The recalled drugs were manufactured at the company’s plant in Fort Washington, reports a www.myfoxphilly.com article. Federal officials are saying that the “adverse events” and side effects do seem to be connected to the recall. McNeil is a division of Johnson & Johnson.

All drugs have some side effect or another. However, a defective or contaminated drug can potentially create severe reactions that may lead to fatality. Victims who have been seriously injured as a result of a drug manufacturing defect, design flaw, or inaccurate warning label may be able to receive compensation for their losses. Product liability attorneys in Philadelphia strive to protect consumer rights in defective product or dangerous drug cases.

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Glaxo reportedly faced about 13,000 claims for damages involving Avandia out of which 700 cases were settled in May for $60 million and about 5,000 were consolidated in Philadelphia. Damages in those cases could have added up to $6 billion. Despite the lawsuits piling up, Glaxo has consistently defended the safety record of Avandia. The company has maintained that it acted properly in conveying the drug’s potential cardiovascular risks to federal regulators and physicians.

Defective drugs in Philadelphia can cause catastrophic injuries or even deaths. Patients take prescription drugs with the hope that it will improve their health. Often, that is the case. However, there are times when pharmaceutical companies put a drug, which is not properly tested, on the market. It is the consumer, as we have repeatedly seen, who pays the ultimate price for big corporations’ mistakes.

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The most recent FDA recall involves Sagent Pharmaceuticals’ metronidazole injection, USP 500mg / 100mL, manufactured by Claris Lifesciences and distributed by Sagent. The recall follows the discovery of non-sterility in two lots of metronidazole injection. This product defect involving the contamination of the antimicrobial drug that is administered intravenously to patients has the potential to result in infections. Based on a US Recall News report, the infections, in turn, could be lethal particularly in patients with compromised immune systems.

It is well-known that almost all drugs have potential side effects. But when serious injuries or fatalities occur as the result of negligence on the part of the drug manufacturer, injured victims or their families have a right to compensation and may want to contact a skilled Philadelphia, PA product liability attorney.

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According to the Nature Publishing Group, the FDA is scheduled to make a decision regarding Provenge’s approval by May 1. Interestingly, some vaccines have received license to be used in other countries; however, no vaccines have been allowed on the U.S. market. Based on the article, a university of Pittsburgh School of Medicine immunologist stated that an FDA-approved vaccine “would legitimize the field” and provide prospective new treatment for male patients with highly developed prostate cancer.

The functionality of Provenge relies on being custom-made for each particular patient by harvesting one of his immune cells and exposing them to a cancer-related protein called prostatic acid phosphatase. When the vaccine is given to the patient, the exposed cells are supposed to initiate an immune assault on tumor cells.

For officials, consumers and vaccine injury lawyers who may be questioning the safety of the vaccine, others hope that Provenge will help lower the amount of prostate cancer deaths, which amounted to over 28,000 men in the United States in 2008, according to the article. One of the main concerns with any new vaccine or drug is making sure that it will not create any potential or new health problems due to an undetected manufacturing or design flaw. Similarly, manufacturers are responsible for conducting a wide scope of clinical trials to ensure that any potential side effects are identified and outweigh the risk of not taking the product.

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As a Business Week report mentions, after Hospira Inc. announced a recall for Propofol and Liposyn for the second time on April 1, 2010 since six months ago, the U.S. Food and Drug Administration issued a warning letter on April 12. As two vital drugs that were sold to medical professionals and hospitals, Propofol (an anesthetic agent) and Liposyn (an intravenous nutritional product) were contaminated with particulates from the manufacturing process. Hospira recalled both of these products in October 2009 due to equipment failure at the Clayton, North Carolina manufacturing facility. Apparently, as the FDA was examining the Clayton plant in January and February, agency officials also reviewed Hospira’s Rocky Mount, North Carolina plant. It was at this second location where the FDA discovered a malfunction to authorize the processes utilized in manufacture.

While pharmaceutical products should be designed and manufactured to help people, some consumers are left to wonder whether the timeframe of these processes is cut-down in order to boost profits. If a drug maker rushes through significant elements of the manufacturing process, mistakes can be made, and flaws or defects may be left overlooked until innocent people suffer as a result. Fortunately, in the case of Propofol and Liposyn, no reports of patients experiencing serious side effects or injury have been reported at this time.

In instances where a drug company or individual breaches FDA rules, before resulting to more extreme measures, the FDA first works with the company or individual in reviewing manufacturing operations and establishing ways for regulations to be better implemented. Especially when the same two products have experienced two different issues that have prompted recalls, the FDA will also issue warning letters that are meant to encourage a drug manufacturer (or any other manufacturer or seller of medical devices, food, cosmetics, or various other products) to make and follow voluntary solutions to the issue.

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Why are LABAs used to treat asthma when they could potentially exacerbate attacks and cause death? When used properly, LABAs can help people who have COPD (a lung condition) or asthma to breathe more easily. They are also useful in the treatment of exercise-induced asthma attacks. People with asthma usually take LABAs via nebulizer or inhaler, and this helps airway muscles relax, allowing air to flow more easily in and out of the lungs. Effects of LABAs are also long lasting, continuing in the neighborhood of 12 hours. Furthermore, the FDA believes that the benefits of LABAs in helping to relieve asthma symptoms outweigh possible risks, when used properly.

