Parker Waichman LLP Injury Alerts
Taking Most Weight Loss Products Continues to be Little More Than a Game of Russian RouletteSep 1, 2009
Taking Most Weight Loss Products Continues to be Little More Than a Game of Russian Roulette
Weight loss products, both over-the-counter (OTC) and prescription, have recently come under scrutiny by the Food and Drug Administration (FDA), due to adverse event reports (reports made by healthcare professionals and consumers regarding health issues caused by drug). These reports link many of these popular products to serious health conditions, the most common being liver damage.
The FDA has added to its drug surveillance list several of the ingredients found in weight loss products currently on the market. Investigations have revealed that some active ingredients found in these weight loss products, which have often gone unlisted on product labels, are undeclared pharmaceuticals (drugs that have been marketed in products for purposes outside the scope for which they have been approved).
Since these drugs are not listed on the label, and have not been approved for such marketing or use, these ingredients are considered illegal regardless of their individual legal status.
Some of the illegal ingredients cited by the FDA include:
- Sibutramine: prescription-only appetite suppressant; controlled substance.
- Fenproporex: controlled substance; not approved for marketing in the U.S.; may cause arrhythmia (a disorder of your heart rate or rhythm) and possible sudden death.
- Fluoxetine: prescription-only antidepressant.
- Bumetanide and furosemide: potent diuretics (drugs that increase the production of urine); prescription only.
- Cetilistat: experimental obesity drug; not approved for marketing in the U.S.
- Phenytoin: prescription-only anti-seizure medication.
- Phenolphthalein: solution used in chemical experiments; a suspected carcinogen; not approved for marketing in the U.S.
A report by Worst Pills, Best Pills lists 72 weight loss products that contain illegal prescription drugs. The list includes:
- 8 Factor Diet
- 999 Fitness Essence
- Perfect Slim 5x
- ProSlim Plus
- Slim Express 360
- Venom Hyperdrive 3.0
For more information and to view the complete list, go here.
Due to decreased FDA regulation, there has been an increase in dangerous weight loss products and supplements released to the market recently.
Manufacturers have removed some products from shelves under the advisement of the FDA, but it is also important to recognize that undeclared pharmaceuticals are not the only source of adverse health risks. Popular prescription and OTC weight loss products that are currently still on the market, containing FDA approved drugs, have been linked with adverse health risks, and are currently under investigation.
The FDA does not regulate dietary supplements as tightly as medications. Manufacturers need not prove to the FDA that their products are safe and effective before they can be sold. The FDA regulators monitor aftermarket reports for signs of trouble, and in recent years, companies have been put under stricter requirements to alert the FDA when they learn of problems. The FDA issues an alert and investigates potential risks when patterns of adverse health emerge from reports.
The following are several of the products making headlines as a result of their dangerous health effects.
Iovate Health Sciences Inc., manufacturer of the popular weight loss product Hydroxycut, recalled fourteen products in the Hydroxycut line from the market in May 2009, including:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Capsules
- Hydroxycut Max Liquid Capsules
- Hydroxycut Regular Drink Packets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Natural
Hydroxycut was classified as a dietary supplement by its distributors, and as such, was not verified by the FDA prior to going to market. According to FDA adverse event reports, the drug has been linked to serious liver injury and at least one case of liver failure. Symptoms of liver damage include: jaundice (yellowing of eyes and skin), nausea, vomiting, fatigue, light color stools, brown urine, stomach or abdominal pain, and itching.
Dr. Linda Katz of the FDA's food and nutrition division said the agency has received 23 reports of liver problems, including the death of a 19-year-old boy. Seizures and cardiovascular disorders have also been reported.
The FDA, as well as many consumer and medical watchdog groups, have advised consumers to discontinue use of all Hydroxycut products immediately.
Alli and Xenical
The FDA added Orlistat to its drug surveillance list in August 2009, after it was linked to liver damage. Orlistat is the main active drug in Alli, an OTC weight loss drug manufactured by GlaxoSmithKline, as well as prescription drug Xenical, produced by Roche. The FDA approved Xenical in 1999. Alli was approved in 2007.
Unlike other weight loss remedies which work by suppressing the appetite or increasing metabolism, Orlistat prevents the digestive system from absorbing dietary fat, thereby reducing daily calorie intake.
The FDA has reported 32 cases of liver damage in people taking products containing Orlistat between 1999 and 2008. Six of those cases resulted in liver failure; 30 of those cases occurred outside the US. Although Orlistat is approved in over 100 countries, it has raised serious health concerns, especially in the UK.
