Reumofan Plus Alert By FDA | Health Officials In Mexico Recall The Dietary Supplement

FDA, Food and Drug Administration has issued an alert on Reumofan Plus found in the market as a Natural dietary supplement for conditions involving pain relief and treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions..
Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.

FDA analysts found several active pharmaceutical ingredients not listed on the label that could be harmful;

• diclofenac sodium – a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines.
• methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery. 

Following is the press release by FDA; (Comunicado de prensa En Español)

For Immediate Release: June 1, 2012
¹Media Inquiries: Sarah Clark-Lynn, 301-796-9110, sarah.clark-lynn@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

FDA issues alert on Reumofan PlusHealth officials in Mexico order recall based on potentially harmful pharmaceutical ingredients

The U.S. Food and Drug Administration is warning consumers that Reumofan Plus, marketed as a “natural” dietary supplement for pain relief and other serious conditions, contains several active pharmaceutical ingredients not listed on the label that could be harmful.

Consumers who are currently taking Reumofan Plus or who have recently stopped taking Reumofan Plus should immediately consult a health care professional. Consumers should not buy or start using the product.

Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

The FDA has received multiple reports of adverse events associated with the use of Reumofan Plus, including liver injury, sudden worsening of glucose (sugar) control, weight gain, swelling, leg cramps, and adrenal suppression (problems with kidney functioning).

An FDA laboratory analysis of Reumofan Plus found that it contains:

• diclofenac sodium – a prescription non-steroidal anti-inflammatory drug (NSAID) that may cause increased risk of cardiovascular events such as heart attack and stroke, as well as serious gastrointestinal (GI) adverse events including bleeding, ulceration, and fatal perforation (causing a hole) of the stomach and intestines.
• methocarbamol – a prescription muscle relaxant that can cause sedation, dizziness, low blood pressure, and impair mental or physical abilities to perform tasks such as driving a motor vehicle or operating machinery.

These ingredients also may interact with other medications and result in serious adverse events.

The Mexican Ministry of Health discovered that at least one lot of the product contains the corticosteroid dexamethasone, a drug that acts as an anti-inflammatory and immune system suppressant.

According to FDA adverse events reports, consumers reported symptoms suggesting that some lots of Reumofan Plus may contain corticosteroids. At least one report from a health care professional treating a patient with adverse events from using Reumofan Plus, confirmed adrenal suppression. Abrupt discontinuation of corticosteroids after long-term or high dose use can cause fatigue, nausea, low blood pressure, low blood sugar levels, fever, muscle, and joint pain, dizziness, and fainting.

Health care professionals are urged to ask their patients about use of Reumofan Plus and other products marketed as dietary supplements when patients present with unexplained symptoms that suggest NSAID toxicity, depression, or the use or abrupt discontinuation of corticosteroids.

Additionally, health care professionals should evaluate patients who have used Reumofan Plus for drug and disease interactions involving diclofenac, methocarbamol, and corticosteroids, and consider whether a corticosteroid taper regimen may be appropriate in those who have used Reumofan Plus.

Health care professionals and consumers are encouraged to report any adverse events related to Reumofan Plus to FDA’s MedWatch Safety Information and Adverse Event Reporting Program:

• online at www.fda.gov/Medwatch/report.htm³;

• by phone at 800-FDA-1088 (800-332-1088); or,

• by returning FDA form 3500, available on the MedWatch “Download Forms” page by mail to the address on the pre-addressed form or by fax at 800-FDA-0178.

Fluoroquinolone Antimicrobial Drugs Carry Risk Of Developing Tendinitis And Tendon Rupture In Patients Taking Fluoroquinolones For Systemic Use.

[Posted 07/08/2008] FDA notified healthcare professionals that a BOXED WARNING and Medication Guide are to be added to the prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use. Fluoroquinolones are associated with an increased risk of tendinitis and tendon rupture. This risk is further increased in those over age 60, in kidney, heart, and lung transplant recipients, and with use of concomitant steroid therapy. Physicians should advise patients, at the first sign of tendon pain, swelling, or inflammation, to stop taking the fluoroquinolone, to avoid exercise and use of the affected area, and to promptly contact their doctor about changing to a non-fluoroquinolone antimicrobial drug. Selection of a fluoroquinolone for the treatment or prevention of an infection should be limited to those conditions that are proven or strongly suspected to be caused by bacteria. [July 08, 2008 - Drug Information Page - FDA] [July 08, 2008 - Information for Healthcare Professionals - FDA] [July 08, 2008 - News Release - FDA]

Tags: FDA Alert, Fluoroquinolones, tendinitis, tendon rupture

Synchromed and IsoMed Implantable Infusion Pumps Bring Increased Rate Of Inflammatory Masses

On January 16, 2008, Medtronic notified healthcare professionals about an increased rate of inflammatory masses in patients receiving intrathecal drugs through the company's Synchromed EL, Synchromed II and IsoMed implantable infusion pump systems. This letter, which also gave patient management and treatment recommendations, was an update to two earlier communications.

