Charlottesville Personal Injury Lawyer - supplement

Supplements - More Dangerous Than They Appear (Or Advertised)?

Greg Webb — Fri, 25 Sep 2009 01:00:00 GMT

In its September 7^th article “What’s Really in Supplements?” The Wall Street Journal (WSJ)discusses the harmful side effects of a growing trend in the American dietary and strength conditioning communities: the taking of over-the-counter supplements.

Many supplements purport to aid in the building of muscle mass or in weight loss, claiming to do what prescription or illegal drugs do via an herbal means. However, the truth is that a great deal of these supplements contain at least trace amounts of the very drugs they claim to emulate.

Recent reports from the Food and Drug Administration (FDA) address the discovery of illegal performance-enhancing drugs in “allegedly natural supplements.” The WSJ article states that “[n]early two-thirds of American adults take dietary supplements, a broad category that includes vitamins, minerals and herbal products.” Supplement manufacturers are able to get their products quickly to market because they don’t require the extensive testing that new drugs do, and thus don’t require approval by the FDA. Furthermore, the WSJ says that “supplements that are made from products that were on the U.S. market before 1994 – as most commonplace ones are – can be sold without being reviewed by the FDA beforehand. Companies that include newer substances are supposed to inform the agency before they go on the market, but they don’t have to wait for approval.”

The recent attention stirred by the reports will be discussed during a hearing this month by a Senate Judiciary subcommittee. The focus of the hearing will be on dietary-supplement safety.

While officials at the Council for Responsible Nutrition are arguing that “no new laws are needed, citing new FDA manufacturing standards for supplements…as well as a requirement for supplement makers to tell the FDA when they get reports of serious side effects, which took effect at the end of 2007,” consumer advocates continue to call for closer monitoring.

A 2007 survey conducted by the British lab HFL Sport Science regarding supplements “found the undisclosed presence of steroids in at least trace amounts in 25% of the 52 samples analyzed,” and a 2008 article published in the journal Gastroenterology claimed that “9% of the 300 cases then recorded” could potentially be linked to supplement-taking. Since December 2008, “the FDA has issued warnings about more than 70 weight-loss supplements that included potentially dangerous ingredients.” The side effects of such ingredients could include seizure, heart attack and stroke. Liver and kidney failure have also been common in cases where a supplement taken regularly contained anabolic steroids. “Ed Wyszumiala, general manager of dietary supplement programs for NSF International, a nonprofit organization in Ann Arbor, MI that certifies supplements’ safety, says the drugs and steroids likely get into the products through a combination of deliberate spiking and inadvertent contamination.”

Vice President Andrew Shao of the Council for Responsible Nutrition “says safety problems are a ‘rare occurrence.’” He considers the HFL survey a “‘marketing tactic’” and says that consumers need to know what they’re taking as well. This is true. Consumers who take dietary supplements should be aware their ingredients and what those ingredients do. Research has been conducted on numerous herbs, most of which can be found online. In addition, Travis Tygart, chief executive of the U.S. Anti-Doping Agency, says that people who are interested in take supplements should speak with a physician. This would also help prevent dangerous interactions between prescription drugs and the supplements.

Preventative measures could include researching evidence, side effects and interactions at the National Library of Medicine (www.medlineplus.gov) under “Drugs and Supplements,” searching for specific supplements at www.fda.gov, as well as reading closely into what a supplement’s packaging discloses in subtext. “Certain suffixes in chemical names are common for steroids or tweaked versions of them. Among them are –one, -ene, -iol and –bol, though these can also appear in the names of legitimate ingredients. Some products also use versions of steroid names in their brands, like ‘tren’ to connote trenbolone.”

People using supplements should be aware of warning symptoms that could be indicative of an escalating problem. These include nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellow corneas and skin, and discolored urine, as cited by the FDA as warning signs of potential steroid use.

The Wall Street Journal article contains a complete list of resources for researching supplements.

