FDA has important new information about a very rare, but serious, side effect in nursing infants whose mothers are taking codeine.  Differences in drug metabolism among mothers taking codeine may contribute to side effects in nursing infants.

Infants of nursing mothers taking codeine may have an increased risk of morphine overdose if the mother is an ultra-rapid metabolizer of codeine.  When codeine enters the body and is metabolized, it changes to morphine, which relieves pain.  Many factors affect codeine metabolism, including a person’s genetic make-up.  Some people have a variation in a liver enzyme and may change codeine to morphine more rapidly and completely than other people.  These people are ultra-rapid metabolizers and are more likely to have higher than normal levels of morphine in their blood after taking codeine.  Nursing mothers taking codeine may also have higher morphine levels in their breast milk.  These higher levels of morphine in breast milk may lead to life-threatening or fatal side effects in nursing babies.  In most cases, it is unknown if someone is an ultra-rapid codeine metabolizer.

Codeine has been used safely for many years in nursing mothers.  Codeine is an ingredient in many prescription pain relievers and some over-the-counter cough syrups.
Once the body changes codeine to morphine, the morphine relieves the pain or cough and may also be responsible for any side effects people may experience.  Infants exposed to very high levels of morphine through breast milk can get a morphine overdose as described below.

Last year, a medical journal described a healthy 13-day-old breastfed baby who died from a morphine overdose.  The mother was taking less than the usual amount of codeine normally prescribed for episiotomy pain (Koren, et al, Lancet, vol 368 p. 704, Aug 2006).  Laboratory tests showed high levels of morphine in the baby’s blood, and genetic testing showed that the baby’s mother was an ultra-rapid metabolizer of codeine.

FDA is issuing this public health advisory to inform healthcare professionals and nursing mothers about the following important safety information:

• When prescribing codeine for a nursing mother, doctors should prescribe the lowest dose for the shortest amount of time to relieve pain or cough.  Doctors need to tell their nursing patients how to recognize signs of high morphine levels in themselves and their babies.

• If you are a nursing mother taking codeine, call your doctor if you become extremely sleepy and have trouble caring for your baby.

• Breastfed babies usually nurse every two to three hours and should not sleep more than four hours at a time.  If your baby shows signs of increased sleepiness (more than usual), difficulty breastfeeding, breathing difficulties, or limpness, talk to the baby’s doctor immediately.  If you cannot reach the doctor right away, take the baby to an emergency room or call 911 (or local emergency services).

• Nursing mothers should talk to their doctors if they have any questions about taking codeine.

The estimated number of ultra-rapid metabolizers varies among different population groups from less than 1 per 100 people up to 28 per 100 people.  For people who are ultra-rapid metabolizers, the risk of having an adverse event when taking codeine is not known.

Anyone can be an ultra-rapid metabolizer without knowing it.  The only way to find out is with a genetic test.  There is a FDA-cleared test to determine whether a patient is an ultra-rapid metabolizer, but there is limited information about using this test for codeine metabolism.   At this time, the test result alone may not correctly predict if a mother’s breast milk will have too much morphine if she uses codeine to treat pain.  This test isn’t a substitute for a doctor’s judgment.

Among pain relievers, ultra-rapid metabolism has only been reported as a problem with codeine, although it has the potential to affect other narcotics.  All narcotics can cause the same serious side effects in breastfed babies if the levels of drug in breast milk are too high.

FDA has asked the makers of prescription codeine-containing products to include information about differences in codeine metabolism and concerns with breastfeeding in the drug label.  Use of codeine products to manage pain after birth is common, but reports of serious side effects in nursing infants are very rare.  Doctors who prescribe codeine need to be aware of the potential for the increased risks to breastfeeding babies of mothers who are ultra-rapid metabolizers of codeine.

The FDA urges healthcare providers and nursing mothers to report side effects that occur while using codeine to the FDA’s MedWatch Adverse Event Reporting program.

Source | FDA

The U.S. Food and Drug Administration (FDA) is alerting consumers to possible serious health risks from eating olives that may be contaminated with a deadly bacterium, Clostridium botulinum. C. botulinum can cause botulism, a potentially fatal illness. The olives are made by Charlie Brown di Rutigliano & Figli S.r.l, of Bari, Italy and are being recalled by the manufacturer. No illnesses have been reported to date in connection with this recall.

