Migraine Medication
FDA Drug Safety Communication: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.
Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact your health care professional. Do not bathe, shower, or swim while wearing the patch. Read the Patient Informationleaflet and the Instructions for Use section in the drug label, and talk with your health care professional if you have any questions or concerns.
Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the Zecuity patch immediately. Consider a different formulation of sumatriptan or switch these patients to an alternative migraine medicine. Evaluate patients and the application site as needed.
The Zecuity patch contains the active ingredient sumatriptan, a prescription medicine used to treat acute migraine headaches in adults. The patch delivery system is designed to deliver a dose of medicine by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.
Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed.
Source : FDA (June 2016)
Amerge (naratriptan) Tablets
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Summary View
CONTRAINDICATIONS
Increase in Blood Pressure
Source : FDA (Oct 2013)
FDA: Risk of oral birth defects in children born to mothers taking topiramate
The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy.
The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.
Topiramate was previously classified as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.
(see Data Summary)
Additional Information for Patients
Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate monotherapy during the first trimester of pregnancy. The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% - 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 21.3 as compared to the risk in a background population of untreated women (95% Confidence Interval:7.9 – 57.1). The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts (3.2 %) among infants exposed to topiramate monotherapy, a 16-fold increase in risk compared to the risk in their background population (0.2%).
The benefits and the risks of topiramate should be carefully weighed when prescribing this drug for women of childbearing age, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. Appropriate alternative treatment should be considered . Inform women of childbearing age of the increased risk for having a baby with an oral cleft if they become pregnant while using topiramate.
Cleft lip and cleft palate range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking and ear infections. Surgery is often used to close the lip and palate. With treatment, most children with cleft lip or palate do well.3
Source : FDA 04/03/2011
Link to Source
FDA wants birth defect data from Vivus
The FDA has asked Vivus ($VVUS) to assess the feasibility of analyzing existing healthcare databases to determine the incidence of oral cleft in women who've taken topiramate for migraines. Vivus obesity drug candidate Qnexa is a combination of two existing drugs: topiramate and the appetite suppressant phentermine. When the FDA issued a complete response letter for Qnexa in October, it included a request for a plan to handle the risks Qnexa may present to women who are pregnant or may become pregnant.
In a release, Vivus noted that of the 15 women in clinical studies who'd given birth after taken the drug, none had offspring with birth defects. But there are six published reports of children with oral cleft born to women who've taken topiramate. In a release, Vivus noted its Qnexa resubmission will be decided once it reaches an agreement with the FDA on the feasibility assessment. "Left unanswered by Vivus is what happens if those existing healthcare databases cannot provide the new safety information requested by FDA," observes Adam Fuerestein of TheStreet. The company originally planned to resubmit Qnexa in the first half of this year.
Vivus is in a tight race with Orexigen and Arena Therapeutics to gain approval for a new obesity drug. It's a notoriously difficult development field littered with failures. So far Orexigen is in the lead; in December an expert panel voted 13 to 7 in favor of approving its drug Contrave.
- take a look at Vivus' release
Source : FierceBiotech
Link to Source
The U.S. Food and Drug Administration (FDA) is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptan iontophoretic transdermal system) patch for migraine headaches. We are investigating the cause and extent of these serious side effects and will update the public with new information when our review is complete.
Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact your health care professional. Do not bathe, shower, or swim while wearing the patch. Read the Patient Informationleaflet and the Instructions for Use section in the drug label, and talk with your health care professional if you have any questions or concerns.
Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the Zecuity patch immediately. Consider a different formulation of sumatriptan or switch these patients to an alternative migraine medicine. Evaluate patients and the application site as needed.
The Zecuity patch contains the active ingredient sumatriptan, a prescription medicine used to treat acute migraine headaches in adults. The patch delivery system is designed to deliver a dose of medicine by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.
Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, we are investigating these serious adverse events to determine whether future regulatory action is needed.
Source : FDA (June 2016)
Amerge (naratriptan) Tablets
Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
Summary View
CONTRAINDICATIONS
- Hypersensitivity to Amerge (angioedema and anaphylaxis seen).