Originally posted at InjuryBoard by Greg Webb

Popular Dietary Supplements Alleged to Contain Steroids

Greg Webb — Wed, 12 Aug 2009 10:46:31 GMT

Federal authorities filed court papers last month alleging that two over-the-counter dietary supplements commonly used by high school football players contain steroids. Tren Extreme and Mass Extreme, manufactured by American Cellular Labs, are marketed as a potent legal alternative to steroids. However, search warrants were executed alleging that the supplements contain illegal designer steroids including Madol, a substance first identified six years ago during the investigation into the Bay Area Laboratory Co-operative.

Authorities say that Max Muscle, a supplement store with approximately 100 locations across the country, paid American Cellular Labs to be the exclusive retailer of these products, which are also available online.

An individual at Max Muscle’s corporate office said that no one was available to comment on how many of the company’s stores carried American Cellular products. A Max Muscle outlet in Iowa was offering an online promotion of Tren Xtreme for free, but a salesman reported that the store no longer sold the brand.

Travis Tygart, head of the United States Anti-Doping Agency, said that the substance helps athletes quickly gain strength and muscle mass and is popular amount high school football players because it works. He did not offer an estimate regarding how many high school athletes have used the product.

The investigation into American Cellular Labs is led by Jeff Novitzky of the FDA and prosecutors from the U.S. attorney’s office for the Northern District of California. Novitzky has been the face of the government’s investigation into the distribution of performance-enhancing drugs since 2002.

The FDA has jurisdiction over dietary supplements, which are defined as products that offer general health benefits but do not claim to treat specific conditions. Manufacturers of dietary supplements are responsible for recording and ensuring the accuracy of the claims that they make regarding the safety and efficacy of their products. The FDA is only empowered to act in cases when it identifies a harmful or adulterated product on the market. If authorities find that a supplement contains an undeclared pharmaceutical ingredient like a steroid, the product is considered to be an illegal drug.

Steroids are naturally produced organic compounds that can be used legally to treat conditions like testosterone deficiency. Athletes have also used illegal forms of steroids for performance enhancement. Such usage is particularly concerning in preteen and teenage boys, because artificially high levels of testosterone can stop bone growth.

Investigators first became concerned about products made by American Cellular Labs after reports of severe liver and kidney problems in people who had used the two products. In one case, a liver transplant doctor reported that a 38-year-old male patient who had used the products had to be hospitalized with severe liver dysfunction and acute kidney failure which required dialysis.

While legal steroids entail risks, unknowingly taking supplements that contain illegal compounds is even riskier because the drugs come with unknown risks, according to Dr. Pieter Cohen of the Harvard Medical School. When prescribing similar drugs for men who have a deficiency, doctors closely monitor patients to avoid higher-than-normal hormone levels, but designer steroids have not been studied for safety. Cohen added that while there is no research showing that the new compounds are safe in humans, there is evidence that analogs of pharmaceutical compounds have let to life-threatening diseases that required transplantation in the past.

Originally posted at InjuryBoard by Greg Webb

Homeopathic Drugs - "Remedies" - Potentially Hazardous?

Greg Webb — Mon, 29 Jun 2009 08:00:00 GMT

Although it was sold for many years as a drug for colds, Zicam Cold Remedy was never tested by federal regulators for safety like many other drugs. Because the drug is considered a “homeopathic remedy,” categorized as a highly diluted drug made from natural ingredients, they can legally be sold without any checks for safety, effectiveness, or even the right ingredients by the federal government. This was perfectly legal until consumers began losing their sense of smell.

Many scientists and health care professionals regard these homeopathic remedies as modern day snake oil, ineffective but mostly harmless because the substances in them are in such small amounts. They are similar to dietary supplements, which use many of the same natural ingredients and are also not tested for safety or benefit. The AP’s analysis of side-effect reports filed by the Food and Drug Administration (FDA), however, found more than eight hundred homeopathic ingredients were implicated in health problems last year; complaints ranged from vomiting to attempted suicide.

