Archive | Drugs

Pfizer plans to recall 38,000 Lipitor

Pfizer, a New York-based drug maker, said that it plans to recall almost 38,000 Lipitor, a drug used for lowering cholesterol, due to reports of musty odors linked with the product.

Again, the company is extending a recall of 40 milligram tablets that were supplied in the U.S. Pfizer named two reports of consumers of unusual odor linked to Lipitor, which the company said were distributed by the third-party maker.

In addition, the newest occurrence tracks two previous recalls of Lipitor compelled in August and prior this month, which were also connected to complaints of strange odor. Almost 332,000 Lipitor were recalled in those happenings combined.

Moreover, the company concerned that the added recalls may be needed because products produced before it made definite production transforms can still be in the market. The recall continues a series of industrialized-quality difficulties in the drug manufacturing.

On the other hand, Johnson & Johnson has also made a string of recalls of their over the counter medicines last year, including the recalled of Tylenol due to same reports of Lipitor, a musty odors. This week, GlaxoSmithKline PLC agreed to compensate $750 million and appeal guilty to a criminal lawsuit to resolve a government search of making insufficiencies at Puerto Rico’s plant, which supplied contaminated medicines.

Furthermore, Pfizer stated on Friday that the odor is reliable with the existence of a chemical substance called, 2,4,6 tribromoanisole, or TBA, which was found at an extreme low level in a complaint sample of Lipitor all throughout the search that directed to the initial recalled. TBA is used to preserve wood on pallets to transfer and store products. This is also the same chemical that was caught up in the Tylenol recalled of Johnson & Johnson that led to relation with strange odors.

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Another Kidney Cancer Drug Got Conditional Approval from the European Commission

Kidney cancer normally occurs in the lining of tiny tubes inside the kidney. Based on some studies done before, this usually occurs to people who are over 40. Factors such as having genetics conditions, smoking, misusing pain medicines for a long period of time may possibly increase risk factors that leads in having kidney cancer. And as for treating one’s kidney cancer, it will require that person to undergo necessary treatments and drugs depending the patient’s age, overall health status and how advanced the cancer has reached on his system.

And recently, a new kidney cancer drug, GlaxoSmithKline’s Votrient, got the conditional approval of the European Commission on Tuesday, June 15, 2010. According to the company, they are paving their way for the drug’s rollout across the entire European Union.

The move had been anticipated to follow a recommendation coming from the European Medicine Agency in February. They assume that their very own developed drug will be soon cleared for use and act as a first-line treatment for advanced renal cell carcinoma and for those patients who had their cytokine therapy for advanced illness.

As for U.S., Votrient had victoriously got the U.S Food and Drug Administration’s approval in October 2009.

It only shows that the drug is still awaited due to it garnered conditional approval in Europe. Considering Votrient, officials and experts of European Medicines Agency demands to see a citation where it indicates the assessment between the drug and Pfizer’s Sutent.

Votrient or pazopanib, its chemical name, establish an impression as a modest driver for Glaxo for the next few years. It is expected that this drug will garner a global sales of $284 million in 2014. This consensus forecast was made by Thomson Reuters.

Once this drug is approved, it will surely be lined-up with other kidney cancer drugs such as Roche’s Avastin, Pfizer’s Torisel and Sutent, Nexavar of Onyx Pharmaceuticals and Bayer, lastly, the Afinitor of Novartis.

These drugs, including Votrient, target the vascular endothelial growth factor receptor where it tries to limit new blood vessels that feed tumors.

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Newly Approved Cure for Prostate Cancer

Base on the new research conducted by Sanofi-Aventis about their very own chemotherapy drug Jevtana, improves survival chances by 30% in men who have prostate cancer, whose tumors do not respond to any normal method for cure.

Even though Sanofi stated that Jevtana had reached its purpose from the 755-patient text, analysts were still expecting for the details of the presented drug and its effect to the patients.

According to the study leader, Oliver Sartor of Tulane Cancer Center in New Orleans, the clear survival help brought hope to those men who have prostate cancer. These men they are referring are those who are having their standard treatment yet their illness constantly grows.

