Articles Posted in pharmaceuticals

Pfizer, Inc., an American multinational pharmaceutical conglomerate, and the maker of many popular drugs such as Lipitor and Viagra, had better hope that the latter of those inventions doesn’t exacerbate the already enormous concern caused by their latest product recall.

According to a recent report by MSNBC, Pfizer is recalling more than 1 million packets of birth control pills because of a packaging error; apparently a number of the 28-count blister packs contain an incorrect amount of inactive or active ingredient tablets and the tablets might be in the wrong order. Because the contraceptive pills can’t be taken as intended – despite no fault on the part of the consumer – the risk of unwanted pregnancies is increased. As a result, Pfizer could be made to answer to Illinois personal injury lawsuits resulting from the error.

The pills affected, Lo/Ovral-28 is intended to be taken each day; they contain Levonorgestrel, a second-generation synthetic progestogen that is a common active ingredient in hormonal birth controls and emergency contraceptive pills. The active-ingredient pills, taken for the first three weeks, are white-ish in color, while the inactive pills, taken for the last week to help women keep track of when they should begin their next pack of pills, are pinkish.

It sounds like something out of a horror movie, but it’s actually the subject of the FDA’s latest recall.

Bedford Laboratories, a pharmaceutical- and medical device-manufacturing corporation has just recalled two vaccines after it was found that vials of the injections contained glass particles.

Bedford Laboratories is an American manufacturer that supplies an extensive selection of critical-care and medically necessary multisource and specialty injectable products to the healthcare marketplace. This is the second recall for the same product; according to the FDA’s report, the recalls were first initiated in August of 2011 after visible glass particles were found in a limited number of vials in the affected lots.

Novartis International AG, the second-most lucrative pharmaceutical company in the world, has just recalled a number of over-the-counter medications because packages of pills may have accidentally included doses of powerful prescription medications.

Although the U.S. Food and Drug Administration is not recalling all containers of these medications because they may be otherwise medically necessary, the FDA has released a public warning, cautioning consumers about the potential mix-up.

According to reports by the Associated Press, the problem arose at an American Novartis production facility, which has subsequently been shut down. In 2010, Novartis International AG, a major manufacturer of generic prescription drugs, recorded sales of $46.806 billion. A number of the prescription drugs inadvertently included in the over-the-counter medications were opioids (drugs used in the treatment and management of pain) that are otherwise sold under the labels Percocet, Endocet, Opana, and Zydone. Pieces of the prescription drugs made their way into containers of the over-the-counter remedies, which is what caused the concern and the resulting recall.

This past Sunday, Novartis AG issued a nationwide retraction of certain bottled versions of Excedrin (a headache pain-reliever), Bufferin (an anti-inflammatory medication for minor aches and pains), Gas-X (a pill intended to relieve pain caused by excess gas in the stomach), and No-Doz (a caffeine stimulant), saying that they may contain stray, broken, or chipped parts of prescription tablets of drugs which were manufactured at the same plant.

This situation is a prime example of Illinois product liability law; product liability is an area of Chicago personal injury law that focuses on dangerous and defective products. Although no injuries have yet been reported as a result of the mistake, because Novartis AG’s negligence led to the prescription medications’ inclusion in over-the-counter products, Novartis could be liable for damages if injuries do arise.

Said the FDA’s recall report, mixing of different products in the same bottle could result in consumers taking the incorrect product and receiving a higher or lower strength pain-reliever drug than otherwise intended, or receiving an unintended ingredient. This could potentially result in overdose, interaction with other medications a customer may be taking, or an allergic reaction if the consumer is allergic to the unintended ingredient.

Although the Consumer Health division of Novartis has publicly stated that the recall is a precautionary measure, the tainted over-the-counter packages were distributed to wholesale and retail stores across the country. With such widespread dissemination, the risk to consumers is enormous.

