Ustekinumab, a monoclonal antibody, which is a self-injectable biological drug that was given every 3 months, had shown wonderful safety and efficacy results in the phase- III clinical trials on 1,200 patients with chronic plaque psoriasis. Patients with moderate to severe plaque psoriasis received 45 or 90 milligrams of the drug every 4 weeks. This drug achieved 75% reduction in psoriasis just within 12 weeks. The drug may become a first choice of treatment if it shows same results in the long term. These results were announced at the World Congress of Dermatology in Buenos Aires, Argentina. Mechanism of action of Ustekinumab: It is a monoclonal antibody that targets cytokines, interleukin 12 (IL-12) and interleukin 23 (IL-23). It was well tolerated with no significant adverse reactions. This drug significantly reduced the severity of the psoriasis in the study. This drug was developed by Johnson and Johnson. The company is also conducting trials to find its efficiency against gastrointestinal inflammatory disease, Crohns disease.Why Ustekinumab is new hope for psoriasis patients?Most of the current drugs for psoriasis target Tumor Necrosis Factor (anti-TNFs) but Ustekinumab acts against Interleukins. It is more patient compliant than current drugs as it can be taken every 12 weeks. In the trials, it achieved 75% reduction in 70% patients just within 12 weeks. It is definitely a new hope for more than 125 million psoriasis patients all over the world. 25% of these people have moderate to severe psoriasis. The company may apply for regulatory approval of Ustekinumab for psoriasis within 3-4 months. Humira is another psoriasis drug that is waiting for regulatory approval. … [Read more...]
Adverse drug reactions are rising in America
3-fold rise in adverse drug reactions since the FDA began a new reporting system in 1998. Pain killers and immunomodulators are causing more adverse drug reactions. 20% of drugs accounted for 87.1% of adverse effects. These findings are reported in the Archives of Internal Medicine. Moore and his colleagues analyzed the entire serious adverse drug reactions submitted to the FDA through its Adverse Event Reporting System, commonly known as MedWatch reports. Adverse events are those defined as resulting in death, a birth defect, disability, hospitalization or requiring intervention to prevent harm. The number of such events grew from 34,966 in 1998 to 89,842 in 2005. During the same period, the number of deaths rose from 5,519 to 15,105. From 1998 to 2005, the number of prescriptions written each year grew by 25%. Women were involved in 55.5% of the events. A disproportionate share occurred among the elderly -- a full third of events in a group that accounts for 12.6% of the population. Children group is surprisingly reporting fewer drug side effects compared to adults. Top 6 drugs causing deaths: Oxycontin, Fentanyl, morphine, acetaminophen and methadone are the pain killers. The sixth was the antipsychotic drug Clozapine. Appearance of Acetaminophen (over the counter drug) in the list is a concern. Top drugs causing the most non-fatal adverse events: Estrogens, Insulin, interferon beta, Paroxetine, Clozapine, Oxycontin, warfarin and Fentanyl. Paroxetine is an antidepressant, interferon beta is used to treat multiple sclerosis and cancer, and warfarin is an anti-clotting agent. Appearance of Insulin in the list is a serious concern. The study found the two top drugs listed in fatal reports were powerful painkillers oxycodone and fentanyl and were attributed to about 9,000 deaths. Other drugs in a list of top 15 drugs cited in death reports included anti-psychotics and acetaminophen, the active ingredient in over-the-counter pain drugs like Tylenol as well as prescription drugs. Moore also said newer so-called biotech drugs that modify the immune system to diseases like multiple sclerosis, rheumatoid arthritis and Crohn's disease were associated with about 10,000 serious adverse reports, and accounted for about 15% of the rise in overall adverse event reports over the eight-year study period. Most of the drugs carry black-box warnings discussing serious side effects and the possibility of death. The top two drugs with the most reports of non-fatal serious side effects were estrogen-containing products, used in birth-control pills and hormone-replacement therapy, and insulin, a drug used to treat diabetes, the study said. Source: Archives of Internal Medicine. … [Read more...]
