Drug Interaction and FDA Advisories

Information from the Food and Drug Administration (FDA) and other authoritative sources concerning possible interactions between commonly used herbs and drugs or new information concerning adverse effects of commonly used herbal preparations.

Advisories and News About Foods, Herbs and Drugs

2009

June 16, 2009: Intranasal Zinc Products

Warnings on Three Zicam Intranasal Zinc Products
The Food and Drug Administration (FDA) warned consumers to stop using and discard three zinc-containing Zicam intranasal products. The products may cause a loss of sense of smell.

February 3, 2009: Prenatal and iron supplements

ETHEX Corporation issues voluntary nationwide recall of prescription prenatal and iron supplements to wholesale level
Patients should contact their physicians or healthcare providers if they have experienced any problems, or to obtain replacement medications or prescriptions.

January 27, 2009: Venom HYPERDRIVE 3.0

FDA warns consumers against dietary supplement containing undeclared drug
Consumers should immediately stop taking Venom HYPERDRIVE 3.0, as the product contains sibutramine, a potent drug that poses potential safety risks. 

January 23, 2009: Peanut Butter with Salmonella typhimurium

Peanut Butter Recalls: Salmonella typhimurium
The FDA has confirmed that peanut butter and paste products by the Peanut Corporation of America is the source of the recent Salmonella outbreak. 

2008

August 21, 2008: Mussels from Bantry Bay Seafood

Warning on Certain Mussel Products from Bantry Bay Seafood
Bantry Bay Seafood's frozen cooked mussel products may be contaminated with azaspiracid toxins, which are known to cause gastrointestinal upset.

August 1, 2008: Peppers from Mexico

Warnings on Raw Jalapeno and Serrano Peppers from Mexico
The FDA has advised consumers to avoid raw jalapeno and serrano peppers from Mexico and any food product containing them due to a sample testing that was positive for Salmonella.

2007

August 9, 2007: Red Yeast Rice

Avoid Red Yeast Rice Products Promoted on Internet as Treatments for High Cholesterol
FDA is warning consumers not to buy or eat three red yeast rice products promoted and sold on Web sites. The products may contain an unauthorized drug that could be harmful to health. The products are promoted as dietary supplements for treating high cholesterol. 

May 21, 2007: Shark Cartilage Capsules

NBTY, Inc., Conducts Nationwide Recall of Shark Cartilage Capsules Because of Possible Health Risk
Three lots of shark cartilage capsules, made in 2004 and packaged under various brands, have been recalled due to possible Salmonella contamination. 

April 19, 2007: Bio-Identical Hormones

Bio-Identical Hormones: Sound Science or Bad Medicine
Statement of FDA Center for Drug Evaluation and Research Director Steven K. Galson, M.D., M.P.H., before the Senate Special Committee on Aging

2006

September 18, 2006: Carrot Juice
FDA Consumer Advisory on Refrigeration of Carrot Juice
Following three cases in Georgia of botulism associated with carrot juice that may not have been properly refrigerated, FDA is advising consumers to keep all carrot juice - including pasteurized - refrigerated. Inadequate refrigeration of carrot juice can allow botulism-causing spores to multiply to a level where they can cause illness. 

August 21, 2006: BeneFin, MGN-3, or Skin Answer

FDA Notifies Consumers of Restitution Program for Purchases of Lane Labs' Products
FDA is notifying consumers who bought any of three Lane Labs products -- BeneFin, MGN-3 or Skin Answer -- that they are eligible for a partial refund. A New Jersey federal court ordered the company to pay back customers who bought the products between Sept. 22, 1999, and July 12, 2004. The court ruled that the products, touted as treatments for cancer and HIV, were marketed without FDA approval. 

July 31, 2006: Hydrogen Peroxide

FDA Warns Consumers Against Drinking High-Strength Hydrogen Peroxide for Medicinal Use
FDA is warning consumers not to drink high-strength hydrogen peroxide products for medicinal purposes, especially a product marketed as "35% Food Grade Hydrogen," which has been advertised as a treatment for AIDS, cancers, emphysema and other diseases. Such products taken orally can cause serious harm or death, the agency says.

2005

December 12, 2005: Miracle II Neutralizer

FDA Warns Consumers About Unapproved and Bacterially-Contaminated Miracle II Neutralizer and Miracle II Neutralizer Gel Drug Products
FDA has warned consumers not to use Miracle II Neutralizer or Miracle II Neutralizer Gel products because they are contaminated with bacteria and have not been proven safe and effective. Marketer Tedco, Inc., has promoted the products for treatment of cataracts, AIDS, cancer, diabetes and other unapproved uses, which FDA calls "deceptive and untruthful claims." 