The olives should not be eaten alone or in other foods, even if they do not appear to be spoiled. Consumers should discard these products or return them to the point of purchase. If in doubt, consumers should contact the retailer and inquire whether its olives are part of the recall.

The olives are sold under the following brands: Borrelli, Bonta di Puglia, Cento, Corrado’s, Dal Raccolto, Flora, Roland and Vantia, and have codes that start with the letter “G” and are followed by 3 or 4 digits. All sizes of cans, glass jars and pouches of Cerignola, Nocerella and Castelvetrano type olives are affected.

Symptoms of Botulism

Symptoms of botulism include general weakness, dizziness, double vision, trouble with speaking or swallowing, difficulty in breathing, weakness of other muscles, abdominal distension and constipation. People experiencing these symptoms should seek immediate medical attention. Consumers may also report illnesses associated with consumption of these olives to the nearest FDA district offices.

Charlie Brown di Rutigliano & Figli S.r.l, initiated a recall of these olives on March 27, 2007. The recalled olives had been distributed to wholesalers, who have marketed them nationally to restaurants and retail stores. FDA concluded that additional warnings are needed because, to date, the company has not contacted importers with specific instructions on the recall.

In addition to re-emphasizing its warning to consumers, FDA is making the following requests:

Importers of these olives should discontinue distribution, isolate held stocks and notify customers to take similar actions to prevent the products from reaching consumers. Importers should contact their local FDA office for assistance in implementing the recall.

Food manufacturers who have repacked the olives for sale under different names or who have used them in the production of other food should contact their local FDA office.

Restaurants, delicatessens, and other food service providers should discontinue using the olives, dispose of their opened containers and contact their suppliers for instructions on what to do with unopened containers.

####

Do I Have a Food Poisoning Lawsuit?

If you or a loved one have been the vicitm of food poisoning, you should contact us immediately. You may be entitled to compensation for your food poisoning related injuries.

Food Poisoning Lawsuit Resource

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The U.S. Food & Drug Administration in association with The Center for Drug Evaluation and Research has released a podcast regarding the recent Permax Recall.

The information contained in the podcast is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

Source | FDA / CDER

Run Time — 6:32 minutes

>>> CLICK HERE TO LISTEN TO PERMAX RECALL PODCAST <<<

Full Transcript Below

[music]

On March 29, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Voluntary Market Withdrawal of Permax.

The drug is also known and marketed by its generic name pergolide [per-go-lide].

I am Pat Clarke from F-D-A’s Center for Drug Evaluation and Research.

We are notifying you that the companies that manufacture and distribute pergolide have agreed to withdraw this drug from the market due to the potential for heart valve damage.

Two new studies showed that patients with Parkinson’s disease who were treated with pergolide had an increased chance of serious damage to their heart valves when compared to patients who did not receive the drug.

Pergolide is a member of a class of drugs known as dopamine [dough-pah-mean] agonists and is used with levodopa and carbidopa to manage the signs and symptoms of Parkinson’s disease, which include tremors and slowness of movement.

If you are a patient with Parkinson’s disease who is taking pergolide, you should take these two steps:

• First, contact your health-care professional to discuss alternate treatment options.
• Second, DO NOT STOP taking Pergolide without consulting your health-care professional. Stopping pergolide too quickly can be dangerous and several other effective treatments are available.

If you are a health-care professional who prescribes pergolide, you should consider the three following items:

• First, Assess your patient’s need for dopamine-agonist therapy. If continued treatment with a dopamine-agonist is necessary, another dopamine-agonist should be substituted for pergolide. There are other dopamine agonists approved for the treatment of Parkinson’s disease that are not associated with heart valve damage. Published transition regimens describe the conversion from one dopamine-agonist to another.
• Second, if treatment with a dopamine-agonist is to be discontinued, pergolide should not be stopped abruptly, because rapid discontinuation of all dopamine-agonist therapies can be dangerous. Instead, gradually decrease the dose of pergolide.
• Third, you should tell patients who will be taken off pergolide that other effective options for treatment exist, including three other dopamine agonists that are not associated with damage to heart valves.

In 2006, a boxed warning regarding the risk of serious heart valve damage was added to the labeling for pergolide. The two recent studies, published in The New England Journal of Medicine in January 2007, confirm earlier studies that also described this problem.

