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FDA Approvals for 4th Quarter of 2015

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Recently, the following drugs have received approved by the FDA:
Gilead Sciences received approval in November for Genvoya in the treatment of HIV-1 infection.
Those needing management of osteoarthritis pain now have another option in Vivlodex from Iroko Pharmaceuticals.
Aristada from Alkermes received approval for the treatment of schizophrenia.
Those suffering from severe pain may find relief in Belbuca from Endo Pharmaceuticals.
Several new cancer treatments are now available:
Alecensa from Roche has been approved for the treatment of ALK-positive, metastatic non-small cell lung cancer.
Cotellic from Genentech was approved in November for the treatment of BRAF V600E or V600K melanoma.
Janssen Biotech has received approval for Darzalex for the treatment of multiple myeloma.
For the treatment of patients with multiple myeloma who have received prior therapies, Empliciti from Bristol-Myers Squibb has been approved.
Imlygic from Amgen has been approved for the treatment of unresectable recurrent melanoma.
Millennium Pharmaceuticals has been approved for Ninlaro for the treatment of multiple myeloma.
Onivyde from Merrimack has been approved for the treatment of metastatic pancreatic cancer following gemcitabine-based therapy.
A new treatment for metastatic squamous non-small cell lung cancer has been approved: Portrazza from Eli Lilly.
AstraZeneca has been approved for Tagrisso for the treatment of EGFR T790M mutation positive non-small cell lung cancer.
Those suffering from liposarcoma or leiomyosarcoma be find relief in Yondelis by Janssen which as approved in October.
Two new treatments for those with lung disease are now available:
Nucala from GlaxoSmithKline has been approved for the treatment of severe asthma with an eosinophilic phenotype.
For the long-term maintenance treatment of airflow obstruction in patients with COPD, Utibron Neohaler from Novartis has been approved.
 
For more information about these new medications, talk to your doctor for pharmacist to find out more.

Foot Care for Diabetics

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For most people, small foot injuries like calluses or blisters are a minor nuisance. Though they are sore, you know that with a little TLC and some over-the-counter medications, they will usually heal in a short amount of time.  However, if you are diabetic, these small wounds can grow into major problems.
“The average person will unconsciously change the way they walk to minimize that callus forming, because for many people it hurts,” explains Marc House, DPM, a podiatrist at the Podiatry Associates of Indiana, Foot & Ankle Institute in Indianapolis. “With diabetes, you don’t feel it, so you continue to walk on the area.”
Foot facts for diabetics:

  • Diabetes can damage nerves in the feet, so many people with diabetes don’t have normal sensation in their feet.
  • Diabetes can lead to narrowed arteries in the legs, causing poor blood flow to the feet.
  • Minor wounds may heal poorly and become infected as a result of the reduced blood flow.

Every year thousands of lower-limb amputations, including foot removal surgeries, are performed on people with diabetes due to nerve and circulation issues. So, taking care of your feet is extremely important if you’re a diabetic.
Here are some important steps you can take to care for your feet:

  1. Inspect your feet daily. Stay on the lookout for signs of possible trouble such as red spots, blisters, and cuts. If you can’t see the bottoms of your feet, lay a mirror on the floor and use it to inspect your soles. Let your doctor know if you notice any sores or cuts on your feet that don’t heal within a day or two.
  2. Wash your feet every day with mild soap and lukewarm water. Make sure the water isn’t too hot (over 90 degrees F). Pat them dry after washing and be sure to dry between your toes to minimize the risk of fungal infections.
  3. After washing and drying your feet, use lotion or petroleum jelly to keep the skin smooth — but don’t put it between your toes. Non-medicated powder can also help keep your feet dry.
  4. When trimming your nails, but your toenails straight across to help prevent ingrown nails. Be sure to file your toenails, too, so they aren’t sharp on the corners. Consult your doctor to be sure it’s safe for you to cut your own nails.
  5. Never walk barefoot. That goes for inside and outside. Always feel inside your shoes with your fingers before you put them on to make sure a sharp object isn’t hiding inside.
  6. Keep them warm. If your feet get cold, put on warm socks. Avoid using heating pads on your feet — they may burn you.
  7. Get a check-up. Ask a health care provider to check your feet at every visit.
  8. Use a pumice stone. If your doctor says it’s okay, use a pumice stone to treat calluses. Never use a sharp blade on your feet.
  9. Wear the right shoes and socks. Buy shoes that have plenty of support, but are not too tight. Also choose shoes made of material that breathes and look for a cushioned sole to absorb pressure. Also be sure to wear clean, lightly cushioned socks at all times to prevent blisters. Avoid sandals, high heels, flip-flops and shoes with open or pointed toes. Ask your doctor if you need special shoes or inserts that are fitted to your feet.
  10. Control your blood sugar. As with most diabetes complications, you’re less likely to have foot problems if you aggressively manage your blood sugar. Work closely with your doctor to keep your blood sugar under control.
  11. Don’t smoke. You probably already know that smoking is bad for your heart and lungs, but you may not know that it also decreases blood flow to your feet — increasing the risk of sores and infection. Ask your doctor for tips to help you quit.
  12. Wiggle your toes.  And move your feet around many times a day to keep the blood flowing. Avoid standing in one position for a long time or sitting with your legs crossed. These can block blood flow to your feet.

