Kybella (deoxycholic acid) is a cytolytic drug indicated to improve the appearance of fullness associated with submental fat (double chin).




Kybella is a synthetic form of deoxycholic acid, a molecule that occurs naturally in the body to aid in the breakdown and absorption of dietary fat.



The U.S. Food and Drug Administration (FDA) has approved Kybella (deoxycholic acid), an injectable cytolytic drug indicated to improve the appearance of fullness associated with submental fat, commonly called "double chin." It is the first and only approved non-surgical treatment for this condition.



What is Kybella?


Kybella is a prescription medicine used in adults to improve the appearance and profile of moderate to severe fat below the chin (submental fat), also called "double chin."



It is not known if this medicine is safe and effective in children less than 18 years of age.



It is not known if it is safe and effective for use outside of the submental area.




Kybella side effects


Kybella can cause serious side effects, including:



Nerve injury in the jaw that can cause an uneven smile or facial muscle weakness



Trouble swallowing



The most common side effects include: swelling, bruising, pain, numbness, redness, and areas of hardness in the treatment area.



This is not a complete list of all the possible side effects. Call your healthcare provider for medical advice about side effects.



How will I receive Kybella?



Kybella is injected into the fat under your chin by your healthcare provider.



The injections will be given at least one month apart. You and your healthcare provider will decide how many treatments you need.



What are the ingredients in Kybella?



Active ingredient: deoxycholic acid



Inactive ingredients: benzyl alcohol, dibasic sodium phosphate, hydrochloric acid, sodium chloride, sodium hydroxide and water for injection, USP.


Jadenu (deferasirox) とは

Jadenu (deferasirox) is a tablet formulation of Exjade, an iron chelator indicated for the treatment of chronic iron overload due to blood transfusions in patients 2 years of age and older.


Jadenu (デフェラシドックス)はエクスジェイドの錠剤であり、2歳以上の患者を対象に、輸血を原因とした慢性の鉄過剰症の治療に用いる鉄キレート化剤である。


What is deferasirox?


Deferasirox binds to iron and removes it from the blood stream.


Deferasirox is used to treat iron overload caused by blood transfusions in adults and children at least 2 years old.


Deferasirox is also used to treat chronic iron overload syndrome caused by a genetic blood disorder in adults and children who are at least 10 years old.


Deferasirox may also be used for purposes not listed in this medication guide.



What is the most important information I should know about deferasirox?



You should not use this medicine if you have severe kidney disease, advanced cancer, a blood cell or bone marrow disorder, or low levels of platelets in your blood.



Deferasirox can harm your liver or kidneys. Stop using deferasirox and call your doctor at once if you have swelling, rapid weight gain, shortness of breath, pain in your upper stomach, loss of appetite, pain in your side or lower back, little or no urinating, dark urine, clay-colored stools, or jaundice (of the skin or eyes).



Deferasirox may also cause stomach or intestinal bleeding. Call your doctor at once if you have symptoms of stomach bleeding such as bloody or tarry stools, or coughing up blood or vomit that looks like coffee grounds.



While using deferasirox, you may need frequent blood tests and you may need a liver biopsy.


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What is albuterol inhalation?


Albuterol is a bronchodilator that relaxes muscles in the airways and increases air flow to the lungs.


Albuterol inhalation is used to treat or prevent bronchospasm in people with reversible obstructive airway disease. Albuterol is also used to prevent exercise-induced bronchospasm.


Albuterol inhalation may also be used for purposes not listed in this medication guide.



Albuterol inhalation side effects


Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.


Call your doctor at once if you have a serious side effect such as:


· bronchospasm (wheezing, chest tightness, trouble breathing), especially after starting a new canister of this medicine;

· とくに新しい吸入装置で開始した後における気管支痙攣(喘鳴、胸部の圧迫感、呼吸困難)

· chest pain and fast, pounding, or uneven heart beats;

· 胸痛と心拍数の増加、動悸、不整脈

· tremor, nervousness;

· 振戦、焦燥感

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.





What is glatiramer?


Glatiramer is a combination of four amino acids (proteins) that affect the immune system.


Glatiramer is used to treat multiple sclerosis (MS) and to prevent relapse of MS.


Glatiramer will not cure MS, but it can make relapses occur less often.


