FDA's MedWatch Safety Alerts: December 2012
- Dangerous Supplement Sold as ‘WOW’
- Recall: Zicam Extreme Congestion Relief Nasal Gel
- Recall: Hydrocodone Bitartrate and Acetaminophen Tablets for Pain Relief
- A Dangerous Mix: Xyrem and Alcohol or Some Other Drugs
- Serious Skin Reactions When Incivek Is Taken With Other Drugs
- Pradaxa Should Not Be Used With Mechanical Prosthetic Heart Valves
- Recall: Dietary Supplements for Sexual Enhancement
- Recall: SLIMDIA Revolution Weight-Loss Dietary Supplement
- Stop-Smoking Drug Chantix and Risk of Heart Problems
- Recall: Protandim Because of Possible Metal Fragments
- Drug Safety Labeling Changes
After products approved by the Food and Drug Administration (FDA) are on the market, the agency continues to monitor them for problems.
FDA encourages health care professionals and consumers to report problems with medical products, including
- unexpected and undesirable side effects
- quality problems, such as a drug with an unusual odor or color, or a device with defective parts
- unclear or confusing instructions
- failure to deliver the expected benefit.
Report problems to FDA's MedWatch Adverse Event Reporting Program either online, by regular mail, by fax, or by phone.
- Regular Mail: Use postage-paid, pre-addressed FDA form 3500
- Fax: 800-FDA-0178
- Phone: 800-332-1088
MedWatch reports can signal a safety problem and may lead to FDA action to protect the public from harm, serious illness or death.
Here are some of the most recent safety alerts and ongoing safety reviews prompted by reports FDA has received through MedWatch.
A potentially harmful dietary supplement—Reumofan Plus—is being relabeled by distributors and sold under the name “WOW.” The product, marketed on various websites, claims to treat arthritis, muscle pain, osteoporosis, bone cancer and other conditions.
FDA laboratory analysis confirmed that WOW contains the same prescription drug ingredients that are in Reumofan Plus: dexamethasone (a corticosteroid used to treat inflammatory conditions), diclofenac sodium (a non-steroidal anti-inflammatory drug), and methocarbamol (a muscle relaxant). These ingredients can cause serious injury.
In 2012, FDA twice warned the public about taking Reumofan Plus—marketed as a "natural" dietary supplement—because it contains active ingredients found in prescription drugs that should only be used under the supervision of a health care professional. These ingredients are not listed on the label.
Risk: FDA has received reports of serious harm, and even death, after the use of Reumofan Plus, including
- liver injury
- severe bleeding
- corticosteroid withdrawal syndrome, which may include nausea, low blood pressure, low blood sugar levels, fever, muscle and joint pain, dizziness and fainting
- adrenal suppression of production of the hormone cortisol, which can be life-threatening
- Immediately call a health care professional if you are now taking Reumofan Plus or WOW.
- Do not use any products with "Riger Naturals S.A." printed on the bottom of the bottle. Reumofan Plus is manufactured in Mexico by Riger Naturals.
For More Information
- Consumer Update: Dangerous Supplement Now Sold as 'WOW' (includes product photos)
- Reumofan Plus Dietary Supplement Relabeled and Sold as “WOW”: Public Warning - Undeclared Drug Ingredients (December 2012)
- Reumofan Plus: Recall - Undeclared Drug Ingredient (August 2012)
One lot of Zicam Extreme Congestion Relief nasal gel has been recalled after a sample taken from this lot was found to contain the potentially harmful bacteria Burkholderia cepacia. The affected lot is 2J23, expiration 09/15. The liquid nasal gel is packaged in a 0.5 oz. spray bottle contained in an outer carton, bearing national drug code (NDC) number 62750-005-10. The product was distributed nationwide. See more product photos here.
Risk: Burkholderia cepacia pose little medical risk to healthy people. However, the bacteria in a nasal spray could lead to respiratory infections in people with a compromised immune system or chronic lung conditions. The organism is resistant to many antibiotics and may be difficult to get rid of in this sensitive group of people.
Recommendation: Stop using the product and contact the manufacturer, Matrixx Initiatives, for a full refund at 1-877-942-2626 Monday through Friday from 8 a.m. to 8 p.m. CST and Saturday 9 a.m. to 1 p.m. CST.
Certain lots of a combination pain-relief medication have been recalled because they may contain a higher dose of two ingredients—acetaminophen and hydrocodone—than intended. The medication, hydrocodone bitartrate and acetaminophen tablets, USP 10 mg/500 mg, was distributed between Feb. 20, 2012, and Nov. 19, 2012, to wholesale distributors and retail pharmacies nationwide.
