How Dialysis Works

In dialysis, blood is allowed to flow, a few ounces at a time, through a special filter that removes wastes and extra fluids. The clean blood is then returned to the patients body. Removing the harmful wastes and extra salt and fluids helps control blood pressure and keep the proper balance of chemicals like potassium and sodium in the body.

Dialysis Patients must undergo treatment 3 times a week for 3 to 5 hours at a time.

Conditions Related to Kidney Failure

Kidneys not only clean the blood but they also make hormones and balance chemicals. When the kidneys stop working, patients may have problems with anemia and conditions that affect your bones, nerves, and skin. Some of the more common conditions caused by kidney failure are extreme tiredness, bone problems, joint problems, itching, and “restless legs.”

Anemia and Erythropoietin (EPO)

Anemia is a condition in which the volume of red blood cells is low. Red blood cells carry oxygen to cells throughout the body. Without oxygen, cells can’t use the energy from food, so someone with anemia may tire easily and look pale. Anemia can also contribute to heart problems.

Renal Osteodystrophy

Renal osteodystrophy, or bone disease of kidney failure, affects 90 percent of dialysis patients. It causes bones to become thin and weak or formed incorrectly and affects both children and adults. Symptoms can be seen in growing children with kidney disease even before they start dialysis. Older patients and women who have gone through menopause are at greater risk for this disease.

Itching (Pruritus)

Many people treated with hemodialysis complain of itchy skin, which is often worse during or just after treatment. Itching is common even in people who don’t have kidney disease; in kidney failure, however, itching can be made worse by wastes in the bloodstream that current dialyzer membranes can’t remove from the blood.

Sleep Disorders

Patients on dialysis often have insomnia, and some people have a specific problem called the sleep apnea syndrome, which is often signaled by snoring and breaks in snoring.

Many people on dialysis have trouble sleeping at night because of aching, uncomfortable, jittery, or “restless” legs. You may feel a strong impulse to kick or thrash your legs. Kicking may occur during sleep and disturb a bed partner throughout the night. The causes of restless legs may include nerve damage or chemical imbalances.

Amyloidosis

Dialysis-related amyloidosis (DRA) is common in people who have been on dialysis for more than 5 years. DRA develops when proteins in the blood deposit on joints and tendons, causing pain, stiffness, and fluid in the joints, as is the case with arthritis.

Dear Mr. Hemelt:

This letter concerns your firm’s marketing of the products Zicam Cold Remedy Nasal Gel, Zicam Cold Remedy Gel Swabs, and Zicam Cold Remedy Swabs, Kids Size.

FDA has concluded that these products may pose a serious risk to consumers who use them. Specifically, FDA has received more than 130 reports of anosmia, (loss of sense of smell, which in some cases can be long-lasting or permanent), associated with use of these products.

To protect consumers, and in light of the violations described below, we ask that within fifteen working days of receipt of this letter, you notify this office in writing of the specific steps that you have taken to correct the violations.

These products are available without a prescription, and they contain zinc gluconate (identified as zincum gluconicum on their labels) as their active ingredient. All are administered by direct application to the nasal cavity and, as described in the labeling, are intended for use in “adults and children 3 years of age and older (with adult supervision).” These products are referred to hereafter as the “Zicam Cold Remedy intranasal products.”

According to the labeling accompanying the Zicam Cold Remedy intranasal products, each of these products “reduces” the “duration of the common cold” and the “severity of cold symptoms,” including specifically “sore throat • stuffy nose •sneezing • coughing • congestion.” These claims make these products drugs, as defined by section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or to affect the structure or function of the body of man or other animals.

We are not aware of any data establishing that the Zicam Cold Remedy intranasal products are generally recognized as safe and effective for the uses identified in their labeling.[1] On the contrary, as described below, there is evidence that these products pose a serious safety risk to consumers. Because they are not generally recognized as safe and effective for their labeled uses, these products are new drugs, as defined by section 201(p) of the Act, 21 U.S.C. § 321(p).

Under sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless an FDA‑approved application is in effect for it. There are no approved new drug applications (NDAs) on file with FDA for any of the Zicam Cold Remedy intranasal products; you market them without FDA approval.

