FDA statement from Douglas Throckmorton, M.D.,

FDA statement from Douglas Throckmorton, M.D., deputy center director for regulatory programs, Center for Drug Evaluation and Research, on new warnings about the use of codeine and tramadol in children & nursing mothers.

The health and safety of children is a top priority at the FDA, which is why today we are requiring a series of changes to the labeling of two types of opioid medications in order to help better protect children from serious risks associated with these medicines – codeine (found in some prescription pain and cough medicines and some over-the-counter cough medicines) and tramadol (found in some prescription pain medicines).

We are requiring these changes because we know that some children who received codeine or tramadol have experienced life-threatening respiratory depression and death because they metabolize (or break down) these medicines much faster than usual (called ultra-rapid metabolism), causing dangerously high levels of active drug in their bodies. This is especially concerning in children under 12 years of age and adolescents who are obese or have conditions that may increase the risk of breathing problems, like obstructive sleep apnea or lung disease. Respiratory depression can also occur in nursing babies, when mothers who are ultra-rapid metabolizers take these types of medicines and pass it along to their children through their breast milk.

This isn’t the first time we have taken action on codeine to better ensure the safety of our children. Since 2013, prescription codeine labeling has contained a Boxed Warning and Contraindication for children up to age 18 years of age regarding the risk of life-threatening respiratory depression following the use of codeine for pain management after the removal of the tonsils (tonsillectomy) and/or adenoids (adenoidectomy). Now, labels for both codeine and tramadol are being updated to include additional Contraindications and Warnings; among the updates are Contraindications for use of codeine or tramadol in all children younger than 12 years of age, warnings about their use in children 12-18 years of age with certain medical conditions, and a stronger warning recommending against their use in nursing mothers. In addition to these labeling changes, labeling for tramadol-containing products will also get a Contraindication for post-operative pain management in children up to age 18 years of age who have undergone tonsillectomy and/or adenoidectomy, which is already in labeling for codeine products.

We urge health care providers, stakeholders and the public to read the Drug Safety Communication that we issued today, which provides more detailed information regarding the new Warnings and Contraindications, and the data that informed them. We also encourage parents to review the ingredients of pain medicines to see whether they include codeine or tramadol, and cough medicines to see if they contain codeine. It’s also important to check non-prescription cough and cold medicines that may be sold over the counter, as some of these medicines also include codeine. In all cases, if the medicine contains codeine or tramadol, parents should consult a health care provider before giving their children the medicines or taking them when nursing.

We understand that there are limited options when it comes to treating pain or cough in children, and that these changes may raise some questions for health care providers and parents. However, please know that our decision today was made based on the latest evidence and with this goal in mind: keeping our kids safe.

The FDA, an agency within the U.S. Department of Health and Human Services, promotes and protects the public health by, among other things, 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.

https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm553285.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery

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As you enjoy fresh produce this summer, please remember these safe handling tips.

Produce: Selecting and Serving it Safely

As you enjoy fresh produce, follow these safe handling tips to help protect yourself and your family.

Fruits and vegetables are an important part of a healthy diet. Your local markets carry a wide variety of nutritious fresh fruits and vegetables. However, harmful bacteria that may be in the soil or water where produce grows can come in contact with fruits and vegetables and contaminate them. Fresh produce may also become contaminated after it is harvested, such as during storage or preparation.

Eating contaminated produce can lead to foodborne illness, often called “food poisoning.” So as you enjoy fresh produce, follow these safe handling tips to help protect you and your family. 

Buy Right

You can help keep produce safe by making wise buying decisions.

• Choose produce that is not bruised or damaged.
• When buying pre-cut, bagged or packaged produce — such as half of a watermelon or bagged salad greens — choose only those items that are refrigerated or surrounded by ice.
• Bag fresh fruits and vegetables separately from raw meat, poultry, and seafood when packing them to take home from the market

Store Properly

Proper storage of fresh produce can affect both quality and safety.

• Store perishable fresh fruits and vegetables (like strawberries, lettuce, herbs, and mushrooms) in a clean refrigerator at a temperature of 40° F or below. Use a refrigerator thermometer to check! If you’re not sure whether an item should be refrigerated to keep its quality, ask your grocer.
• Refrigerate all produce that is purchased pre-cut or packaged .

Separate for Safety

Keep fruits and vegetables that will be eaten raw separate from raw meat, poultry, and seafood — and from kitchen utensils used for those products.

