FDA Approves Development of Drug for Wegener's Granulomatosis

(Weston-Based) and Genentech (California) won an approval from U.S. Food and Drug Administration to develop a drug as a part of a new treatment for Wegener's Granulomatosis and Microscopic Polyangiitis diseases. These are very rare and fatal diseases.

The drug Rituxan (FDA approved) is used to treat rheumatoid arthritis, chronic lymphocytic leukemia and non-Hodgkin’s lymphoma. This drug can now also be used in combination with corticosteroids - to treat two other diseases - Wegener’s Granulomatosis and Microscopic Polyangiitis. These diseases impact small blood vessels of the lungs, kidneys, sinuses and other organs. There are many people in U.S. afflicted with these diseases.

Rituxan can be used as an alternate treatment for the CYC chemotherapy treatment for the diseases. The CYC chemotherapy and Rituxan have shown similar results at six months. Based on study and results FDA has approved Rituxan to be used for the same.

The FDA had alerted in 2006 informing that two patients taking the drug (Rituxan) to treat systemic lupus erthematosus were not approved to use the drug. Both the patients had died due to an infection of the central nervous system known as Progressive multifocal leukoencephalopathy. Treating Systemic lupus erythematosus with the drug is not appoved use of the drug.

In 2010, a man sued Biogen and Genentech, as he suffered an infection which paralyzed him. He said that Rituxan had made him more prone to such infections. He was under the medication for thrombotic thromboctopenic purpura, a blood disease that is very rarely found. Rituxan is not an approved drug for the same.

FDA says TNF blockers can lead to Blood Cancer

A Rare Blood Cancer is on the rise and it stems from the intake of a certain class of inflammatory drug which are used to combat digestive ailments. This form of cancer is found in young patients and the US health experts are quite concerned about it. The FDA had already issued a warning stating that there is a chance of an increased risk of lymphomas and other types of cancers which are usually related to the prolonged use of TNF blockers in adolescents and children. 2 days back, FDA said that blood cancer often affect young adults and adolescents who were on the prescription of TNF blockers. They also said that medicines like azathioprine have this tendency to suppress our body’s immune system. Mercaptopurine, which is used for leukemia was also named by the FDA with potential harmful effects. Blood cancer is also called as Hepatosplenic T-Cell Lymphoma or HSTCL. Remicade and Humira’s product labels have been duly updated. Same goes for Azathioprine and Mercaptopurine. Their respective product labels have been updated as the warnings about HSTCL have been included in them. Most of the cases were seen in patients who were being for Crohn’s disease or ulcerative colitis. It is being said that these TNF Blockers have the ability to suppress the immune system and this maybe hazardous to the patients. When this happens, there would be inflammation and you could be stricken with various immune system related diseases. The FDA are taken proper preventive measures to avoid its spread.

Research based on Generic Drugs, the formation and Key analysis

In Russia and Ukraine, there has been a new study with an objective of researching and analysis information about the Generic Drugs. As they are considered to be a great innovation it is felt there is a need to study and concentrate on this subject.

This new Research named Generic and Innovative Drug Market in Russia and Ukraine 2011 will concentrate on the study and the assessment of the comparative analysis of both Generic and Innovative drugs trends and developments that have been happening in the past few years. Here there is a mutual comparison carried on where their varied attributes are associated and evaluated.

There were varied topics discussed upon. However the significant subjects include identifying the best drugs in the pharmacy industry of Russia and Ukraine, identifying the counterfeit and the fake drugs that are sold as Generics, the name of the key manufacturers over there. The reimbursement and the pricing policies of the generics and the innovative medications will be discussed too. Besides this they would also have to work on their methodology in which the report will be conducted and the synopsis of this study.

The short synopsis included this chief features that includes giving a brief idea about the data and the statistics of the research, the predictions of the future years regarding this industry, policies and programs etc. also there is a need to illustrate the significant points regarding the leading pharmacy industry.

Basically this study might give an enlightening idea about the future prospects of this pharmacy industry.

