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Entries in Warning (2)

Thursday
Aug232012

FDA Warning: Reumofan Supplements Contain Risky Drugs

Agencia el Universal/El Universal de Mexico/Newscom(NEW YORK) -- Consumers searching for a miracle cure for the aches and pains of arthritis should beware: The FDA has issued a new warning about the potential health risks of Reumofan and Reumofan Plus, two products marketed as natural dietary supplements for treating arthritis, muscle pain, osteoporosis, bone cancer and other conditions.

The FDA said it found both supplements contain several potentially dangerous ingredients that are not listed on the label. Since the first warning was issued in June, consumers have begun to speak up.

"The FDA has received dozens of additional adverse event reports, including death and stroke, associated with the use of Reumofan Plus," said Sarah Clark-Lynn, an FDA spokesperson. "Other reports include liver injury, severe bleeding, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps and withdrawal syndrome, and adrenal suppression."

FDA lab analysis of the products revealed the presence of several prescription drugs that are linked to serious side effects, the agency said.

Dexamethasone, a corticosteroid commonly used to treat inflammatory conditions, can weaken the immune system, elevate blood sugar levels and increase the risk of bone and muscle injuries. It's also been associated with psychiatric problems.

When taken over long periods of time or in high doses, the drug may damage the adrenal glands, impairing their ability to produce hormones. Sudden discontinued use, especially when the drug has been taken long-term or in high doses, may lead to withdrawal syndrome, with users experiencing fatigue, nausea, low blood pressure, low blood sugar levels, fever, dizziness, and muscle and joint pain.

Diclofenac sodium, a non-steroidal anti-inflammatory drug (NSAID) also detected in the supplements, increases the risk of cardiovascular events, such as heart attack and stroke, as well as serious gastrointestinal problems including bleeding, ulceration, and fatal perforation of the stomach and intestines. Additionally, the analysis found the muscle relaxant methocarbamol, which can cause drowsiness, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks, such as driving a motor vehicle or operating machinery.

Tests on samples of Reumofan Plus found it contained diclofenac sodium and methocarbamol, the FDA said.

"The hidden drug ingredients in Reumofan Plus and Reumofan Plus Premium can lead to serious, even life-threatening, health consequences. The longer you take the products, the higher the risk," Clark-Lynn said. "Because of the hidden corticosteroid, consumers taking these products are urged to immediately consult with their doctor to safely discontinue use of the product."

Dr. Stephen Dahmer, an integrated medicine family physician in private practice at the Continuum Center for Health and Healing, Beth Israel Medical Center, said supplements can be as dangerous as medications. "Anyone can have an adverse or allergic reaction to almost any supplement so you do need to be careful about what you take and make sure you only buy reputable, high-quality brands," he said.

None of his patients has taken Reumofan but he urged anyone with osteoarthritis to steer clear. And he said he's on the lookout for symptoms in patients who suffer from arthritis in case they've taken the pills without telling him.

The supplements are manufactured in Mexico by the company Riger Naturals. They are usually labeled in Spanish but may also be labeled in English. In the U.S., GNC, Vitamin Shoppe and other large national retailers don't appear to be carrying the products either on the shelves or on their websites, but they can easily be purchased on supplement websites or eBay.

The Mexican Ministry of Health issued its own health warning to the public about Reumofan and has ordered Riger Naturals to recall the products. The FDA is asking doctors and consumers to report any side effects related to the two supplements to the FDA's MedWatch Safety Information and Adverse Event Reporting Program.

Copyright 2012 ABC News Radio

Tuesday
Dec062011

Feds Issue Warning on HCG Weight Loss Products

FDA(WASHINGTON) -- The U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters Tuesday to seven companies that market over-the-counter homeopathic HCG weight loss products, calling for these companies to take “corrective action.”

There are currently no HCG products sold online or in stores that are approved for weight loss. Still, alternative versions of the hormone -- found as drops, sprays, and pills -- are marketed by many companies as a weight loss supplement.

It’s unclear how much HCG is contained in these products or whether the products truly contained HCG, even if labeled as such.

“Whether they contain it or not, they are illegal and unapproved drugs,” Elizabeth Miller, acting director of Division of Non Prescription Products and Health Fraud at Food and Drug Administration said at Tuesday’s press conference.

HCG diet product labels typically state that the product should be taken with a very low calorie diet. But there is no study that shows that taking any product containing HCG has additional benefit to weight loss besides being on a low caloric diet, Miller said at Tuesday’s press conference.

“Almost more than any other [market], the weight loss industry is fad driven,” Richard Cleland, assistant director of the division of advertising practices at the Federal Trade Commission said at Tuesday’s press conference. “Also, unfortunately it is fraud driven.”  

Human chorionic gonadotrpin (HCG), otherwise known as a fertility hormone, is produced in pregnant women’s placentas and is also found in a pregnant women’s urine.  The hormone is FDA-approved as a prescription injection drug to treat some cases of infertility.

Weaker studies have suggested that HCG can also absorb excessive fat tissue.  

It’s not clear how many people are on the diet or buy these products, but Miller and Cleland said that heavy marketing on the Internet indicates there is a large consumer market.

About 8 million people a year fall victim to consumer fraud on the Internet, Cleland said.

Companies that have been issued a warning letter have 15 days to respond to the FDA and the FTC with steps they have taken to correct their violation.

According to the FDA website, “firms that do not correct the violations may face enforcement action, possible legal penalties, or criminal prosecution.”

Copyright 2011 ABC News Radio







ABC News Radio