FDA to take final call on smokeless tobacco products

Dissolvable Tobacco products are restricted for kids below 18 years. Tobacco products may have smell like candy bar but they are not for kids, the United States Food and Drug Department highlighted in a conference this week.

Dissolvable tobacco products are available in market, such as mint flavored, stick and strips of fumeless tobacco. These products are relief to those, to whom smoking is restricted. The desire for nicotine to satisfy ones need, Dissolvable tobacco products are made.

Star Scientific Inc., is promoting two new dissolvable tobacco product, namely Ariva and Stonewall. Even R.J. Reynolds Tobacco Co. is going to promote their Camel Strips,Camel Orbs, and Camel Sticks in 2 towns. Health Supporters are fretful about these Tobacco products, children and teens are more likely to it. The nicotine in product is the reason for addiction.

A pediatrician at Massachusetts General Hospital in Boston, Dr. Jonathan Winickoff commented the products look like a candy although, the nicotine levels in it is the cause of addiction in adolescents and adults.

The smokeless tobacco dissolvable products are second very popular cause of nicotine toxin substance in broods. A study showed in Journal Pediatrics, April 2010.

Winickoff also said that if youth is previously consuming cigarettes then there is not a single question arises that youth is not indulging Dissolvable tobacco products. Parents must bother for their kids and prevent then from consuming those nicotine products. Dissolvable products smell like candy or in mint taste it doesn’t mean that they are harmless, they are equally harmful as cigarettes are.

Headaches, diarrhea, vomiting, nausea are the signs of nicotine symptoms, whereas dangerous nicotine toxic substances leads in heart palpitations, involuntary twitching, muscle paralysis and may even cause deaths.

When experimented, 1 milligram of nicotine given to toddler, diarrhea and vomiting takes place. It is found that Camel Dissolvable Tobacco Products contain 0.6mg to 3.1 mg of nicotine, liable to products. A normal typical cigarette contains 1mg of nicotine.

Orbs manufacturer R.J Reynolds commented that major steps are taking place as to cure unintended breakdown of Camel Dissolvable Tobacco Products in youth, and providing instructions to poison management centers regarding probable consequences of unintended consumption.

Tobacco Products must be out of reach from children below and 18 years, is the warning line written on products.

Food and Drug Administration department has all the power to put control over these products, according to 2009 Family Smoking Prevention and Tobacco Control Act. Winickoff stated that FDA will take major steps in controlling these tobacco products among youth.

FDA has approved 1st biologic medication for children with ulcerative colitis (UC)

The U.S. Food and Drug Administration (FDA) has approved Remicade (infliximab) to moderately treat the vigorous ulcerative colitis (UC) in patients younger than six years, and have a insufficient reaction to the unconventional therapy.

There are around 1.4 millions of Americans adults and kids living with inflammatory bowel disease (IBD). Its is said that they are split between ulcerative colitis (UC) and Crohn’s disease. Predictably there are 150000 children below the age of 17 who are living with the symptoms of inflammatory bowel disease (IBD).

Ulcerative colitis (UC) is a kind of inflammatory bowel disease (IBD) that distress the inside layer of the large intestine (colon) and rectum and the cause of ulcerative colitis (UC) is still unidentified. Ulcerative colitis (UC) can affect people for all age group, even thought it is high to be affect at the age of 15-30.

Earlier there was no approved therapy for ulcerative colitis (UC) which is a distressing disease and had an insufficient respond to this conventional therapy. Due to this approval, Remicade (infliximab) represents an unconventional treatment in treating children suffering from inflammatory bowel disease (IBD).

Remicade (infliximab) permit is supported by the proof from a sufficient and well controlled study in young ones suffering from ulcerative colitis (UC). Treating ulcerative colitis (UC) with infliximab, strength 5 mg/kg has clinically responded to the patients in 8 weeks and established a safe profile, with a clinical examination carried out in adults as well.

In small kids all the vaccines should be up to date prior to initiating the medication with infliximab and should avoid receive vaccination while treating with infliximab. Few of the most frequent side effects of infliximab is worsening of ulcerative colitis (UC), respiratory infections, and headache.

FDA to Cancel License Indication of Bevacizumab

Genentech has a new proposal for keeping its licensed indication for bevacizumab (Avastin) in breast cancer.

Genentech has come up with a proposal to maintain license of its medicine Bevancizumab. Genentech wants FDA to maintain breast cancer as licensed indication of Bevancizumab. The drug is brand named as Avastin and is used in treatment of cancer (Metastatic Colorectal Cancer).

US FDA is mulling to cancel the license of the drug for usage in breast cancer treatment. Commissioner of FDA is yet to confirm it.

Despite manufacturer's efforts to convince review team not to revoke the license, members of drug review panel has voted against use of the drug in breast cancer.

In meeting, company addressed many concerns which were expressed by members of panel. Genentech argued that patients suffering from metastatic disease had fewer approved treatments. Manufacturer claimed, in documentation submitted to FDA, Bevacizumab has been found very effective when administered with paclitaxel in patients who are suffering from severe form of metastatic.

With these facts company advocated fast approval of bevacizumab plus paclitaxel subject to supporting research and change in labeled usage if risk factors are addressed.