The company's analysis shows that the incidence of inflammatory masses is about five times higher (about 0.5 percent vs. about 0.1 percent) than it was in 2001 and is expected to continue to increase. The masses occurred at or near the distal tip of the intrathecal catheters, and have been reported with a variety of intrathecal infusions, including opioids, baclofen and pharmacy-compounded drugs. The highest incidence was reported with opioid use. High doses or high concentrations of opioids may increase the risk of inflammatory mass, but the exact etiology is not known.

The company's recommendations for managing patients include the following:

• With intrathecal opioids, administer the lowest effective dose and concentration.

• Closely monitor patients to identify the prodromal signs and symptoms of inflammatory mass.

• Consider a neurological consultation and imaging studies to confirm or rule out the presence of an inflammatory mass.

Finally, Medtronic strongly advises physicians to know which intrathecal drugs are approved for use in these devices, including preservative-free morphine sulfate sterile solution, Lioresal® intrathecal baclofen injection, and preservative-free ziconotide sterile solution. The effect of administering other drugs through these devices has not been assessed, and that includes drugs compounded by pharmacies.

Additional Information:

FDA MedWatch Safety Alert. Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps. March 21, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#Neuromodulation

Tags: Inflammatory Masses, FDA Alert, intrathecal drugs, Synchromed EL, Synchromed II, IsoMed, infusion pump systems, intrathecal catheters, opioids, Medtronic

Conventional And Atypical Antipsychotics Issues.

Antipsychotics, Conventional and Atypical

Audience: Neuropsychiatric and geriatrics healthcare professionals
FDA notified healthcare professionals that both conventional and atypical antipsychotics are associated with an increased risk of mortality in elderly patients treated for dementia-related psychosis. In April 2005, FDA notified healthcare professionals that patients with dementia-related psychosis treated with atypical antipsychotic drugs are at an increased risk of death. Since issuing that notification, FDA has reviewed additional information that indicates the risk is also associated with conventional antipsychotics. Antipsychotics are not indicated for the treatment of dementia-related psychosis. The prescribing information for all antipsychotic drugs will now include the same information about this risk in a BOXED WARNING and the WARNINGS section.

Tags: fda warning, Drug Labeling, antipsychotics, Antipsychotic drugs, dementia, schizophrenia

Salmonellosis Outbreak , Red Tomato Warning By FDA Expanded Nationwide

Red Tomato Warning Expanded Nationwide

We have been reporting about this Tomato scare for a while;
Raw Red Tomatoes Advisory (Do Not Eat!) Extends Nationwide

FDA Warning, New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes, Salmonella Outbreak
Now FDA has expanded the warning nationwide.

The Food and Drug Administration (FDA) is expanding its warning to consumers nationwide that a salmonellosis outbreak has been linked to consumption of certain raw red plum, raw red Roma, raw red round tomatoes, and products containing these tomatoes.

FDA recommends that consumers not eat these tomatoes unless they have been grown and harvested from states, countries, and territories that have NOT been associated with this outbreak. The list, which will be updated as more information becomes available, can be found at www.fda.gov/oc/opacom/hottopics/tomatoes.html#retailers.

FDA also recommends that retailers, restaurants, and other food service operators not offer raw red Roma, raw red plum, and raw red round tomatoes unless they are from sources that have not been associated with the outbreak. If unsure of where tomatoes are grown or harvested, consumers are encouraged to contact the store where the tomato purchase was made.

The following types of tomatoes are NOT likely to be the source of this outbreak. Consumers should continue to eat

• cherry tomatoes
• grape tomatoes
• tomatoes sold with the vine still attached
• tomatoes grown at home

Since mid-April 2008, there have been at least 145 reported cases of salmonellosis caused by Salmonella Saintpaul nationwide, including at least 23 hospitalizations. States reporting illnesses linked to the outbreak include: Arizona, California, Colorado, Connecticut, Idaho, Illinois, Indiana, Kansas, New Mexico, Oklahoma, Oregon, Texas, Utah, Virginia, Washington, and Wisconsin.

For More Information

FDA Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01848.html

Tags: salmonellosis outbreak, FDA Alert, Red Tomato Warning

KEMADRIN® (procyclidine hydrochloride) tablets Discontinued.

King Pharmaceuticals®, Inc. has decided to discontinue the manufacture of KEMADRIN® (procyclidine hydrochloride) tablets. KEMADRIN® tablets will remain available through pharmacies and wholesalers until current supplies are depleted.

KEMADRIN® tablets are distributed through King Pharmaceuticals®, Inc. No additional product will be available after King, pharmacy, and wholesaler supplies are exhausted.

If you have any questions or concerns, you may contact our Professional Information Services Department at 800-776-3637.

KEMADRIN® (procyclidine hydrochloride) is a synthetic antispasmodic compound indicated in the treatment of parkinsonism including the postencephalitic, arteriosclerotic, and idiopathic types. Partial control of the parkinsonism symptoms is the usual therapeutic accomplishment.