November 14, 2005: 'Alternative Hormone Therapies'

FDA Issues Warning Letters to Marketers of Unapproved 'Alternative Hormone Therapies'
FDA has taken action against companies marketing unapproved "alternative hormone therapies." The agency considers these products unapproved drugs that have not been shown to be safe and effective for their touted benefits of treating or preventing diseases such as cancer, heart disease and osteoporosis.

October 25, 2005: Fruit Products

FDA Warns Companies To Stop Marketing Fruit Products With Unproven Disease Treatment and Prevention Claims
FDA is warning 29 companies to stop making claims that their fruit products can treat or prevent cancer, heart disease, arthritis and other diseases. 

June 30, 2005: Green Tea

FDA Issues Information for Consumers about Claims for Green Tea and Certain Cancers

May 20, 2005: Whole Grains

Speech before Whole Grains and Health: A Global Summit, by the FDA Acting Commissioner, Lester M. Crawford, D.V.M., Ph.D.

April 1, 2005: Food Labels

FDA Asking for Public Comment on Food Label Changes

February 25, 2005: SciFit Procut and Thermogen II

Illegal Dietary Supplements Seized

2004

December 20, 2004: Ginseng

FDA Initiates Seizure of Ginseng Because of Potentially Risky Pesticide Residues

November 4, 2004: Dietary Supplements

FDA Announces Major Initiatives for Dietary Supplements

October 2004: Herbal Medicines and Nutritional Supplements

Ocular Side Effects from Herbal Medicines and Nutritional Supplements (abstract)
In a review by F. W. Fraunfelder, M.D., eight herbal and nutritional agents used to treat eye and other problems were found to have ocular side effects according to reports received by the National Registry of Drug-Induced Ocular Side Effects and case reports from the literature. 

March 22, 2004: Seasilver

Dietary Supplement Firms, Seasilver USA, Inc., and Americaloe, Inc., Sign Consent Decree With FDA To Stop Selling Product Claiming To Cure "Over 650" Diseases
The Food and Drug Administration (FDA) today announced that Seasilver USA, Inc., and Americaloe, Inc., of Carlsbad, California, and their principals, Bela Berkes and Jason Berkes, have signed a consent decree of permanent injunction in which they agreed to stop manufacturing and distributing violative products, including "Seasilver" – a purported cure-all liquid supplement. 

2003

November 17, 2003: Royal Tongan Limu

Royal Tongan Limu Dietary Supplements Promoted to Treat Various Diseases Destroyed
The FDA has announced that NBTY, Inc., of Bohemia, NY, has completed its voluntary destruction of approximately 90,000 units of Royal Tongan Limu, a dietary supplement promoted to treat various diseases like cancer, arthritis and attention deficit disorder (ADD). The destruction of the product, witnessed by FDA Chicago District, occurred October 13-17, 2003, at a landfill in Desoto, IL. It involved approximately $2,700,000 worth of product. Royal Tongan Limu was distributed by Dynamic Essentials, a subsidiary of NBTY located in Lake Mary, FL. Dynamic Essentials has ceased operation, and no longer promotes or sells the products on its Web site.

September 12, 2003: Milk

FDA Warns Milk Producers to Remove "Hormone Free" Claims From the Labeling of Dairy Products
FDA has sent warning letters to four processors of whole milk, reduced-fat milk and ice cream, informing them that their products are misbranded because the labels contain the false statements "no hormones" or "hormone free." FDA explains that all milk contains naturally occurring hormones, and milk cannot be processed in a way that renders it hormone free. 

September 10, 2003: Star Anise

FDA Issues Advisory on Star Anise "Teas"
Following reports linking brewed teas made with the herb star anise to illnesses affecting about 40 persons, 15 of them infants, FDA is advising consumers to avoid drinking those teas. Though the agency has not identified the specific type of star anise involved in the illnesses, it issued the advisory as an interim measure while gathering more information. 

September 9, 2003: Menopausal Hormone Therapy

FDA Launches Collaborative Campaign to Inform Women About Menopausal Hormone Therapy
Menopause & Hormones
FDA has joined with two members of Congress to launch a nationwide campaign aimed at raising awareness about recent findings on risks and benefits of menopausal hormone therapy. Included in the campaign are a menopause and hormone therapy fact sheet, along with a "purse guide" that provides questions for discussion with a healthcare professional, both available online or in printed form.

