Showing posts with label FDA Advisory. Show all posts
Showing posts with label FDA Advisory. Show all posts

Thursday, June 06, 2019

Did You Have A Problem with Dietary Supplements? Stop Using, Seek Help And Please Report To The FDA



If you think that a dietary supplement may have caused you or someone you know to have a serious reaction or illness, immediately stop using the product. The symptoms could be any of these;
Serious reactions or illnesses may include:
  • itching, rash, hives, throat/lip/tongue swelling, wheezing
  • low blood pressure, fainting, chest pain, shortness of breath, palpitations, irregular heart beat
  • severe, persistent nausea, vomiting, diarrhea, or abdominal pain
  • difficulty urinating, decreased urination
  • fatigue, appetite loss, yellowing skin/eyes, itching, dark urine
  • severe joint/muscle pain
  • slurred speech, one-sided weakness of face, arm, leg, vision (stroke)
  • abnormal bleeding from nose or gums
  • blood in urine, stool, vomit, or sputum
  • marked mood, cognitive, or behavioral changes, thoughts of suicide
  • visit to Emergency Room or hospitalization

.  and fill out a safety report here

Saturday, April 13, 2019

FDA and CDC are gearing up to fight multi state outbreak of Salmonella Carrau originating from Caito Foods Melons

Our recalls blog posted earlier about Caito foods recall based on Salmonella Carrau contamination. Now FDA is bring together forces to fight the multi state outbreak of Salmonella Carrau. FDA and CDC are gearing up to fight multi state outbreak of Salmonella Carrau originating from Caito Foods Melons and Outbreak Investigation so far has led to the following information;

The CDC reports 93 people became ill between Mar. 4, 2019 and Mar. 31, 2019.
23 people have been hospitalized.
To date, no deaths have been reported.
The cases are spread across nine states: AL, IL, IN, KY, MI, MO, MN, OH, WI.
People who became ill range in age from less than one (1) to 98 years, with a median age of 53.
57 percent of ill people are female.
To date, one (1) common production facility was identified and a recall was initiated.
16 states had stores where recalled product was distributed.
The FDA is continuing to investigate this outbreak and will share more information as it becomes available.

The U.S. Food and Drug Administration and the U.S. Center for Disease Control and Prevention, along with state and local officials, are investigating a multi-state outbreak of Salmonella Carrau infections. The CDC reports that pre-cut melons (cantaloupe, honeydew, and watermelon) are the likely source of this outbreak and Caito Foods, LLC has issued a voluntary recall for affected products.

The FDA is advising consumers not to eat pre-cut melon products produced at the Caito Foods facility in Indianapolis, Indiana. Caito Foods, LLC distributed products produced at this facility in Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin. To date, recalled pre-cut melons was reported by Caito Foods, LLC to be sold from Kroger under the Renaissance Food Group label, Kroger under Boar's Head Private Label, Target under the Garden Highway Label, Trader Joes under the Trader Joes label, Walmart under a Freshness Guaranteed label, and Amazon/Whole Foods under the Whole Foods Market Label. Caito Foods, LLC has recalled products that contain pre-cut melons to prevent further distribution of potentially contaminated products. However, consumers may still have these products in their homes.
Consumers that consumed any pre-cut melon should look for signs and symptoms of a Salmonella infection. Symptoms include diarrhea, fever and abdominal cramps that typically develop within 12 to 72 hours of exposure and last for about 4 to 7 days.
If consumers might have symptoms of a Salmonella infection they should consult their health care professional.
People with questions about food safety can call the FDA at 1-888-SAFEFOOD or consult the FDA's website.

The pre-cut melon products were packaged in clear, plastic clamshell containers under several different brands or labels, so consumers are advised to look at the packaging to determine if the melon is distributed by Caito Foods, LLC and, if so, to not eat it. Some of these containers may be labeled as products of "Renaissance Foods Group." Retailers and wholesale customers should check their inventories and shelves to confirm that none of the products are present or available for purchase by consumers or in warehouse inventories.
The FDA advises consumers not to eat recalled pre-cut fruit products containing any melon produced at the Caito Foods facility in Indianapolis, Indiana.
If consumers have any of the recalled product they should dispose of it or return the product for a refund.

