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U.S. Department of Health and Human Services

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FDA's MedWatch Safety Alerts: June 2011


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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.

  • Online
  • 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 prompted by reports FDA has received through MedWatch.

Depacon, Depakote, and Similar Drugs: Risk of Reduced Cognitive Development in Children Exposed During Pregnancy

Study results have indicated that children born to mothers who took valproate sodium or related products throughout their pregnancy tend to score lower on IQ and other cognitive tests than children born to mothers who took other anti-seizure medications during pregnancy.

Cognitive tests are commonly used to assess development in areas such as intelligence, abstract reasoning, and problem solving.

Valproate products include

  • Depacon (valproate sodium)
  • Depakote, Depakote CP, and Depakote ER (divalproex sodium)
  • Depakene, Stavzor, and their generics (valproic acid)

Valproate products are FDA-approved to treat seizures and bipolar disorder, and to prevent migraine headaches. They are also prescribed for unapproved uses (off-label) in the treatment of other conditions, particularly other psychiatric disorders.

FDA Actions: To reflect this new risk, FDA will be revising the labels of all valproate products and the Medication Guide—printed material given to consumers along with their prescription medication.

Recommendations

  • Do not stop taking valproate without talking to a health care professional, even if you’re pregnant. Stopping the drug suddenly can cause serious problems.
  • If you’re a woman of childbearing age and you decide to take valproate, use an effective birth control method. Talk to your health care professional about the best kind for you to use.
  • Before you start valproate, tell your health care professional if you are pregnant or are planning to become pregnant.
  • If you become pregnant while taking valproate, tell your health care professional right away. Ask about registering with the North American Antiepileptic Drug Pregnancy Registry at 1-888-233-2334 or www.massgeneral.org/aed/. The registry collects additional information about the safety of antiepileptic drugs during pregnancy.
  • Talk to your healthcare professional about the best way to feed your baby if you take valproate. (The drug passes into breast milk, but its effects on developing babies are not known.)
  • If you took valproate while pregnant, let your child’s pediatrician know.

For More Information

Questions and Answers: Children born to mothers who took the anti-seizure medication Valproate while pregnant may have impaired cognitive development

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Recall: Tylenol Extra Strength Caplets, Risperdal, and Risperidone

The following products have been recalled due to a musty, moldy, or other unusual odor.

  • Tylenol Extra Strength Caplets, 225 count bottles, lot ABA619, which were manufactured in February 2009 and distributed in the U.S.
  • Risperdal (risperidone) Tablets, 3mg bottle of 60 tablets, lot 0GG904, expiration May 2012
  • Risperidone Tablets, 2mg bottles of 60 tablets, lot 0LG175, expiration August 2012

Tylenol is an over-the-counter fever reducer and pain reliever. Risperdal and Risperidone are prescription drugs used to treat certain mental illnesses.

The unusual odor has been linked to the presence of trace amounts of a chemical known as 2,4,6-tribromoanisole (TBA). TBA is not considered to be toxic. However, some people have reported temporary, non-serious stomach or intestinal problems after taking the recalled products.

Recommendations

  • Stop using the recalled Tylenol. Contact McNeil Consumer Healthcare by visiting www.tylenol.com or by calling 888-222-6036 Monday–Friday, 8 a.m. to 8 p.m. Eastern Time, for instructions about receiving a refund or coupon.
  • Do not stop taking Risperdal or risperidone without talking to your health care professional. If you smell an unusual odor, return the tablets to your pharmacist and ask for a replacement. For more information, call Ortho-McNeil-Janssen Pharmaceuticals’ Recall Line at 800-634-8977 Monday–Friday, 9 a.m. to 5 p.m. Eastern Time, or visit www.risperdal.com and www.patriotpharmaceuticals.com.

For More Information

Tylenol Extra Strength Caplets, 225 count bottles: Recall - Uncharacteristic Odor

Risperdal (risperidone) and Risperidone: Recall - Uncharacteristic Odor

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Recall: Nature Relief Instant Wart and Mole Remover

Nature Relief Instant Wart and Mole Remover has been recalled because the active ingredient, calcium oxide, can cause severe burns—particularly to areas of thin or sensitive skin, such as on the face, around the eyes, and on external sex organs.

This product has been sold through the Internet as a kit containing “Repair Cream,” “Antiseptic Wash,” “Triple Antibiotic Ointment,” toothpicks, and a “vanity kit" with cotton balls, swabs, and nail files.

Recommendations

  • Stop using this product and throw out the remaining contents by sealing them in a plastic bag before placing in the garbage.
  • See a licensed medical professional to have moles removed and ensure they are not cancerous.

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Recall: Endocet Tablets

Endo Pharmaceuticals has recalled the following products because some bottles may contain different strength tablets, resulting in people taking more than the intended dose of acetaminophen. Too much acetaminophen can cause severe liver damage.

  • Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, lot 402415NV, Expiry 01/2014
  • Endocet (oxycodone/acetaminophen, USP) Tablets, 10 mg/325 mg 100 count bottles, lot 402426NV, Expiry 01/2014

See photos of the recalled tablets.