Letter from King Pharmaceuticals

Tags: FDA Alert, Drug Discontinuation, KEMADRIN® (procyclidine hydrochloride), KEMADRIN® tablets, King Pharmaceuticals®

CORTISPORIN® Ophthalmic Suspension Discontinued.

King Pharmaceuticals®, Inc. has decided to discontinue the manufacture of CORTISPORIN® Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension).
CORTISPORIN® Ophthalmic Suspension will remain available through pharmacies and wholesalers until current supplies are depleted.
CORTISPORIN® Ophthalmic Suspension is distributed through King Pharmaceuticals®, Inc. No additional product will be available after King, pharmacy, and wholesaler supplies are exhausted.
If you have any questions or concerns, you may contact our Professional Information Services Department at 800-776-3637. CORTISPORIN® Ophthalmic Suspension (neomycin and polymyxin B sulfates and hydrocortisone ophthalmic suspension) is a sterile antimicrobial and anti-inflammatory suspension indicated for steroid-responsive inflammatory ocular conditions for which a corticosteroid is indicated and where bacterial infection or a risk of bacterial infection exists.

Letter from King Pharmaceuticals

Tags: FDA Alert, Drug Discontinuation, CORTISPORIN® Ophthalmic Suspension

New Labeling Changes for Regranex Gel 0.01% (becaplermin)

FDA Announces New Labeling Changes for Regranex
Product to carry boxed warning

The U.S. Food and Drug Administration today announced the addition of a boxed warning to the label of Regranex Gel 0.01% (becaplermin) to address the increased risk of cancer mortality in patients who use 3 or more tubes of the product. Regranex is a topical cream indicated for the treatment of leg and foot ulcers that are not healing in diabetic patients.

The WARNINGS section of the product has been updated to include a BOXED WARNING and a description of the epidemiologic data that is the basis for the revised label. These data come from a retrospective study that compared cancer incidence and cancer mortality among 1,622 patients exposed to Regranex to 2,809 otherwise similar patients who were not exposed. The results were consistent with no overall increase in cancer incidence among the patients exposed to Regranex. However, there was a five-fold increased risk of cancer mortality in the group exposed to three or more tubes of Regranex.

"In announcing this label change, FDA still cautions health care professionals to carefully weigh the risks and benefits of treating patients with Regranex," said Susan Walker, M.D., director of the Division of Dermatological and Dental Products. "Regranex is not recommended for patients with known malignancies."

In late March FDA issued an Ongoing Safety Review Communication on Regranex notifying the public that it was conducting a safety review. This follow-up communication is in keeping with FDA’s commitment to notify the public of any regulatory changes with this FDA approved product.

Regranex is a medicine that is a recombinant form of human platelet-derived growth factor which is applied directly to diabetic foot and leg ulcers that are not healing. The recombinant form of platelet growth factor has a biologic activity that is much like that produced naturally by the body. Growth factors cause cells to divide more rapidly. It is for this reason that the manufacturer continued to monitor studies begun before Regranex was approved in December 1997 for any evidence of adverse effects such as increased numbers of cancers. In a long term safety study completed in 2001, there were more deaths from cancer in people who used Regranex than in those who did not use it.

Following the report of the study completed in 2001, an additional study was performed using a health insurance database that covered the period from January, 1998 through June, 2003. This study used the database to identify two groups of patients with similar diagnoses, drug use, and use of health services, one of which used Regranex and one group that did not. The results of this study showed that deaths from cancer were higher for patients who were given three or more prescriptions for treatment with Regranex than those who were not treated with Regranex. No single type of cancer was identified, but rather deaths from all types of cancer, combined were observed.

To read about Regranex and FDA's follow-up communication go to:

Becaplermin (marketed as Regranex) Information

Update of Safety Review: Follow-up to the March 27, 2008, Communication about the Ongoing Safety Review of Regranex (becaplermin)

Tags: FDA Alert, Drug Safety, Labeling Changes for Regranex, becaplermin

FDA Warning, New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes, Salmonella Outbreak

FOR IMMEDIATE RELEASE June 3, 2008

Media Inquiries: Michael Herndon, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers in New Mexico and Texas Not to Eat Certain Types of Raw Red Tomatoes

The Food and Drug Administration is alerting consumers in New Mexico and Texas that a salmonellosis outbreak appears to be linked to consumption of certain types of raw red tomatoes and products containing raw red tomatoes. The bacteria causing the illnesses are Salmonella serotype Saintpaul, an uncommon type of Salmonella.

The specific type and source of tomatoes are under investigation. However, preliminary data suggest that raw red plum, red Roma, or round red tomatoes are the cause. At this time, consumers in New Mexico and Texas should limit their tomato consumption to tomatoes that have not been implicated in the outbreak. These include cherry tomatoes, grape tomatoes, tomatoes sold with the vine still attached, and tomatoes grown at home.