Pergolide is marketed by Valeant under the trade name Permax and sold and manufactured as the generic drug pergolide by Par and Teva.

In light of this additional safety information and the availability of alternative treatments for Parkinson’s disease that do not have comparable safety problems, the companies that manufacture and sell pergolide have stopped shipping pergolide for distribution.

The companies will, in cooperation with us, work to remove from the market both Permax and generic versions of pergolide.

The effect of this voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health-care professionals and patients to discuss appropriate treatment options and to change treatments.

One of the drugs that was included in the recent studies showing increased chance of heart valve problems is another dopamine agonist — Dostinex — also known by the generic name Cabergoline.

This drug is approved in the united states for the treatment of hyperprolactinemic [hyper-pro-lack-teh-knee-mick] disorders — conditions in which there are elevated levels of prolactin [pro-lack-tin] in the blood.

Dostinex is not approved in the United States for the treatment of Parkinson’s disease. For hyperprolactinemic disorders, a considerably lower dose of Dostinex is used. At these lower doses of Dostinex, there appears to be little chance of heart problems; therefore, Dostinex will remain on the U.S. market for the treatment of hyperprolactinemic disorders.

We are working with the manufacturers of pergolide to determine if it is possible to make the drug available to those few patients who are currently taking pergolide under these two conditions:

• First, where previous efforts to switch to a different treatment have been unsuccessful.
• Or, second, where efforts subsequent to this advisory to switch therapies are also unsuccessful.

In the interim, health-care professionals and patients should consider all treatment options with the understanding that in the future, the drug may no longer be available.

We are asking health-care professionals to report serious adverse events in connection with pergolide to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at F-D-A dot gov slash MedWatch.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot gov slash C-D-E-R.

[music]

Do I Have a Permax or Pergolide Lawsuit?

If you or a loved one have taken Permax or Pergolide and suffered from any of the side effects listed below, you should contact us immediately. You may be entitled to compensation and we can help.

Side Effects

• heart-valve damage (Aortic and Mitral Valve Injuries)
• Primary Pulmonary Hypertension
• cardiac valvulopathy
• valvular heart disease
• leaky heart valves
• pulmonary fibrosis (retroperitoneal, pleural, and pericardial fibrosis)

Click Here To Learn More: Permax (Pergolide) Recall Information

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The U.S. Food & Drug Administration in association with The Center for Drug Evaluation and Research has released a podcast regarding the recent Zelnorm Recall.

The information contained in the podcast is very informative.  

We’d like to commend the FDA for making this type of valuable information available to the American public.  It not only helps the average consumer but also those people with visual disabilities that must utilize screen readers, etc.  Nice work FDA!

Source | FDA / CDER

Run Time — 4:57 minutes

>>> CLICK HERE TO LISTEN TO ZELNORM RECALL PODCAST <<<

Full Transcript Below

[music]

On March 30, 2007, the Food and Drug Administration issued a Public Health Advisory titled: Voluntary Market Withdrawal of Zelnorm.

The drug is also known and marketed by its generic name Tegaserod [te-gas-a-rod] maleate.

I’m Pat Clarke from F-D-A’s Center for Drug Evaluation and Research.

FDA issues this public health advisory to inform patients and health-care professionals that the sponsor of Zelnorm, Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm. Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

We announce the following four items effective immediately:

• First, at our request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
• Second, patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
• Third, patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke.
• Finally, physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

Zelnorm is a prescription medication approved for the short-term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years-of-age with chronic constipation.

In late February and early March 2007, Novartis Pharmaceuticals gave us the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions. The data from all the studies were combined to assess the chance of side effects on the heart and blood vessels. In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm. These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill. The average age of patients in these studies was 43 years and most patients — 88 percent were women.

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small. However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.

Thirteen patients treated with Zelnorm or zero point one percent, had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died) six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke. Among the patients taking the sugar pill, only one or zero point zero one percent had symptoms suggesting the beginning of a stroke that went away without complication.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects. FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.

We have also indicated to Novartis a willingness to consider limited re-introduction of Zelnorm at a later date if a population of patients can be identified in whom the benefits of the drug outweigh the risks. However, before we make a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting.

