New arthritis drug approved by FDA
Attorney Ronald E. Johnson of Schachter & Hendy concentrates on legal issues regarding medical issues. The New York Times recently reported that the Food and Drug Administration approved a new drug from Johnson and Johnson that fights three forms of arthritis caused by immune-system disorders.
The new medication is called Simponi. It is a follow-up drug to Remicade, also marketed by Johnson & Johnson in the US and Europe, and in other countries by Schering-Plough Corporation, that brought in $5 billion last year.
The new drug can be used for rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, all chronic disorders involving the immune system attacking joints. Simponi is made to be injected under the skin once a month, and given with other drugs that suppress the immune system. It is intended for use in combination with the immunosuppressant drug methotrexate in patients with rheumatoid arthritis. It also may be used with or without methotrexate for psoriatic arthritis and alone in patients with ankylosing spondylitis, a chronic inflammatory arthritis of the spine.
Simponi is in a class of drugs that targets and neutralizes tumor necrosis factor-alpha (TNF-α). This is a protein that, when overproduced in the body due to chronic inflammatory diseases, can cause inflammation and damage to bones, cartilage and tissue. Simponi includes a boxed warning alerting patients and health care professionals to the risk of tuberculosis and invasive fungal infections with use of the drug.
The FDA also required a risk evaluation mitigation strategy (REMS) for Simponi, as it required for other TNF-α blockers. The REMS for Simponi includes a Medication Guide for patients and a communication plan to help prescriber’s understand the drug’s risks. The most common adverse reactions to Simponi include upper respiratory tract infection, sore throat and nasal congestion.
According to the New York Times, Johnson & Johnson and Schering have described the drug as the new standard of so-called tumor necrosis factor blockers, a group of drugs that includes Enbrel from Wyeth and Amgen, and Humira from Abbott Laboratories. Unlike Simponi, those drugs are generally injected once every week or two weeks.
The website, http://arthritis.about.com/od/arthritismedications/a/drug_safety.htm
has safety tips for patients using arthritis. They suggest that it is up to patients to make sure the drugs they use are safe. They should fully understand the prescription after discussing it with both their doctor and their pharmacist. It is important for the medication to be taken on time every day to make sure their work correctly. Patients should talk to their doctors each time they seem them about their medication.
They stress that it is up to the patient to understand new prescriptions and to know the possible side effects. They have 10 safety tips:
1. Become familiar with the name of the medication and write notes on the strength and directions yourself
2. Don't be shy about making the doctor take extra time with you so you understand why you are taking this particular medication
3. Ask the doctor the time frame, how long before you will see improvement
4. Ask for samples of medications
5. List all your medications and the possible side effects and understand how the medications interact with each other
6. In a journal, write down the date, times of day you take your medications, how you feel before and after you take them, and make notes of other pertinent details or questions you have formulated. Show your journal/symptom diary to your doctor at your next appointment.
7. Safely dispose of medications with other toxic substances to protect the environment
8. Always double-check your medication against pharmacy errors
9. Check the FDA website to make sure your medication is safe
10. Patients should be aware of contraindications, meaning some patients should take certain arthritis medications
11. Patients should research the effects of alcohol on their medication
12. In a journal, write down the date, times of day you take your medications, how you feel before and after you take them, and make notes of other pertinent details or questions you have formulated. Show your journal/symptom diary to your doctor at your next appointment.