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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.
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.
Recommendations
- 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
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
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
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.
Recommendations
- 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
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
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm304093.htm
In early March 2012, federal officials learned of infections from Salmonella Bareilly, bacteria that can cause diarrhea, fever and abdominal cramps if eaten in contaminated food. Left untreated, the illness can lead to death in high-risk populations, such as infants, older adults, and pregnant women.
Since then, about 250 people have been infected in 24 states and the District of Columbia, according to the Centers for Disease Control and Prevention (CDC).
The source of this outbreak is no longer a mystery, thanks in part to the efforts of the Food and Drug Administration’s (FDA) special urgent-response unit—the Incident Management Group (IMG). “The IMG serves as the agency’s focal point for coordinating emergency response activities,” says Ellen Morrison, director of the agency’s Office of Crisis Management.
The IMG operates out of the high-tech Emergency Operations Center (EOC) at FDA headquarters in Silver Spring, Maryland, and shifts into high gear when an emergency arises. The group’s composition varies according to the type of emergency, which could be an outbreak or a different kind of crisis.
“For the Salmonella outbreak, we assembled more than 30 agency experts in the EOC from offices across the agency to investigate the outbreak and track down its source,” says Mark Russo, director of FDA’s Office of Emergency Operations, a component of the crisis-management office directed by Morrison.
Prime Suspect
In the end, the prime suspect was a frozen raw yellowfin tuna product, called Nakaochi Scrape, imported from India. This tuna is used to make sushi, and many of the people who became ill reported eating sushi, with spicy tuna a common ingredient.
The road to that conclusion was long and winding.
And the journey actually started with FDA’s Coordinated Outbreak Response and Evaluation Network (CORE). This branch of FDA—on the frontlines of response to outbreaks of foodborne illness—evaluated and monitored the initial reports.
When the size, scope, severity and complexity of an outbreak require more staff and greater coordination, CORE may elevate the response to the IMG level and work from the EOC with colleagues from other parts of the agency and CDC.
Beginning on April 2, 2012, and for the next three weeks, Russo says, FDA experts on such subjects as outbreak investigation coordination, epidemiology, public and environmental health, food safety, seafood, imported products, legal issues, and cartography scrutinized thousands of pages of invoices, shipping records and bills of lading.
“There were probably hundreds of dedicated people from the FDA and other federal, state, and local agencies trying to pinpoint the outbreak’s cause,” Russo says. CDC worked with state and local public health officials to coordinate the epidemiologic aspects of the investigation, analyzing data that includes information on the cases, their distribution, and risk factors.
Meanwhile, local and state health agencies continued to interview people who had become ill. “But you’d be surprised,” Morrison says, “Not everyone has accurate recall when it comes to exactly what they ate on a certain date and where.”
By early April, CDC had identified six clusters of cases around restaurants or grocery stores in five states. Interviews suggested that the common food consumed and likely source of infection was sushi made with raw tuna—and specifically, spicy tuna.
This was just the beginning. “We needed to keep narrowing the focus down,” Morrison explains. “These groceries and restaurants may have used the same supplier or distributor. They may have used the same packager or manufacturer.”
After analyzing reams of data, the IMG selected and mapped four of the clusters of illnesses in Connecticut, Rhode Island, Texas, and Wisconsin as the investigation’s focus. Further analysis verified that all four had received the same imported, frozen raw Nakaochi Scrape tuna product from a single tuna processing facility in India.
With the source identified, FDA quickly alerted consumers and health agencies to the potential dangers of eating the recalled product. FDA provided information on symptoms of illness, at-risk populations, and precautions consumers can take in the future.
The company that imported the tuna from India—Moon Marine USA Corporation of Cupertino, California—voluntarily recalled the product.
What Activates the EOC
Outbreaks like this are only one kind of crisis that sends EOC into action. Morrison or her designee may activate it during incidents or events that require more complex levels of response than would ordinarily be provided. That includes:
- life-threatening outbreaks of illness
- man-made emergencies
- National Special Security Events—high profile meetings, ceremonies or other events that terrorists could target
- national level exercises designed to test preparedness for an emergency
In 2011, the EOC was activated three times to
- coordinate agency response to a magnitude 8.9 earthquake in Japan that, triggered a 30-foot tsunami off the Pacific coast
- investigate the possible link between SimplyThick—a thickening agent used to aid people with difficulty swallowing—and necrotizing enterocolitis, a potentially fatal infection in premature infants.
- participate in a nationwide test of emergency response systems to help prepare for response to man-made and natural disasters.