To be on the safe side, take note of these recommendations by the Food and Drug Administration:

• Use single-ingredient asthma products that contain LABAs only when combined with asthma controller medicines; never use them alone. These include products such as Serevent® (generic: salmeterol) or Foradil® (generic: formoterol).
• Do not use combination medications Symbicort (budesonide and formoterol) and Advair (fluticasone and salmeterol).
• If LABAs are necessary to treat asthma, use them temporarily for the shortest period possible.

Additionally, if you are using a product that contains LABAs, read the Medication Guide, talk to your health care provider about warning signs of exacerbated asthma as well as any other questions you might have.

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However, will this really help move things along? The FDA process for approving a new prescription drug before it is available for sale in the U.S. entails several steps that can take years to navigate.

FDA testing begins in the laboratory, progresses to animals and then continues on to humans. There are two phases of human studies. Phase 1 of the human studies tests focuses on determining the safety of the drug. If Phase 1 does not reveal any undesirable toxicity, it can move on to Phase 2. Phase 2 concentrates on the drug’s effectiveness by aiming to find out how the drug works on people with certain conditions or diseases.

After testing, companies send the FDA an application (the New Drug Application, usually about 100,000 pages long), which includes the results of the drug’s tests, information that helps prove that the company can appropriately manufacture it and the proposed label for the drug. The label is required to contain information about the effectiveness and potential risks of the drug, as well as how to use it.

The FDA then takes the drug under review, a process that can take up to 2½ years. If a panel of scientists and physicians show that the prescription drug’s benefits exceed known risks, it will approve the drug, and it can be available for purchase in the U.S.

On average, it takes 12 years for a new prescription drug to go from the laboratory to the pharmacy shelf. In fact, only one in 1,000 compounds entering the laboratory testing stage ever makes it to the human testing stage.

Will hiring 50 more scientists really help clear up the backlog of FDA applications and move things along? Alternatively, is there something inherently wrong with the system as a whole?

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The marketability of this product is huge; as the demand for cigarettes declines, tobacco companies are concentrating on providing consumers with alternatives to cigarettes including snuff, cigars and chewing tobacco. Still, the FDA expressed concern that the lozenges, called Ariva-BDL, might appeal to young adults and children and asked that Star Scientific produce information and research so that this issue can be addressed.

Whether Ariva-BDL has below detectable amounts of certain cancer-causing chemicals or not, it still contains nicotine – a chemical that has been linked to mouth cancer. In fact, recent research has produced evidence that indicates nicotine levels in smoking cessation products can worsen genetic mutations common in mouth cancer. Simply put, nicotine could be more carcinogenic than we thought.

While nicotine replacement products are, for the most part, much less dangerous than cigarettes, smokers are already at a higher risk of oral cancer. Some may already have lesions of which they are unaware. Doctors worry that habitually consuming nicotine via replacement products after quitting smoking may keep people at a high risk of mouth cancer.

Whether the FDA deems Ariva-BDL or any nicotine replacement product as a “modified risk” product in the future, consumers should heed product labeling; labels usually advise that consumers cut down their use of the product after three months and stop altogether after six.

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At issue, according to the report, is an accelerated process currently used for devices that have some similarity to other devices already on the market and approved by the FDA.

FDA officials say it can be difficult to measure how similar a new product may be to others, and that this lack of clarification can cause significant problems related to the approval of new devices.

Many who are making medical devices for the market urge the FDA not to conduct a major overhaul of their policies, saying this could create deterrence for new technologies that can help heal the public.

The FDA division in charge of this approval process, called 510(k), must figure out a way to thoroughly evaluate medical devices to make sure they are safe for the market. Consumer advocacy groups claim that loopholes like the accelerated process can allow potentially harmful products to slip through to the market.

A look into the industry shows that many companies are submitting a series of similar products and devices to the FDA, hoping that newer engineered products will be judged similar to those already on the market. One problem is that these devices can include more extreme treatment methods, meriting further investigation by the regulatory agency. Consumer advocates point to significant cases of recalls within the medical device industry to show that some FDA approved medical devices are later found unsafe for public use. Those involved in handling product liability insurance for large medical device manufacturers will want to be acquainted with any future changes in FDA approval. Experts in product insurance law also need to know how recalls will affect a company and how class action suits or other events can change realities within an industry.

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One of the primary reasons cited for the high cost of prescription drugs is the FDA’s lengthy and costly approval process. But how effective can this process be, considering it takes an average 12 years and hundreds of millions of dollars for a new prescription drug to travel from the laboratory to market shelves? In addition, how is important information about a drug missed until after it has already entered the market?

What about drugs like Colchicine? The FDA did not approve Colchicine because it predated the FDA approval process; it existed like thousands of other drugs on the market, as a generic drug that is much more affordable than brand-name drugs. In Colchicine’s case, its branded counterpart costs nearly 50 times more per pill. This is because URL Pharma (the drug company) convinced FDA officials that the brand name version of Colchicine is safer, in spite of the fact that many physicians have disputed URL Pharma’s claims.

It is a shame that the FDA is allowing URL Pharma to charge an outlandish amount for a medication that was already available at a fraction of the price. Furthermore, it will probably force the long-used generic brand off the market under the pretense that the generic brand is less safe due to its label. The FDA found that the brand name drug’s regimen for recommended dosing and its interaction label make it safer than the Colchicine generic alternative.

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