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A state inspection of a pharmacy in Fayetteville, North Carolina, has led to the recall of more than 600 drugs in a variety of dosages and formulations, officials announced in late March. The U.S. Food and Drug Administration (FDA) and the North Carolina Board of Pharmacy (NCBOP) have issued a warning to medical professionals and patients regarding all compounded drugs made or distributed by the Prescription Center pharmacy, which has been since shut down.

Compounded Drug Recall

The NCBOP said in a news release that it was recalling all nonsterile and sterile products that were compounded, repackaged, and distributed by the pharmacy from September 10, 2014 to March 10, 2015. The listing of recalled products includes antidepressants, antibiotics, antiviral medications, immunosupressants, and others which were distributed to all 50 states and Canada. “This recall is due [to] the pharmacy's inability to ensure sterility, stability, and potency for these products,” the Board of Pharmacy said. While no complaints of injuries have been received by the board, the NCBOP and FDA are advising clinicians to quarantine any products from the Prescription Center and not to administer them to human or animal patients.

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Tagged in: Drugs Fda Recall

Lupron is a hormonal regulator that has several dangerous, if not oft-publicized side effects of which every patient should be aware. The drug is prescribed to help slow early-onset puberty in teenagers, to men who exhibit signs of prostate cancer, and to help treat women with endometriosis, a rare condition in which the lining of the uterus grows outside the actual uterus. According to the U.S. Food and Drug Administration (FDA), the first adverse reaction to Lupron was discovered in 2012, after marketing of the drug had already began, and consisted of a rarely-reported complication of the liver. Six months later, the FDA reported that Lupron could result in lung complications and disease, and one year later, the FDA found serious complications of the drug that could lead to liver injury or convulsions, such as those experienced by patients who suffer from epilepsy.

Most patients take Lupron in the form of a daily shot, according to WebMD. In children, dosage is based on weight and what type of therapy for which the drug is being administered. One easy test to see if the drug is defective is to check the liquid for particles or discoloration, according to WebMD. The site of the injection should be changed periodically, so as not to overload one particular area with too much of the drug at any given time.

Regardless of where or how it is injected, however, Lupron can have deadly side effects. According to Wellsphere.com, one doctor advised that the drug should be pulled from the market as early as 2008. The doctor alleged that the manufacturing company of Lupron did not adequately study the possible side effects of the drug before approving it for consumer use. In 2009, the pharmaceutical company agreed to pay $875 million “to settle claims that it paid kickbacks to doctors to promote Lupron,” Wellsphere.com reports. More than 12,000 reports of Lupron's negative side effects have been reported to the FDA, resulting in more 1,100 deaths.

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In recent years, testosterone therapies to help men with erectile dysfunction or low testosterone levels have become more common than ever. With the advances in such medication, however, come advances in risks that accompany such treatment. According to WebMD.com, testosterone replacement therapy (TRT), are not as common as one may think. Part of this could because of the many risks that accompany TRT and the fact that many physicians are not yet familiar with the overall picture of such therapy.

Testosterone gels carry their own set of risks separate from those associated with pill therapy. Pill therapy can have unwanted side effects such as acne, sleep apnea, and breast enlargement, according to WebMD. Yet when a man uses a testosterone cream or gel, it can have unintended side effects for his family. “If a woman or child comes into contact with testosterone gels, it can cause side effects in them, including hair growth and premature puberty,” according to WebMD. Most doctors say that this transference is rare, but men using testosterone gel should take care to wash their hands thoroughly after use to mitigate the possibility of such unwanted side effects.

Yet transference to women and children is not the only highly publicized negative effect of testosterone gels. According to Bloomberg News, earlier this year, Abbott Laboratories (ABT), the manufacturer of AndroGel, a very common brand of TRT gel, was sued by five men claiming that the ABT failed to properly warn patients of severe side effects of the gel on their hearts. One man allegedly had a stroke as a result of AndroGel use.

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Cymbalta is a multi-use prescription drug most commonly used as an anti-depressant. Despite several clinical trials during the approval process of Cymbalta that alleged Cymbalta caused depression in otherwise healthy patients, the U.S. Food and Drug Administration did not recall the drug for use as an anti-depressant, according to the New York Times. Most tellingly, the suicide of 19-year-old drug tester Traci Johnson, who had no other symptoms of depression, brought the issues with Cymbalta to wider attention. Four years after this negative publicity, in 2008, Eli Lilly, the manufacturer of Cymbalta, sought to have the drug approved for treatment for chronic pain, especially in patients suffering from Fibromyalgia. The drug was not approved for such use in 2008. It would eventually be approved for such treatment in 2010, according to another article in the New York Times.

Cymbalta has been back in the news recently, as several lawsuits have been brought against Eli Lilly by patients using Cymbalta as an antidepressant. These patients claim to have experienced “brain zaps and other side effects” when attempting to stop taking the drug, according to Law360.com. Yet Eli Lilly representatives have responded to the claims by saying that medical professionals were made well aware of the risks when prescribing Cymbalta to their patients, and thus the fault does not lie with the drug manufacturer for failing to make patients aware of the risks of use.

According to Law360.com, Lilly earned $18 billion from 2004 to 2011 for the sales of Cymbalta. Like other antidepressants, patients are discouraged from suddenly stopping to take Cymbalta, as this can lead to serious conditions, either physical (ie: nausea, headache) or emotional (ie: irritability, anxiety, nightmares). The complaint alleges that if patients had known how difficult it would be to stop taking Cymbalta, they would never have started to take it in the first place.

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Sometimes prominent drugs are recalled and no one knows about it. This was the case with a 2010 Food and Drug Administration (FDA) recall of the birth control Yaz, a contraceptive approved by the FDA for use among women as young as 14 years old. Yaz and Beyaz—a similar FDA-approved medication made by the same manufacturer, Berlex, Inc.—hit the market when it was approved in 2006, according to Drugs.com. Beyaz is primarily used to treat acne, while Yaz is marketed as the contraceptive. The only warnings on the Yaz website for either drug alert women who smoke and women over the age of 35 to increased risks of blood clot or stroke when taking the drug.

The trouble for the popular contraceptive came in 2010, when lawsuits started to pop up across the country alleging that women who were on the medication experienced a much higher rate of blood clots than the manufacturer had described. Bayer, the parent company for Yaz, was sued in 1,100 lawsuits that year, according to CBSNews.com. When Bayer began to face these lawsuits, Yaz was its best-selling product, according to CBS. As a result, one may think that a recall of the product would have been widely publicized. Not so.

The FDA issued a recall of the drug in November 2009, but it never made consumer headlines. This regardless of the fact that it “involved 32,856 boxes of Yaz, at three packs per box, and 122,208 boxes of Ocella, an identical product,” reports CBS. Despite its magnitude, the recall was hidden in the “Enforcement Report” section of the FDA website, meaning that anyone who wanted to know about the recall would already have had to know to look there.

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