“I’ve worked in emergency operations for more than 15 years,” Morrison says. But I still find it impressive to walk into the EOC and watch the experts in action. They are the core of a massive team effort.”
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
May 3, 2012
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm302779.htm
These days, a trip to the supermarket or drugstore is like a trip around the world.
Many of the products you and your family buy, the medicines you use, and the foods you eat are from other countries. Did you know, for example, that 80 percent of our seafood and 80 percent of the active ingredients in medications consumed in the United States comes from abroad?
“Global Engagement”, a new, in-depth report from the Food and Drug Administration (FDA), tells how the agency works to ensure that the imported foods, medical products, and other goods it regulates meet the same high standards for safety and quality set for products manufactured domestically.
The report was compiled to provide a face and voice to FDA’s global work, which includes overseas inspections and collaborations with governments in other countries, says FDA’s Mary Lou Valdez, associate commissioner for international programs.
Rather than focusing on the efforts of one FDA office or center, the report describes for the first time—through data, charts, vignettes, quotes, and narratives—the global engagement efforts taking place across the agency. The report also explains some of the challenges that FDA faces in fulfilling its mission.
“It truly is a different world for all of us working to ensure product safety,” says Valdez. “We had to recognize the complexity of the world in which we’re regulating.”
From Farm to Fork
Take food. FDA regulates most food products in the United States, from the lettuce you put in your family’s dinner salad, to the eggs and juice you serve for breakfast. As of 2011, roughly one in six FDA-regulated food products consumed in the United States comes from abroad. And the percentage is much higher in foods like fruits (about 50 percent) and vegetables (about 20 percent).
So the agency—empowered by the Food Safety Modernization Act signed into law in 2011—is focusing its efforts on making sure that foods from other countries meet U.S. safety standards before they reach the United States, and your family’s dinner plates. Investigators with FDA’s Office of Regulatory Affairs travel the globe to inspect facilities that produce food bound for the United States. Additionally, FDA’s Office of International Programs has stationed investigators in multiple overseas posts to complement these inspection efforts.
“Consumers around the world, not just in the United States, expect and demand safe food, no matter its source,” says Michael Taylor, FDA’s deputy commissioner for foods.
The Global Drugstore
These strategies also apply to medical products, which include prescription and over-the-counter drugs, biologics (like vaccines and tissue), and devices that range from tongue depressors to complex diagnostic tools.
Forty percent of drugs—generic and prescription—consumed in the United States are now manufactured in other countries.
Globalization of the medical product industry presents regulatory challenges from product development to final use by the consumer:
- The clinical trials of all medical products required for FDA approval are increasingly conducted abroad, adding the complexity of the review process.
- Many U.S. consumers can purchase medicines via the Internet directly from foreign sources, increasing their potential exposure to unsafe or ineffective medical products.
- Many medical devices are sold in nearly identical forms around the world but are known by different trade names, making it difficult to warn medical professionals and consumers about potential dangers.
Global Strategies
The report outlines a variety of strategies to increase its engagement in the international public health community. These include:
- Opening new FDA posts overseas in key areas such as China, India, the Middle East, Europe, and Latin America. These help FDA build strong relationships with officials overseas and see first-hand how foreign-based facilities are operating.
- Developing strong and consistent international regulatory standards to allow countries to share a common foundation of science-based goals for product safety and quality. FDA’s Office of International Programs works with FDA’s centers and offices to share information, strategies and tools with other countries.
- Sharing and analyzing information and data in a way that will help regulatory agencies around the world use finite resources strategically.
- Working with other countries to monitor, prepare for, and respond to public health challenges, such as pandemics (widespread epidemics of infectious disease), natural disasters or broad distribution of tainted FDA-regulated products.
- Developing innovative strategies and tools for risk-based monitoring and inspection of imported products. An example is the PREDICT Application, a data-mining and pattern-tracing tool that FDA uses to screen imported products and identify those that pose the greatest risk to public health.
- Working with international partners to advance the science used to assess the safety and effectiveness of regulated products, which can lead to more cost-effective and timely product development. One example is the development of vaccine technology by FDA’s Center for Biologics Evaluation and Research that was used, through an international partnership, to protect millions in Africa against meningitis.
“FDA is no longer a domestic agency,” says Valdez. "We have gone global because consumers’ products come from many corners around the globe. We have made significant contributions towards assuring global product safety and quality.”
“And we will continue to make many more to promote the health and well being of the American people and our fellow citizens around the world," she says.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
April 23, 2012
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm301141.htm
Young children have died or become seriously ill from accidental exposure to a skin patch containing a powerful pain reliever. As a result of this, the Food and Drug Administration (FDA) is issuing a safety alert to warn patients, caregivers and health care professionals about the dangers of accidental exposure to and improper storage and disposal of the fentanyl patch.