Salmonella can cause serious and sometimes fatal infections particularly in young children, frail or elderly people, and those with weakened immune systems. Healthy persons often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, the organism can get into the bloodstream and produce more severe illnesses. Consumers in New Mexico and Texas who have recently eaten raw tomatoes or foods containing raw tomatoes and are experiencing any of these symptoms should contact their health care provider. All Salmonella infections should be reported to state or local health authorities.

From April 23 though June 1, 2008, there have been 57 reported cases of salmonellosis caused by Salmonella Saintpaul in New Mexico and Texas, including 17 hospitalizations. Approximately 30 reports of illness in Arizona, Colorado, Idaho, Illinois, Indiana, Kansas, and Utah are currently being investigated to determine whether they are also linked to tomatoes. There are no reported deaths.

FDA recognizes that the source of the contaminated tomatoes may be limited to a single grower or packer or tomatoes from a specific geographic area. FDA also recognizes that there are many tomato crops across the country and in foreign countries that are just becoming ready for harvest or will become ready in the coming months. In order to ensure that consumers can continue to enjoy tomatoes that are safe to eat, FDA is working diligently with the states, the Centers for Disease Control and Prevention, the Indian Health Service, and various food industry trade associations to quickly determine the source and type of the contaminated tomatoes. As more information becomes available, FDA will update this warning.

Last year FDA began a multi-year Tomato Safety Initiative to reduce the incidence of tomato-related foodborne illness. The Initiative is a collaborative effort between FDA and the state health and agriculture departments in Virginia and Florida, in cooperation with several universities and members of the produce industry.

A key element of the Food Protection Plan -- a scientific and a risk-based approach to strengthen and protect the nation's food supply—is prevention. FDA encourages producers to critically reexamine their operations and apply the scientific principles and regulations established decades ago to provide a safe product for the consumer.

Information on safe handling of produce can be found at www.cfsan.fda.gov/~dms/prodsafe.html.

Tomato consumer page can be found at http://www.fda.gov/oc/opacom/hottopics/tomatoes.html

Updates from the Centers for Disease Control and Prevention can be found at http://www.cdc.gov/

Tags: Salmonella Outbreak, CDC Warning, FDA Alert, Raw Red Tomatoes

Mommy's Bliss Nipple Cream Can Be Harmful To Nursing Infants

FOR IMMEDIATE RELEASE May 23, 2008

Media Inquiries: Rita Chappelle, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Warns Consumers Against Using Mommy's Bliss Nipple Cream
Product can be harmful to nursing infants

The U.S. Food and Drug Administration is warning consumers not to use or purchase Mommy's Bliss Nipple Cream, marketed by MOM Enterprises, Inc., because the product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants. The product is promoted to nursing mothers to help soothe and heal dry or cracked nipples. Product labeling specifically states that there is no need for mothers to remove the cream prior to nursing. However, the ingredients contained in the product may be harmful to nursing infants.

Potentially harmful ingredients in Mommy's Bliss Nipple Cream are chlorphenesin and phenoxyethanol. Chlorphenesin relaxes skeletal muscle and can depress the central nervous system and cause respiratory depression (slow or shallow breathing) in infants. Phenoxyethanol is a preservative that is primarily used in cosmetics and medications. It also can depress the central nervous system and may cause vomiting and diarrhea, which can lead to dehydration in infants.

Mothers and caregivers should watch for a decrease in an infant's appetite. More serious signs would be difficulty in awakening the child, limpness of extremities or a decrease in an infant's strength of grip and a change in skin color. Please seek immediate medical attention if your child is showing these signs and symptoms.

"The FDA is particularly concerned that nursing infants are being unwittingly exposed by their mothers to this product with dangerous side effects," said Janet Woodcock, M.D., director, FDA's Center for Drug Evaluation and Research. "Additionally, these two ingredients may interact with one another to further compound and increase the risk of respiratory depression in nursing infants."

Though the FDA has not received any reports of injury to infants, the agency is alerting the public because of the potential harm this product can have on a child.

Chlorphenesin can also harm the mother by causing dermatitis, a skin condition that can worsen the drying and cracking of nipple skin.

MOM Enterprises, Inc. is based in San Rafael, Calif. The company has stated that it has discontinued marketing the nipple cream with the potentially harmful ingredients. The FDA is advising consumers to discontinue use of Mommy's Bliss Nipple Cream and to consult a health care professional if they experience problems or believe that their infant may have experienced problems due to this product. Nursing mothers with cracked, painful nipples, which is often a side effect of nursing, should speak with their health care professional or a certified lactation consultant if the problem is severe or for other treatment options.

Consumers are strongly encouraged to report adverse events related to this product or any FDA approved product to MedWatch, the agency's voluntary reporting program, by e-mail at www.fda.gov/medwatch/report.htm, or by phone at 800-332-1088, or by fax to 800-332-0178. Consumers may also mail reports of adverse events to MedWatch, Food and Drug Administration, 5600 Fishers Lane, Rockville, MD, 20852-9787.

