasize recommendations made in the original label about the need for physicians to consider using lower starting doses of the drug in some individuals as a means of reducing the risk of rhabdomyolysis (serious muscle damage).
The revised labeling notes that this may be particularly important for treating Asian American patients, since clinical trial data suggest that they (along with patients on cyclosporine or patients with severe renal insufficiency) may have higher drug levels and therefore be at greater risk for muscle injury due to Crestor than the general population.
Kidney failure of various types has also been reported in patients treated with Crestor, as well as other statins. However, patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) also may be at higher risk for kidney failure even when they are not prescribed statin therapy. Based on FDAs review of these cases and the available data from controlled trials, FDA cannot confirm that recommended doses of statins, including Crestor, can cause or worsen kidney failure.
Sidney M. Wolfe, MD, Director, Public Citizen's Health Research Group, criticized the FDA and said that inaction to recall Crestor is yet another example of "the agency's dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs". Below are excerpts from Dr. Wolfe's statement:
Like statements from AstraZeneca, the FDA's statement is replete with false and misleading information. Rather than responding in a public health-positive manner to our March 2004 petition and banning this drug, the FDA has done exactly what AstraZeneca wanted with minimal labeling changes and surely has pleased one of the drug companies contributing to the $150 million in drug industry funding that the FDA is receiving this year for drug review.
Since the last supplement to our petition to ban Crestor (submitted in October 2004), which was based on adverse reaction reports through August 26 of last year, there have been an additional 52 U.S. cases of life-threatening muscle damage (rhabdomyolysis) reported to the FDA and an additional 12 U.S. cases of kidney failure or impairment in people not having rhabdomyolysis reported to the agency up to the end of January of this year. The total of such U.S. cases reported since the drug was first marketed in September 2003 is now 117 cases of rhabdomyolysis and 41 cases of kidney failure, both higher than seen with the other currently marketed statins. Because of concerns about the safety of Crestor, several countries, including Germany, Norway and Spain, have not approved the drug.
Although the increased rate of rhabdomyolysis is not as high as that of the now-banned Baycol, the FDA is well aware that the rate is higher than that of the other statins, a fact it covers up by saying the rate is 'similar.' The FDA statement also includes other 'facts' that are extremely misleading if not false:
FDA Statement: "Data available to date from controlled trials, as well as post-marketing safety information, indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins."
Response: Crestor was the only statin that caused rhabdomyolysis at any dose in clinical trials prior to approval. (The cases occurred at 80 mg, a dosage not approved, but most of the post-marketing cases are occurring at 10 or 20 mg.)
FDA Statement: "Mild, transient proteinuria (or protein in the urine, usually from the tubules), with and without microscopic hematuria (minute amounts of blood in the urine), occurred with Crestor, as it has with other statins, in Crestor's pre-approval trial."
Response: Although the FDA admits that with Crestor, "The frequency of occurrence of proteinuria appeared dose-related," it fails to mention that this dose-related increase in proteinuria and hematuria (blood in the urine) was seen only with Crestor and not with any other statin.
FDA Statement: "In clinical trials with doses from 5 to 40 mg daily, this effect was not associated with renal impairment or renal failure (i.e., damage to the kidneys)."
Response: (from FDA medical officer during the July 2003 FDA hearing on Crestor approval): "These three cases of renal insufficiency of unknown etiology are of concern because they present with a clinical pattern, which is similar to the renal disease seen with rosuvastatin in these clinical trials. Proteinuria and hematuria could be potentially managed with regular urinalysis screening. However, if they are the signals for the potential progression to renal failure in a small number of patients, this may represent an unacceptable risk since currently approved statins do not have similar renal effects." (emphasis added)
Rather than being a "Public Health Advisory," as the announcement is titled, this FDA statement is more like an AstraZeneca Health Advisory. In its inability to serve two masters, the FDA has sided once again with its funders in the drug industry.
Recommended article: FDA hijacked by the drug industry
FDA has simply issued a health advisory against Crestor to re-emphasize recommendations made in the original label about the need for physicians to consider using lower starting doses of the drug in some individuals as a means of reducing the risk of rhabdomyolysis (serious muscle damage).
