February 21, 2016
The FDA has approved Transformative advances in drug treatments for the treatment of chronic hepatitis C for the estimated 3.2 million Americans that have the disease so they can lead a longer and a healthier life. This is good news for baby boomers and they make op three out of four adults that have the hepatitis C virus. There are also millions of Americans that have the virus, but don’t know it yet.
Hepatitis C is curable and there are drug therapies today that are easier and effective for patients to take. Deputy Director of the Division of Antiviral Products in FDA’s Center for Drug Evaluation and Research Jeffrey S. Murray, M.D is an internist with a specialty in infectious diseases and says that new drugs are working well for Hepatitis C.
Curable and Preventable Disease
Hepatitis is an inflammation of the liver and it refers to a group of viral infections which impact the liver. The common types are A, B, and C hepatitis and each is caused by a different virus.
The most common chronic blood-borne infection in the U.S., is hepatitis C. The disease doesn’t have a vaccine, but it can be prevented by avoiding risky behaviors that spread the disease like sharing syringes, needles or other drug injection equipment.
If you were diagnosed with hepatitis C in the past it meant that you faced many months of painful injections. Today, there have been new strides in science and alternative therapies.
The interferon-based injections make those that take them ill and they have flulike symptoms says Murray. The interferon lasts about six months to a year, but only cures about 40% to 50% of those with hepatitis C.
Patients with advanced liver disease couldn’t take traditional treatments because it would make them sick. Patients today with hepatitis C, can use pill combinations that have a high cure rate and work faster than older injections.
The pills today have 90%-100% viral cure rates in about 12 weeks’ time. This reduces the treatment to three months down from a year. It’s also much easier for hepatitis C patients to swallow a pill than to take a pain injection.
New regimes for hepatitis C include Sovaldi (sofosbuvir), which is the first approved drug to treat various types of hepatitis C without the need for any co-administration of interferon. The FDA has approved three protease inhibitors in recent years called Victrelis (boceprevir), Olysio (simeprevir), and Incivek (telaprevir) for the treatment of hepatitis C. Olysio is a protease inhibitor which blocks a protein that is required by hepatitis C to replicate itself. This drug is a component of combination treatments for hepatitis C.
The FDA provides information and gives notice of public events where you have opportunities to comment on policies, issues, and attend upcoming advisory committee meetings for people that have hepatitis C or B.
February 14, 2016
Arthritis is often referred to an old age disease, but this isn’t necessarily the case.
One of the most common chronic diseases that impact children is juvenile arthritis. It’s estimated that there are around 300,000 young people that are diagnosed with the disease. Common symptoms of the disease are tenderness, inflammation, joint pain, as well as joint stiffness. Limping in the morning may be an early sign of the condition.
At the FDA, Nikolay Nikolov is a clinical team leader and a rheumatologist he indicates that parents and children with juvenile arthritis have good reason to have optimism. In recent years there has been new therapies developed by drug companies and approval given by the FDA the help to control and moderate the condition. This helps prevent significant problems and disability in later years.
No one knows the exact causes of juvenile arthritis as it’s an autoimmune disorder. The immune system usually helps the body fight infection, but in the case of arthritis, it attacks the tissues.
Juvenile arthritis has several subgroups which are called Juvenile Idiopathic Arthritis (JIA). These start before the age of 16 and can cause swelling in one or more joints which lasts around six weeks. JIA impacts the knees, ankles, wrists, and other joints of the body. The largest group is called Polyarticular JIA and it impacts many joints. Systemic JIA is another subgroup and it impacts the entire body and cases skin rashes and fever in many cases.
In the past, children were treated with non-steroidal anti-inflammatory drugs (NSAIDs) for inflammation and pain relief using products like aspirin or ibuprofen. Children that have severe juvenile arthritis are treated with drugs which suppress the immune system of the body. Common products used for this are methotrexate and corticosteroids.
Now systemic JIA and Polyarticular JIA are treated with new medications which are called biologics. These are extracted or manufactured from biological sources.
The New Treatments for Juvenile Arthritis
Nikolov says that as our science has advanced at the molecular level, we ae learning more about what drives arthritis and we are able to identify important targets.
Targets include molecules that control and drive inflammation in the body which are called cytokines. These include interleukins (IL), tumor necrosis factor (TNF), and other proteins which occur naturally and work to stimulate the immune response in the body. The biologics used in treating juvenile arthritis are given subcutaneously (under the skin) or intravenously over a period of years. Different biologics work better for the subgroups of juvenile arthritis.
There’s no long-term safety information for the use of these drugs in children, but we have significant experience using them in adults that have RA. The Biologics are used to treat juvenile arthritis are potent drugs which suppress the immune system and can raise risks of opportunistic (unusual) infections, regular infections, and tuberculosis.
When a drug is found to benefit adults with RA in large clinical trials it may be studied by drug manufacturers to see if children with juvenile arthritis may benefit from the drug. The FDA considers the potential and known risks of a drug to determine is the benefits of using that drug outweigh the risks for children with juvenile arthritis.
February 6, 2016
Hyperhidrosis, or excessive sweating, is a common disorder which produces a lot of unhappiness. An estimated 2-3% of Americans suffer from excessive sweating of the underarms (axillary hyperhidrosis) or of the palms and soles of the feet (palmoplantar hyperhidrosis). Underarm problems tend to start in late adolescence, while palm and sole sweating often begins earlier, around the age 13 (on the average). Untreated, these problems may continue throughout life.
Sweating is embarrassing, it stains clothes, ruins romance, and complicates business and social interactions. Severe cases can have serious practical consequences as well, making it hard for people who suffer from it to hold a pen, grip a car steering wheel, or shake hands.
If you just sweat more than other people when it’s hot or you’re exerting yourself, that’s not usually a sign of trouble. Sweating is a normal reaction when your body’s working harder and needs to cool itself down.
Hyperhidrosis doesn’t usually pose a serious threat to your health, but it can sometimes lead to physical and emotional problems.
Excessive sweating increases the risk of developing fungal infections, particularly on the feet – most commonly fungal nail infections and athlete’s foot. The emotional impact of living with hyperhidrosis can be severe. Many people with the condition feel unhappy and, in some cases, depressed.
Through a systematic evaluation of causes and triggers of hyperhidrosis, followed by a judicious, stepwise approach to hyperhidrosis treatment, many people with this annoying disorder can sometimes achieve good results and improved quality of life.