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MedWatch Safety Alerts, May 2012

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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 (http://www.fda.gov/medwatch/report.htm)
  • 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.

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Counterfeit ADHD Drug Has Wrong Active Ingredients

FDA warns that a counterfeit version of Teva Pharmaceutical Industries’ Adderall 30 milligram tablets, which preliminary laboratory tests found contains the wrong active ingredients, is being sold on the Internet.

Adderall, a prescription drug, is approved to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy (a disorder that causes excessive sleepiness).  It is classified as a controlled substance—a class of drugs that can potentially be abused; pharmacists are required to use special procedures when dispensing them.

Risk: The counterfeit versions of Adderall should be considered unsafe, ineffective and potentially harmful.
The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Authentic Adderall 30 mg tablets produced by Teva are round and orange/peach, with "dp" embossed on one side and "30" on the other side of the tablet.

Adderall contains four active ingredients—dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these ingredients, the counterfeit product contains tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

Currently on the FDA’s drug shortage list, Adderall is in short supply due to issues with the supply of the active pharmaceutical ingredient. Teva continues to release product as it becomes available.

Recommendations

  • Anyone who believes they have the counterfeit version of Teva’s Adderall 30 mg tablets should not take it.
  • Consumers should talk to their health care professional about their condition and options for treatment.
  • Consumers should be extra cautious when buying their medicines from online sources.  Rogue websites and distributors may especially target medicines in short supply for counterfeiting.

For More Information

FDA News Release

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Some HCV and HIV Drugs Are Less Effective Together

FDA is updating the drug label of Victrelis (boceprevir), a medication used to treat hepatitis C, to state that patients should not take it with certain drugs prescribed for patients with the human immunodeficiency virus (HIV). Two studies showed that using Victrelis together with ritonavir-boosted HIV protease inhibitors reduces the levels, and thus the effectiveness, of these medicines in the blood.

Risk: Reduced effectiveness of these medications may cause increases in the amount of HCV or HIV virus in the blood.

Victrelis is used with the medicines peginterferon alfa and ribavarin to treat chronic hepatitis C infection in adults. HIV protease inhibitors are a class of antiviral drugs used to treat HIV infection. A protease is an enzyme that facilitates cellular production of HIV particles and ritonavir is an HIV protease inhibitor used to “boost” other HIV protease inhibitors, increasing their levels in the blood and making them more effective.

Ritonavir-boosted HIV protease inhibitors include:

  • Reyataz (atazanavir)
  • Prezista (darunavir)
  • Kaletra (lopinavir/ritonavir)

Recommendations 

  • Do not stop taking any medications without discussing any questions or concerns with a health care professional.
  • Health care professionals who have started patients infected with both chronic hepatitis C and HIV on these combined therapies should closely monitor them for HCV treatment response and for increased levels of hepatitis C and HIV viruses in the blood.

For More Information

FDA Drug Safety Communication

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Recall: West Coast Nutritionals Dietary Supplements

West Coast Nutritionals, Ltd., in Houston is recalling all lots of its dietary supplements Firminite, Extra Strength Instant Hot Rod, and Libidron. An FDA lab analysis of Firminite found undeclared tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making these products unapproved new drugs.

Risk: Tadalafil may interact with nitrates found in some prescription drugs, such as nitroglycerin, and may lower blood pressure to dangerous levels. People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. FDA advises that tadalafil also may cause side effects such as headaches and flushing.

The affected products may have been ordered online at www.firminite.com, www.instanthotrodextrastrength.com, www.libidron.com, or www.amazon.com and were distributed to customers and retailers nationwide and worldwide. They are marketed as dietary supplements intended for use as male enhancement products.

Recommendations

  • Stop using these products and return any unused products to West Coast Nutritionals. Customers with questions can call (877) 782-6464 Monday thru Friday, 9 a.m-6 p.m. PST for more information.