Press Release

FDA Fast Facts: FDA works with partners to investigate Salmonella Carrau outbreak linked to pre-cut melon, warns consumers to avoid eating recalled product
  U.S. Food and Drug Administration (FDA) logo (PRNewsfoto/FDA)
NEWS PROVIDED BY

U.S. Food and Drug Administration
Apr 12, 2019, 23:23 ET

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SILVER SPRING, Md., April 12, 2019 /PRNewswire/ -- The U.S. Food and Drug Administration and the U.S. Center for Disease Control and Prevention, along with state and local officials, are investigating a multi-state outbreak of Salmonella Carrau infections. The CDC reports that pre-cut melons (cantaloupe, honeydew, and watermelon) are the likely source of this outbreak and Caito Foods, LLC has issued a voluntary recall for affected products.

The FDA is advising consumers not to eat pre-cut melon products produced at the Caito Foods facility in Indianapolis, Indiana. Caito Foods, LLC distributed products produced at this facility in Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin. To date, recalled pre-cut melons was reported by Caito Foods, LLC to be sold from Kroger under the Renaissance Food Group label, Kroger under Boar's Head Private Label, Target under the Garden Highway Label, Trader Joes under the Trader Joes label, Walmart under a Freshness Guaranteed label, and Amazon/Whole Foods under the Whole Foods Market Label. Caito Foods, LLC has recalled products that contain pre-cut melons to prevent further distribution of potentially contaminated products. However, consumers may still have these products in their homes.

The pre-cut melon products were packaged in clear, plastic clamshell containers under several different brands or labels, so consumers are advised to look at the packaging to determine if the melon is distributed by Caito Foods, LLC and, if so, to not eat it. Some of these containers may be labeled as products of "Renaissance Foods Group." Retailers and wholesale customers should check their inventories and shelves to confirm that none of the products are present or available for purchase by consumers or in warehouse inventories.

"Upon learning that this outbreak is likely linked to pre-cut melon from a Caito Foods' facility in Indiana, the FDA began working with the company and retailers to promptly recall the product and prevent further exposure to consumers. We are continuing to aggressively investigate the source of the product in order to determine where the melons were sourced from and how they became contaminated. As our investigation unfolds, we're advising consumers to take action now by discarding any implicated pre-cut melon product that may still be in their fridge or freezer," said FDA Deputy Commissioner for Food Policy and Response Frank Yiannas. "Responding to food safety problems is a vital part of the FDA's mission and to protecting consumers. The FDA and Indiana State Department of Health are investigating the facility and will conduct an inspection that'll help identify the actions the company will need to take to prevent an outbreak like this from happening again. We will provide further updates as we learn more."

The FDA is continuing its investigation into the specific type of melon that may be implicated in this outbreak. Salmonella Carrau is rare and has been historically been found in imported melon.

The following is an update on the FDA's outbreak investigation.

Snapshots

Outbreak Investigation Summary

The FDA and CDC believes a multi-state outbreak of Salmonella Carrau infections is likely linked to pre-cut melon products produced at the Caito Foods, LLC's facility in Indianapolis, Indiana.
Caito Foods, LLC distributed products produced at this facility in Illinois, Indiana, Iowa, Kansas, Kentucky, Michigan, Minnesota, Missouri, Nebraska, New York, North Carolina, Ohio, Pennsylvania, Tennessee, West Virginia, and Wisconsin.
Caito Foods, LLC recalled products that contain pre-cut melons. These products contain cantaloupe, honeydew, or watermelon, or may be mixes of some or all of these melons and other pre-cut fruit.
The FDA is working with Caito Foods, LLC at the facility to determine the cause of the outbreak and sanitation measures necessary before production can begin again.
This outbreak is not related to the Salmonella outbreak that happened last year related to Caito Foods, LLC and pre-cut melon, which involved a different type of Salmonella.
Salmonella Carrau is a rare type of Salmonella and has been historically seen in imported melon.
The FDA's traceback investigation will examine shipping records to try to determine, if possible, a farm of origin for the melons.
Advice for Consumers