Increase in Blood Pressure
- Significant elevation in blood pressure, including hypertensive crisis with acute impairment of organ systems, has been reported on rare occasions in patients treated with 5-HT1 agonists, including patients without a history of hypertension. Monitor blood pressure in patients treated with Amerge. Amerge is contraindicated in patients with uncontrolled hypertension.
- There have been reports of anaphylaxis and anaphylactoid and hypersensitivity reactions, including angioedema, in patients receiving Amerge. Such reactions can be life threatening or fatal. In general, anaphylactic reactions to drugs are more likely to occur in individuals with a history of sensitivity to multiple allergens. Amerge is contraindicated in patients with a history of hypersensitivity reaction to Amerge.
Source : FDA (Oct 2013)
FDA: Risk of oral birth defects in children born to mothers taking topiramate
The U.S. Food and Drug Administration (FDA) is informing the public of new data that show that there is an increased risk for the development of cleft lip and/or cleft palate (oral clefts) in infants born to women treated with Topamax (topiramate) during pregnancy.
The benefits and the risks of topiramate should be carefully weighed when prescribing this drug to women of childbearing age, particularly for conditions not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered for these patients. If the decision is made to use topiramate in women of childbearing age, effective birth control should be used. Oral clefts occur in the first trimester of pregnancy before many women know they are pregnant.
Topiramate was previously classified as a Pregnancy Category C drug, which means that data from animal studies suggested potential fetal risks, but no adequate data from human clinical trials or studies were available at the time of approval. However, because of new human data that show an increased risk for oral clefts, topiramate is being placed in Pregnancy Category D. Pregnancy Category D means there is positive evidence of human fetal risk based on human data but the potential benefits from use of the drug in pregnant women may be acceptable in certain situations despite its risks.
(see Data Summary)
Additional Information for Patients
- If you take topiramate during pregnancy, there is a higher risk that your baby will develop a cleft lip and/or cleft palate. Oral clefts happen early in pregnancy, before many women even know they are pregnant. For this reason, women of childbearing age should talk to their healthcare professionals about other treatment options.
- Women of childbearing age who do decide to take topiramate and are not planning a pregnancy should use effective birth control (contraception) while taking topiramate. Women should talk to their healthcare professionals about the best kind of birth control to use while taking topiramate.
- Before you start topiramate, you should tell your healthcare professional if you are pregnant or are planning to become pregnant. Healthcare professionals may discuss other treatment options with you.
- You should tell your healthcare professional right away if you become pregnant while taking topiramate. You and your healthcare provider should decide if you will continue to take topiramate while you are pregnant.
- Topiramate should not be stopped without talking to a healthcare professional, even in pregnant women. Stopping topiramate suddenly can cause serious problems. Not treating epilepsy during pregnancy can be harmful to women and their developing babies.
- If you become pregnant while taking topiramate, you should talk to your healthcare professional about registering with the North American Antiepileptic Drug Pregnancy Registry. You can enroll in this registry by calling 1-888-233-2334. The purpose of this registry is to collect additional information about the safety of antiepileptic drugs during pregnancy. Information about the North American Drug Pregnancy Registry can be found at http://www.massgeneral.org/aed/1.
- Topiramate passes into breast milk, but its effects on developing babies remain unknown. You should talk to your healthcare professional about the best way to feed your baby if you take topiramate.
- You should report any side effects you experience to the FDA MedWatch program using the information in the "Contact Us" box at the bottom of the page.
- You should read the Medication Guide when picking up a prescription for topiramate. It will help you understand the potential risks and benefits of this medication.
- You should inform women of childbearing age of the increased risk for oral clefts when topiramate is used in the first trimester of pregnancy.
- You should weigh the benefits and risks of topiramate when prescribing this drug to women of childbearing age, particularly when treating a condition not usually associated with permanent injury or death. Alternative medications that have a lower risk of oral clefts and other adverse birth outcomes should be considered. Healthcare professionals should discuss the relative risks and benefits of appropriate alternative therapies.