Recommendation: Stop taking the recalled products and call your health care professional immediately for further instructions. You may contact Endo’s agent, Stericycle, at 866-723-2681 to return the products.

For More Information

New Steps Aimed at Cutting Risks from Acetaminophen

Acetaminophen and Liver Injury: Q & A for Consumers

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Recall: Butalbital, Acetaminophen, and Caffeine Tablets; and Hydrocodone Bitartrate and Acetaminophen Tablets

Qualitest has recalled the following products because some bottles may contain incorrect tablets and people may unintentionally take butalbital and caffeine instead of hydrocodone.

  • Butalbital, Acetaminophen, and Caffeine Tablets, USP 50mg/325mg/40mg, 500 count, lots C0390909A, C0400909A, C0410909A, and C0590909B
  • Hydrocodone Bitartrate and Acetaminophen Tablets, USP 7.5mg/500mg, 1,000 count, lots C0390909A, C0400909A, C0410909A, and C0590909B

Risk: Unintentionally taking butalbital could result in symptoms such as drowsiness, lightheadedness, dizziness, and nausea. People with an allergy to butalbital could experience an allergic reaction. Side effects due to caffeine are less likely; however, those with a sensitivity to caffeine may experience symptoms such as tremors, irritability, and difficulty sleeping. People  receiving hydrocodone for chronic pain might experience worsening pain and withdrawal symptoms as a result of this substitution.

See photos of the recalled tablets. 

Recommendations

  • Do not use the recalled products.
  • If you have a filled prescription of the recalled Hydrocodone Bitartrate and Acetaminophen manufactured by Qualitest, stop taking it and call your health care professional immediately for further instructions.
  • For more information, contact Qualitest at 800-444-4011, Monday–Friday, 8 a.m. to 5 p.m. Central Standard Time.

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Recall: Unapproved Drug Sold as “Sexual Enhancer” Dietary Supplement

A product sold as a dietary supplement contains active drug ingredients that are not listed on the label, making it an unapproved drug.

Via Xtreme Ultimate Sexual Enhancer Dietary Supplement for Men was distributed throughout the U.S., Puerto Rico, and Canada to Internet and retail consumers. Only lots 809013 and 806030 are covered in this recall.

See a photo of the recalled product. 

Risk: The product contains substances similar to sildenafil, which is an active ingredient in an FDA-approved drug for erectile dysfunction. These substances may interact with prescription drugs known as nitrates, including nitroglycerin, and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

Recommendations

  • Stop using this product immediately and contact your health care professional if you have had any problems that you think may be related to taking this product.
  • If you have questions about the product or need instructions for returning it, call Global Wellness LLC at 954-922-1133, Monday–Friday, 9 a.m. to 4 p.m. Eastern Standard Time.

For More Information

Hidden Risks of Erectile Dysfunction "Treatments" Sold Online

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Chantix: Risk of Heart Attack and Other Cardiovascular Events

The use of Chantix (varenicline) may be associated with a small, increased risk of certain heart and blood vessel (cardiovascular) problems in people who have cardiovascular disease. This new safety information will be added to the drug’s label and the Medication Guide—printed material given to people along with their prescription medication.

Chantix is FDA-approved to help smokers quit smoking. Smoking is a major risk factor for cardiovascular disease.

Risk: FDA reviewed a clinical trial of 700 smokers with cardiovascular disease, which showed that certain cardiovascular events—including heart attack—were reported more frequently in people treated with Chantix than in those treated with an inactive substance (placebo).

Recommendations

  • Call your health care professional if you have concerns about Chantix or experience new or worsening symptoms of cardiovascular disease while taking Chantix, such as
  • Shortness of breath or trouble breathing
  • New or worsening chest pain
  • New or worse pain in legs when walking
  • Read the Medication Guide you get along with your Chantix prescription.

For More Information

Varenicline (marketed as Chantix) Information

FDA 101: Smoking Cessation Products

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Proscar, Propecia, Avodart, and Jalyn: Increased Risk of Prostate Cancer

The use of a class of prescription drugs known as 5-alpha reductase inhibitors (5-ARIs) may increase the risk of being diagnosed with a more serious form of prostate cancer (high-grade prostate cancer).

This new safety information will be added to the label of 5-ARIs, which include

  • Proscar (finasteride 5 mg)
  • Propecia (finasteride 1 mg)
  • Avodart (dutasteride)
  • Jalyn (dutasteride with tamsulosin)

5-ARIs are primarily used to treat the symptoms of benign prostatic hyperplasia (BPH)—a common condition in men older than 40 that is characterized by an enlarged prostate and symptoms such as frequent urination and difficulty emptying the bladder.

Risk: FDA reviewed two large studies, which showed an overall reduction in the risk of lower-grade forms of prostate cancer, but also showed an increased risk of high-grade prostate cancer.

Recommendation: Discuss any questions or concerns about 5-ARIs with your health care professional.