During the study, partakes were given Jevtana together with the older recommended drug prednisone, and researchers found that the patients survived for about 15.1 months. And as for those patients who were given mitoxantrone and prednisone lived 12.7 months only.

Based on the records, 7.5% patients who took Jevtana reported to have fever with decline in white blood cell count compare to 1.3% of those on mitoxantrone.

After the presentation of the results from the conducted study the company submitted, it remained waiting for approval from the U.S. regulator and submitted data needed for FDA review. According to the company, once this drug is approved, it will inevitably storm the market later this year. Moreover, some analysts say that this newly developed drug will surely get similar price to Taxotere, another cancer medicine, which cost $2,500 per round of treatment.

After a few months of waiting, the U.S. Food and Drug Administration finally approved Jevtana on Thursday, June 17, 2010. This newly approved cancer drug will be used as a chemotherapy drug together with the steroid prednisone to treat men who have prostate cancer.

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Lisette Lee was Arrested in Ohio for Carrying 506 Pounds of Pot

A California woman who is traveling with a bodyguard on a private jet plane was arrested on fort Columbus International Airport in Ohio because of carrying 506 pounds or 230 kg of marijuana hidden in 13 luggage’s, which was revealed by the federal authorities.

The woman recognized as Lisette Lee, her bodyguard and another two private assistants were apprehended on Monday evening following the tip obtained by the Drug Enforcement Administration that this 28-year-old woman was traveling having a questionable amount of suitcases.

The federal authorities stated that after the hired plane landed in Columbus, one of the suspect’s assistants along with her bodyguard assisted the baggage workers unloading few of the suitcases. It took two men to carry a couple of the huge luggage that were compact with bricks of pot, as well as three vehicles to transport the entire luggage, according to the authorities.

The authorities likewise confiscated from her bag three cellular phones, marijuana, cocaine, and drug paraphernalia as well as suspected drug journals showing approximately 300,000 dollars in transactions.

She was charged with conspiracy and illegal drugs possession with the intention to distribute. Lee’s attorneys, Dave Thomas and Bill Meeks and, didn’t quickly send back a message left on Wednesday. Lee was now being held without bail on a Friday court hearing that is still undecided.

DEA agent Anthony Marotta stated that Lee’s bodyguard and her two private assistants were released undecided possible accusations.

She told the investigators that she hired the plane from Van Nuys, California to Columbus to visit her boyfriend and deliver equipment to a horse farm. Lee likewise added that it was already her fourth such travel.

Lee revealed a friend just paid her 60,000 dollars to carry over a dozen luggages from L.A. to Columbus in an isolated hotel room wherein she stay for a couple of days, then bringing back few pieces of suitcases, the authorities confirmed.

She later told the investigators that she along with her escort understood the horse story was false and that they were probably entailed with “weapons and money laundering or something,” which the authorities wrote in court documents.

If she will be convicted, Lisette Lee could face up to forty years imprisonment, and a $2 million fine.

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New Wipes On Market Can Test For A Dozen Drugs

Now, with a new product just introduced, you can simply wipe any item you can touch and perform your own drug test for the presence of of a large variety of well known drugs. The product called the Securetec DrugWipe®, can test for the presence of marijuana, heroin, oxycodone, amphetamines, crystal meth and many other drugs.

Currently available on a limited basis in several areas in the US, the drug wipes are being distributed by certified technicians from the Securetec Corporation. Law enforcement agencies are definitely interested in acquiring this highly portable testing device that is approximately the size of a couple of Q-tips. The manufacturer is claiming a 100% accuracy rating for the Securetec DrugWipe®.

Initial interest seems to be from a broad range of services including health care centers, treatment services and law officers. Early feedback indicates employers are checking their options for using the product in the workplace.

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Amgen Drug a Good Help to avoid Osteoporosis

It is a good thing for women who are in postmenopausal stage to have this Amgen Drug that is fighting for osteoporosis. The Food and Drug Administration has taken their part and they approved the drug on Tuesday. The Amgen’s Drug Prolia will now be allowed to be on sale. This is a good option for women to prevent the occurrence of fractures. It is a good thing that it also got the approval of the European.

