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Generic Lipitor Recall Announced by Ranbaxy Laboratories Due To Impurities

Generic Lipitor Recall Announced by Ranbaxy Laboratories Due To Impurities

With global sales of more than $1 billion annually, Ranbaxy Laboratories is one of the biggest names in the collection of pharmaceutical companies that international giant Daiichi Sankyo has gathered over the past decade. Founded and operating in India, Ranbaxy has made its name as a developer of off-patent prescription medication, meaning that it produces and sells generic versions of popular drugs after the original manufacturers’ patents have expired. Most recently, in 2011, Ranbaxy was granted approval by the U.S. Food and Drug Administration to produce a generic version of Pfizer’s Lipitor, which is used in lowering patients’ cholesterol. However, Ranbaxy has a tumultuous history when it comes to product safety, and that came to light once again last week with a very concerning recall.

On Friday, Ranbaxy announced that it was recalling 10-, 20- and 40-milligram dosage strengths of Atorvastatin calcium tablets, or generic Lipitor, because the pills may contain traces of glass particles. Earlier this year, the company also recalled batches of the drug Pantoprazole in the Netherlands because of issues regarding impurities, and both scenarios have raised more concerns with the manner in which the company produces its drugs. According to ABC News, this recall is simply the latest in a string of controversies for Ranbaxy.

Since 2006, the FDA has been dealing with a variety of issues stemming from Ranbaxy’s questionable production methods, from failure to test the shelf life of medications in 2006 to an importation ban in the U.S. in 2008 because the company allegedly lied about drug ingredients. By 2009, the FDA was officially disregarding any new applications from Ranbaxy, and in 2011, the administration reached a settlement with Ranbaxy in the form of a consent decree, which means that the pharmaceutical company had to subject its entire operation to an independent party for five years to ensure that it was meeting acceptable standards.

While it is unclear how this latest recall will affect the company’s standing with the FDA, Ranbaxy officials are assuring its global markets that this problem is not widespread.

“The recall is limited to the U.S. market only and affects specific lots numbers and strengths of this molecule manufactured by Ranbaxy only for sale in the U.S.”

“Atorvastatin calcium tablets or any other product containing this molecule distributed outside the US is not affected in any way by this recall. The activities taking place in the U.S. will not affect Ranbaxy’s ability to continue to supply product in any other markets.”

While Ranbaxy’s U.S. representatives have revealed very little additional information, the company has still moved forward with the launch of its new acne treatment medication, Absorica

Meningitis Outbreak: Second Pharmaceutical Company Shut Down In Wake of 28 Meningitis Fatalities

Meningitis Outbreak: Second Pharmaceutical Company Shut Down In Wake of 28 Meningitis Fatalities

For the past month, health clinics and medical care centers in 23 states have been dealing with contaminated steroid injections that have lead to a fungal meningitis outbreak. To date, 28 people have died as a result of these injections that had been used by physicians and health care providers in treating back pain, and there have been at least 363 additional non-fatal cases of illness reported in 23 states.

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FDA Announces Removal of Generic Wellbutrin XL 300 mg

FDA Announces Removal of Generic Wellbutrin XL 300 mg

Part of the process of achieving Food and Drug Administration approval for prescription medication is the clinical trial. During a clinical trial, the drug will be tested multiple times to determine whether it works and if it has any side effects. To determine this information, the drug is tested against a placebo so accurate comparisons can be made, and a placebo, of course, is simply nothing more than an inert pill. But it’s important to realize that while placebos are meant to do absolutely nothing, prescription drugs are actually supposed to do something.

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Actos Link To Bladder Cancer Leads To Decrease In Manufacturer’s Profits

Actos Link To Bladder Cancer Leads To Decrease In Manufacturer’s Profits

Amid recent warnings from the FDA and the public’s mounting worry over evidence that Actos (pioglitazone) may cause bladder cancer, Takeda Pharmaceutical Company is suffering a significant dent in its profits due to falling sales of the once popular diabetic drug.

Takeda Pharmaceutical Company, the biggest maker of drugs in Japan, has stated that it experienced net profits of only $1.74 billion for the six months before the end of September. The pharmaceutical company further states that it will have had a 31 percent decrease in its profit margin by March 2012.

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Actos Multidistrict Litigation Pending As EMA And FDA Still Pushing Drug As Second Line Treatment

Actos Multidistrict Litigation Pending As EMA And FDA Still Pushing Drug As Second Line Treatment

The European Medicines Agency has recently announced that, despite a serious risk for causing bladder cancer, the prescription medication Actos – or Glustin as it is known in some European countries – should still be prescribed by physicians as a second or third line treatment option for patients suffering from Type 2 diabetes. The EMA – as well as the U.S. Food and Drug Administration – contended as recently as July 2011 that Actos createded a greater risk of bladder cancer to patients using the drugs than those not using them.

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Takeda Attorneys Agree With Plaintiff Claim To Consolidate Actos Lawsuits

Takeda Attorneys Agree With Plaintiff Claim To Consolidate Actos Lawsuits

Back in August, plaintiffs suing the drug maker Takeda Pharmaceuticals filed motions to consolidate the lawsuits of bladder cancer patients who have taken Takeda’s drug Actos. On September 29, Takeda attorneys filed a response to the U.S. Judicial Panel on Multidistrict Litigation agreeing with the plaintiffs that multidistrict litigation, or MDL, should be formed to consolidate all pre-trial litigation in these cases.

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Despite Bladder Cancer Risk, European Medicines Agency Does Not Recall Actos

Despite Bladder Cancer Risk, European Medicines Agency Does Not Recall Actos

Despite a reported link to an increased risk of bladder cancer, European drug regulators have determined that a recall of the diabetes drug Actos is not necessary. On October 21, 2011 the European Medicines Agency issued a clarification of its position on Actos, also marketed as Glustin in Europe. The EMA is now urging doctors to only recommend the drug to patients if other medications for diabetes have proven effective.

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