The recalled lots are manufactured by Qualitest Pharmaceuticals and have lot numbers beginning with the letter “C” and NDC numbers listed here. In addition, three recalled lots manufactured by Qualitest were repackaged and distributed by Mylan Institutional under the label of UDL Laboratories. The lot numbers for these recalled products are 3037841, 3040859 and 3042573.
Risk: Consumers could take more than the intended dose of acetaminophen or hydrocodone. An increased dose of acetaminophen may result in liver damage, especially in people on other medications that contain acetaminophen, people with liver disease, or people who consume three or more alcoholic beverages a day.
People who take a higher dose of hydrocodone than intended could experience more severe or frequent side effects—such as extreme sleepiness, or dangerously slowed breathing—particularly in those who are elderly, have severe kidney or liver impairment, or are also taking interacting medications, such as other sedating drugs or certain antidepressants.
- If you have questions about the recalled Qualitest product (lot numbers listed here), call the company at 800-444-4011 Monday through Friday from 8 a.m. to 5 p.m. CST.
- If you have questions about the recalled Mylan product (lot numbers 3037841, 3040859 and 3042573), call the company at 800-848-0462 Monday through Friday from 8 a.m. to 5 p.m. EST.
- If you are not sure if you have the recalled product or have any concerns about the drug, talk to your pharmacist or other health care professional.
The use of Xyrem (sodium oxybate) with alcohol or central nervous system (CNS) depressant drugs can lead to severe breathing problems. CNS drugs include
- opioid analgesics
- sedating antidepressants or antipsychotics
- general anesthetics
- muscle relaxants.
Xyrem is FDA-approved to reduce attacks of muscle weakness (cataplexy) and to treat daytime sleepiness in people who have a sudden, incontrollable need to sleep (narcolepsy).
Risk: Using a combination of Xyrem and alcohol or CNS depressants increases the risk of breathing problems that may lead to loss of consciousness, coma and death. Many of the deaths reported to FDA occurred in patients who were prescribed Xyrem for unapproved uses, such as fibromyalgia, insomnia or migraine. Sodium oxybate, the active ingredient in Xyrem, is also called GHB, a known street drug of abuse that has been associated with bad CNS side effects, including death.
- Do not drink alcohol or take drugs for insomnia while taking Xyrem.
- Tell your health care professional if you are taking CNS depressant drugs; he or she may wish to consider an adjustment in the dosages of Xyrem or other drugs.
- If you already have a medical condition that affects your breathing, such as a lung condition or sleep apnea (a condition where you stop breathing for short periods when you are asleep), you may have a higher risk of serious side effects when you take Xyrem. Talk to your health care professional to make sure Xyrem is still right for you.
- Do not stop taking Xyrem without talking to your health care professional.
For More Information
- Xyrem (Sodium Oxybate) Information
- Comunicado de la FDA sobre la seguridad de los medicamentos: Advertencia sobre el uso de Xyrem (oxibato de sodio) con bebidas alcohólicas o medicamentos ya que puede causar depresión respiratoria
FDA is requiring the addition of a boxed warning to the label of the hepatitis C drug Incivek (telaprevir). The warning states that Incivek treatment combined with the drugs peginterferon alfa and ribavirin must be immediately stopped in people who get a progressive severe rash or a rash with symptoms affecting the entire body.
Risk: FDA has received reports of serious skin reactions, some fatal, in people who take Incivek along with the drugs peginterferon alfa and ribavirin.
- If you take Incivek with peginterferon alfa or ribavirin, and you have any of the following signs or symptoms, call your health care professional immediately:
- rash with or without itching
- severe rash with raised bumps, blisters or ulcerations
- rash that does not improve after two to three days
- rash that gets progressively worse
- mouth sores or ulcers
- swelling of the face
- red or inflamed eyes like “pink eye”
- Do not stop taking Incivek with peginterferon alfa and ribavirin without first talking to your health care professional.
The blood thinner Pradaxa (dabigatran etexilate mesylate) should not be used to prevent stroke or blood clots in people who have mechanical heart valves, also known as mechanical prosthetic heart valves. FDA is requiring the Pradaxa label to carry a warning against the use of the drug in patients with mechanical heart valves.
Risk: A clinical trial in Europe was recently stopped because Pradaxa users were more likely to experience strokes, heart attacks and blood clots forming on the mechanical heart valves than were users of the blood thinner warfarin. There was also more bleeding after valve surgery in the Pradaxa users than in the warfarin users.
- If you have had a heart valve replacement and are taking Pradaxa, talk to your health care professional as soon as possible about your treatment.