Novartis AG plans to notify distributers and customers, and is urging customers to return potentially hazardous packages. Our Chicago personal injury lawyers have handled numerous cases in which customers have been injured by dangerous, defective, or diseased products. If you or a loved one have suffered as a result of using an unsafe product, contact an attorney to be apprised of your rights under the law.
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The Food and Drug Administration has just released another medication recall, this time for Fentanyl pan-relieving patches, after manufacturers discovered that the patches were releasing medicine into the bloodstream faster than intended.

Fentanyl is a synesthetic opiod that acts quickly to treat pain, but has a short duration of relief. It is commonly used both as an anesthetic and a pain-reliever, and it is estimated to be more than 100 times more powerful than heroin, per dose. Fentanyl patches are prescribed to patients suffering from chronic, severe pain. When the patch is designed correctly, it slowly releases a very small dose of medication. However, if too much of the medication is delivered or the fentanyl from the patch comes into direct contact with the skin and too much fentanyl is released into the bloodstream, there is a risk of fatal overdose.

There have been a number of problems with fentanyl patches since they were first put on the market in 1994 as a result of manufacturing issues, and several Illinois wrongful death lawsuits have arisen as a result of problems with the patch’s design.

A recent report released by MSNBC and the Associated Press details the fact that the popular contraceptive pill, Yaz, may not be as safe as drug manufacturers originally thought.

Concerns arose with Yaz and other, newer forms of birth control when federal health scientists discovered that more recent forms of birth control treatments appear to increase the risk of potentially fatal blood clots. The study compared the latest birth control medications and their effects to symptoms and side effects associated with older forms of contraceptive drugs. The FDA’s report showed that on average, women taking Yaz had a 75% higher risk of developing a blood clot than women taking older types of contraceptive pills. A related study published earlier this week in the British Medical Journal also found that women taking Yaz and other newer medications had twice the risk of blood clots as women taking the older hormone levonorgestrel.

Bayer, a major chemical and pharmaceutical producer in the United States that is a branch of the German pharmaceutical conglomerate, manufactures Yaz. Yaz, Yasmin, and related pills containing the same hormones as found in Yaz, were Bayer’s second-most successful line of products last year, and brought in almost $1.6 billion in sales, worldwide.

Our Illinois personal injury lawyers are concerned about the FDA’s recall of Avandia, a pharmaceutical intended to treat diabetes.

Avandia is one of the most popular drugs used in the treatment of patients with diabetes. It works by binding to receptors in human fat cells, and making those cells more responsive to insulin. Nevertheless, recent reports have shown a strong link to major health problems, including the risk of death.

Avandia is manufactured by London, United Kingdom-based GlaxoSmithKline, which is the third-largest pharmaceutical company in the world, after Johnson & Johnson and Pfizer. Complaints and concerns about the drug started around the year 2000, and the FDA has recently undertaken extensive testing to determine potential health and safety hazards associated with Avandia. In response to these tests, the FDA has approved further restrictions on the sale and prescription of this drug.

Earlier this month, the FDA ordered a product recall of nearly 500 prescription medications used for treating colds, coughs, and allergies from the United States market. The reason, according to the Food and Drug Administration (FDA), is that the drugs contain ingredients that have not been approved by federal regulators. These products had not been formally evaluated by federal regulators and is being referred to as the latest in a series of actions by the FDA to stop the sale of products sold without government authorization. The FDA stated that the agency was unsure if the drugs were safe or effective and believe that their existence on the market poses an untenable risk to US consumers. Hence, removing these unapproved products will reduce potential risks to consumers.

The unapproved drugs have been linked to some minor problems, such as drowsiness and irritability. However, the agency is concerned that medical problems associated with the drugs may be significantly underreported. Some of the products are labeled as suitable for children, but contain ingredients covered by a 2008 FDA advisory that warned against over-the-counter medications in children under the age of 2. Some of the drugs combine two varieties of the same ingredient that could cause excessive drowsiness. Agency officials do not know how many patients are taking the drugs that would be removed from the market. Over-the-counter medications, which are used more frequently than prescription drugs, are not affected by the FDA’s order. Many questioned whether physicians were aware that they prescribed a drug that was never approved by the FDA.