“These types of events are tragic; you never want this to happen. We are looking for ways that we can help prevent this from happening in the future,” says Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “This reinforces the need to talk to patients and their families to make sure that these patches are stored, used and disposed of carefully.”
The fentanyl transdermal system—the patch marketed under the brand name Duragesic and available as a generic product—contains fentanyl, a potent opioid pain reliever, and treats patients in constant pain by releasing the medicine over the course of three days. (Opioids are synthetic versions of opium that are used to treat moderate and severe pain.) An overdose of fentanyl—caused when the child either swallows the patch or applies it to his or her own skin—can cause death by slowing breathing and increasing the levels of carbon dioxide in the blood.
According to Zachary A. Oleszczuk, PharmD, in FDA’s Division of Medication Error Prevention and Analysis, there have been 26 cases of accidental exposure to fentanyl since 1997, most of them involving children younger than 2 years old. There have been 10 deaths and an additional 12 cases requiring hospitalization.
Reducing the Risk
“The best thing a patient can do is to follow the instructions on the medicine label and talk to a health care professional about how to prevent anyone else from coming in contact with the fentanyl patch,” says Throckmorton.
Children are particularly vulnerable to a fentanyl overdose because, unlike adults, they have not been exposed to this type of potent medicine before and are more vulnerable to its effects. And a greater amount of the medicine is released if the patch is chewed and swallowed. Even after the patch is worn for three days, it may still retain more than 50 percent of the fentanyl.
Focusing on the prevention of medical errors, Oleszczuk and his colleagues at FDA report that infants and toddlers have unique risks of accidental exposure to fentanyl. Infants are often held by adults, increasing the chances that a partially detached patch could be transferred from adult to child. Toddlers are more likely to find lost, discarded or improperly stored patches and ingest them or stick them on themselves.
Early signs of fentanyl exposure could be hard to identify in young children. Lethargy has been among the reported symptoms, but that could be misinterpreted as fatigue. If there is reason to suspect that a child has been exposed to a fentanyl patch, Throckmorton says that emergency medical help should be sought immediately.
To reduce the possibility that children will be exposed to fentanyl, FDA recommends that fentanyl patch users take these precautions:
- Keep fentanyl patches and other drugs in a secure location that is out of children’s sight and reach. Toddlers may think the patch is a sticker, tattoo or bandage.
- Consider covering the fentanyl patch with an adhesive film to make sure the patch doesn’t come off your body.
- Throughout the day, make sure—either by touching it or looking at it—that the patch is still in place.
Proper Disposal
FDA recommends disposing of used patches by folding them in half so that the sticky sides meet, and then flushing them down a toilet. They should not be placed in the household trash where children or pets can find them.
FDA recognizes that there are environmental concerns about flushing medicines down the toilet. However, FDA believes that the risk associated with accidental exposure to this strong narcotic medicine outweighs any potential risk associated with disposal by flushing. When the patches are no longer needed, disposing by flushing completely eliminates the risk of harm to people in the home.
FDA has included fentanyl patches on a list of medicines that should be flushed down a toilet because they could be especially harmful, and possibly fatal, in a single dose if used by someone other than the person for whom the medicine was prescribed.
FDA has issued two public health advisories—in 2005 and 2007—about the safe use of fentanyl patches and is continuing its outreach to patients, caregivers and health care professionals about the dangers of accidental exposure.
Health care professionals and patients are asked to report any cases of accidental exposure to the FDA’s MedWatch Safety Information and Adverse Event Reporting program.
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
April 19, 2012
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300803.htm
On This Page:
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 and ongoing safety reviews prompted by reports FDA has received through MedWatch.
Celexa: Dose Level Boosts Risk of Abnormal Heart Rhythms
FDA is clarifying dosing recommendations and warnings for the antidepressant Celexa (citalopram hydrobromide). In August 2011, the agency issued a Drug Safety Communication stating that citalopram should no longer be used at doses greater than 40 milligrams (mg) per day because it could cause potentially dangerous abnormalities in the heart’s electrical activity. Use of citalopram is discouraged at any dose for people with certain medical conditions. However, because some patients may lack viable alternatives, the citalopram label (the package insert that comes with a prescription medicine) has been changed to describe precautions they should take when using it. The revised label also describes lower doses that should be taken by people over 60 years old.
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. 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 citalopram or change your dose without talking to your health care professional. Stopping citalopram suddenly can cause withdrawal effects.
- If you are currently taking a citalopram dose greater than 40 mg per day, talk to your healthcare professional.