Having diabetes can cause serious damage to your feet, but that doesn’t mean you’re destined to have foot problems. Just be sure to manage your blood sugar wisely, avoid smoking, wear proper shoes, exercise regularly and have your feet checked regularly by your doctor to prevent long-term complications.
 
 

When should you take antibiotics?

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So you’re not feeling well. Maybe you have a sore throat or your sinuses are wreaking havoc in your head? How do you know if you need an antibiotic or if an antihistamine or analgesic is enough?
If you are suffering from the common cold or the flu, an antibiotic will not help you. Antibiotics only work on illnesses caused by bacteria and they are not effective against viruses.
You should consult your doctor if you think you have a bacterial infection. If a physical exam is not enough to determine the cause of your illness, then he or she may also order a blood or urine test to confirm a diagnosis. Once the doctor determines whether an infection, or a simple virus, he or she may prescribe you with an antibiotic.
Be sure to follow the exact instructions for taking the medication. Prescriptions are written to cover the time needed to help your body fight all the harmful bacteria. If you stop your antibiotic early, the bacteria that have not yet been killed can restart an infection.
Don’t think that you can save your medication for one infection and use it for another infection later on. Leftover antibiotics are not a complete dose, and they will not work to kill all your disease causing bacteria. Always talk to your doctor because your symptoms may not be caused by bacteria. If you do have another bacterial infection, a complete dose of the appropriate antibiotic is needed to kill all the harmful bacteria. And the medication prescribed for an earlier infection may not work on a later infection — especially if you only have a partial dose.
How safe are antibiotics?
Antibiotics are generally safe and should always be taken as prescribed by your doctor. However, they may alter the effectiveness of other medications and cause side effects or allergic reactions. If you are experiencing any adverse effect of your medicine, consult your doctor right away.
Antibiotics can kill most of the bacteria in your body that are sensitive to them and that includes good bacteria. By destroying the bacterial balance, it may cause upset stomach, diarrhea, vaginal infections, or other problems.
If you take antibiotics unnecessarily you may contribute to the development of antibiotic resistance. If you become sick and your bacteria are resistant to your prescribed antibiotic, your illness lasts longer and you may have to make return office and pharmacy visits to find the right drug to kill the germ. For more serious infections it is possible that you would need to be hospitalized or could even die if the infection could not be stopped. Also, while the resistant bacteria are still alive, you act as a carrier of these germs, and you could pass them to friends or family members.
How does a doctor decide which antibiotic to prescribe?
Your doctor will examine you and consider all of your symptoms in order to tell if they should prescribe an antibiotic and, if so, which one. Physicians can also take a culture to see if bacteria are causing a particular illness, such as a throat culture to determine if you have strep throat. If the cause of the infection is unclear, but suspected to be due to bacteria, the doctor may prescribe a broad-spectrum antibiotic that is useful for controlling a wide variety of bacterial types. The physician may choose either a generic or name-brand antibiotic depending on your circumstances.
What should women know before taking antibiotics?
Antibiotics often lead to a vaginal yeast infection. Because antibiotics kill the normal bacteria in the vagina, yeast no longer have competition for food and grow rapidly. Yeast cells begin attacking tissues in the vagina, usually causing one or all of the following symptoms: itching, burning, pain during sex and vaginal discharge. If you think you have a yeast infection, consult a physician.
Antibiotics may also reduce the effectiveness of birth control pills.
As with other medications, some antibiotics may be transmitted to a fetus, and some may cause harm. Therefore, you should never take antibiotics without your doctor’s knowledge if you are pregnant or nursing.

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