- If the decision is made to prescribe topiramate to women of childbearing age, healthcare professionals should recommend use of effective contraception for women who are not planning a pregnancy, keeping in mind the potential for a decrease in hormonal exposure and a possible decrease in contraceptive efficacy when using estrogen-containing birth control with topiramate.
- You should inform patients of the North American Antiepileptic Drug (NAEED) Pregnancy Registry and encourage patients who become pregnant to enroll by calling 1-888-233-2334.
- You should report adverse events involving topiramate to the FDA MedWatch program, using the information in the "Contact Us" box at the bottom of the page.
Data from the North American Antiepileptic Drug (NAAED) Pregnancy Registry indicate an increased risk of oral clefts in infants exposed to topiramate monotherapy during the first trimester of pregnancy. The prevalence of oral clefts was 1.4% compared to a prevalence of 0.38% - 0.55% in infants exposed to other antiepileptic drugs (AEDs), and a prevalence of 0.07 % in infants of mothers without epilepsy or treatment with other AEDs. The relative risk of oral clefts in topiramate-exposed pregnancies in the NAAED Pregnancy Registry was 21.3 as compared to the risk in a background population of untreated women (95% Confidence Interval:7.9 – 57.1). The UK Epilepsy and Pregnancy Register reported a similarly increased prevalence of oral clefts (3.2 %) among infants exposed to topiramate monotherapy, a 16-fold increase in risk compared to the risk in their background population (0.2%).
The benefits and the risks of topiramate should be carefully weighed when prescribing this drug for women of childbearing age, particularly when topiramate is considered for a condition not usually associated with permanent injury or death. Appropriate alternative treatment should be considered . Inform women of childbearing age of the increased risk for having a baby with an oral cleft if they become pregnant while using topiramate.
Cleft lip and cleft palate range from a small notch in the lip to a groove that runs into the roof of the mouth and nose, possibly leading to problems with eating, talking and ear infections. Surgery is often used to close the lip and palate. With treatment, most children with cleft lip or palate do well.3
- U.S. National Library of Medicine. National Institutes of Health. Topiramate monograph. Available at http://www.nlm.nih.gov/medlineplus/druginfo/meds/a697012.html2. Accessed January 6, 2011.
- SDI, Vector One®: National (VONA) and Total Patient Tracker (TPT). January 2007-December 2010. Data extracted 2-9-11
- U.S. National Library of Medicine. National Institutes of Health. Cleft Lip and Palate health topic. Available at http://www.nlm.nih.gov/medlineplus/cleftlipandpalate.html3. Accessed January 6, 2011.
Source : FDA 04/03/2011
Link to Source
FDA wants birth defect data from Vivus
The FDA has asked Vivus ($VVUS) to assess the feasibility of analyzing existing healthcare databases to determine the incidence of oral cleft in women who've taken topiramate for migraines. Vivus obesity drug candidate Qnexa is a combination of two existing drugs: topiramate and the appetite suppressant phentermine. When the FDA issued a complete response letter for Qnexa in October, it included a request for a plan to handle the risks Qnexa may present to women who are pregnant or may become pregnant.
In a release, Vivus noted that of the 15 women in clinical studies who'd given birth after taken the drug, none had offspring with birth defects. But there are six published reports of children with oral cleft born to women who've taken topiramate. In a release, Vivus noted its Qnexa resubmission will be decided once it reaches an agreement with the FDA on the feasibility assessment. "Left unanswered by Vivus is what happens if those existing healthcare databases cannot provide the new safety information requested by FDA," observes Adam Fuerestein of TheStreet. The company originally planned to resubmit Qnexa in the first half of this year.
Vivus is in a tight race with Orexigen and Arena Therapeutics to gain approval for a new obesity drug. It's a notoriously difficult development field littered with failures. So far Orexigen is in the lead; in December an expert panel voted 13 to 7 in favor of approving its drug Contrave.
- take a look at Vivus' release
Source : FierceBiotech
Link to Source