We are asking health care professionals to report serious adverse events in connection with Zelnorm to us through the MedWatch program by phone at 1-800-F-D-A-ten-88 or by the Internet at W-W-W dot F-D-A dot gov slash MedWatch.

Updated information about drugs with emerging safety concerns is available 24 hours a day at our Web site W-W-W dot F-D-A dot gov slash C-D-E-R.

[music]

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

FDA Update on Peanut Butter Recall

As a follow-up to the recent Salmonella outbreak linked to peanut butter, the U.S. Food and Drug Administration (FDA) is informing consumers that ConAgra has extended their recall of all Peter Pan peanut butter, and all Great Value peanut butter beginning with product code 2111, including peanut butter toppings, back to October 2004. This information was obtained recently as part of the ongoing investigation being conducted by FDA.

Consumers who have purchased any of the products since October 2004 should discard them. FDA’s advice to consumers continues to be not to eat any Peter Pan peanut butter or any Great Value peanut butter beginning with the 2111 product code.

FDA will provide updates on recalled products, including any other products that may have been made with potentially contaminated peanut butter and distributed to consumers.

Symptoms of foodborne illness caused by Salmonella include fever, diarrhea and abdominal cramps. In persons with poor underlying health or weakened immune systems, Salmonella can invade the bloodstream and cause life-threatening infections or death. Individuals who have recently eaten peanut butter-containing products from these companies and who have experienced any of these symptoms should contact their doctor or health care provider immediately and report the illnesses to their state or local health authorities. Similarly, institutional food establishments and other food service providers who have received reports of illness from consumers after they consumed a product containing this peanut butter are encouraged to share that information with their local health department.

FDA is continuing to work closely with the Centers for Disease Control and Prevention, and with states and local officials to identify how the contamination occurred in order to prevent similar foodborne illness outbreaks.

####

If you or someone you know has become sick with Salmonella food poisoning after eating peanut butter, you should seek medical attention immediately by visiting your doctor of by dialing 911.

Free Lawsuit Review: After you have received appropriate medical attention, you should contact us. You may be entitled to compensation for your injuries and we can help.

Source | FDA

FDA is issuing this public health advisory to inform patients and health care professionals that the sponsor of Zelnorm (tegaserod maleate), Novartis Pharmaceuticals Corporation, has agreed to stop selling Zelnorm.  Zelnorm is being taken off the market because a new safety analysis has found a higher chance of heart attack, stroke, and worsening heart chest pain that can become a heart attack in patients treated with Zelnorm compared to those treated with a sugar pill they thought was Zelnorm.

FDA announces the following, effective immediately: 

• At FDA’s request, Novartis Pharmaceuticals Corporation has agreed to stop selling Zelnorm.
• Patients being treated with Zelnorm should contact their physician to discuss alternative treatments for their condition.
• Patients who are taking Zelnorm should seek emergency medical care right away if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking or other symptoms of a heart attack or stroke. 
• Physicians who prescribe Zelnorm should work with their patients and transition them to other therapies as appropriate to their symptoms and need.

Zelnorm is a prescription medication approved for short term treatment of women with irritable bowel syndrome with constipation and for patients younger than 65 years with chronic constipation.   In late February and early March 2007, Novartis Pharmaceuticals gave FDA the results of new analyses of 29 clinical studies of Zelnorm for treatment of a variety of gastrointestinal tract conditions; the data from all the studies were combined to assess the chance of side effects on the heart and blood vessels.  In each study, patients were assigned at random to either Zelnorm or a sugar pill they thought was Zelnorm.  These 29 studies included 11,614 patients treated with Zelnorm and 7,031 treated with a sugar pill.  The average age of patients in these studies was 43 years and most patients—88%–were women. 

The number of patients who suffered a heart attack, stroke or severe heart chest pain that can turn into a heart attack was small.  However, patients treated with Zelnorm had a higher chance of having any of these serious and life-threatening side effects than did those who were treated with a sugar pill.  Thirteen patients treated with Zelnorm (0.1%) had serious and life-threatening cardiovascular side effects; among these, four patients had a heart attack (one died), six had a type of severe heart chest pain which can quickly turn into a heart attack, and three had a stroke.  Among the patients taking the sugar pill, only one (or 0.01%) had symptoms suggesting the beginning of a stroke that went away without complication.