• Wash cutting boards, dishes, utensils, and countertops with soap and hot water between preparing raw meat, poultry, and seafood and preparing produce that will not be cooked.
• If possible, use one cutting board for fresh produce and a separate one for raw meat, poultry, and seafood.
• If you use plastic or other non-porous cutting boards, run them through the dishwasher after use

Prepare Safely

When preparing any fresh produce, begin with clean hands. Wash your hands for at least 20 seconds with soap and warm water before and after preparation.

• Cut away any damaged or bruised areas on fresh fruits and vegetables before preparing and/or eating. Throw away any produce that looks rotten.
• Wash all produce thoroughly under running water before preparing and/or eating, including produce grown at home or bought from a grocery store or farmers’ market. Washing fruits and vegetables with soap, detergent, or commercial produce wash is not recommended.
• Even if you do not plan to eat the skin, it is still important to wash produce first so dirt and bacteria are not transferred from the surface when peeling or cutting produce.
• Scrub firm produce, such as melons and cucumbers, with a clean produce brush.
• After washing, dry produce with a clean cloth towel or paper towel to further reduce bacteria that may be present on the surface

What About Pre-Washed Produce?

Many pre-cut, bagged, or packaged produce items are pre-washed and ready-to-eat. If so, it will be stated on the packaging, and you can use the produce without further washing.

If you choose to wash produce marked as “pre-washed” or “ready-to-eat,” be sure that it does not come in contact with unclean surfaces or utensils. This will help to avoid cross contamination.

About Foodborne Illness

Know the Symptoms

Consuming dangerous foodborne bacteria will usually cause illness within 1 to 3 days of eating the contaminated food. However, sickness can also occur within 20 minutes or up to 6 weeks later. Although most people will recover from a foodborne illness within a short period of time, some can develop chronic, severe, or even life-threatening health problems.

Foodborne illness can sometimes be confused with other illnesses that have similar symptoms. The symptoms of foodborne illness can include:

• Vomiting, diarrhea, and abdominal pain
• Flu-like symptoms, such as fever, headache, and body ache

Take Action

If you think that you or a family member has a foodborne illness, contact your healthcare provider immediately. Also, report the suspected foodborne illness to

• Contact the Consumer Complaint Coordinator in your area.
• Contact MedWatch, FDA’s Safety Information and Adverse Event Reporting Program: By Phone: 1-800-FDA-1088 Online: File a voluntary report at http://www.fda.gov/medwatch

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Medical researchers have long studied the ability of stem cells, which can regenerate and form almost any cell type in the body, to treat numerous chronic diseases. So if you find the way to appropriately activate your Stem Cells, you can reduce wrinkles, scarfs and many others effects of time on the skin or any other tissue.

Stem cells contain two key components: growth factors, which play a role in cell division, the growth of new cells, and the production of collagen and elastin; and proteins, which regulate that stem-cell division. When applied to your skin, these two components help firm wrinkles and slow the development of new lines.

The activation of the Stem Cells to Regenerate and heal, it is made by the Growth Factors.

Growth factors are vital to maintaining a youthful appearance. The skin contain multiple growth factors that regulate natural cellular renewal and damage repair processes to keep skin healthy. These growth factors are responsible for helping to reverse the visible effects of chronological aging and premature aging due to environmental factors. The consequences of environmental exposure and the normal processes of aging lead to excessive free radical damage of skin and scalp cellular components, resulting in the breakdown of collagen and elastin networks in the dermis and producing the effect of visible facial aging. This same type of damage eventually impairs growth factor function, so they are less able to repair oxidative damage, and the damage becomes permanent.

There is a new technology in the market called GF-technology developed by Dr. Ahmed Al-Qahtani, with cutting edge methods of producing human growth factors and utilizing them in topical skin care products. Growth factors (GF) are found in many different cell types in the human body. They are a group of specialized proteins with many functions, the most important being the activation of cellular proliferation and differentiation. Growth factors turn essential cellular activities “on” and “off,” and they play a role in increasing cell production, cell division, blood vessel production, and collagen and elastin production. In recent decades, scientific research into GF biological functions has shown that medical GF-technology is related to resolving many cell developmental diseases.

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FDA approves first leadless pacemaker to treat heart rhythm disorders.

The U.S. Food and Drug Administration today approved the first pacemaker that does not require the use of wired leads to provide an electrical connection between the pulse-generating device and the heart. While the Micra Transcatheter Pacing System works like other pacemakers to regulate heart rate, the self-contained, inch-long device is implanted directly in the right ventricle chamber of the heart.