In the case of Zicam, the FDA tied the drug to 130 cases of consumers losing their sense of smell. Because of this, the agency asked Zicam manufacturer Matrixx Initiatives to stop marketing three products that contain zinc gluconate: Zicam Cold Remedy Nasal Gel, Nasal Swabs, and the discontinued Swabs in Kids' Size. In order for the drugs to be marketed again, the FDA requires they be tested for safety and benefit like other conventional drugs.

Are homeopathic remedies like Zicam effective? Many people swear by them, but is it essentially having a “placebo effect” on them? This writer is highly skeptical of these remedies, but, as long as they are essentially “harmless”, it is effectively just a situation of folks’ throwing away good money on these “remedies”. When the harm shifts from merely economic to real health problems, however, then a true harm to society may be occurring. The latter result may be indicative of a systemic problem requiring some form of intervention and oversight. Because of the number of issues that have arisen over the past decade or so with supplements and remedies, it seems as if we may be seeing a systemic problem, compounded by the greed of manufacturers producing and marketing these products.

Originally posted at InjuryBoard by Greg Webb

Zicam Cold Remedy Should Stop Being Used Says FDA

Greg Webb — Tue, 16 Jun 2009 15:14:43 GMT

The U. S. Food and Drug Administration (FDA) stated via a press release today that consumers should stop using three over-the-counter Zicam Cold Remedy products, including: nasal gel, nasal swabs and the "kids size" swabs (which were discontinued). The reason for the FDA warning is because these products can cause the loss of smell, or "anosmia", which could be permanent.

Anyone who has experienced problems after using the Zicam products should immediately contact a doctor. The loss of smell, while obviously affecting one's quality of life, can be dangerous as well, eliminating one of the senses that protects us from danger.

The FDA does not officially have oversight power over Zicam's manufacturer, Matrixx Initiatives out of Arizona, because Zicam is considered a "remedy" rather than a drug. This is further evidence of the need to regulate the herbal remedy and supplement industry, which may be a ticking timebomb waiting to go off. The fact that these manufacturers have what amounts to a blank check with regard to the products they produce is astounding, not to mention many of the claims they make regarding their products.

Matrixx claims that Zicam is safe and that the allegations are "scientifically unfounded and misleading". Matrixx concedes that about 130 consumers have reported loss of smell since 1999 after using Zicam products.

Originally posted at InjuryBoard by Greg Webb

FDA Says Stop Using Popular Weight Loss Supplement Hydroxycut

Greg Webb — Fri, 01 May 2009 17:13:01 GMT

The U.S. Food and Drug Administration (FDA) says it has received 23 reports of serious liver injuries related to peoples' use of Hydroxycut products. Hydroxycut products are widely used dietary supplements for weight loss. The products are also used as "energy enhancers" and "fat burners".

The liver damage reports obtained by the FDA include problems ranging from jaundice to an injury so severe it required a liver transplant. There are also reports of seizures, cardiovascular disorders, and rhabdomy olysis (which can lead to kidney failure).

The recalled products include Hydroxycut Regular Rapid Release Caplets, Hydroxycut Carb Control and Hydroxycut Max Drink Packets. For more information on this recall, see the FDA website at www.fda.gov/bbs/topics/NEWS/2009/NEW02006.html

The products are manufactured by lovate Health Sciences in Ontario, Canada. The company is pulling 14 products, although the FDA says that not all of the products have been shown to be dangerous.

The products recalled contain a number of different ingredients, including herbal extracts. Dietary supplements do not require the same level of scrutiny before being sold to the public that pharmaceutical drugs require in the U.S.. Many consumer advocates have argued for years that there needs to be better governmental oversight of these industries. It seems that this latest incident is further evidence of the latter.

The FDA states that any people who have taken the recalled products should immediately see a physician if they have symptoms of nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach pain, itching, or loss of appetite, all of which may be indicators of a liver injury.

Originally posted at InjuryBoard by Greg Webb