Congressmen Says “He didn’t have Sex because he was Almost Impotent”

If you are caught on sex romp and wish to bail out of the situation, then blame it on your decreasing libido. Atleast this is what a Congressman is saying to save his face. He is now behind bars of having sex with a prostitute, but he writes from his prison saying that he did not have sex with her and the Justice department is aware of this fact. He is now ready to challenge the authorities and is ready to prove his point by claiming it was impossible for him to have sex with a prostitute because according to him, his prostate surgery had led to severe erectile failures. He says that after the surgery, he was almost impotent even after taking the pills which are used to counter Erectile Dysfunction such as cialis. He claims that even after a year of taking these medications, he was finding it tough to get a normal erection. Apart from that, he was also charged on allegations of bribery in the form of gift acceptance. But he says that they are all just reimbursements. In 2005, he said he is not guilty of charges of mail fraud and tax evasion. If congressmen started to behave in this way, we don’t know what will happen to the country. Defending his sexcapades and sidelining them saying that he was impotent seems quite absurd.

Indications of Coli form bacteria in Semen

Over a period of time, men undergo a semen test. And many come across observing the indications of coli form bacterial in the substance. People are still confused of the impacts this bacteria may make on their health. Some people doubt of developing erectile dysfunction; whereas others fear of developing any other sexual difficulty.

As per the medical practitioners, there are many such cases linking up the connection of these bacteria from infertility. If this is the scenario then the condition can be easily treated using antibiotic treatments to manage impaired semen parameters. According to experts, in men older than 40, Coli form bacteria is a most common organism responsible for developing epididymis. However, the observance of this bacterium in male genitals is pretty common; age plays a major role, as for men younger than 40 the organism is colonized only in the genital areas and is not responsible for causing any sort of infection.

For elderly with large prostates, there are chances of urine left in the bladder after urinating, this helps the bacteria to grow, and this further is responsible for the bacteria to move through the genital tract and cause infections like epididymis.

Men generally don’t have to worry about this organism, only if you are experiencing any sure fire symptoms like urgency while urinating, hesitancy, nocturia, intermittency there is nothing to worry about the observance of this bacteria.

Escalating drug prices, Time to Revise FDA Approval Process?

Few weeks back, Jim Doyle, the reporter of St Louis Post Dispatch came together with a series of compelling accounts on KV Pharmaceuticals. It had got to do with the mystifying economics of the approval by the FDA and with producers of the drug as well. Doyle has presented the whole thing in a very detailed way, mainly in the first and last installments; he gives you an overview about the whole working of the system, so that the people can understand them in a much better way. One of the first stories to be published proclaimed that the rates of one prenatal drug could increase 16 fold and this would be the result of the approval by the FDA. Due to this, the local pharmaceutical company would end up earning tons of money. The second story published is quite an interesting one. It concerns the criticizing of a former chief of the same company by a US District Judge. The Judge condemned him by accusing him of power abuse, greed and being reckless in his handling of the affairs of the firm.

But he concludes his reports with a stern warning. He is of the opinion that there would huge long terms costs involved because of the quick approval by the FDA. These costs could medical as well as the monetary part. So he is indirectly citing that the fast track approvals of the drugs by KV pharmaceuticals might not be a good move and that it could have some serious implications in the future. The rates of the drugs are reaching its zenith, so its time to a timely check.

Bubble gum with high levels of Lead recalled by FDA

With each passing day, we come across companies recalling their products so that it cannot harm humans in anyway. Now we heard that the Food and Drug Administration of the US have decided to recall Toxic Waste Short Circuits Bubble Gum because according to them, it contains elevated amounts of lead that can affect the health of humans. When the amounts of lead are more, it could harm the health of children, infants and women who are pregnant. This bubble gum is being imported from Pakistan and is being marketed by Candy Dynamics. They themselves have asked for its recall. The FDA recently conducted a test on this gum and they found out that the levels of lead in it are 0.189 parts per million and the FDA tolerates only upto 0.1 ppm. Its size is 32 oz and it was distributed from January this year. So far, no illness has come to the light following the usage of the bubble gum. Candy Dynamics are now urging the people to destroy the product by calling at 317-228-5012. This is certainly a good move by the FDA because they want to risk the lives of the people by approving a gum which has a high concentration of lead. This product is being sold at retailers in Michigan and other parts of the US. It is also available in Canada. The bubble gum was imported through mail order. The company manufacturer’s now have some serious thinking to do about the gum. McNeil Called Off Tylenol, Motrin and Zyrtec; Use Generic FDA Pulls back the Medtronic Pump fill