There may be patients for whom no other treatment options are available and in whom the benefits of Zelnorm treatment outweigh the chance of serious side effects.  FDA will work with Novartis to allow access to Zelnorm for those patients through a special program.

FDA has also indicated to Novartis a willingness to consider limited re-introduction of Zelnorm at a later date if a population of patients can be identified in whom the benefits of the drug outweigh the risks.  However, before FDA makes a decision about limited re-introduction, any proposed plan would be discussed at a public advisory committee meeting. 

Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

Source | FDA 

The Food and Drug Administration (FDA) has requested that Novartis Pharmaceuticals Corporation of East Hanover, New Jersey, voluntarily discontinue marketing of Zelnorm (tegaserod) based on the recently identified finding of an increased risk of serious cardiovascular adverse events (heart problems) associated with use of the drug. Novartis has agreed to voluntarily suspend marketing of the drug in the United States.

Zelnorm is a prescription medicine approved in July 2002 for short-term treatment of women with irritable bowel syndrome whose primary symptom is constipation. It was subsequently approved in August 2004 for treatment of chronic constipation for men and women under age 65. Zelnorm is marketed in 55 countries.

FDA is currently advising patients who are using Zelnorm to contact their health care providers to discuss treatment alternatives. Patients who are taking Zelnorm should seek emergency medical care if they experience severe chest pain, shortness of breath, dizziness, sudden onset of weakness or difficulty walking or talking, or other symptoms of a heart attack or stroke.

“This decision reflects the FDA’s commitment to continuously monitor approved drugs throughout their marketing life, and take action when we believe the risks exceed the benefits,” said Dr. Douglas Throckmorton, Deputy Director for the Center for Drug Evaluation and Research. “Here, a potential risk of very serious harm to patients who have this non-life-threatening condition was recently identified, making this action necessary.”

Throughout February and March 2007, Novartis reported to FDA the results of a new analysis of 29 short-term (1 - 3 months) randomized, controlled clinical trials of Zelnorm. FDA has concluded, based on these data that for most patients the benefits of this drug no longer outweigh the risks.

The analysis included more than 11,600 patients treated with Zelnorm and over 7000 patients treated with placebo. The data showed that the risk of serious cardiovascular adverse events (e.g., angina, heart attacks, and strokes) associated with use of Zelnorm is higher than with placebo treatment. Thirteen Zelnorm-treated patients (or 0.1%) had confirmed cardiovascular ischemic events, and only 1 placebo-treated patient (or 0.01%) with an event.

FDA will work with Novartis to allow access to Zelnorm as an investigational drug for patients with no other treatment options where the benefits may outweigh the risks. FDA has also indicated to Novartis the possibility of considering limited re-introduction of Zelnorm at a later date if a population of patients can be identified in which the benefits of the drug outweigh the risks. Any such proposal would be the subject of a public advisory committee meeting before an FDA decision.

For more information, visit http://www.fda.gov/cder/drug/advisory/tegaserod.htm

####Do I Have a Zelnorm Lawsuit?

If you or a loved one have taken Zelnorm and suffered a serious cardiovascular (heart attack, stroke, angina) or gastrointestinal side effect, you should contact us immediately. You may be entitled to compensation and we can help.

Click Here - Free Confidential Case Evaluation: Zelnorm Lawsuit

Source | FDA

Agency Working with Product Manufacturers

The U.S. Food and Drug Administration (FDA) today announced that manufacturers of pergolide drug products, which are used to treat Parkinson’s disease, will voluntarily remove these drugs from the market because of the risk of serious damage to patients’ heart valves.

The products being withdrawn are Permax, the trade name for pergolide marketed by Valeant Pharmaceuticals, and two generic versions of pergolide manufactured by Par and Teva. Pergolide is in a class of medications called dopamine agonists and is used with levodopa and carbidopa to manage the symptoms (tremors and slowness of movement) of Parkinson’s disease.

In 2006, an estimated 12,000 patients received prescriptions for pergolide from retail pharmacies in the United States. Patients taking pergolide should contact their doctors to discuss alternate treatments. Patients should not stop taking the medication, as stopping pergolide abruptly can be dangerous.

There are alternative therapies available for Parkinson’s disease, including three other dopamine agonists that have not been associated with valvular heart disease. The removal of pergolide products is not expected to adversely affect patient care because of the alternative therapies available.