Genentech sought revised labeling and change in indication of the drug Bevacizumab. According to new proposal, the drug remains in metastatic breast cancer but its usage would be limited in women with severe type of breast cancer such as severe hormone receptor positive breast cancer or triple negative cancer.

Senators Seek Change in FDA's Interest Conflict Rule

A vital amendment is on way. US senators are about to bring change in rule for advisers involve in reviewing new drug approvals. This is because there were lots of cases when FDA could not find experts because of conflicts of interest.

Lawmakers want FDA to loose regulations according to which advisers are not allowed to review new drug application if the respective person is financially associated with manufacturers. Current regulation makes it hard to find experts to be hired on review panel.

FDA is largely funded by fees taken from manufacturer of drug who are seeking FDA approval to make drug available in market. Hence, FDA's funding bill is a way to make major changes in the way FDA work.

Issue was raised by Mike Enzi and Al Franken, senators from Republican and Democratic party respectively.

FDA has to postpone meeting of drug-review committee while finding adviser without any conflicts. Expert doctors are already recruited by manufacturers as consultant and rule prevents FDA to hire same doctor in advisory panel.

FDA in May reported 23% vacant position in advisory panel.

Although FDA is free to avoid recommendations from advisor, it usually follows.

In the wake of Vioxx pain drug controversy, FDA made regulatory changes which restricted appointment of a person with financial ties fearing impact on one's view.

There are currently 10 panelists in FDA advisory panel who were also consulted by drug manufacturers. 9 panelists recommended bringing a drug in market which was called back in 2004.

Hamburg, FDA Commissioner, is also in favour of relaxed rule.

FDA Proposes New Rule for Targeted Treatment

As per new policy, targeted therapies seeking for FDA approval would also require approval for devices the therapy is performed with.

Pharma companies are developing more targeted treatments designed according to patients' genetic structure. Manufacturers of such treatments would have to get the device reviewed if the new proposed amendment come into effect.

Before giving approval to the medicine/therapy, FDA wants to test the device used in therapies. With that being said, therapy as well as device both would require clearance certificate from FDA.

Medicines that are targeted for specific patients only, are prescribed after a diagnostic test. Efficacy of the treatment is determined by studying genetic structure of a patient. After a thorough study physicians determine whether the therapy is fit to the patient or not. Such pre-tests are known as companion diagnostics (or targeted medicines).

One such drug in review is lung cancer drug Crizotinib of Pfizer. This drug targets genetic mutaion found in non-smokers with lung cancer of type NSCLC. Pre-test for the drug has been developed by Abbott.

However, new proposed rule has two exceptional situations where a medicine and its companion test can get approval without FDA. Medicine and its diagnostic test may get auto-approval either a disease is life threatening and no other treatment is found or benefits of the treatment is far more than the risk.

For the first time FDA approves a drug for treating Melanoma

Till this date the pharmacy and medical science have failed in delivering a medication that could cure Melanoma. Whatever drug was presented to treat this disorder, it was seen that they were somewhere below the standards of FDA (Food And Drug Administration). Dr. Richard Pazdur who is the director of the Office of Oncology products for drug evaluation and research in the department of the FDA (Food And Drug Administration). On the other hand, Melanoma is posing an increasing threat. The latest statistics reveal that Melanoma is rising since 2010. Especially in U.S around 8300 men have died due to this disorder. This research was carried out by the National Cancer Institute. Melanoma is fatal and can the last stage of this can be extremely dangerous as there are hardly any medication capable of treating it. By proving to be the first FDA approved drug to treat Melanoma effectively, this medication has truly won hearts of many. Here the melanoma tumors are attacked skillfully. To check its effectiveness, there was an international study conducted where around 676 patients were studied. The conclusion of the research clearly stated that Yervoy could surely postpone the threat caused by Melanoma when taken in combination with other therapy. However there might be adverse effects associated with this disorder that has to be made aware to the patients who might consume this drug. For this purpose, there will be a guide that will talk about all the necessary facts that the consumer has to be made aware of before the ingestion.

Lupus nephritis to be cured by a FDA approved drug

For the first time in 50 years, there is a medication that has been a medication that has been approved by FDA (Food And Drug Administration) for treating Lupus Nephritis. This kidney disorder is a form of systemic lupus systemic lupus erythematosus. Here the immune system is attacked as it is affected.

Till this time, the medications were not being approved as they used to restrain the functions of immune system. When the immune system was affected, it indirectly made the patients suffer from other worse health problems owing to heir weak immunity.

Benlysta was the injectable drug that could cure the disorder without lowering the immunity as it would only try to combat the hyperactive immune system. This is what Dr. Mary Anne Dooley from the University of North Carolina said supporting the FDA approval. However FDA feels that it has not been very beneficial for African Americans and is further into research and studying about this to find a proper medication to cure this disorder in them that might be effectual for them.

Till this time it has been difficult to diagnose and correct this disorder. So, with the innovation of this medication, it has been possible for those suffering from Lupus Nephritis as till this time there was no right medication that could cure it without affecting the body with its adverse effects. Now there is a ray of hope can be seen in those patients who have been desperately and in their diseased condition waiting for a remedy.