Tags: FDA Alert, fda warning, Mommy's Bliss Nipple Cream, MOM Enterprises, chlorphenesin, phenoxyethanol, respiratory depression

New Chantix (Varennicline) Medication Guide and Label Approved By FDA

FDA approves new Medication Guide and Label for Varenicline (marketed as Chantix)
FDA ALERT [2/1/2008]: FDA is issuing this Alert to highlight important revisions to the WARNINGS and PRECAUTIONS sections of the full prescribing information for Chantix regarding serious neuropsychiatric symptoms. Serious neuropsychiatric symptoms have occurred in patients taking Chantix. These symptoms include changes in behavior, agitation, depressed mood, suicidal ideation, and attempted and completed suicide. While some patients may have experienced these types of symptoms and events as a result of nicotine withdrawal, some patients taking Chantix who experienced serious neuropsychiatric symptoms and events had not yet discontinued smoking. In most cases, neuropsychiatric symptoms developed during Chantix treatment, but in others, symptoms developed following withdrawal of Chantix therapy.

FDA first informed the public about the possibility of serious neuropsychiatric symptoms in the November 20, 2007 FDA Early Communication About an Ongoing Safety Review. At that time, information about serious neuropsychiatric symptoms in patients taking Chantix was added to the POST-MARKETING EXPERIENCE section of the prescribing information. As FDA’s review of the issue has progressed, it appears increasingly likely that there is an association between Chantix and serious neuropsychiatric symptoms. As a result, FDA requested that Pfizer, the manufacturer of Chantix, elevate the prominence of this safety information to the WARNINGS and PRECAUTIONS sections of the Chantix prescribing information. In addition, FDA is working with Pfizer to finalize a Medication Guide for patients.

[5/16/2008]: The issues described in this communication have been addressed in the product labeling and FDA has approved the Medication Guide. If either you, your family or caregiver notice agitation, depressed mood, or changes in behavior that are not typical for you, or if you have suicidal thoughts or actions, stop taking Chantix and call your doctor right away.

Tags: FDA Alert, FDA Action, Chantix label change, Varenicline

FDA Alert & Information on Mycophenolate Mofetil (marketed as CellCept) and

FDA ALERT [5/16/2008] - Inosine Monophosphate Dehydrogenase Inhibitors (IMPDH) Immunosuppressants

FDA is aware of reports of infants born with serious congenital anomalies, including microtia and cleft lip and palate, following exposure to mycophenolate mofetil (MMF) during pregnancy. MMF, the active drug substance in CellCept, is an ester of the active metabolite mycophenolic acid (MPA), the active drug substance in Myfortic. In most cases, the mothers were taking MMF following an organ transplant to prevent organ rejection. However, some mothers taking MMF were being treated for immune-mediated conditions such as systemic lupus erythematosus (SLE) and erythema multiforme. Treatment began before their pregnancies and continued into the first trimester or until the pregnancy was detected. MMF is approved in the U.S. for use in the prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac or hepatic transplants and MPA is approved in the U.S. for use in the prophylaxis of organ rejection in patients receiving allogeneic renal transplants. In patients who are transplant recipients, these drugs are almost always used in combination with other immunosuppressant drugs.

MMF and MPA increase the risk of spontaneous abortion in the first trimester and can cause congenital malformations in the offspring of women who are treated during pregnancy. The labeling for both MMF and MPA was revised in November 2007 to change the Pregnancy Category to "D" (positive evidence of human fetal risk, but potential benefits may warrant use of the drug in pregnant women despite the potential risk) and to add these findings about the risk of early pregnancy loss and congenital malformations to the boxed warning.

FDA is continuing to work with the manufacturers of these drug products to develop and implement means to mitigate the risks of fetal exposure.

This information reflects FDA’s current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded there is a causal relationship between the drug product and the emerging safety issue. Nor does it mean that FDA is advising health care professionals to discontinue prescribing this product. FDA is considering, but has not reached a conclusion about whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.

FDA is investigating a potential association between the use of CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid), medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease.

PML is a rare disorder that affects the central nervous system. When it occurs, it is usually in patients with immune systems suppressed by disease or medicines. It happens when the polyomavirus, also known as the JC virus, is activated. The JC virus is found in most adults but does not usually cause symptoms. Scientists do not know exactly how the JC virus is activated. Once activated, the JC virus attacks the cells that make myelin, the protective coating around nerve cells. Signs and symptoms of PML can include localized neurologic signs and symptoms including vision changes, loss of coordination, clumsiness, memory loss, difficulty speaking or understanding what others say, and weakness in the legs. Many patients who develop PML die. Patients who survive may have permanent disability due to irreversible nerve damage. More information on PML can be found at the National Institutes of Health website.

CellCept is approved to prevent heart, liver, and kidney transplant rejection and Myfortic is approved to prevent kidney transplant rejection. Mycophenolate mofetil, the drug ingredient in CellCept, is metabolized by the body to mycophenolic acid, the drug ingredient in Myfortic. Both CellCept and Myfortic are used with other drugs to suppress the immune system.