“Based on important new drug safety information, FDA has been working with the manufacturers of pergolide products to voluntarily remove these drugs from the market,” said Douglas Throckmorton, M.D., deputy director of FDA’s Center for Drug Evaluation and Research. “The FDA’s increased evaluation of post-market safety is benefiting the public because, in this case, as new data about the product became available, we were able to remove a less safe drug from the market.”

Two recent New England Journal of Medicine studies confirm previous findings associating pergolide with increased chance of regurgitation (backflow of blood) of the mitral, tricuspid, and aortic valves of the heart. Valve regurgitation is a condition in which valves don’t close tightly, allowing blood to flow backward across the valve. Symptoms include shortness of breath, fatigue and heart palpitations.

In light of this additional post-market safety information, the companies that manufacture and sell pergolide will stop shipping pergolide for distribution and, in cooperation with FDA, will withdraw the products from the market.

Permax was approved in 1988 for Eli Lilly and Company as an adjunctive therapy with levodopa in Parkinson’s disease. Valvular heart disease was first described in association with pergolide in 2002. In 2003, FDA asked Lilly to add valvulopathy (abnormality of cardiac valves) to the warnings section of Permax labeling, at which time a Dear Healthcare Practitioner letter was sent by Lilly. In 2006, the warning was upgraded to a black box warning, the FDA’s strongest form of warning, because of new data concerning risks of heart valve damage.

FDA today is issuing a Public Health Advisory (PHA) detailing the removal of pergolide products from the market. The PHA, which is available at www.fda.gov/cder/drug/advisory/pergolide.htm includes information and recommended actions for physicians, pharmacists and patients.

The effect of the voluntary withdrawal on supplies of pergolide currently in pharmacies will not be immediate. This delay will allow time for health care providers and patients to discuss appropriate treatment options and time to change treatments.

FDA is working with the manufacturers of pergolide to determine if it might be possible, once the drug is withdrawn from the market, to make the drug available under an Investigational New Drug Application (IND) for those few patients who are currently receiving pergolide and who cannot be successfully converted to other available treatments.

###

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

FDA notified healthcare professionals of a nationwide Class I recall of
RF Denervation probes used with the Smith & Nephew Electrothermal 20S
Spine System in RF heat lesion procedures for the relief of pain. The
product was mislabeled. The device is a non-sterile (not germ free)
device but it was labeled incorrectly as sterile (germ-free). It is a
reusable item that is intended to be sterilized (made germ-free) by the
medical facility prior to each use, including initial use. This error
may result in infections with associated risks including, organ failure
and/or death.

Read the complete MedWatch 2007 Safety summary, including a link to the
FDA recall notice and firm press release, at:

http://www.fda.gov/medwatch/safety/2007/safety07.htm#RFprobes

Source | FDA

FOR IMMEDIATE RELEASE — Andover, MA — March 26, 2007 — Smith & Nephew Inc. is initiating a nationwide recall of 539 RF Denervation probes for the part numbers and models listed in the table below.

The Smith & Nephew RF Denervation probes are indicated for use exclusively with the Smith & Nephew ELECTROTHERMAL(TM) 20S SPINE SYSTEM in RF heat lesion procedures for the relief of pain. The RF Denervation Probes, which are provided in a non-sterile condition, were mislabeled as sterile which potentially could result in a patient infection.

Customers who have product that is being recalled should return it to Smith & Nephew per the recall instructions. The recall includes the following products and lot numbers:

Part #

Description

Lot numbers

7210270

RF Denervation Probe

602549, 602550, 602846, 602847

7210271

RF Denervation Probe

602541, 602542, 602556, 602557, 602558, 602559, 602560, 602561, 602562, 602848, 602849, 602999

7210272

RF Denervation Probe

602543, 602570, 602571, 602850, 603000

The company voluntarily recalled the products after learning of the labeling error. FDA has been apprised of this action. No injuries have been reported to date associated with this issue.

Product was distributed to 134 domestic and international customers. It can be identified by the product number, name, and lot numbers identified above. Smith & Nephew has notified its distributors and customers and is arranging for return and replacement of all recalled products.

Denervation Probe Investigation

If you or a loved one have used the Smith & Nephew probe and received a serious infection; we would like to speak with you. Please contact us by using the form at the bottom of this page or by dialing (866) 588-0600.