We recognize that the labeling for Zicam Cold Remedy intranasal products identifies them as homeopathic drug products with an active ingredient measured in homeopathic strength—Zincum Gluconicum 2X. Nothing in the Act or the regulations issued under it exempts homeopathic drugs from the new drug approval requirements. We acknowledge that many homeopathic drug products are manufactured and distributed without FDA approval under enforcement policies set out in the FDA’s Compliance Policy Guide entitled, “Conditions Under Which Homeopathic Drugs May be Marketed (CPG 7132.15)” (the CPG). The enforcement discretion set forth in the CPG is not unlimited, however. The CPG states that it “delineates those conditions under which homeopathic drugs may ordinarily be marketed in the U.S.” (emphasis added) The qualifying word “ordinarily” indicates that the CPG specifically contemplates that there may be circumstances where a product that otherwise may meet the conditions set forth in the CPG may nevertheless be subject to enforcement action.

A significant and growing body of evidence substantiates that the Zicam Cold Remedy intranasal products may pose a serious risk to consumers who use them. Specifically, FDA has received more than 130 reports of anosmia (loss of sense of smell, which in some cases can be long-lasting or permanent),associated with use of these products; some individuals also report loss of sense of taste.[2] By comparison, FDA has received few reports of anosmia associated with other widely-used intranasal products for treatment of the common cold that are marketed subject to approved NDAs or according to an OTC drug monograph. Further, there is evidence in the published scientific literature that various salts of zinc can damage olfactory function in animals and humans.

A homeopathic drug product marketed without an approved NDA is not subject to the enforcement discretion set forth in the CPG when there is evidence of a safety risk associated with the product, as is the case for the Zicam Cold Remedy intranasal products. Under these circumstances, the Agency enforces the Act’s new drug approval requirement, a provision that is essential to protect the public health by holding firms responsible for demonstrating, based on adequate and well-controlled clinical investigations, that a product is safe and effective for each of its intended uses before marketing it. Therefore, an approved NDA is required for the Zicam Cold Remedy intranasal products, regardless of their homeopathic status. Your introduction of the Zicam Cold Remedy intranasal products into interstate commerce, without an approved application, violates sections 301(d) and 505(a) of the Act, 21 U.S.C. §§ 331(d) and 355(a).

Additionally, Zicam Cold Remedy intranasal products are misbranded under section 502(f)(2) of the Act, 21 U.S.C. § 352(f)(2), because their labeling does not bear adequate warnings regarding the risk of anosmia associated with the product. In light of this failure to bear adequate warnings, these products are also misbranded under section 502(a) of the Act, 21 U.S.C. § 352(a), taking into account the considerations set forth in section 201(n) of the Act, 21 U.S.C. § 321(n).

The issues and violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above and for preventing their recurrence or the occurrence of other violations. It is your responsibility to assure that your firm complies with all requirements of federal law and FDA regulations. A description of the new drug approval process can be found on FDA’s internet website at http://www.fda.gov/cder/regulatory/applications/default.htm. Any questions you may have regarding this process should be directed to the Food and Drug Administration, Division of Drug Information (HFD‑240), Center for Drug Evaluation and Research, 5600 Fishers Lane, Rockville, Maryland 20857.

You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction. Other federal agencies may take this Warning Letter into account when considering the award of contracts.

Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the corrections. Furthermore, please advise this office what actions you will take to address product that you have already distributed.

In addition to the reports FDA has received directly from consumers, the agency is aware that Matrixx appears to have more than 800 reports related to loss of sense of smell associatedwith Zicam Cold Remedy intranasal products. Please contact Elisabeth Walther at the contact information below to arrange submission of all reports you have related to loss of sense of smell associated with Zicam Cold Remedy intranasal products. Please indicate which of these reports have been previously submitted to FDA.

Additionally, if another firm or firms manufacture the products identified above, your reply should include the name and address of all such firms. If the firm from which you receive the products is not the manufacturer, please include the name of your supplier in addition to the manufacturer. Address your reply to the U.S. Food and Drug Administration, Center for Drug Evaluation and Research, Office of Compliance, 10903 New Hampshire Ave., Silver Spring, MD 20993-0002, Attention: Elisabeth Walther, Pharmacist.

Sincerely,

Deborah M. Autor, Esq.
Director
Office of Compliance
Center for Drug Evaluation and Research
U.S. Food and Drug Administration

Intranasal products are administered through the nose.

What products are affected by this warning?

FDA’s action affects Zicam’s three intranasal products that contain zinc. The three Zicam products claim to reduce the duration of the common cold and the severity of cold symptoms.