On November 8, 2007, Roche, the maker of CellCept, submitted an evaluation of its PML cases in patients who have received CellCept in addition to other immunosuppressive medicines. Roche also submitted recommendations to the FDA for including information about PML in the CellCept prescribing information. On March 14, 2008, Roche informed the FDA of the Dear Health Care Professional letter it issued in Europe on February 18, 2008.

Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE), an autoimmune disorder that is sometimes treated with CellCept; however, CellCept and Myfortic are not approved for treating SLE or similar autoimmune disorders.

Roche is aware of cases of PML in transplant recipients and patients with systemic lupus erythematosus (SLE), an autoimmune disorder that is sometimes treated with CellCept; however, CellCept and Myfortic are not approved for treating SLE or similar autoimmune disorders.

FDA is reviewing data, including postmarketing reports it has received of PML in patients who took CellCept, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information.

FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revised prescribing information for CellCept and Myfortic about PML. As soon as FDA completes the review, FDA will communicate the conclusions and recommendations to the public. Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic. Decreasing total immunosuppression may improve the outcome of patients who develop PML.

This communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs.

FDA urges both healthcare professionals and patients to report side effects from the use of CellCept and Myfortic to the FDA's MedWatch Adverse Event Reporting program

• online at [www.fda.gov/medwatch/report.htm];
• by returning the postage-paid FDA form 3500 [available in PDF format at [www.fda.gov/medwatch/getforms.htm] to 5600 Fishers Lane, Rockville, MD 20852-9787;
• faxing the form to 1-800-FDA-0178; or
• by phone at 1-800-332-1088

Tags: FDA Advisory, FDA Alert, alert on CellCept, alert on Myfortic, mycophenolate mofetil, mycophenolic acid, PML, systemic lupus erythematosus

Safety Review of CellCept (mycophenolate mofetil) and Myfortic (mycophenolate acid).

FDA informed healthcare professionals that the Agency is investigating a potential association between the use of CellCept and Myfortic, medicines used to prevent organ rejection, and the development of progressive multifocal leukoencephalopathy (PML), a life-threatening disease. PML is a rare disorder that affects the central nervous system usually occurring in patients with immune systems suppressed by disease or medicines. FDA is reviewing data submitted by Roche, including postmarketing reports it has received of PML in patients who took CellCept or Myfortic, and the proposed revisions to the CellCept prescribing information. FDA has asked Novartis, the maker of Myfortic, for data on PML cases and to revise the Myfortic prescribing information to include the same information about PML included in the CellCept prescribing information. FDA anticipates it may take about 2 months to complete its review of the postmarketing reports and the proposed revisions to the prescribing information. As soon as the review is completed, FDA will communicate the conclusions and recommendations to the public. Until further information is available, patients and healthcare professionals should be aware of the possibility of PML, such as localized neurologic signs and symptoms in the setting of a suppressed immune system, including during therapy with CellCept and Myfortic.

[April 10, 2008 - Communication About an Ongoing Safety Review - FDA]
tag: 4 healthcare professionals, FDA Alert, CellCept, Myfortic, organ rejection, multifocal leukoencephalopathy, PML,

Adverse Events from Botox and Myobloc, An Early Communication From FDA.

FDA has issued an early communication about serious adverse events, including respiratory failure and death, from Botox and Botox Cosmetic (Botulinum toxin Type A), and Myobloc (Botulinum toxin Type B). These events were related to how the product was used, and not to a defect in the manufacturing process. The events occurred one day to several weeks after treatment, and from a wide range of dosages.

In the affected patients, the botulinum toxin may have spread beyond the injection site and caused symptoms associated with botulism, including dysphagia and respiratory insufficiency. The most severe effects were seen in children, and the most commonly reported use in children was for limb spasticity in cerebral palsy, which is an unapproved use. Adverse reactions also occurred in patients receiving the drug for approved indications.

FDA is evaluating all the adverse event reports, as well as the medical literature in this area, and will let health professionals and the public know about any new information or conclusions.

In the meantime, healthcare professionals who use botulinum toxins should be alert to the potential for systemic effects from local injections, including dysphagia, dysphonia, weakness, dyspnea, or respiratory distress. They should tell patients and caregivers about the symptoms of botulism and to seek immediate medical attention if they occur.

Finally, practitioners should understand that the potency of botulinum toxin, which is expressed in "Units" ("U"), is not comparable from one botulinum toxin product to the next.

Additional Information:

FDA MedWatch Safety Alert. Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B). February 8, 2008.
http://www.fda.gov/medwatch/safety/2008/safety08.htm#botox

tag: FDA Alert, Botox, Botox Cosmetic, Botulinum toxin Type A, Myobloc, Botulinum toxin Type B, botulism, dysphagia, cerebral palsy, dyspnea,

FDA Alert on Tussionex, a Long-Acting Prescription Cough Medicine

FOR IMMEDIATE RELEASE March 11, 2008

Media Inquiries: Christopher Kelly, 301-827-6242 Susan Cruzan, 301-827-6242 Consumer Inquiries: 888-INFO-FDA

FDA Issues Alert on Tussionex, a Long-Acting Prescription Cough Medicine
Containing Hydrocodone
Agency gives new safety information on proper use of Tussionex as a cough suppressant

The U.S. Food and Drug Administration issued an alert today on the safe and correct use of Tussionex Pennkinetic Extended-Release Suspension in response to numerous reports of adverse events--including death--associated with the misuse and inappropriate use of this potent cough medication.