The FDA advises consumers not to eat recalled pre-cut fruit products containing any melon produced at the Caito Foods facility in Indianapolis, Indiana.
If consumers have any of the recalled product they should dispose of it or return the product for a refund.
Consumers that consumed any pre-cut melon should look for signs and symptoms of a Salmonella infection. Symptoms include diarrhea, fever and abdominal cramps that typically develop within 12 to 72 hours of exposure and last for about 4 to 7 days.
If consumers might have symptoms of a Salmonella infection they should consult their health care professional.
People with questions about food safety can call the FDA at 1-888-SAFEFOOD or consult the FDA's website.
By the Numbers (as of 4/12)

Outbreak Investigation

The CDC reports 93 people became ill between Mar. 4, 2019 and Mar. 31, 2019.
23 people have been hospitalized.
To date, no deaths have been reported.
The cases are spread across nine states: AL, IL, IN, KY, MI, MO, MN, OH, WI.
People who became ill range in age from less than one (1) to 98 years, with a median age of 53.
57 percent of ill people are female.
To date, one (1) common production facility was identified and a recall was initiated.
16 states had stores where recalled product was distributed.
The FDA is continuing to investigate this outbreak and will share more information as it becomes available. For more information on this investigation:

FDA's outbreak investigation
Recall Notice from Caito Food, LLC
FDA's Salmonella information
The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines, and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation's food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

Media Inquiries: Peter Cassell, 240-402-6537, peter.cassell@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

Related Links
http://www.fda.gov

Thursday, February 28, 2019

FDA Issues A Safety Communication About Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries

Caution When Using Robotically-Assisted Surgical Devices in Women's Health including Mastectomy and Other Cancer-Related Surgeries: FDA Safety Communication

Date Issued

February 28, 2019

Audience

  • People with breast cancer or those at high risk for breast cancer who are considering the surgical removal of one or both breasts (mastectomy) using robotically-assisted surgery
  • People considering robotically-assisted surgery for the prevention or treatment of other cancers
  • Health care providers who perform robotically-assisted procedures as part of cancer prevention or treatment
  • Health care providers who advise patients on the need for mastectomy

Medical Specialties

Breast Surgery, Obstetrics and Gynecology, Gynecological Oncology, General Surgery, Surgical Oncology, Endocrine Surgery, Hepatobiliary Surgery, Thoracic Surgery, Urology, Colorectal Surgery, Medical Oncology, Radiation Oncology, Oncology Nurses, Primary Care.

Device

Robotically-assisted surgical devices enable surgeons to perform a variety of surgical procedures through small cuts (incisions) in a patient's body. This type of surgery may help reduce pain, blood loss, scarring, infection, and recovery time after surgery in comparison to traditional surgical procedures.
Computer and software technology allow a surgeon to precisely control surgical instruments attached to mechanical arms through small incisions while viewing the surgical site in three-dimensional high definition.

Purpose

The FDA takes women's health issues very seriously. The FDA is issuing this safety communication because it is important for health care providers and patients to understand that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established. There is limited, preliminary evidence that the use of robotically-assisted surgical devices for treatment or prevention of cancers that primarily (breast) or exclusively (cervical) affect women may be associated with diminished long-term survival. Health care providers and patients should consider the benefits, risks, and alternatives to robotically-assisted surgical procedures and consider this information to make informed treatment decisions.

Summary of Problem and Scope

Since robotically-assisted surgical devices became available in the US, robotically-assisted surgical procedures were widely adopted because they may allow for quicker recovery and could improve surgical precision. However, the FDA is concerned that health care providers and patients may not be aware that the safety and effectiveness of these devices has not been established for use in mastectomy procedures or the prevention or treatment of cancer. Patients and health care providers should also be aware that the FDA encourages health care providers who use robotically-assisted surgical devices to have specialized training and practice in their use.