For More Information

Press Release – West Coast Nutritionals

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FDA Reviewing Zithromax Death Risk Study

FDA is reviewing the results of a study published in the May 17, 2012 edition of the New England Journal of Medicine reporting disclaimer icon a small increase in cardiovascular deaths, and in the risk of death from any cause, in people treated with a five-day course of the antibiotic azithromycin (Zithromax).

Risk: Changes in the electrical activity of the heart—specifically, prolongation of the QT interval, a measure of the heart’s electrical activity—can lead to a risk of a potentially fatal abnormal heart rhythm called Torsades de Pointes.

The study detected increased risks of QT prolongation when comparing the use of azithromycin with other antibiotics— amoxicillin, ciprofloxacin—or no drug.

People at risk for developing QT prolongation include those with underlying heart conditions and those who tend to have low levels of potassium and magnesium in their blood.

Recommendations

  • Do not stop taking your medication without talking to a health care professional.

For More Information

Statement—Center for Drug Evaluation and Research

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MS Drug Investigation Continues

FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod), an oral medication used in adults to reduce the frequency of MS flare-ups and delay physical disability.  The agency also has received reports of MS patients who died of heart problems or unknown causes, but has not concluded whether the drug caused any of the deaths, and is continuing to investigate the cases.

Risk: At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed. However, the agency has added specific recommendations for health care professionals regarding monitoring patients after the first dose, and advises against its use in certain patients.

Although the maximum heart rate lowering effect of Gilenya usually occurs within six hours of the first dose, the maximum effect may occur as late as 20 hours after the first dose in some patients. For this reason, FDA advises against the use of Gilenya in patients with certain pre-existing or recent (within last six months) heart conditions or stroke, or who are taking certain medications for heart arrythmia (abnormal rhythm).

Recommendations

  • Patients with MS should not stop taking Gilenya without talking to their healthcare professional.
  • Health care professionals who prescribe Gilenya should follow the recommendations in the approved drug label. 
  • Health care professionals should provide heart monitoring longer than six hours, including continuous, overnight electrocardiogram (ECG) monitoring, in patients who are at higher risk for, or who may not tolerate, bradycardia (slow heartbeat).

For More Information

Drug Safety Communication 5/14/12

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MDS/Multiple Myeloma Drug Raises Risk of New Cancers

FDA is reviewing the findings of clinical trials conducted both in the United States and in other countries that found that patients treated with Revlimid (lenalidomide) may be at an increased risk of developing new types of cancer compared to patients who did not take the drug. Revlimid is used to treat a type of blood disorder known as myelodysplastic syndrome (MDS). It is also used along with other drugs to treat people with the cancer known as multiple myeloma.

Risk: Clinical trials conducted after Revlimid was approved by FDA showed that newly-diagnosed patients treated with Revlimid had an increased risk of developing new cancers—specifically, acute myelogenous leukemia, myelodysplastic syndromes, and Hodgkin's lymphoma— compared to similar patients who received a placebo.

Recommendations

  • At this time, there is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated for multiple myeloma and MDS.
  • Health care professionals and patients should consider both the potential benefit of Revlimid and the risk of new cancers when making treatment decisions, and patients should be monitored for this risk.

For More Information

Drug Safety Communication

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Safety Labeling Changes

In April 2012, FDA required safety labeling changes to be made to 43 drug products, including Atacand (Candesartan Cilexetil) and Miacalcin (Calcitonin-Salmon) Nasal Spray and Injection. Atacand should not be taken by pregnant women, and there have been reports of tremors, allergic and digestive problems tied to Miacalcin.

Five changes were to blood pressure medicines containing aliskiren, warning against combining them with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs) in people with diabetes, because it increases their risk for kidney disease, low blood pressure and higher-than-normal potassium levels. ACEIs and ARBs relax blood vessels by blocking the effects of a hormone that causes vessels to narrow.

Four were to birth control pills containing drosperinone and ethinyl estradiol—including Beyaz, Safyral, Yasmin, and Yaz—which carry a higher risk of blood clots.

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.

June 7, 2012

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