June 10, 2003: Coral Calcium Supreme

FTC Charges Marketers of Coral Calcium Supreme Dietary Supplement and a Pain-Relief Product With Making False and Unsubstantiated Claims
As part of a federal program to crack down on products with unsubstantiated health claims, FDA and the Federal Trade Commission have taken action against the marketers of Coral Calcium Supreme, a dietary supplement falsely promoted as treating or curing cancer and other diseases.

2002

October 2, 2002: Sprouts

Consumers Advised of Risks Associated with Eating Raw and Lightly Cooked Sprouts
Prompted by several outbreaks in the last two years of serious foodborne illness linked to eating raw or lightly cooked sprouts, FDA is advising that children, the elderly, and those with reduced immune function should avoid sprouts entirely. Others are urged to take certain steps to reduce their risk of illness if they eat alfalfa, mung bean or other kinds of sprouts.

August 29, 2002: Foods, Cosmetics and Dietary Supplements

Announcing CAERS - the CFSAN Adverse Event Reporting System
FDA's Center for Food Safety and Applied Nutrition (CFSAN) is developing a new procedure for tracking and analyzing adverse event reports involving foods, cosmetics and dietary supplements. Called the CFSAN Adverse EventsReporting System (CAERS), the new process will help identify potential public health issues associated with products in the marketplace. Officials expect CAERS to be pilot tested in the coming months and be operational by May 2003.

March 10, 2003: Dietary Supplements

FDA Proposes Labeling and Manufacturing Standards For All Dietary Supplements
Factsheet
Background
FDA has proposed a rule that would, for the first time, establish standards to ensure that dietary supplements do not contain contaminants or impurities, and that product ingredients are listed accurately. Among the proposals are requirements for design of physical plants, quality control procedures, product testing, maintaining records and handling consumer complaints.

Safety of Imported Drugs

Importing Prescription Drugs
Looks Can Be Deceiving (pdf)
FDA's Center for Drug Evaluation and Research has created a brochure for consumers that explains the many concerns the agency has about the practice of traveling to foreign countries to buy medications for personal use or ordering medications from foreign sources (through Web sites, for example).

Curcumin and Chemotherapy Drugs

Dietary Curcumin Inhibits Chemotherapy-Induced Apoptosis in Models of Human Breast Cancer. Sivagurunathan Somasundaram, Natalie A. Edmund, Dominic T. Moore, George W.Small, Yue Y. Shi and Robert Z. Orlowski. The Lineberger Comprehensive Cancer Center [S. S., N. A. E., D. T. M., G. W. S., Y. Y. S., R. Z. O.] and the Department of Medicine [R. Z. O.], Division of Hematology/Oncology, The University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599.

Curcumin, the major component of the spice turmeric, is used as a coloring and flavoring additive in many foods and has attracted interest because of its anti-inflammatory and chemopreventive activities. However, this agent also inhibits the generation of reactive oxygen species (ROS) and the c-Jun NH2-terminal kinase (JNK) pathway, and, because many chemotherapeutic drugs generate ROS and activate JNK in the course of inducing apoptosis, we considered the possibility that curcumin might antagonize their antitumor efficacy. Studies in tissue culture revealed that curcumin inhibited camptothecin-, mechlorethamine- and doxorubicin-induced apoptosis of MCF-7, MDA-MB-231 and BT-474 human breast cancer cells by up to 70%. Inhibition of programmed cell death was time and concentration dependent, but occurred after relatively brief three-hour exposures, or at curcumin concentrations of 1 µM, that have been documented in Phase I chemoprevention trials. Under these conditions, curcumin exhibited antioxidant properties and inhibited both JNK activation and mitochondrial release of cytochrome c in a concentration-dependent manner. Using an in vivo model of human breast cancer, dietary supplementation with curcumin was found to significantly inhibit cyclophosphamide-induced tumor regression. Such dietary supplementation was accompanied by a decrease in the activation of apoptosis by cyclophosphamide, as well as decreased JNK activation. These findings support the hypothesis that dietary curcumin can inhibit chemotherapy-induced apoptosis through inhibition of ROS generation and blockade of JNK function, and suggest that additional studies are needed to determine whether breast cancer patients undergoing chemotherapy should avoid curcumin supplementation, and possibly even limit their exposure to curcumin-containing foods.

Aloe

The FDA issued a final ruling that aloe and cascara sagrada will not be included in the final monograph (pdf) for over-the-counter (OTC) laxative drug products because they have not been shown to be generally safe and effective as stimulant laxatives.