This new discovery in science will surely be a good help in the medicine industry. This drug is also known scientifically as denosumab. This is indeed considered as a big help and is one of the important in the future for Amgen. It is said that the FDA already confirmed their decision about the drug in two months before the agency’s expected action date which is July 25.

It is a terrible statistic that one out of every two women who are already over the age of 50 is very prone to break a bone. This is because of the risk they have when it comes to osteoporosis. The research has been done by the National Arthritis and Musculoskeletal and Skin Diseases. Dr. Julie Beitz who is the director of an F.D.A. of drug evaluation said, “Due to its prevalence, osteoporosis is a serious concern to public health.” This should be one of the greatest concerns of the public because of its increasing occurrence. “The approval of Prolia provides another treatment option for postmenopausal women with osteoporosis who are susceptible to fractures.”

Prolia has been trusted because of the study done which is named as pivotal. Prolia has been proven to reduce the problem in fractures especially in vertebral and nonvertebral and hip fractures. This is of course common in postmenopausal women.

The drug Prolia was given by injection once every six months. This will work to decrease the cracking of bones. This is a good thing because this can increase bone mass and will inhibit the proteins so that it won’t destroy the bone-destroying cells.

Expectantly, Thomson Reuters think that the Amgen drug will be a hit and will give a global sale of $3.3 billion in year 2014.

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Antihypertensive Drugs

Hypertension is a disease caused by high blood pressure. Experts say that the novel drug aliskiren can address the limitations of currently available anti-hypertensive drugs. Aliskiren is different from other anti-hypertensive drugs, because it acts at the beginning of the blood pressure-regulating process. This drug is the only high blood pressure medication that inhibits rennin, an enzyme that is secreted by the kidney.
Rennin initiates a process that causes the blood vessels to narrow. When blood vessels narrow, blood pressure increases. When rennin is inhibited, aliskiren helps the blood vessels to relax. When the blood vessels are relaxed, the blood pressure lowers.
When blood pressure is low, the kidney releases rennin that causes the blood vessel to narrow again and this will result in an increase in blood pressure. Some experts claim that when you use the high blood pressure medication aliskiren, you will just increase the possibility of having hypertension. Some of the experts are not convinced of using aliskiren because they are saying that aliskiren will only increase the secretion of rennin due to the lowering of blood pressure. They claim that it will only increase the chance of having hypertension.
More than 85% of the Filipinos with hypertension cannot control their high blood pressure. The survey suggests that more effective anti-hypertension drugs are needed.
Aliskiren is one way of lowering the blood pressure and preventing hypertension.  Patients will not need to go a long road just to lower their blood pressure. Because of the effects of aliskiren, blood pressure easily goes down but it does not permanently regulate the blood pressure. It is just a medication for faster relief and for the prevention of hypertension.
Novartis is trying to provide different kinds of anti-hypertensive medicines for Filipino patients. They are claiming that aliskiren is the most effective medicine that helps lower blood pressure. Many experts believe that with the use of aliskiren, many hypertensive patients can control their high blood pressure and prevent the occurrence of hypertension.

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Food and Drug Administration (FDA) Declines InterMune Drug (ITMN)

The InterMune Inc (ITMN.O) stated that FDA has declined their approval for its drug in treating lung blemishing and requested a new clinical experiment to prove that is works, allowing its shares to decrease at 80%. The new clinical experiment might hold the drug out in the market for years.

InterMune was looking for approval from the Food and Drug Administration for its trial medicine pirfenidone in treating idiopathic pulmonary fibrosis, an unusual critical condition in which the lungs suffer blemishing due to unidentified causes. According to Brian Skorney, ThinkEquity analyst it is really a serious issue for the company and they really need to obtain more details from FDA, however, it seems like it will be a very compelling delay for several years.

The investors had been anticipating the approval after a Untied States panel of professional advisors to the FDA in March had agreed to support the drug in spite some reservations concerning negative effects, allowing InterMune shares to increase at 60% at the time. Nevertheless, Tuesday’s disappointment delivered the share dropping back to $9.45 wherein the committee suggested to approval of the pirfenidone by a 9-3 edge, and according to the Chief Executive Dan Welch, they are upset with the result.