Glatiramer may also be used for purposes not listed in this medication guide.


What is the most important information I should know about glatiramer?


Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.


What should I discuss with my healthcare provider before using glatiramer?


You should not use this medication if you are allergic to glatiramer or to mannitol.


To make sure glatiramer is safe for you, tell your doctor about your other medical conditions.


FDA pregnancy category B. Glatiramer is not expected to harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment.


It is not known whether glatiramer passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.


How should I use glatiramer?


Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.


Glatiramer is injected under the skin. You may be shown how to use injections at home. Do not self-inject this medicine if you do not understand how to give the injection and properly dispose of used needles and syringes.


This medicine comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.


Wash and dry your hands before preparing the syringe and giving the injection.


Use a different place on your body each time you give yourself an injection. Your doctor will show you the places on your body where you can safely inject the medication. Do not inject glatiramer into the same place two times within 1 week.


Glatiramer prefilled syringes are for a single use only. Throw away the vials or syringes after each injection.


Store the prefilled syringes and vials (bottles) of glatiramer in the refrigerator. Do not allow the medicine to freeze.


Before using the prefilled syringe, take it out of the refrigerator and let it warm at room temperature for 20 minutes. Do not warm the medication in a microwave or hot water. Do not remove air bubbles from the prefilled syringe or you may accidentally remove a small amount of the medicine.

充填済みシリンジを使用する前に、冷蔵庫から取り出して室温で20分間温めます。電子レンジや熱湯で温めないようにしてください。充填済みシリンジから 気泡を取り除いたり、誤って薬剤の少量を取り除いたりしないでください。

You may also store glatiramer at room temperature, away from moisture, light, and high heat.Glatiramer will keep for up to 30 days if stored at room temperature. Throw away any unused glatiramer that has been at room temperature for longer than 30 days.


Do not use glatiramer if it has changed colors or has particles in it. Call your pharmacist for new medication.




April 15, 2015 -- The U.S. Food and Drug Administration today approved Corlanor (ivabradine) to reduce hospitalization from worsening heart failure.

201545日、FDAは心不全の悪化による入院を減らす薬剤として、Corlanor (ivabradine)を承認しました。

Corlanor is approved for use in certain people who have long-lasting (chronic) heart failure caused by the lower-left part of their heart not contracting well. The drug is indicated for patients who have symptoms of heart failure that are stable, a normal heartbeat with a resting heart rate of at least 70 beats per minute and are also taking beta blockers at the highest dose they can tolerate.



Heart failure is a common condition affecting about 5.1 million people in the United States. It is a condition in which the heart can't pump enough blood to meet the body's needs. Heart failure develops over time as the heart's pumping action grows weaker. The leading causes of heart failure are diseases that damage the heart, such as coronary heart disease and high blood pressure.



“Heart failure is a leading cause of death and disability in adults,” said Norman Stockbridge,M.D., Ph.D., director of the Division of Cardiovascular and Renal Products in the FDA’s Center for Drug Evaluation and Research. “Corlanor is thought to work by decreasing heart rate and represents the first approved product in this drug class.”

「心不全は成人の死亡の障害の主要原因である」とFDANorman Stockbridge氏は 述べます。「Corlanorは心拍数を減らすことで効果を発揮すると考えられており、この薬剤クラスで初の承認薬となる」

Corlanor was reviewed under the FDA’s priority review program, which provides for an expedited review of drugs that are intended to treat a serious disease or condition and may provide a significant improvement over available therapy. It was also granted fast track designation, which helps facilitate the development and expedite the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need. For products that have been designated as fast track, FDA may review portions of a marketing application on a rolling basis.

CorlanorFDAの優先審査プログラム化で審査されました。このプログラムの対象は、重度の疾患や状態を治療するもので、 さらに既存の医薬品に比べて有意な改善をもたらす薬剤です。また、ファスト・トラック指定も認められました。これは満たされていない医療ニーズや生命を脅かす重篤症状を適応症とする薬剤の開発と審査を促進するためのものです。ファスト・トラック指定を受けた製品に関しては、FDAが原則に基づいて販売申請の一部を審査することがあります。


The safety and efficacy of Corlanor was studied in a clinical trial of 6,505 participants. Corlanor reduced the time to first occurrence of hospitalization for worsening heart failure compared to an inactive drug (placebo).