The products (listed with their size and product numbers) are

• Zicam Cold Remedy Nasal Gel (15mL, NDC 62750-003-10)
• Zicam Cold Remedy Swabs (20 swabs, NDC 67250-003-20)
• Zicam Cold Remedy Swabs, Kids Size (20 swabs, NDC 67250-003-21)

The Zicam intranasal zinc products are widely sold in pharmacies, other retail stores, and on the Internet. Zicam Cold Remedy Swabs, Kids Size, has already been discontinued, but FDA is concerned that consumers may have the product in their home. FDA has special concerns regarding use of intranasal zinc in children. Children may experience a loss of sense of smell but may be less likely to communicate the condition.

Are oral zinc products affected by this warning?

No. This warning does not involve oral zinc tablets and lozenges taken by mouth.
Dietary zinc is also not subject to this warning. Zinc is an important trace mineral that is an essential part of the human diet. Among other things, Zinc is needed for a healthy immune system (the body’s defense), and is critical for normal growth. Zinc primarily comes from food. The best way to get the daily requirement of essential vitamins and minerals is to eat a balanced diet that contains a variety of foods.

Why did FDA take action?

The agency has received more than 130 reports of anosmia—the loss of sense of smell—associated with use of these three Zicam products.
Many people who experienced a loss of sense of smell say that the condition occurred with the first dose, although some people have reported loss of sense of smell after later doses. FDA is concerned that the loss of sense of smell may be permanent.

What steps did FDA take?

• FDA issued a public health advisory warning consumers to stop using and discard or return the Zicam zinc-containing intranasal products.
• The agency sent a warning letter to Matrixx Initiatives advising the firm that these products cannot be marketed without FDA approval. The warning letter also states that the products do not include adequate warnings about the risk of loss of sense of smell.

What should consumers do if they experience harm related to these products?

FDA recommends they contact their health care professional if they experience loss of sense of smell or other problems after using any zinc-containing products that are administered into the nose.

The agency asks health care professionals and consumers to report possible cases of loss of sense of smell or other problems after use of these products to FDA through the MedWatch program, either online or by phone at 1-800-FDA-1088.

Date Posted: June 16, 2009

Dear Mr. President:

The purpose of this letter is to draw your attention to the frustration and outrage that FDA physicians and scientists, public advocacy groups, the press, and the American people, have repeatedly expressed over the misdeeds of FDA officials. Recent press reports revealed extensive evidence of serious wrongdoing by Dr. Andrew von Eschenbach, Dr. Frank M. Torti, top FDA attorneys, Center and Office Directors, and many others in prominent positions of authority at FDA. As a result, Dr. Frank M. Torti, Acting Commissioner and the FDA’s first Chief Scientist, abruptly left the Agency. But, the many other FDA managers who have failed to protect the American public, who have violated laws, rules, and regulations, who have suppressed or altered scientific or technological findings and conclusions, who have abused their power and authority, and who have engaged in illegal retaliation against those who speak out, have not been held accountable and remain in place.

On Monday, March 30, 2009, Dr. Joshua Sharfstein, newly appointed Principal Deputy Commissioner, assumed the position of Acting Commissioner until Dr. Margaret Hamburg is confirmed. Numerous FDA physicians and scientists are certain that Dr. Hamburg and Dr. Sharfstein will bring the necessary change to FDA to guarantee integrity, accountability, and transparency, to ensure that all future decisions are solely based on science and in accordance with the laws, rules, and regulations. However, sweeping measures are needed to end the systemic corruption and wrongdoing that permeates all levels of FDA and has plagued the Agency far too
long.

The latest example of wrongdoing was reported on March 23, 2009 from a Federal District Court Judge who ruled that FDA’s decision on the Plan B drug1 was “arbitrary and capricious because they were not the result of reasoned and good faith agency decision-making.” FDA’s top leaders at the Center for Drug Evaluation and Research (CDER) testified that they “didn’t have a choice, and . . .
[weren’t] sure that [they] would be allowed to remain [in their positions if they] didn’t agree” to ignore the science and the law. To the contrary, they should be removed from their positions of authority precisely because they didn’t follow the science and the law. The judge further ruled that there was “unrebutted evidence that the FDA’s [decision] stemmed from political pressure rather than permissible health and safety concerns.” The “improper political influence” and the many “departures from its own policies” reveal that such FDA officials are incapable of ensuring integrity and science at FDA.