Pacemakers are surgically implanted medical devices that generate electrical impulses to treat irregular or stalled heart beats, and nearly 1 million people worldwide are implanted with pacemakers each year. The leads in a traditional single chamber pacemaker run from the pacemaker, implanted under the skin near the collarbone, through a vein directly into the heart’s right ventricle; the leads deliver electric pulses from the generator to the right ventricle and help coordinate timing of the chamber’s contractions. Micra eliminates these leads, which can sometimes malfunction or cause problems when infections develop in the surrounding tissue, requiring a surgical procedure to replace the device.  

“As the first leadless pacemaker, Micra offers a new option for patients considering a single chamber pacemaker device, which may help prevent problems associated with the wired leads,” said William Maisel, M.D., M.P.H., acting director of the Office of Device Evaluation at the FDA’s Center for Devices and Radiological Health. Micra is intended for patients with a heart arrhythmia called atrial fibrillation or those who have other dangerous arrhythmias, such as bradycardia-tachycardia syndrome.

The FDA evaluated data from a clinical trial of 719 patients implanted with the Micra device, which found that 98 percent of patients in the trial had adequate heart pacing (known as pacing capture threshold) six months after the device was implanted. Complications occurred in fewer than 7 percent of participants in the clinical trials and included prolonged hospitalizations, blood clots in the legs (deep vein thrombosis) and lungs (pulmonary embolism), heart injury, device dislocation and heart attacks. 

Micra is contraindicated for patients who have implanted devices that would interfere with the pacemaker, who are severely obese, or who have an intolerance to materials in the device or the blood thinner heparin. It is also contraindicated for patients with veins that are unable to accommodate the 7.8 millimeter introducer sheath or pacemaker implant.

The Micra device is manufactured by Medtronic, located in Mounds View, Minnesota.

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.

http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm494417.htm

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Federal judge approves consent decree with Florida dietary supplement distributor, Viruxo.

A Florida dietary supplement distributor has been ordered by a federal court to stop selling its product, which it claimed could treat herpes. Senior U.S. District Judge James S. Moody, Jr. for the Middle District of Florida entered a consent decree of permanent injunction between the United States and James R. Hill of Florida, doing business as Viruxo LLC, a distributor of dietary supplements.

The complaint, filed by the U.S. Department of Justice on behalf of the U.S. Food and Drug Administration, sought a permanent injunction against Hill for unlawfully distributing an unapproved new drug and misbranded drug. The complaint also includes a civil fraud charge for Hill’s intent to defraud consumers by promoting his product to cure, mitigate, treat, or prevent a disease despite the absence of well-controlled clinical studies or any other credible scientific evidence to substantiate his claims.

As part of the decree, Hill represented to the court that he is not directly or indirectly engaged in distributing dietary supplements or drugs.

However, if Hill intends to resume distributing dietary supplements or drugs, he must notify the FDA in writing at least 90 days before doing so and comply with additional requirements specified in the decree. “Products being sold as treatments for which they have not been studied or approved defrauds consumers and can cause harm if proper treatment is delayed,” said Melinda Plaisier, FDA associate commissioner for regulatory affairs. “When a company refuses to comply with regulations, we will take enforcement action to protect the public.” In April 2011, the FDA and the U.S. Federal Trade Commission sent Hill a warning letter for making therapeutic claims on his website establishing that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The FDA has not approved Hill’s product for any use.

In addition, the warning letter stated that Hill’s product is also a misbranded drug because its labeling failed to provide adequate directions for use. Despite assurances that Hill was correcting violations noted in the warning letter, he continued to market his product on the internet to consumers as a treatment for herpes. The consent decree prohibits Hill from marketing misbranded or unapproved new drugs.

Before Hill can resume operations, he must, among other things, hire a labeling expert, remove all representations from his website and other promotional materials that his product can cure, mitigate, treat, or prevent disease, and receive written permission from the FDA to resume operations. In addition, the decree requires Hill to notify the FDA at least 14 days before the creation of a new website, or link or reference to another website, which conveys information about his products. 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.

More Information

FDA approves Opdivo to treat advanced form of kidney cancer.