- Seek immediate care if you experience an irregular heartbeat, shortness of breath, dizziness, or fainting while taking citalopram.
- If you are taking citalopram, your health care professional may occasionally order an electrocardiogram (ECG, EKG) to monitor your heart rate and rhythm.
- Your health care professional may also order tests to check levels of potassium and magnesium in your blood.
- Read the Medication Guide for citalopram carefully and discuss any questions you have with your health care professional.
- Health care professionals and patients are encouraged to report any side effects related to the use of these products to MedWatch.
For More Information
Taking Statins With HIV or Hepatitis C Drugs Raises Muscle Injury Risk
FDA has notified health care professionals of updates to prescribing information for protease inhibitors and certain statin drugs. Protease inhibitors are antiviral drugs used to treat HIV—the virus that causes AIDS—and the Hepatitis C virus (HCV). Statins are used with diet and exercise to reduce low-density lipoprotein (LDL, or “bad”) cholesterol. Taking protease inhibitors and statins together raises levels of statins in the blood and increases the risk of muscle injury.
Risk: The most serious form of this muscle injury, called rhabdomyolysis, can damage the kidneys and cause kidney failure, which can lead to death.
HIV and HCV protease inhibitors should never be taken with lovastatin (Mevacor) and simvastatin (Zocor). Health care providers are advised to use caution when prescribing atorvastatin (Lipitor).
Recommendations
- Health care professionals and patients are encouraged to report any side effects related to the use of these products to MedWatch.
- Patients are asked to contact their health care professionals if they have questions about either protease inhibitor or statins.
For more information
Some Skin Care Products May Contain Mercury
FDA has notified health care professionals and warned consumers not to use skin creams, beauty and antiseptic soaps or lotions that might contain the toxic metal mercury. These products, found in at least seven states, claim to be skin lighteners and anti-aging treatments that remove age spots, freckles, blemishes and wrinkles. Adolescents may use them to treat acne. They are manufactured abroad and sold illegally in the United States—often in shops in Latino, Asian, African or Middle Eastern neighborhoods, and online—or brought to the U.S. from other countries. FDA and state health officials have found more than 35 products containing unacceptable levels of mercury.
Risk: Mercury poisoning can cause damage to the kidneys and the nervous system, and interfere with brain development in unborn children and very young children.
Recommendations
- Check the label of any skin lightening, anti-aging, or other skin product. If there is no label or no ingredients listed, do not use the product.
- Do not use—or immediately stop using—products that list these ingredients: mercurous chloride, calomel, mercuric, mercurio or mercury.
- Thoroughly wash hands and any other body parts that have come in contact with the product.
- Contact a health care professional or medical clinic for advice.
For more information
Recall: Gerber Good Start Gentle Powdered Infant Formula
Gerber Products Company has recalled one lot of Gerber Good Start Gentle Powdered Infant Formula, 23.2 ounce plastic package, because the product might have a noticeable off-odor. The recall applies to batch GXP1684, expiration date of March 5, 2013. Gerber is working with retailers to retrieve any remaining product from this batch.
Risk: In some cases, spit-up and other gastrointestinal complaints have been reported.
Recommendations
- If you have the product with the batch code and expiration date mentioned above, contact the Gerber Parents Resource Center at 1-800-487-7763.
- Report problems or side effects related to the use of this product to MedWatch.
For More Information
Recall: Brilliant Blue G Compounded by Franck’s Lab
FDA has received reports from several states of eye infections (fungal endophthalmitis) in patients who were given an ophthalmic solution called Brilliant Blue G (BBG) during eye surgeries. FDA, the Centers for Disease Control and Prevention, and local and state public health agencies are actively investigating these cases.
The BBG was supplied by Franck’s Compounding Lab, Ocala, FL., which issued a recall on March 9, 2012, of all lots of Brilliant Blue G. Brilliant Blue G is not an approved drug in the U.S.
Risk: Endophthalmitis is a serious condition involving swelling (inflammation) within the eyeball.
Recommendations
- Report problems or side effects related to the use of Brilliant Blue G to MedWatch.
For More Information
Safety Labeling Changes
In February 2012, FDA required safety labeling changes to be made to 65 drug products, including eight 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.
The list also included warnings for conjugated estrogen products Premarin Vaginal Cream and Prempro and Premphase Tablets, as the cause for anaphylaxis, a reaction that may include trouble breathing, chest tightness, dizziness, fainting, itching and hives, and swelling of the mouth and throat.
For More Information
This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.
April 19, 2012
Original article: http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm300978.htm
Original article: http://www.fda.gov
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