Tussionex is a prescription cough medicine containing hydrocodone, a narcotic ingredient, and the antihistamine chlorpheniramine. The product is approved for use in adults and children over the age of six years old, and should be given no more frequently than every 12 hours (“extended-release”).

“There is a real and serious risk for overdosing if this medication is not used according to the labeling,” said Curtis Rosebraugh, M.D., M.P.H., acting director of the FDA's Office of Drug Evaluation II. “Today’s action is an example of the FDA working with drug manufacturers throughout a product’s lifecycle to keep health care professionals and patients informed of new safety data.”

Adverse event reports associated with Tussionex have included life-threatening side effects and deaths in patients, including children. These reports reveal physicians and other health professionals are sometimes prescribing, and patients are sometimes taking, more than the recommended dose or taking the medication more frequently than every 12 hours. The reports also show that Tussionex is sometimes prescribed or given to children less than 6 years old, for whom this medication is not approved.

Highlights of the FDA’s recommendations to health care professionals include:

• Tussionex should not be used (is contraindicated) in patients less than 6 years old. FDA has received reports of death in children less than 6 years of age who have been prescribed Tussionex.
  
  
• Consult the prescribing information to determine the correct dose and dosing frequency of Tussionex. Tussionex is an extended-release formulation that should not be prescribed at an interval less than 12 hours.
  
  
• Discuss with the patient the amount of and frequency of Tussionex to be given. Instruct patients not to take, and parents not to administer Tussionex more frequently than every 12 hours.

Highlights of the FDA’s recommendations to patients include:

• One of the two ingredients in this long-acting cough product is hydrocodone, a narcotic. Too much hydrocodone can cause life-threatening breathing problems and death. Call your doctor right away if you have taken this medicine and have trouble breathing, slow heartbeat, severe sleepiness or cold, clammy skin.
  
  
• For Tussionex, use a medicine syringe or other device designed to measure liquid medications. A household teaspoon or tablespoon should not be used because the spoons vary in size and you may receive too much or too little of the medicine. Ask your doctor or pharmacist if you are unsure how to measure the medicine.
  
  
• If the cough is not controlled despite taking the prescribed dose at the recommended interval, talk to your doctor.

The manufacturer of Tussionex Pennkinetic Extended-Release Suspension (UCB Inc, Smyrna, Ga.) has agreed to update the labeling, including information that Tussionex should not be prescribed to or used in children less than 6 years of age, as well as the need for accurate dosing.

For more information and the full list of the FDA's recommendations, visit http://www.fda.gov/cder/drug/infopage/hydrocodone/default.htm

This alert does not impact short-acting cough products containing hydrocodone that can be given every 4 to 6 hours. However, the FDA is reviewing safety information on these other hydrocodone containing cough products and will provide updates as new information becomes available.

tag: FDA Alert, Tussionex, Hydrocodone, cough suppressant Alert, Tussionex Pennkinetic Extended Alert, cough medication Alert, antihistamine chlorpheniramine, narcotic ingredient, UCB Inc,

FDA updates safety information for long acting beta agonists (LABA).

Advair Diskus, Advair HFA, Brovana, Foradil, Serevent Diskus, and Symbicort Information
(Long Acting Beta Agonists)

On November 18, 2005, FDA alerted health care professionals and patients that several long-acting bronchodilator medicines have been associated with possible increased risk of worsening wheezing (bronchospasm) in some people, and requested that manufacturers update warnings in their existing product labeling. This information has now been included in updated labeling.

On March 2, 2006, FDA approved new safety labeling and Medication Guides for patients for Serevent Diskus (salmeterol xinafoate) and Advair Diskus (fluticasone propionate; salmeterol xinafoate). On June 19, 2006, FDA approved new safety labeling and a Medication Guide for patients for Foradil (formoterol fumarate), and also approved Advair HFA. Symbicort Inhalation Aerosol was approved on July 21, 2006.

March 5, 2008 Update: On November 28, 2007, a Pediatric Advisory Committee (PAC) meeting was held. At this meeting, FDA raised concerns about the safety of long-acting beta2 adrenergic agonists (LABAs) in pediatric patients with asthma. The PAC has agreed with an FDA recommendation to continue assessment of the risks of LABAs and seek advice from a future advisory committee (http://www.fda.gov/ohrms/dockets/ac/oc07.htm#pac).

In January, 2008 FDA requested manufacturers of Advair Diskus, Advair HFA, Brovana Inhalation Solution, Foradil Aerolizer, Perforomist Inhalation Solution, Serevent Diskus, and Symbicort Inhalation Aerosol to provide information regarding controlled clinical studies conducted with these products in order to further evaluate the safety of LABAs when treating asthma.