The U.S. Food and Drug Administration today approved Opdivo (nivolumab) to treat patients with advanced (metastatic) renal cell carcinoma, a form of kidney cancer, who have received a certain type of prior therapy. “Opdivo provides an important therapy option for patients with renal cell carcinoma,” said Richard Pazdur, M.D., director of the Office of Hematology and Oncology Products in the FDA’s Center for Drug Evaluation and Research. “It is one of few therapies that have demonstrated the ability to extend patients’ survival in treating this disease.” Torisel (temsirolimus), approved in 2007, is the only other FDA-approved therapy that has demonstrated overall survival in renal cell cancer.


Renal cell carcinoma is the most common form of kidney cancer in adults and forms in the tissues of the kidney that make urine. The National Cancer Institute estimates 61,560 new cases and 14,080 deaths from kidney and renal pelvis cancer in the United States this year.

“Additionally, Opdivo’s extended indication, from melanoma and non-small cell lung cancer to renal cell cancer, demonstrates how immune therapies can benefit patients across a wide range of tumors,” continued Dr. Pazdur.

Opdivo works by targeting the cellular pathway known as PD-1/PD-L1 (proteins found on the body’s immune cells and some cancer cells). By blocking this pathway, Opdivo may help the body’s immune system fight cancer cells. Opdivo is intended for use in renal cell carcinoma in patients who have received prior anti-angiogenic therapy (treatments that interfere with the blood vessels that contribute to the growth of cancerous cells).

The safety and efficacy of Opdivo for this use were demonstrated in an open-label, randomized study of 821 patients with advanced renal cell carcinoma whose disease worsened during or after treatment with an anti-angiogenic agent. Patients were treated with Opdivo or another type of kidney cancer treatment called everolimus (marketed as Afinitor). Those treated with Opdivo lived an average of 25 months after starting treatment compared to 19.6 months in those treated with Afinitor. This effect was observed regardless of the PD-L1 expression level of patients’ renal cell tumors. Additionally, 21.5 percent of those treated with Opdivo experienced a complete or partial shrinkage of their tumors, which lasted an average of 23 months, compared to 3.9 percent of those taking Afinitor, lasting an average of 13.7 months.

The most common side effects of Opdivo for this use are conditions relating to abnormal weakness or lack of energy (asthenic conditions), cough, nausea, rash, difficulty breathing (dyspnea), diarrhea, constipation, decreased appetite, back pain and joint pain (arthralgia).

Opdivo also has the potential to cause serious side effects that result from the immune system effect of Opdivo (known as “immune-mediated side effects”). These severe immune-mediated side effects involve healthy organs, including the lung, colon, liver, kidneys, hormone-producing glands and the brain.

The FDA granted the Opdivo application a breakthrough therapy designation, fast track designation, and priority review status. These are distinct programs intended to facilitate and expedite the development and review of certain new drugs in light of their potential to benefit patients with serious or life-threatening conditions.

Opdivo is marketed by Bristol-Myers Squibb based in Princeton, New Jersey. Torisel is marketed by Pfizer, based in New York, New York. Afinitor is marketed by Novartis Pharmaceuticals of East Hanover, New Jersey.

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.

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FDA strengthens requirements for surgical mesh for the transvaginal repair of pelvic organ prolapse to address safety risks.

The U.S. Food and Drug Administration today issued two final orders to manufacturers and the public to strengthen the data requirements for surgical mesh to repair pelvic organ prolapse (POP) transvaginally, or through the vagina. The FDA issued one order to reclassify these medical devices from class II, which generally includes moderate-risk devices, to class III, which generally includes high-risk devices, and a second order that requires manufacturers to submit a premarket approval (PMA) application to support the safety and effectiveness of surgical mesh for the transvaginal repair of POP.
The orders will require manufacturers to address safety concerns, including severe pelvic pain and organ perforation, through a rigorous PMA pathway to demonstrate safety and effectiveness. The actions apply only to mesh devices marketed for the transvaginal repair of POP. These orders do not apply to surgical mesh for other indications, like stress urinary incontinence (SUI) or abdominal repair of POP.

“These stronger clinical requirements will help to address the significant risks associated with surgical mesh for repair of pelvic organ prolapse,” said William Maisel, M.D., M.P.H., deputy director of science and chief scientist for the FDA’s Center for Devices and Radiological Health. “We intend to continue monitoring how women with this device are faring months and years after surgery through continued postmarket surveillance measures.”

Surgical mesh has been used by surgeons since the 1950s to repair abdominal hernias; in the 1970s, gynecologists began implanting surgical mesh for the abdominal repair of POP and, in the 1990s, for the transvaginal repair of POP. In 2002, the first mesh device with this indication was cleared for use as a class II moderate-risk device, and there are five manufacturers who are currently marketing this product.