- Do not stop using Pradaxa or other blood thinners without guidance from your health care professional. Stopping blood thinners suddenly may increase your risk of blood clots or a stroke.
Performance Plus Marketing has recalled certain products marketed as dietary supplement sexual enhancers for men:
- Libigrow and Libigrow XXXtreme
- Blue Diamond and Blue Diamond Platinum
- Mojo Nights and Mojo Nights Supreme
These products contain sulfoaildenafil and thioaildenafil, which are not listed on the label. Sulfoaildenafil and thioaildenafil are close in structure to sildenafil, an active ingredient in an FDA-approved prescription drug used to treat erectile dysfunction, making the products unapproved drugs. The products were sold to distributors and retail stores nationwide and also on the Internet.
Risk: Sildenafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. Consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.
- Don’t use these products; return them immediately to the place of purchase for a full refund.
- Contact your health care professional if you have experienced any problems that may be related to taking these products.
- If you have any questions, contact the company’s recall coordinator at 800-625-8806 Monday through Friday from 9:00 a.m. to 5:30 p.m. PST.
For More Information: Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova: Recall - Undeclared Ingredients Sulfoaildenafil and Thioaildenafil
SLIMDIA Revolution—a product promoted as a dietary supplement for weight loss—has been recalled because FDA laboratory analysis confirmed that it contains sibutramine, a controlled substance that was removed from the market in October 2010 for safety reasons. The product has been sold on the Internet and in some retail stores.
Risk: Sibutramine is known to substantially increase blood pressure or pulse rate in some people, and may present a significant risk for patients with a history of heart disease or stroke. This product may also interact in life-threatening ways with other medications.
- Stop using this product immediately and throw it away or return it to the company, P&J Trading, for a full refund. Call 1-714-726-6544 Monday through Friday from 9 a.m. to 5 p.m. PST for instructions on the return and refund process.
- Talk to a health care professional as soon as possible if you have experienced any problems that may be related to taking this product.
Results are in on a large analysis (meta-analysis) of clinical trials that compared patients who received the drug Chantix (varenicline) to those who received a placebo (an inactive treatment).
The results showed that the Chantix users had more major heart and blood vessel problems (cardiovascular adverse events) than people who took the placebo. However, these problems (including cardiovascular-related death, nonfatal heart attack and nonfatal stroke) were uncommon in both the Chantix and placebo groups, and the increased risk was not statistically significant—meaning it’s uncertain whether the higher risk for the Chantix group was due to the drug or due to chance. The Chantix label has been updated to include the results of the meta-analysis.
Chantix is a prescription medicine used to help adults quit smoking. FDA first notified the public about a possible increased risk of cardiovascular adverse events with Chantix in June 2011, and required Chantix’s manufacturer to conduct the meta-analysis.
Smoking is a major risk factor for cardiovascular disease, and Chantix may help you quit smoking. Quitting smoking can decrease the chances of developing lung disease, heart disease and some cancers.
- Talk to your health care professional if you experience new or worsening symptoms of cardiovascular disease while taking Chantix, for example:
- Shortness of breath or trouble breathing
- New or worsening chest pain
- New or worse pain in legs when walking
- Sudden onset of weakness, paralysis, numbness, or difficulty speaking or understanding speech
- Read the medication guide you get along with your Chantix prescription. It explains the risks associated with the use of Chantix.
For More Information:
- Chantix (Varenicline): Safety Communication - Updated Safety Review on the Risk of Cardiovascular Adverse Events
- FDA 101: Smoking Cessation Products
LifeVantage Corp. announced a recall of its dietary supplement called Protandim, the Nrf2 Synergizer, with certain lot numbers because it may contain small metal fragments. The fragments were originally discovered in batches of turmeric extract, an ingredient in Protandim that was purchased from a third-party supplier.
Protandim is packaged in a cylindrical blue bottle containing 30 caplets. The potentially affected Protandim was distributed in the U.S. and Japan between July and November 2012.
Recommendation: Stop using Protandim with the recalled lot numbers. You can find the lot number on the left side of the product label when looking at the front of the label, directly above the scan bar.
For More Information: Protandim by LifeVantage Corporation: Recall - Possible Metal Fragments in Product
In November 2012, FDA required safety labeling changes to be made to 30 drug products.
In general, changes were made to the prescribing information and, in some cases, to the patient package inserts and medication guides (paper handouts for patients that come with many prescription medicines) to warn about potential harmful reactions, tell who shouldn’t take the drug, or give other safety information.
For More Information: Monthly Safety Labeling Changes
This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.
Jan. 17, 2013