St. John’s Wort

NIH Clinical Center research shows that St. John’s wort may reduce the effectiveness of several drugs by speeding up activity in a key pathway responsible for their breakdown. The end result is that blood levels of these drugs decrease because the body breaks them down faster. St. John’s wort especially affects Crixivan (indinavir) and other protease inhibitors used to treat HIV infection. It also may affect cyclosporine, a drug used to help prevent organ transplant rejection, and other immunosuppressant drugs and other medications that work through the same pathway, including birth control pills, cholesterol-lowering medications such as Mevacor (lovastatin), cancer medications, seizure drugs and blood thinners such as Coumadin (warfarin). Doctors and patients should be aware of these negative drug interactions that could interfere with the proper functioning of these drugs. For more information, visit NCCAM’s Web site, or the FDA Center for Drug Evaluation and Research’s Web site, or call the FDA Center for Food Safety and Applied Nutrition at 201-332-4010.

Kava

December 30, 2002 - Kava Banned in the United Kingdom (pdf).

April 1, 2002 - FDA Alert - Kava supplements pose possible liver injury risk: FDA is advising consumers of the potential risk of severe liver injury associated with dietary supplements containing the ingredient kava. These products typically are promoted for uses such as relaxation, sleeplessness and menopausal symptoms. For further information, visit MedWatch: The FDA Safety Information and Adverse Event Reporting Program Web site.

The German Federal Institute for Drugs and Medical Devices (BfArM) banned all products containing the herb kava (kava kava, Piper methysticum) or the synthetic lactone kavain due to the risk of liver damage. Products containing kava in dilutions greater than 1:10,000 remain legally marketable in Germany under the BfArM decision. 

Some Kava toxicity has been associated with certain extracts and/or chronic overdoses as described in a review by Marc Blumenthal of the American Botanical Council.

Grapefruit

Health Canada advises the public not to consume grapefruit or grapefruit juice while taking medications used to treat anxiety, depression, high blood pressure, HIV/AIDS, cancer, irregular heart rhythms, infections, psychotic problems, erectile dysfunction, angina, convulsions, gastrointestinal reflux, high cholesterol or organ graft rejections due to the risk of potentially serious interference with blood drug levels. The advisory cautions that sour oranges and tangelos may also interfere with blood drug levels, but most other citrus fruits are considered safe, including sweet oranges, lemons, limes, citrons and tangerines.

Recommendations for discontinuance of eight herbs before surgery (pdf)
From Ang-Lee MK, Moss J, and Yuan C-S, Herbal Medicines and Perioperative Care. JAMA, July 11, 2001, 286, 2, 213.

Other FDA News

June 17, 2008: Online Cancer Fraud

Beware of Online Cancer Fraud
The FDA and the U. S. Federal Trade Commision has launched a new initiative to target online cancer fraud. Update includes signs of health fraud and red flags. 

September 20, 2006: Nutrition Facts Label

HHS and FDA Announce New Tools to Help Consumers Use the Nutrition Facts Label
Make Your Calories Count: Use the Nutrition Facts Label for Healthy Weight Management
Eating Healthier and Feeling Better Using the Nutrition Facts Label
As part of an agency effort to help consumers choose nutritious foods and achieve a healthy weight, FDA has created two tools that aim to explain how to use the Nutrition Facts label. One tool, "Make Your Calories Count," is an online interactive program that takes viewers through a series of food label exercises. The second tool, "Nutrition Facts Label," is a brochure that can help consumers shop and plan healthy meals.

June 28, 2004: Leeches

FDA Clears Medicinal Leeches for Marketing

February 20, 2003: Zoetron Machine

FTC, Canada and Mexico Officials Crack Down on Foreign Companies That Offer Bogus Cancer Treatment
The U. S. Federal Trade Commission, in coordination with officials in Canada and Mexico, has charged CSCT, Inc., based in British Columbia, with making false claims that it can treat cancer by using an electromagnetic device known as the "Zoetron machine," which purportedly uses a pulsed magnetic field to heat and kill cancer cells.

According to the FTC, the defendants charge consumers $15,000 up front for several weeks of "treatments" in Tijuana, Mexico. The complaint is not a finding or ruling that the defendant actually has violated the law. The case will be decided by the court. 

December 18, 2002: Consumer Health Information

FDA Announces Initiative to Provide Better Health Information for Consumers
FDA's Consumer Health Information for Better Nutrition Initiative
Dietary Supplement Enforcement Report
The FDA's new Consumer Health Information for Better Nutrition initiative is designed to encourage makers of foods and dietary supplements to make science-based health claims about their products. The initiative also aims to help eliminate false or misleading claims related to dietary supplements. FDA also has released a report explaining its enforcement strategy to curb bogus labeling claims.