On October 14, 2008, FDA physicians and scientists wrote to members of the House Energy and Commerce Committee reporting that top FDA officials at the Center for Devices and Radiological Health (CDRH) had distorted the scientific review of medical devices and then retaliated against those who brought this to light.2 Congressman John Dingell (then Chairman) and Congressman Bart Stupak (Chairman, Subcommittee on Oversight and Investigations) wrote to then FDA Commissioner Dr. Andrew C. von Eschenbach (since resigned), stating that there were “well-documented allegations that senior managers within CDRH” had “acted in violation of the law … [and that] sweeping measures may be necessary to address the distortion of science alleged by so many CDRH scientists.”3

On January 7, 2009, FDA physicians and scientists wrote to Mr. John Podesta4: “Through this letter and your action, we hope that future FDA employees will not experience the same frustration and anxiety that we have experienced for more than a year at the hands of FDA managers because we are committed to public integrity and were willing to speak out. Currently, there is an atmosphere at FDA in which the honest employee fears the dishonest employee, and not the other way around.
Disturbingly, the atmosphere does not yet exist at FDA where honest employees committed to integrity and the FDA mission can act without fear of reprisal. … America urgently needs change at FDA because FDA is fundamentally broken, failing to fulfill its mission, and because re- establishing a proper and effectively functioning FDA is vital to the physical and economic health of
the nation.”5

On January 13, 2009, the NY Times6 reported that FDA officials allowed “improper political influence”7 to guide official FDA actions. The Director of the Office of Device Evaluation, Dr. Donna-Bea Tillman, approved8 a medical device used for the detection of breast cancer despite the fact that all of the FDA experts involved recommended against approval of the device three times. Dr. Tillman’s decision to overrule the FDA experts “followed a phone call from a Connecticut congressman [Christopher Shays].”

On January 26, 2009, FDA physicians and scientists wrote to you directly9 seeking your help and recommending that “you remove and hold accountable all managers who have ordered, participated in, fostered or tolerated the well-documented corruption, wrongdoing and retaliation at the Agency.” That letter was prompted by concerns that FDA officials were planning to investigate physicians and scientists in retaliation for the January 13, 2009 story in the NY Times. These concerns were well-
founded.

On March 13, 2009, one week after another episode detailing wrongdoing and improper political influence involving top FDA officials was published in the Wall Street Journal,10 Acting Commissioner Dr. Frank M. Torti and FDA attorneys sprung into action. Their solution— send an FDA-wide email11 admonishing FDA employees that they “must comply with … obligations to keep certain information … confidential … [including] e-mail to and from employees within FDA [that document the] deliberative process” and threatening that “violation … can result in disciplinary sanctions and/or individual criminal liability.”

These threats did not escape the scrutiny of Senator Chuck Grassley,12 Ranking Member of the U.S. Senate Committee on Finance. In a letter to Dr. Torti on March 24, 2009, Senator Grassley wrote:
“Your memorandum … appears to run contrary to many statutes protecting executive branch communications with members of Congress. … I am concerned with the timing of your memorandum, given some recent high profile matters concerning your Agency and the release of information that has shown failures in FDA’s regulatory mission. [This] could be viewed … as an effort to chill and/or prevent FDA employees from exercising their rights under whistleblower protection laws. … Whistleblowers are some of the most patriotic people I know—men and women who labor, often anonymously, to let Congress and the American people know when the Government isn’t working so we can fix it.”

The Wall Street Journal13 and FDA documents14 revealed efforts by top FDA officials (including Dr. von Eschenbach, Dr. Torti, Mr. William McConagha, and other FDA attorneys) to cover-up their attempts to improperly influence, obstruct, impede and distort the due and proper administration of the FDA scientific regulatory process involving a knee implant device. According to the Columbia
University Journalism Review,15 “the [Wall Street] Journal describes a process in this case that’s, well, corrupt. I don’t know what else you’d call it. It even has a smoking gun.”16 An advisory committee of outside experts, convened to provide advice on the safety and effectiveness of the knee implant, was misled and manipulated by Dr. Daniel Schultz (Director of CDRH) as well as top FDA attorneys. Dr. Schultz was accused of “stacking the committee to get the decision the company wanted,” and of falsely stating in an official document that the conclusions reached by the advisory committee were “clear” and “unanimous”—to the contrary, they were not. A letter17 from Senator Grassley to Dr. Torti dated March 6, 2009 indicated that Dr. Schultz and top FDA attorneys had concealed the fact that two of the authors of a major publication presented to the advisory committee in support of the knee implant device, had affiliations with the device manufacturer (“the first author of the article is [the manufacturer’s] Vice President of Scientific Affairs,” Senator Grassley noted). Dr. Jay Mabrey, Chief of orthopedic surgery at Baylor University Medical Center in Dallas and Chairman of the advisory committee, should be commended for his integrity and willingness to speak out once he became aware of what had transpired. Dr. Larry Kessler, former Director of the Office of Science and Engineering Laboratories at FDA, who had direct knowledge of the advisory committee meeting and process, characterized the process as “show[ing] the FDA at its worst.”