The manufacturers have indicated it will take several months to submit the requested information. Following review of this information, FDA plans to bring the issue of the benefit/risk assessment of LABAs in adults and children to an advisory committee in the fall or winter of 2008.

Labels and Medication Guides

• Advair Diskus Label (updated 3/2/2006)
• Advair Diskus Medication Guide for Patients
  
• Advair HFA Label (6/8/2006)
• Advair HFA Medication Guide for Patients
  
• Brovana Label (10/6/2006)
• Brovana Medication Guide for Patients

• Foradil Aerolizer Label (updated 6/19/2006)
• Foradil Aerolizer Medication Guide for Patients
  
• Serevent Diskus Label (updated 3/2/2006)
• Serevent Diskus Medication Guide for Patients
  
  
• Symbicort Inhalation Aerosol Label
• Symbicort Medication Guide for Patients

Patient Information Sheets

• Fluticasone propionate; Salmeterol xinafoate (marketed as Advair Diskus) [HTML] [PDF] (updated 5/15/2006)
• Fluticasone propionate; Salmeterol xinafoate (marketed as Advair HFA) [HTML] [PDF] (posted 7/5/2006)
• Formoterol fumarate (marketed as Foradil Aerolizer) [HTML] [PDF] (updated 7/5/2006)
• Salmeterol xinafoate (marketed as Serevent Diskus) [HTML] [PDF] (updated 5/15/2006)

Other Information

• Historical Information

tag: FDA Alert, Advair Diskus, Advair HFA, Brovana, Foradil, Serevent Diskus, Symbicort, wheezing, bronchospasm, salmeterol xinafoate, fluticasone propionate, salmeterol xinafoate, Medication Guide, LABA

Reports of Clinically Significant Liver Injury With Tysabri (natalizumab)

Tysabri (natalizumab)
Audience: Neurologists, other healthcare professionals, patients
[Posted 02/27/2008] Biogen Idec, Elan and FDA notified healthcare professionals of reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin, occurred as early as six days after the first dose of Tysabri. The combination of transaminase elevations and elevated bilirubin without evidence of obstruction is recognized as an important predictor of severe liver injury that may lead to death or the need for a liver transplant in some patients. Tysabri should be discontinued in patients with jaundice or other evidence of significant liver injury. Physicians should inform patients that Tysabri may cause liver injury.

February, 2008 - Letter - Biogen Idec, Elan]
[January, 2008 - Prescribing Information - Biogen Idec, Elan]

tag: FDA Alert, Drug Advisory, Tysabri, natalizumab, Biogen Idec, Elan, liver injury, serum hepatic enzymes, bilirubin,

Annie's Naturals Issues Allergy Alert on All-Natural Shiitake & Sesame Vinaigrette

Annie's Naturals Issues Voluntary Nationwide Allergy Alert on Undeclared Soy in 8 fl oz. All-Natural Shiitake & Sesame Vinaigrette

Contact:
Aimee Sands
707-254-3700 ext. 103

FOR IMMEDIATE RELEASE -- Napa, CA -- February 11, 2008 -- Annie's Naturals is voluntarily recalling 686 cases of 8 fl oz. bottles of all-natural Shiitake & Sesame Vinaigrette. The product could be mislabeled and may contain soy sauce (contains soy and wheat) and sesame that were not declared on the ingredient statement. People who have an allergy or severe sensitivity to soy run the risk of serious allergic reaction if they consume this product.

There have been no illnesses or injuries reported to date. Anyone concerned about an illness should contact a physician immediately.

Affected product was shipped to grocery and natural food stores in California, Colorado, Connecticut, Florida, Georgia, Indiana, Iowa, Kentucky, Maryland, Michigan, New Hampshire, New Jersey, New York, Oregon, Pennsylvania, South Carolina and Washington, between December 20, 2007 and February 6, 2008.

Consumers can most easily identify impacted product by looking at the product labels – the front label says Shiitake & Sesame Vinaigrette, but the back label and ingredient statement say Low Fat Honey Mustard Vinaigrette. Only dressings with UPC # 0-92325-33319-2 with a Best By Date of 02/20/09/1/E and 02/20/09/2/E are affected.

Organic Shiitake & Sesame Vinaigrette, 16 oz. bottles of Shiitake & Sesame Vinaigrette, and other Annie's Naturals products are not affected by this recall.

The problem occurred during a product changeover when back labels for Honey Mustard Vinaigrette were commingled with back labels for all-natural Shiitake Sesame Vinaigrette. The Honey Mustard Vinaigrette products were unaffected.

Consumers who have purchased 8 fl oz all natural Shiitake & Sesame Vinaigrette are urged to return the product to the place of purchase for a full refund or may call Annie's Naturals Consumer Relations at 1.800.288.1089 to obtain a coupon for a free product.

tag: FDA Alert, Allergy Alert, All-Natural Shiitake & Sesame Vinaigrette, Annie's Naturals