Since Alli launched in the UK in April 2009, the Medicines and Healthcare products Regulatory Agency (MHRA), Great Britain’s equivalent of the FDA, has received 31 reports of adverse effects from Orlistat. Currently, the MHRA is unable to disclose whether those cases resulted exclusively from Alli use, or whether patients were taking the stronger prescription Xenical.
Xenical became available in the UK in 2001. Since then, 24 patients taking it have died - one of liver failure, and the others from heart attacks, gall bladder inflammation, multi-organ failure, and lung clots. There have also been five cases of sudden death where the cause was unclear. The MHRA has received 1,252 reports of potential side effects from Xenical, citing conditions including heart problems, gastrointestinal issues, skin complaints, and nearly 100 were connected with liver problems.
The investigation of Orlistat’s health risks is ongoing. The FDA has yet to ban either Alli or Xenical, stating, “No definite association between liver injury and Orlistat has been established at this time.” …….
Public Citizen, a consumer watchdog group, filed a petition with the FDA to have Xenical pulled from the market after studies identified the drug as a possible carcinogen.
STEAM and S-Drol
STEAM and S-Drol are examples of dietary supplements recalled because of undeclared pharmaceuticals that lead the FDA to declare them unapproved drugs. Distributor Nutracoastal Trading LLC has recalled the supplements.
Sulfoaildenafil, an ingredient approved for the use in drugs such as Viagra, specifically for treatment of erectile dysfunction, was found in STEAM. The FDA found the steroid desoxymethyltestosterone in S-Drol.
Both ingredients have dangerous interactions with other medications; specifically drugs containing nitrates, which are often taken by those suffering from diabetes, heart disease, high blood pressure or elevated cholesterol. The interaction of the two ingredients lowers blood pressure to dangerous levels.
Body Building Supplements
In July 2009, the FDA issued an advisory warning to consumers about the use of certain body building supplements. Investigators found synthetic steroids and steroid-like ingredients in products distributed by American Cellular Laboratories Inc.
The product line, marketed as dietary supplements, contained unapproved and misbranded drugs. The advisory states that these products have not been approved by the FDA, and may pose serious health risks.
The products included in the warning are:
- TREN Xtreme
- MASS Xtreme
- ESTRO Xtreme
- AH-89 Xtreme
- HMG Xtreme
- MMA-3 Xtreme
- VNS-9 Xtreme
- TT-40 Xtreme
Adverse event reports received by the FDA have linked these products and others containing steroids, synthetic steroids, or steroid alternatives to serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung).
Anabolic steroids may cause other serious long-term adverse health consequences including: shrinkage of the testes and male infertility, breast enlargement in males, masculinization of women, short stature in children, adverse effects on blood lipid levels, and increased risk of heart attack and stroke.
The FDA advises consumers to discontinue use of any body building products that claim to contain steroids or steroid-like ingredients. To view the warning issued by the FDA, click here.
How to protect yourself
Many weight loss products contain harmful ingredients and are being illegally marketed as dietary supplements. The first step to protecting yourself is consulting your health care professional before taking any kind of dietary supplements.
The FDA also lists common fraudulent claims made by distributors of potentially dangerous products. These include:
- Promises of an "easy fix” for problems like excess weight, hair loss, or impotency
- Claims such as "scientific breakthrough," "miraculous cure," "secret ingredient," and "ancient remedy"
- Gimmicky terms, such as "hunger stimulation point" and "thermogenesis"
- Claims that the product is safe because it is "natural"
- Undocumented case histories or personal testimonials by consumers or doctors claiming amazing results
- Promises of no-risk, money-back guarantees
The FDA is now proactively looking to recall many of these dangerous drugs. To stay up to date with the latest product recalls please visit the FDA site here.
In a somewhat related matter, the Federal Trade Commission has issued a new set of guidelines that remove the words "results not typical" from weight loss advertising. This means that all of the celebrities (and non-celebrities for that matter) paid to endorse these products, will have to reveal exactly what they did in order to achieve the advertised results.
It has been 29 years since these rules were updated. During that period, the weight loss industry thrived by touting thoroughly unrealistic results over tiny footnotes reading “results not typical.” Now, the manufacturer must either disclose the extent of the weight loss program (“She lost 40 pounds in five months by going to the gym five days a week, doing cardiovascular exercises and taking our product”), or clearly point out what the average person using the product loses in the same amount of time.
If you or a loved one have been injured as a result of taking any dietary supplement or weight loss product, please visit: www.yourlawyer.com, for a free case review by the attorneys at Parker Waichman LLP.