Meanwhile, the company is planning to set an appointment with the FDA as quickly as possible to explain the agency’s worries and opening to be approved. Had it been authorized, pirfenidone that was to be marketed under the recommended brand name Esbriet, might become the first drug in treating idiopathic pulmonary fibrosis, the same condition that killed Hollywood actor Marlon Brando, entertainer Robert Goulet and daredevil Evel Knievel.

Pulmonary fibrosis when not treated triggers difficulty in breathing as well as continues coughing that will become severe over the time, and according to the company, a patient affected with this ailment may just live from 2-5 years. However, approval of pirfenidone is seen as serious to the small biotechnology company, and its one marketed product, Actimmune, has no significant sales.

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Vimovo Drug – Cleared By the Food and Drug Administration (FDA)

The Food and Drug Administration has cleared Vimovo drug for use in treating patients with arthritis. Complimenting on the risk of augmenting stomach ulcers, and this is stated by the agency through an email. Pozen’s shares increased about 21% or $2.30 to $13.15 in lengthy trading time clock base on the Nasdaq Stock Market before being held back.

Vimovo is a fixed mixture of anti-inflammatory drugs naproxen and an instant release version of esomeprazole, an active component in acid reflux treatment Nexium from the London-based AstraZeneca. Both Pozen Inc. as well as AstraZeneca Plc. Won the United States clearance to merchandise this arthritis drug, which is a combination of a painkiller with an ulcer medication. According to Gbola Amusa, an analyst at UBS AG based in London stated in an email that Minovo may produce $500 million in this coming 2014.

Records shows that patients who used Vimovo in two six-month scientific trials augmented fewer ulcers compare to those who used naproxen alone, stated by Pozen, of Chapel Hill in North Carolina in their statement last October 19, 2009. The company that reported a net loss of about $6.9 million in 2009, earned a $10 million payment from AstraZeneca in September following the FDA acknowledgment to review Vimovo, and is now authorized to another $20 million based on the agency’s recommendation. Pozen as well will get royalty payments based on the sales under the companies’ licensing deal.

Yesterday, Eun Yang, an analyst with Jefferies & Co. based in New York stated that the Profit from Vimovo royalties might hit $1.5 million next year and accumulate to $10.9 million in 2013. He added that under this circumstance, Pozen’s calculation might possibly become moneymaking in 2012.

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Adderall Negative Effects

Adderall is a type of drug that manipulates on the brain’s central nervous system. It is applied to command disorders such as narcolepsy (falling asleep unexpectedly) and for hyperactive people.
When using Adderall, it needs a lot of care as well as caution. There are relatively a number of potential negative effects as well as interactions with the use of this medicine. One of consequential risks is in mixing Adderall with an MAO impediment kind of drug. If a person is on any kind of MAO impediment medication, the doctor who is treating the patient should be curious about it, and it is necessary to discontinue the MAO drug about two weeks before beginning any types of therapies with Adderall. If there aren’t enough time mistakes between the MAO drug and starting Adderall, there could precisely have negative effects that could prove very dangerous. Another thing, if a person have overactive thyroid, other cerebral conditions with tension, thickening of the arteries, heart disease or high blood pressure, Adderall might be very threatening to use. It is as well proven that it may trigger death either child or adult, which has a heart condition and uses it.
This type of drug is as well highly addictive. Once a patient begin therapy with Adderall, it is very hard to withdraw from it. Keep in mind that when a physician is recommending this drug, follow the exact guidelines provided with it, and don’t share it with others.  This drug is in fact an amphetamine kind of a drug, and so that makes it habit-forming. Stopping Aderall very sudden may trigger severe heart rhythm agitations and a staggering kind of fatigue.
Adderall being taken by children for hyperactivity can experience troubles concerning their normal growth system, and an underweight problem. Moreover, pregnant women must as well not use this drug because it can trigger premature birth, as well as birth weight that is far beyond low. Adderall isn’t as well safe to use when breastfeeding since it can be transferred to the baby. Although allergic reactions are seldom, however it can happen too. If a person is experiencing trouble breathing, hives as well as tongue swelling, it is very crucial to go to the hospital immediately.

Bring a loved one to a prescription drug abuse treatment center if you see him taking stimulants like Adderall more frequently than what the doctor prescribed.

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