Current evidence on use of robotically-assisted surgical devices

The safety and effectiveness of robotically-assisted surgical devices for use in mastectomy procedures or prevention or treatment of cancer has not been established. However, the FDA is aware of scientific literature and media publications describing surgeons and hospital systems that use robotically-assisted surgical devices for mastectomy.
To date, the FDA's evaluation of robotically-assisted surgical devices has generally focused on determining whether the complication rate at 30 days is clinically comparable to other surgical techniques. To evaluate robotically-assisted surgical devices for use in the prevention or treatment of cancer, including breast cancer, the FDA anticipates these uses would be supported by specific clinical outcomes, such as local cancer recurrence, disease-free survival, or overall survival at time periods much longer than 30 days.
The relative benefits and risks of surgery using robotically-assisted surgical devices compared to conventional surgical approaches in cancer treatment have not been established. The FDA is aware of peer-reviewed literature reporting clinical outcomes for the use of robotically-assisted surgical devices in cancer treatment including one limited report that compared long term survival after radical hysterectomy for cervical cancer either by open abdominal surgery or by minimally invasive surgery (which included laparoscopic surgery or robotically-assisted surgery). In this report minimally invasive surgery appeared to be associated with a lower rate of long term survival compared with open abdominal surgery; however other researchers have reported no statistically significant difference in long term survival when these types of surgical procedures are compared (New England Journal of Medicine, November 2018).
To date, the FDA has not granted marketing authorization for any robotically-assisted surgical device for use in the United States for the prevention or treatment of cancer, including breast cancer. The labeling for robotically-assisted surgical devices that are legally marketed in the United States includes statements that cancer treatment outcomes using the device have not been evaluated by the FDA.

Recommendations for Patients

Before you have robotically assisted surgery to prevent or treat cancer:
  • Be aware that that the safety and effectiveness of using robotically-assisted surgical devices in mastectomy procedures or in the prevention or treatment of cancer has not been established.
  • Discuss the benefits, risks, and alternatives of all available treatment options with your health care provider to make the most informed treatment decisions.
  • Before choosing your surgeon, we recommend asking the following questions:
    • Ask your surgeon about his or her training, experience, and patient outcomes with robotically-assisted surgical device procedures.
    • Ask how many robotically-assisted surgical procedures like yours he or she has performed.
    • Ask your surgeon about possible complications and how often they happen.
If you had treatment with a robotically-assisted surgical device for any cancerous condition and experienced a complication, we encourage you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

Recommendations for Health Care Providers

  • Understand that the FDA has not cleared or approved any robotically-assisted surgical device based on cancer-related outcomes such as overall survival, recurrence, and disease-free survival.
  • Be aware that robotically-assisted surgical devices have been evaluated by the FDA and cleared for use in certain types of surgical procedures, but not for mastectomy.
  • The FDA recommends that you take training for the specific robotically-assisted surgical device procedures you perform.
  • Talk to your patients about your experience and training, and the clinical outcomes expected with the use of robotically-assisted surgical devices.
  • Discuss the benefits, risks, and alternatives of all available treatment options with your patients to help them make informed treatment decisions.
  • Be aware that clinical studies conducted in the United States involving a legally marketed device investigating a new intended use are subject to FDA oversight. For further information, please refer to the FDA's Investigational Device Exemption website.
  • If any of your patients experience adverse effects or complications with a robotically-assisted surgical device, we encouraged you to file a report through MedWatch, the FDA Safety Information and Adverse Event Reporting program.

FDA Actions

  • Robotically-assisted surgical devices are novel and complex systems and the FDA reviews each robotically-assisted surgical device system individually, based on the complexity of the technology and its intended use.
  • The FDA is monitoring adverse events in the literature and reported to the FDA to inform our understanding of the benefits and risks of robotically-assisted surgical devices when used for specific indications.
  • The FDA encourages academic and research institutions, professional societies, robotically-assisted surgical device experts, and manufacturers to establish patient registries to gather data on the use of robotically-assisted surgical devices for all uses, including the prevention and treatment of cancer. Patient registries may help characterize surgeon's learning curves, assess long-term clinical outcomes, and identify problems early to help enhance patient safety.
  • The FDA will update this communication if significant new information becomes available.