The revised labeling notes that this may be particularly important for treating Asian American patients, since clinical trial data suggest that they (along with patients on cyclosporine or patients with severe renal insufficiency) may have higher drug levels and therefore be at greater risk for muscle injury due to Crestor than the general population.
Kidney failure of various types has also been reported in patients treated with Crestor, as well as other statins. However, patients who are candidates for statin therapy (e.g., patients with diabetes, hypertension, atherosclerosis, and/or heart failure) also may be at higher risk for kidney failure even when they are not prescribed statin therapy. Based on FDAs review of these cases and the available data from controlled trials, FDA cannot confirm that recommended doses of statins, including Crestor, can cause or worsen kidney failure.
Sidney M. Wolfe, MD, Director, Public Citizen's Health Research Group, criticized the FDA and said that inaction to recall Crestor is yet another example of "the agency's dangerous cowardice in failing to adequately protect people in this country from uniquely dangerous prescription drugs". Below are excerpts from Dr. Wolfe's statement:
Like statements from AstraZeneca, the FDA's statement is replete with false and misleading information. Rather than responding in a public health-positive manner to our March 2004 petition and banning this drug, the FDA has done exactly what AstraZeneca wanted with minimal labeling changes and surely has pleased one of the drug companies contributing to the $150 million in drug industry funding that the FDA is receiving this year for drug review.
Since the last supplement to our petition to ban Crestor (submitted in October 2004), which was based on adverse reaction reports through August 26 of last year, there have been an additional 52 U.S. cases of life-threatening muscle damage (rhabdomyolysis) reported to the FDA and an additional 12 U.S. cases of kidney failure or impairment in people not having rhabdomyolysis reported to the agency up to the end of January of this year. The total of such U.S. cases reported since the drug was first marketed in September 2003 is now 117 cases of rhabdomyolysis and 41 cases of kidney failure, both higher than seen with the other currently marketed statins. Because of concerns about the safety of Crestor, several countries, including Germany, Norway and Spain, have not approved the drug.
Although the increased rate of rhabdomyolysis is not as high as that of the now-banned Baycol, the FDA is well aware that the rate is higher than that of the other statins, a fact it covers up by saying the rate is 'similar.' The FDA statement also includes other 'facts' that are extremely misleading if not false:
FDA Statement: "Data available to date from controlled trials, as well as post-marketing safety information, indicate that the risk of serious muscle damage is similar with Crestor compared to other marketed statins."
Response: Crestor was the only statin that caused rhabdomyolysis at any dose in clinical trials prior to approval. (The cases occurred at 80 mg, a dosage not approved, but most of the post-marketing cases are occurring at 10 or 20 mg.)
FDA Statement: "Mild, transient proteinuria (or protein in the urine, usually from the tubules), with and without microscopic hematuria (minute amounts of blood in the urine), occurred with Crestor, as it has with other statins, in Crestor's pre-approval trial."
Response: Although the FDA admits that with Crestor, "The frequency of occurrence of proteinuria appeared dose-related," it fails to mention that this dose-related increase in proteinuria and hematuria (blood in the urine) was seen only with Crestor and not with any other statin.
FDA Statement: "In clinical trials with doses from 5 to 40 mg daily, this effect was not associated with renal impairment or renal failure (i.e., damage to the kidneys)."
Response: (from FDA medical officer during the July 2003 FDA hearing on Crestor approval): "These three cases of renal insufficiency of unknown etiology are of concern because they present with a clinical pattern, which is similar to the renal disease seen with rosuvastatin in these clinical trials. Proteinuria and hematuria could be potentially managed with regular urinalysis screening. However, if they are the signals for the potential progression to renal failure in a small number of patients, this may represent an unacceptable risk since currently approved statins do not have similar renal effects." (emphasis added)
Rather than being a "Public Health Advisory," as the announcement is titled, this FDA statement is more like an AstraZeneca Health Advisory. In its inability to serve two masters, the FDA has sided once again with its funders in the drug industry.
Recommended article: FDA hijacked by the drug industry
posted by eCreativa Media | 9:50 PM
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