Over the past several years, the FDA has seen a significant increase in the number of reported adverse events associated with the use of surgical mesh for transvaginal POP repair, and an advisory panel of experts recommended in 2011 that more data is needed to establish the safety of the device. The FDA has since taken several actions to warn doctors and patients about the use of surgical mesh for transvaginal POP repair.

Manufacturers of surgical mesh to treat POP transvaginally will have 30 months, as required by federal law, to submit a PMA for devices that are already on the market. Manufacturers of new devices must submit a PMA before those devices can be approved for marketing.

POP occurs when the muscles and tissue of the pelvic floor become stretched, torn or weakened and can no longer support pelvic organs such as the bladder, bowel or uterus; as a result, the organs drop from their normal position and bulge (prolapse) into the vagina. While not a life-threatening condition, women with POP often experience low back pain or pelvic pressure, painful intercourse, constipation or urinary problems such as leakage or a chronic urge to urinate.

Doctors may perform surgery on women with POP who have significant symptoms, often using a minimally invasive transvaginal technique to reduce recuperation time. Surgical mesh may be permanently implanted during this surgery to reinforce the weakened pelvic floor muscles and repair POP, but over the past several years the FDA has received thousands of reports of complications involving the use of mesh for transvaginal POP repair. The most common problems reported include severe pelvic pain, pain during intercourse, infection, bleeding, organ perforation and urinary problems from mesh eroding into surrounding tissues.

To warn doctors and patients about the use of surgical mesh for transvaginal POP repair, the FDA has:

Issued safety communications in 2008 and in 2011 warning doctors and consumers about an increase in adverse event reports related to mesh used for urogynecological procedures;
Convened an advisory panel in September of 2011 to solicit recommendations on actions to take regarding urogynecologic surgical mesh for transvaginal POP repair;
Issued orders to manufacturers in January 2012 to conduct postmarket surveillance studies to address specific safety and effectiveness concerns related to surgical mesh used for transvaginal repair of POP; and
Issued two proposed orders in May 2014 to reclassify the devices from class II to class III and to require manufacturers to submit a PMA application.
Manufacturers may choose to submit a PMA before the 30-month deadline.
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.

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La llamada de wellmed Global Productos / Testimonios y La Llamada de la Oportunidad.

La llamada de wellmed Global Productos / Testimonios y La Llamada de la Oportunidad.
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La llamada de wellmed Global Productos / Testimonios y La Llamada de la Oportunidad.

La llamada de wellmed Global Productos / Testimonios y La Llamada de la Oportunidad.
HOY Miércoles 30 de Septiembre en sus teléfonos a las 9:00 pm hora del este de EEUU.

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“Vivir hasta los 90 con la Energía de los 30”

Conferencia:
“Vivir hasta los 90 con la Energía de los 30”

Beyond The Leader se une al grupo de Profesionales de WELLMED MIAMI para presentar todo acerca de la Ciencia y Tecnología de las Células Madres. Apoyados por la sabiduría y experiencia del Profesor Dr. Luis Romero y Claudio Dieci, quienes nos hablarán sobre la revolucionaria tecnología de los Factores de Crecimiento como reguladores en la reparación y rejuvenecimiento del cuerpo, de manera natural.

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El Jueves 20 de Agosto en el HOTEL ALOFT at Doral tendremos el gusto de recibirlo para nuestro DESAYUNO COMUNITARIO con el Seminario "AYUDA FEDERAL Y ESTATAL PARA LA FAMILIA".

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FDA approves first treatment for sexual desire disorder. - Addyi approved to treat premenopausal women -

The U.S. Food and Drug Administration today approved Addyi (flibanserin) to treat acquired, generalized hypoactive sexual desire disorder (HSDD) in premenopausal women. Prior to Addyi’s approval, there were no FDA-approved treatments for sexual desire disorders in men or women.

“Today’s approval provides women distressed by their low sexual desire with an approved treatment option,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research (CDER). “The FDA strives to protect and advance the health of women, and we are committed to supporting the development of safe and effective treatments for female sexual dysfunction.”

HSDD is characterized by low sexual desire that causes marked distress or interpersonal difficulty and is not due to a co-existing medical or psychiatric condition, problems within the relationship, or the effects of a medication or other drug substance. HSDD is acquired when it develops in a patient who previously had no problems with sexual desire. HSDD is generalized when it occurs regardless of the type of sexual activity, the situation or the sexual partner.