The culture of wrongdoing and cover-up is nothing new but is part of a longstanding pattern of behavior. For example, in July 2005,18 Dr. Daniel Schultz “approved a medical device against the unanimous opinion of his scientific staff,”19 overruling “more than twenty FDA scientists, medical officers and management staff.”20 According to the New York Times21, the decision represented the first time in the agency’s history that a director “approved a device in the face of unanimous opposition from staff scientists and administrators beneath him.” As described in a Senate Finance Committee report following an investigation led by Senator Grassley,22 Dr. Schultz never revealed to the public that the FDA scientists, medical officers, and all other staff involved, completely
disagreed with his decision. The report also stated that “what remains the same in FDA’s approval of a device or a drug is the requirement that data supporting a sponsor’s application for approval be scientifically sound. Otherwise health care providers and insurers as well as patients may question the integrity and reliability of the FDA’s assessment of the safety and effectiveness of an approved product.”– We completely agree.

Amazingly, just 3 weeks ago, on March 6, 2009, it was reported by the consumer advocacy organization Public Citizen that Dr. Tillman “approved a [medical] device that has failed to demonstrate any clinical benefit” and that showed “trends toward higher risks of death.”23 According to Public Citizen: The March 6, 2009 approval by Dr. Tillman24 “bears an eerie resemblance to another device, Intergel, an anti-scarring device intended for pelvic surgeries that also demonstrated reduced scarring without clinically validated outcomes. … Less than two years after Intergel was approved [by Dr. Schultz25], the company removed the product from the market26 due to reports of post-operative pain, foreign body reactions and tissue scarring requiring repeat surgery, including three deaths among women who received it. This history should have given the FDA pause before once again approving a similar device with a questionable safety record.”27

But now, things may finally change at FDA and meeting the expectations of the public may become a reality. On March 14, 2009, an FDA-wide e-mail was sent from the Acting Secretary of HHS:
“Dr. Margaret “Peggy” Hamburg will be nominated by the President to serve as the next Commissioner and Dr. Joshua “Josh” Sharfstein will serve as the Principal Deputy Commissioner of the FDA. … The FDA is the premier agency of its kind in the world, and President Obama wants to revitalize the agency and empower it to make the best possible decisions for the American people based on the best science available. Dr. Hamburg and Dr. Sharfstein will work hard to support scientific integrity at FDA, strengthening the ability of the agency’s professionals to do their work on behalf of the American people. They are the perfect people to translate the President’s vision for the FDA into reality.”

We share your vision and we urge that you provide all necessary support to enable your new leadership to bring change to FDA without delay as part of your planned healthcare reform. As stated in a recent NY Times editorial, you must “send a clear signal to the bureaucracy that the days of neglect are over. Officials [must] make clear that the … practice of distorting science and weakening regulation to favor industry also is over.”28 – We completely agree.

FDA must carry out its work in a transparent manner based on sound science in order to improve the lives of all Americans, reduce health care costs, and expand health care access. Much work remains to be done at FDA and all pending matters need to be addressed. The wrongdoing revealed in the Wall Street Journal involves top FDA officials and requires immediate investigation. Astoundingly, since May 2008,29 Dr. von Eschenbach, Dr. Torti, Mr. McConagha, and numerous top FDA officials, have been well-aware of other serious wrongdoing, and failed to take any actions, while the physicians and scientists who spoke out and refused to comply have suffered retaliation.

The clearance/approval of medical devices that were not made in accordance with the laws, rules and regulations, need to be re-visited. Furthermore, those FDA employees who have engaged in wrongdoing, who have violated laws, rules, and regulations, who have abused their power and authority, and/or who have engaged in retaliation, should be dealt with swiftly. Immediate and decisive disciplinary action will send a strong message FDA-wide that wrongdoing will no longer be tolerated and those who engage in wrongdoing will be held accountable. Some wrongdoing may be beyond the scope of FDA’s jurisdiction and may need referral to the U.S. Attorney General.

All FDA employees who are committed to public integrity, who follow the laws, rules and regulations, who use science to promote public safety and health, and who have the courage and patriotism to speak out, must be protected and have their professional lives restored. We ask that you accept nothing less.

Sincerely,

[Names Redacted]

Click here for a copy of the Original Letter

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