The most common side effects observed in clinical trial participants were too much slowing of the heart rate (bradycardia), high blood pressure (hypertension), atrial fibrillation, and temporary vision disturbance (flashes of light).


Corlanor will be dispensed with a patient Medication Guide that provides instructions for its use and important drug safety information. Health care professionals should counsel patients about the risk of harm to an unborn baby, and women should not become pregnant while taking Corlanor.


Patients should alert their health care professional if they experience symptoms of an irregular heartbeat, feel that the heart is pounding or racing, have chest pressure, or worsened shortness of breath. Low heart rate is a common side effect of Corlanor and can be serious. Patients should tell their health care professional if they have symptoms such as dizziness, weakness or fatigue.



Corlanor is made by Amgen, based in Thousand Oaks, California.



情報源: 米国食品医薬品局(FDA)


The human intestine, colonized by a dense community of resident microbes, is a frequent target of bacterial pathogens. Undisturbed, this intestinal microbiota provides protection from bacterial infections.
Conversely, disruption of the microbiota with oral antibiotics often precedes the emergence of several enteric pathogens1.
How pathogens capitalize upon the failure of microbiota-afforded protection is largely unknown.
抗生物質関連の病原菌であるSalmonella enterica serovar Typhimurium (S. typhimurium)とClostridium difficileは、腸内で増殖エネルギーを得るために粘膜の糖質成分を異化します。
Here we show that two antibiotic-associated pathogens, Salmonella enterica serovar Typhimurium (S. typhimurium) and Clostridium difficile, use a common strategy of catabolizing microbiota-liberated mucosal carbohydrates during their expansion within the gut.
S. typhimuriumは腸管内腔内のフコースやシアル酸に接近し、各異化経路の遺伝子除去によってin vivoで微生物相の競争力を低下させます。
S. typhimurium accesses fucose and sialic acid within the lumen of the gut in a microbiota-dependent manner, and genetic ablation of the respective catabolic pathways reduces its competitiveness in vivo.
同様に、C. difficileの増殖能は、in vivoにおけるシアル酸濃度の上昇によってさらに増強します。シアリダーゼ不足のBacteroides thetaiotaomicron変異体(腸内共生のモデル生物)を定着させたノトバイオートのマウスでは遊離シアル酸濃度が低下した結果、C. difficileはシアル酸異化経路をダウンレギュレートし、増殖速度を低下させた。
Similarly, C. difficile expansion is aided by microbiota-induced elevation of sialic acid levels in vivo. Colonization of gnotobiotic mice with a sialidase-deficient mutant of Bacteroides thetaiotaomicron, a model gut symbiont, reduces free sialic acid levels resulting in C. difficile downregulating its sialic acid catabolic pathway and exhibiting impaired expansion.
These data show that antibiotic-induced disruption of the resident microbiota and subsequent alteration in mucosal carbohydrate availability are exploited by these two distantly related enteric pathogens in a similar manner. This insight suggests new therapeutic approaches for preventing diseases caused by antibiotic-associated pathogens.


The Food and Drug Administration (FDA) approved the first retinal implant for use in the United States. The FDA’s green light for Second Sight’s Argus II Retinal Prosthesis System gives hope to those blinded by a rare genetic eye condition called advanced retinitis pigmentosa, which damages the light-sensitive cells that line the retina.


For Second Sight, FDA approval follows more than 20 years of development, two clinical trials and more than $200 million in funding. The Argus II has been approved for use in Europe since 2011 and implanted in 30 clinical-trial patients since 2007. The FDA’s Ophthalmic Devices Advisory Panel in September 2012 voted unanimously to recommend approval.

セコンドサイト社にとってこのFDA承認は、20年以上の開発と2件の臨床試験、そして2億ドル以上の資金援助を経て獲得したものです。欧州ではアーガスⅡの使用が2011年に認められ、2007年以降臨床試験で30名の患者に移植が行われてきました。20129月に開催されたFDAOphthalmic Devices Advisory Panel(眼科用医療機器諮問委員会)では、承認の推奨が全会一致で支持されています。

The Argus II includes a small video camera, a transmitter mounted on a pair of eyeglasses, a video processing unit and a 60-electrode implanted retinal prosthesis that replaces the function of degenerated cells in the retina, the membrane lining the inside of the eye. Although it does not fully restore vision, this setup can improve a patient’s ability to perceive images and movement, using the video processing unit to transform images from the video camera into electronic data that is wirelessly transmitted to the retinal prosthesis.