For More Information

Questions and Answers: 5-alpha reductase inhibitors (5-ARIs) may increase the risk of a more serious form of prostate cancer 

5-Alpha Reductase Inhibitor Information

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Actos: Potential Increased Risk of Bladder Cancer

The use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer. This new safety information will be added to the drug’s label and the Medication Guide—printed material given to people along with their prescription medication.

Risk: In September 2010, FDA announced it was reviewing data from an ongoing 10-year study of pioglitazone and the risk of bladder cancer. FDA completed its review of five-year results, which showed that although there was no overall increased risk of bladder cancer with pioglitazone use, an increased risk was found among patients who had used Actos the longest and at the highest doses.

Recommendations

  • Do not take pioglitazone if you are being treated for bladder cancer.
  • Tell your doctor right away if you have any of the following symptoms of bladder cancer:
  • blood or red color in urine
  • urgent need to urinate or pain while urinating
  • pain in back or lower abdomen
  • Read the Medication Guide you get along with your pioglitazone medicine.

For More Information

FDA Drug Safety Communication: Update to ongoing safety review of Actos (pioglitazone) and increased risk of bladder cancer 

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Zocor, Vytorin, Simcor: New Safety Information

FDA has recommended that the use of drugs containing 80 mg of simvastatin—the highest approved dose of the cholesterol-lowering statin—be sharply curtailed because of the risk of muscle injury (myopathy).

The statin is sold under the brand name Zocor and as a single-ingredient generic drug. It is also sold in combination with ezetimibe as Vytorin, and with niacin as Simcor.

FDA is requiring changes to the simvastatin label to add new contraindications (it should not be used at all with certain medications) and dose limitations for using simvastatin with certain medicines.

Risk: People who take simvastatin 80 mg daily have an increased risk of myopathy compared to those taking lower doses of this drug or other drugs in the same class. This risk appears to be higher during the first year of treatment, is often the result of interactions with certain medicines, and is frequently associated with a person’s genetic predisposition (likelihood of developing a certain medical condition) toward simvastatin-related myopathy. The most serious form of myopathy can damage the kidneys and lead to kidney failure, which can cause death.

Recommendations

If you currently take an 80-mg simvastatin-containing medicine

  • Don’t stop taking your medicine unless told to by your health care professional.
  • Review with your health care professional your medical history, your currently prescribed dose of simvastatin, and a list of your other current medications. Certain medications should never be taken with simvastatin.
  • Immediately contact your health care professional if you have muscle pain, tenderness or weakness, dark or red colored urine, or unexplained tiredness.

For More Information

Consumer Update: FDA: Limit Use of 80 mg Simvastatin 

Zocor (simvastatin): Label Change - New Restrictions, Contraindications, and Dose Limitations 

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Thermography Not a Substitute for Mammography: FDA Safety Communication

Thermography is not a replacement for mammography for breast cancer screening or diagnosis.

Thermography produces an infrared image that shows the patterns of heat and blood flow on or near the surface of the body.

Certain facilities, websites, and mobile units are promoting the use of thermography as a tool used by itself for screening and diagnosing breast cancer, claiming that is a substitute for or superior to mammography. They also claim that thermography can detect pre-cancerous abnormalities and diagnose breast cancer long before mammography and that compressing the breast during mammography will cause or spread cancer by pushing cancer cells into additional locations in the body.

FDA has no evidence to support the above claims about thermography. There is evidence that mammography is effective in breast cancer detection. Women who substitute thermography for mammography may miss the chance to detect cancer at its earliest stage.

Recommendations

Women should

  • have regular mammograms according to screening guidelines or as recommended by a health care professional
  • follow a health care professional's recommendations for additional breast diagnostic procedures which could include thermography, clinical breast exam, breast ultrasound, MRI, or biopsy

For More Information

Consumer Update: Thermogram No Substitute for Mammogram 

FDA Safety Communication: Breast Cancer Screening - Thermography is Not an Alternative to Mammography

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Angiotensin Receptor Blockers: Drug Safety Review Completed

Treatment with an angiotensin receptor blocker (ARB) medication does not increase a patient’s risk of developing cancer.

This conclusion is based on FDA’s analysis of 31 clinical trials involving more than 60,000 patients comparing ARBs to other treatments.

A study published in July 2010 suggested that the use of ARBs may be associated with a small,  increased risk of cancer. At that time, FDA announced its intent to conduct a safety review of ARBs.

ARBs are used in people with high blood pressure and some other conditions. Brand names include Atacand, Avapro, Benicar, Cozaar, Diovan, Micardis, and Teveten.

Recommendations

  • Do not stop taking your ARB medication without talking to your health care professional.
  • Discuss any questions or concerns about ARB medications with your health care professional.

For More Information

FDA Drug Safety Communication: No increase in risk of cancer with certain blood pressure drugs—Angiotensin Receptor Blockers (ARBs)
 

This article appears on FDA's Consumer Updates page, which features the latest on all FDA-regulated products.

July 25, 2011

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