“Because of a potentially serious interaction with alcohol, treatment with Addyi will only be available through certified health care professionals and certified pharmacies,” continued Dr. Woodcock. “Patients and prescribers should fully understand the risks associated with the use of Addyi before considering treatment.”

Addyi can cause severely low blood pressure (hypotension) and loss of consciousness (syncope). These risks are increased and more severe when patients drink alcohol or take Addyi with certain medicines (known as moderate or strong CYP3A4 inhibitors) that interfere with the breakdown of Addyi in the body. Because of the alcohol interaction, the use of alcohol is contraindicated while taking Addyi. Health care professionals must assess the likelihood of the patient reliably abstaining from alcohol before prescribing Addyi.

Addyi is being approved with a risk evaluation and mitigation strategy (REMS), which includes elements to assure safe use (ETASU). The FDA is requiring this REMS because of the increased risk of severe hypotension and syncope due to the interaction between Addyi and alcohol. The REMS requires that prescribers be certified with the REMS program by enrolling and completing training. Certified prescribers must counsel patients using a Patient-Provider Agreement Form about the increased risk of severe hypotension and syncope and about the importance of not drinking alcohol during treatment with Addyi. Additionally, pharmacies must be certified with the REMS program by enrolling and completing training. Certified pharmacies must only dispense Addyi to patients with a prescription from a certified prescriber. Additionally, pharmacists must counsel patients prior to dispensing not to drink alcohol during treatment with Addyi.

Addyi is also being approved with a Boxed Warning to highlight the risks of severe hypotension and syncope in patients who drink alcohol during treatment with Addyi, in those who also use moderate or strong CYP3A4 inhibitors, and in those who have liver impairment. Addyi is contraindicated in these patients. In addition, the FDA is requiring the company that owns Addyi to conduct three well-designed studies in women to better understand the known serious risks of the interaction between Addyi and alcohol.

Addyi is a serotonin 1A receptor agonist and a serotonin 2A receptor antagonist, but the mechanism by which the drug improves sexual desire and related distress is not known. Addyi is taken once daily. It is dosed at bedtime to help decrease the risk of adverse events occurring due to possible hypotension, syncope and central nervous system depression (such as sleepiness and sedation). Patients should discontinue treatment after eight weeks if they do not report an improvement in sexual desire and associated distress.

The effectiveness of the 100 mg bedtime dose of Addyi was evaluated in three 24-week randomized, double-blind, placebo-controlled trials in about 2,400 premenopausal women with acquired, generalized HSDD. The average age of the trial participants was 36 years, with an average duration of HSDD of approximately five years. In these trials, women counted the number of satisfying sexual events, reported sexual desire over the preceding four weeks (scored on a range of 1.2 to 6.0) and reported distress related to low sexual desire (on a range of 0 to 4). On average, treatment with Addyi increased the number of satisfying sexual events by 0.5 to one additional event per month over placebo increased the sexual desire score by 0.3 to 0.4 over placebo, and decreased the distress score related to sexual desire by 0.3 to 0.4 over placebo. Additional analyses explored whether the improvements with Addyi were meaningful to patients, taking into account the effects of treatment seen among those patients who reported feeling much improved or very much improved overall. Across the three trials, about 10 percent more Addyi-treated patients than placebo-treated patients reported meaningful improvements in satisfying sexual events, sexual desire or distress. Addyi has not been shown to enhance sexual performance.

The 100 mg bedtime dose of Addyi has been administered to about 3,000 generally healthy premenopausal women with acquired, generalized HSDD in clinical trials, of whom about 1,700 received treatment for at least six months and 850 received treatment for at least one year.

The most common adverse reactions associated with the use of Addyi are dizziness, somnolence (sleepiness), nausea, fatigue, insomnia and dry mouth.

The FDA has recognized for some time the challenges involved in developing treatments for female sexual dysfunction. The FDA held a public Patient-Focused Drug Development meeting and scientific workshop on female sexual dysfunction on October 27 and October 28, 2014, to solicit perspectives directly from patients about their condition and its impact on daily life, and to discuss the scientific challenges related to developing drugs to treat these disorders. The FDA continues to encourage drug development in this area.

Consumers and health care professionals are encouraged to report adverse reactions from the use of Addyi to the FDA’s MedWatch Adverse Event Reporting program at www.fda.gov/MedWatch or by calling 1-800-FDA-1088.

Addyi is marketed by Sprout Pharmaceuticals, based in Raleigh, North Carolina.

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.

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