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FDA's MedWatch Safety Alerts: April 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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Dangerous Mix for People With Diabetes or Kidney Disease

FDA is warning of possible risks for people with diabetes or kidney disease who use blood pressure medicines containing aliskiren in combination with other drugs called angiotensin converting enzyme inhibitors (ACEIs) and angiotensin receptor blockers (ARBs). ACEIs and ARBs relax blood vessels by blocking the effects of a hormone that causes vessels to narrow.

These drug combinations should not be used in people with diabetes or with moderate to severe kidney disease. The labels for the aliskiren drugs below are being updated based on early data from a clinical trial, Aliskiren Trial in Type 2 Diabetes Using Cardio-Renal Endpoints (ALTITUDE).

  • Amturnide (aliskiren hemifumarate, amlodipine besylate, and hydrochlorothiazide)
  • Tekturna (aliskiren hemifumarate)
  • Tekturna HCT (aliskiren hemifumarate and hydrochlorothiazide)
  • Tekamlo (aliskiren hemifumarate and amlodipine besylate)
  • Valturna (aliskiren hemifumarate and valsartan). Valturna will not be sold after July 2012.

Risk: People with diabetes who take aliskiren with ARBs or ACEIs are at risk for kidney disease, low blood pressure and higher-than-normal potassium levels. People who already have kidney disease should also avoid aliskiren.


  • Do not stop taking aliskiren without talking to your health care professional. Stopping the drug suddenly can cause problems if your high blood pressure is not treated.
  • Tell your health care professional if you are taking an ACEI or an ARB. (See a list of ACEI and ARB products in Tables 2 and 3.)
  • Tell your health care professional if you have been diagnosed with diabetes or kidney problems.

For More Information

FDA Drug Safety Communication on Using Aliskiren With ACEIs and ARBs

FDA Consumer Update: Medications for High Blood Pressure

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Contaminated Ultrasound Gel Seized

At FDA’s request, U.S. Marshals have seized Other-Sonic Generic Ultrasound Transmission Gel located at Pharmaceutical Innovations Inc. in Newark, N.J., after an FDA analysis found that product samples contained two dangerous bacterial strains: Pseudomonas aeruginosa and Klebsiella oxytoca. The seizure included all lots of the gel manufactured between June 2011 and December 2011. FDA has also notified health care professionals and facilities to stop using this gel manufactured between these dates. 

The product is a non-sterile gel used to improve the transmission of ultrasound waves. Ultrasound is an imaging method that uses high-frequency sound waves to produce precise images of structures within the body.

Risk: People exposed to the bacteria Pseudomonas aeruginosa on the surface of their skin could develop itchy red skin with raised, weepy bumps (inflammatory dermatitis, also known as eczema). Klebsiella bacteria in the lungs or some other tissues may cause serious infections such as pneumonia, wound infection, or bloodstream infection.

Health care professionals have been advised to identify their patients who have been exposed to the contaminated gel to determine if further evaluation is needed. Be aware that the only ultrasound gel that is sterile is an unopened ultrasound gel container or packet labeled as sterile.

For More Information

FDA Safety Communication on Other-Sonic Generic Ultrasound Transmission Gel

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Higher Risk of Blood Clots With Some Birth Control Pills

Birth control pills that contain drospirenone may be associated with a higher risk of blood clots than other progestin-containing pills. FDA bases this conclusion on its review of recent studies on the risk of blood clots in women taking drospirenone-containing birth control pills.

Drospirenone is a synthetic version of the female hormone progesterone, also referred to as a progestin. FDA is adding information about the studies to the labels of drospirenone-containing birth control pills, which include:

  • Beyaz
  • Drospirenone and ethinyl estradiol
  • Gianvi
  • Loryna
  • Ocella
  • Safyral
  • Syeda
  • Yasmin
  • Yaz
  • Zarah

Risk: The revised drug labels will state that some studies reported as high as a three-fold increase in the risk of blood clots for drospirenone-containing products when compared to products containing levonorgestrel or some other progestins, but other studies found no additional risk of blood clots with drospirenone-containing products.

Recommendation: Women should talk to their health care professional about their risk for blood clots before deciding which birth control method to use.

For More Information

FDA Drug Safety Communication on the Risk of Blood Clots in Women Taking Birth Control Pills Containing Drospirenone

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Recall: X-Rock for Men

FDA tests found that X-Rock, marketed as a dietary supplement for men, contains the active ingredient sildenafil found in an FDA-approved prescription drug product used to treat erectile dysfunction.

X-Rock for Men, sold in one-capsule blister cards, was distributed nationwide to wholesalers and to consumers through the Internet.

Risk: The active ingredient sildenafil may interact with prescription drugs containing nitrates (such as nitroglycerin) and cause dangerously low blood pressure. People with diabetes, high blood pressure, high cholesterol or heart disease are often prescribed drugs containing nitrates. Another similar active ingredient found in X-Rock may also interact with nitrates and cause side effects, such as headaches and flushing.


  • Contact your health care provider if you have experienced any problems that may be related to taking this product.
  • Stop using the product and return it to the place of purchase or directly to the company, XRock Industries LLC, if you bought it as part of its Direct Response Program. Call 877-976-2563 Monday through Saturday 9 a.m. to 9 p.m. EST for instructions on returning the product.

For More Information

Photo of X-Rock for Men

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Safety Labeling Changes

In March 2012, FDA required safety labeling changes to be made to 39 products, including five different drugs that now carry a warning that they should not be taken by pregnant women because of the risk of injury and death to the developing fetus.

For More Information

March Safety Labeling Changes

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

May 15, 2012

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