Saturday, February 09, 2019

Anaplastic Large Cell Lymphoma (BIA-ALCL) And All Breast Implants, A Letter to Health Care Providers - FDA Advisory

Breast Implant Associated-Anaplastic Large Cell Lymphoma (BIA-ALCL) - Letter to Health Care Providers


February 6, 2019
Dear Health Care Providers of the following specialties:
  • Radiology
  • Pathology
  • Plastic Surgery
  • Cosmetic Surgery
  • General Surgery
  • Internal Medicine
  • Obstetrics/Gynecology
  • Oncology
  • General Practice/Family Practice
  • Nurse Practitioners
  • Physician's Assistants
  • Emergency Medicine
The Food and Drug Administration (FDA) wants to increase awareness about an association between all breast implants, regardless of filling or texture, and Breast Implant Associated- Anaplastic Large Cell Lymphoma (BIA-ALCL). The FDA received reports indicating that patients with breast implants have an increased risk of developing this disease within the scar capsule adjacent to the implant.
We want all healthcare providers to be aware of BIA-ALCL, particularly in patients with new swelling, lumps, or pain around breast implants, to expedite diagnosis of this malignancy. We are also asking health care providers to report to the FDA cases of BIA-ALCL in patients with breast implants. This includes reporting individual cases as well as rates you may have experienced during your practice.

BACKGROUND 

BIA-ALCL is a type of lymphoma and is not a cancer of the breast tissue. When breast implants are placed in the body, they are inserted behind the breast tissue or under the chest muscle. Over time, a fibrous scar called a capsule develops around the implant, separating it from the rest of the breast. In patients with breast implants, reported cases of BIA-ALCL were generally found adjacent to the implant itself and contained within the fibrous capsule.
A significant body of medical literature has been published since the FDA's 2011 report on BIA-ALCL, including additional case histories and comprehensive reviews of the natural history and long-term outcomes of BIA-ALCL. Current literature reports various estimates for the incidence of BIA-ALCL. These estimated incidence rates range from a high of 1 per 3,817 patients to a low estimate of 1 in 30,000 (Clemens et al, 2017; Loch-Wilkinson et al, 2017; De Boer et al, 2018). While the majority of patients who develop BIA-ALCL have had textured implants, and most cases reported in the literature describe individuals who have had textured implants, there have been reports of BIA-ALCL in patients with smooth-surfaced implants and many reports do not include the surface texture of the implant at the time of diagnosis.   
As of the latest medical device reports (MDRs) update, the FDA has received a total of 660 MDRs of BIA-ALCL. The FDA has carefully reviewed the 660 MDRs to remove duplicate reports and to control for MDRs in which a BIA-ALCL diagnosis was confirmed by: a physician, positive pathology/cytology test results, or positive for biomarker CD30 and negative for biomarker ALK. The FDA's additional data analysis identified 457 unique MDRs for BIA-ALCL, including the death of nine patients which may be attributable to BIA-ALCL. However, it is important to note that at the time of diagnosis, patients may have their original breast implants or they may have had one or more replacements.
While the MDR reports provide information regarding the implant at the time of BIA-ALCL diagnosis, they do not typically give information about a patient's history of breast implants. Additional cases have been identified through the FDA's contact with other regulatory authorities, scientific experts, and breast implant manufacturers. Recent journal articles explore possible risk factors for developing BIA-ALCL, including the methods used to create the textured surface and the role of biofilm. Additionally, most of the published information about treatment describes removal of the implant and the capsule surrounding the implant, and in some patients, treatment with chemotherapy and radiation.
Though the number of identified cases of BIA-ALCL is small compared to the estimated 1.5 million patients who receive breast implants worldwide every year, confirmed data and published information reviewed to date suggests that patients with breast implants have an increased risk of BIA-ALCL.