Feb. 7, 2013 -- Eli Lilly and Company announced today that it will discontinue the Phase 3 rheumatoid arthritis (RA) program for tabalumab, an anti-BAFF (B cell activating factor) monoclonal antibody, due to lack of efficacy. The decision was not based on safety concerns. The tabalumab Phase 3 program for systemic lupus erythematosus is ongoing and will continue as planned.


イーライリリー・アンド・カンパニーは7日、関節リウマチに対する抗BAFF(B細胞活性化因子)モノクローナル抗体「tabalumab」の効果が不十分であることから、その第三相試験計画を中止することを発表しました。 この決定は安全性の懸念に基づくものではありません。全身性エリテマーデスを適応症としたtabalumabの第三相試験は継続中であり、今後も予定通り進行します。


In December 2012, Lilly discontinued the Phase 3 RA registration study FLEX-M for lack of treatment effect. FLEX-M was investigating tabalumab in patients with moderate-to-severe RA who had an inadequate response to methotrexate therapy.




Based on FLEX-M findings, an interim futility analysis was conducted of the FLEX-V study, which was investigating tabalumab for the treatment of patients with moderate-to-severe RA who had an inadequate response to tumor necrosis factor (TNF) inhibitors.





From Associated Press (January 30, 2013)




Drug developer Isis Pharmaceuticals Inc. and partner Genzyme announced Tuesday that the U.S. Food and Drug Administration has approved their new drug application for Kynamro, clearing the way for Isis’first drug to reach market.


薬剤開発企業のアイシスファーマシューティカル社(Isis Pharmaceutical)とその提携企業のジェンザイム社は火曜、食品医薬品局が「Kynamro」の新薬申請を承認したと発表しました。これによりアイシス社初の医薬品が市場に出回ることになります。


Kynamro is an injectable drug designed to treat patients who are genetically predisposed to have high levels of LDL cholesterol. The drug has been approved for use as an adjunct to lipid-lowering medications and diet for patients with homozygous familial hypercholesterolemia.




HoFH is a rare inherited condition that makes the body unable to remove LDL cholesterol from the blood, causing abnormally high levels of circulating LDL cholesterol. In the United States, HoFH occurs in about one in one million individuals, according to the company.




Approval of the drug was not certain in the past. There were questions about its links to cancer. But the companies said in October that an advisory panel to the FDA decided there was sufficient data on the drug’s safety and effectiveness to allow sales of Kynamro.


The companies said Tuesday that the drug may cause serious side effects, including liver problems.






TUESDAY Jan. 29, 2013 -- People taking certain antidepressants, including Celexa and Lexapro, may have a slightly increased risk of developing an abnormal heart beat.


Researchers say the drugs, which are in a class of medications called selective serotonin reuptake inhibitors (SSRIs), may extend the length of electrical activity in the heart, called a QT interval. A long QT interval is an indicator of abnormal heart rhythms.


"For people who are taking higher doses of citalopram (Celexa) or escitalopram (Lexapro), they should discuss these doses with their doctors," said lead researcher Dr. Roy Perlis, director of the Center for Experimental Drugs and Diagnostics in the psychiatry department at Massachusetts General Hospital in Boston.

「高用量のシタロプラム(セレクサ)やエスシタロプラム(レクサプロ)を服用している患者は、その用量について医師と話し合う必要がある」と、ボストンのマサチューセッツ中央病院精神科実験的薬剤および診断センターのRoy Perlis研究長は話している。

The report was published in the Jan. 29 online edition of the journal BMJ.


Doctors use an electrocardiogram (ECG) to measure the QT interval. The interval varies with heart rate, lengthening when the heart beats slower and shortening when the heart beats faster.


The normal QT interval for men is less than 420 milliseconds and for women it is less than 440 milliseconds. When the timing gets longer, the risk for abnormal heart rhythms increases, the researchers noted.


The U.S. Food and Drug Administration warned recently that Celexa and drugs like it could cause this problem.