Visit the New York Times to read more about the FDA cold drug product recall.

The United States Food and Drug Administration (FDA) issued a massive request last month when it requested that the manufacturers of propoxyphene, known as PXP, a pain reliever, to stop selling drugs that contain PXP. PXP was introduced in 1957 under the trade name of Darvon. Derivatives of Darvon, including Darvon Compound and Darvocet, quickly followed and added other analgesics to the parent drug. When the product recall occurred, an estimated 10 million Americans took drugs containing PXP. Alone, PXP was not very effective in pain-relief and seemed to have an addictive risk.

The Darvocet product recall came after reports that PXP could cause dangerous disturbances in heart rhythm. Individuals critical of PXP have argued for over 20 years that the recalled drug was unsafe for many reasons. The FDA vote was 14-12, reflecting the controversy surrounding the issue. The United Kingdom and the European Union had already banned PXP sales several years prior to the recall. PXP is not the only recently recalled drug with suspected cardiac side effects. In September 2004, Vioxx was recalled based upon heart problems that appeared after 18 or more months of use of the drug. This product recall was despite a spirited defense by its manufacture that the drug was safe. And since that, the FDA has issued new warnings of cardiac risks associated with diabetes drug Avandia. Again, the panel reviewing the dangers of Avandia was deeply divided over whether to withdraw or restrict use of the agent.

While the FDA conducts extensive review of all laboratory and clinical studies to assess the safety of new drugs, the agency depends on the integrity of scientists who conducted the original studies. The FDA unfortunately does not have the capacity to test new drugs independently. The agency must consider other options to review drugs and avoid subsequent product recalls.

One man is trying to get to the heart of the problem of Floxin, a drug that caused him serious side effects. The product liability victim suffered permanent tendon and nerve damage from Floxin and has since acted as an advocate for a complete Levaquin withdrawal. To accomplish this, the product liability victim filed a shareholder proxy for Johnson & Johnson’s, the drug manufacturer’s, next annual meeting. He bought a share of Johnson & Johnson’s stock so that he would be able to attend its annual shareholder meeting and ask the shareholder to: (1) discontinue the sales incentive program for selling Levaquin and Floxin so that they can tell the truth about its toxicity and (2) add to the Levaquin label that side effects include permanent delayed reactions can lead to chronic pain and that medication should be stopped at the slightest sign of reaction.

The product liability victim bought additional Johnson & Johnson shares in order to file a Shareholder Proxy for the next Annual Meeting for shareholders. He stated that he wants them to vote on forcing the company to put a warning on the Levaquin label, stating that it may cause permanent tendon and nerve damage with permanent pain.
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The U.S. Food and Drug Administration (FDA) urged a change to the product labeling for Januvia, an oral Type 2 diabetes drug, over a year ago regarding various Januvia side effects. Many are arguing that the FDA was slow to urge this change regarding the drug side effects, given reports of adverse reactions that had been coming in since Januvia had been approved. On the other hand, Public Citizen had posted Januvia to its Worstpills.org website in June 2007, advising that Januvia should not be used until seven years after its introduction on the market – no earlier than 2014.

In October 2006, Januvia was approved by the FDA and the adverse reactions began rolling in shortly thereafter with the FDA receiving reports of pancreatitis with Januvia starting the very month that the drug was approved. Of 88 reports of pancreatitis reported from October 2006 to February 2009, 19 patients suffered the onset of pancreatitis within a mere 30 days of starting the Januvia drug. Public Citizen noted that even in clinical studies, trial participants were found to experience an increased level of creatinine in their bodies, which is often an early indicator of kidney problems. Anyone considering a Januvia product liability lawsuit may consider the lag time between October 2006 – when the first negative side effect reports were received by the FDA – and September 2009 – when the agency revised the drug’s warning label. This time should have spent to prevent further suffering by those who take Januvia.

Public Citizen is a well-established and trustworthy consumer advocate group, who has an enviable track record of raising concerns about potentially problematic drugs and remains ahead of the curve.

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