RECOMMENDATIONS

In most of the cases reported to the FDA, patients were diagnosed with BIA-ALCL when they sought medical treatment for implant-related symptoms such as pain, lumps, swelling, or asymmetry that developed after their initial surgical sites were fully healed. These symptoms were due to collection of fluid (seroma), or masses surrounding the breast implant. Examination of the fluid and capsule surrounding the breast implant led to the BIA-ALCL diagnosis.
Therefore, the FDA is recommending that health care providers:
  • Prior to implantation, provide all patients with the breast implant manufacturer's labeling, including the patient-specific labeling, as well as other educational material prior, and make sure they are aware of the benefits and risks of the different types of implants. Most confirmed cases of BIA-ALCL have occurred in patients with textured surface implants, although there are known cases in patients with only smooth-surface breast implants.
  • Consider the possibility of BIA-ALCL when treating a patient with late onset, peri-implant seroma. In some cases, patients presented with a mass or masses adjacent to the breast implant. If you have a patient with suspected BIA-ALCL, refer the individual's case to a multidisciplinary team for evaluation.
  • Collect fresh seroma fluid and representative portions of the capsule and send for pathology tests to rule out BIA-ALCL. Diagnostic evaluation should include cytological evaluation of seroma fluid or mass with Wright Giemsa stained smears and cell block immunohistochemistry/flow cytometry testing for cluster of differentiation (CD30) and Anaplastic Lymphoma Kinase (ALK) markers.
  • Develop an individualized treatment plan in coordination with the patient's multi-disciplinary care team. Consider current clinical practice guidelines, such as those from the Plastic Surgery Foundation or the National Comprehensive Cancer Network (NCCN) when choosing your treatment approach.
  • Report all confirmed cases of BIA-ALCL in individuals with breast implants to MedWatch, the FDA Safety Information and Adverse Event Reporting program.
    • Health care personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities. Prompt reporting of adverse events can help the FDA identify and better understand the risks associated with medical devices. In some cases, the FDA may contact you for additional information. The FDA will keep the identities of the reporter and the patient confidential.
  • Submit case reports of BIA-ALCL to the Patient Registry and Outcomes For breast Implants and anaplastic large cell Lymphoma etiology and Epidemiology (PROFILE) Registry to contribute to a better understanding of the causes and treatments of BIA-ALCL. 

FDA ACTIONS

The FDA continues to actively work alongside the American Society of Plastic Surgeons (ASPS), international regulatory agencies and other experts in the clinical and scientific communities to evaluate all available information to understand the nature and possible factors contributing to BIA-ALCL in patients with breast implants.
The FDA will keep the public informed as significant new information becomes available.

CONTACT US

If you have questions about this communication, please contact the Division of Industry and Consumer Education (DICE) at DICE@FDA.HHS.GOV, 1-800-638-2041 or 301-796-7100.
Sincerely,
/s/
William Maisel, MD, MPH
Chief Medical Officer
Center for Devices and Radiological Health
U.S. Food and Drug Administration

Tuesday, December 04, 2018

NOVARTIS' Gilenya (fingolimod) Could Induce Severe Worsening of Multiple Sclerosis After Stopping the Medicine

FDA Drug Safety Announcement 

Severe Worsening of Multiple Sclerosis After Stopping the Medicine, NOVARTIS' Gilenya (fingolimod)

If you are a patient and has been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:
  • weakness
  • trouble using arms or legs
  • changes in thinking, eyesight or balance.
Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.

Drug Label : One of many

AUDIENCE: Patient, Health Professional, Neurology, Pharmacy

ISSUE: FDA is warning that when the multiple sclerosis (MS) medicine Gilenya (fingolimod) is stopped, the disease can become much worse than before the medicine was started or while it was being taken. This MS worsening is rare but can result in permanent disability.

BACKGROUND: Gilenya is one of several medicines approved to treat a form of MS called relapsing MS, which are periods of time when MS symptoms get worse. The medicine was approved in the United States in 2010.

RECOMMENDATION:
Healthcare professionals should:
  • Inform patients before starting treatment about the potential risk of severe increase in disability after stopping Gilenya.
  • Patients should be carefully observed for evidence of an exacerbation of their MS and treated appropriately when Gilenya is stopped.
  • Patients should be advised to seek immediate medical attention if they experience new or worsened symptoms of MS after Gilenya is stopped.
  • Test for new or enhancing lesions by magnetic resonance imaging (MRI) if an increase in disability occurs and begin appropriate treatment as needed.
  • Encourage patients to read the patient Medication Guide they receive with their Gilenya prescriptions, which explains the benefits and risks of the medicine.
Patients who have been instructed to stop Gilenya, should contact your health professional immediately if you experience new or worsened symptoms such as:
  • weakness
  • trouble using arms or legs
  • changes in thinking, eyesight or balance.
Patients should not stop taking the medicine on their own and should speak to their health professional first, as stopping treatment can lead to worsening MS symptoms.

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