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St. Louis Pharmaceutical Blog

Patients using GranuFlo® and NaturaLyte® have suffered from cardiac arrest

GranuFlo® and NaturaLyte® have been prescribed for patients suffering from dialysis. Patients using these drugs have suffered from cardiac arrest. Plaintiffs filing lawsuits are alleging that the manufacturer knew of risks caused by the products prior to issuing warnings. Many individual cases have been filed but the courts are presently considering the site for a MDL (Multidistrict Litigation) to consolidate the filing of these cases in one place in Federal Court.

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Baby Motrin drops recalled after plastic particles found

St. Louis area parents look to doctors and pharmaceutical companies as valuable partners in their effort to keep their babies and children healthy. Most of the time, parents are able to purchase medicines or other products that aid in their children’s well-being with no concerns at all. However, other times, problems can happen and sometimes when least expected. The importance of drug safety or the communication about drug recalls cannot be underestimated as vital elements of public health.
Nearly 200,000 0.5-ounce bottles of Concentrated Motrin Infants’ Drops Original Berry Flavor are being voluntarily recalled by the manufacturer due to the possibility that small plastic particles may be in the bottles. Such particles were found in some containers that had not yet been dispersed to the public at the McNeil Consumer Healthcare unit, a division of the pharmaceutical company Johnson & Johnson.
The plastic pieces are reported to be roughly the side of poppy seeds.

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Recent verdict marks second win for plaintiffs in Fosamax cases

Osteoporosis is a disease that impacts an individual’s bones and bone density. Individuals diagnosed with osteoporosis are at an increased risk for suffering bone fractures and other health problems that may result from necessary surgeries to repair such fractures. In an effort to slow or prevent additional bone density loss associated with osteoporosis, many individuals take prescription medications.
The prescription drug Fosamax is one such drug commonly prescribed to combat the ill-effects associated with osteoporosis. For years, patients have reported possible dangerous side effects associated with use of Fosamax and there are currently more than 4,000 lawsuits pending against the drug’s maker Merck & Co. Inc.
The lawsuits contend the drug maker failed to adequately warn patients of potential dangerous side effects and risks associated with taking Fosamax.

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Birth control pills subject of nearly 10,000 lawsuits

Birth control pills subject of nearly 10,000 lawsuits
On behalf of Greg Roberts of The Roberts Law Firm, P.C. posted in Defective Drugs on Tuesday, September 10, 2013.
Oral contraceptives are extremely commonly prescribed and typically considered to be safe for use. For decades, women in St. Louis and around the country have counted on these medications for birth control as well as hormonal balancing. Despite the list of precautions and potential side effects listed, much of the time, birth control pills are able to be taken and used without problem.
Unfortunately, that is not always the case. Bayer Pharmaceuticals, the maker of two brands of oral contraceptives that are currently the subject of multiple lawsuits, faces a continued string of such suits. Statistics estimate that there are roughly 10,000 cases nationwide claiming that Yaz and Yasmin are essentially defective drugs, causing a host of physical problems for the women who take them.

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Hospital simplifies management of recalled drugs

The U.S. Food and Drug Administration works to oversee all prescription medications and either issue or encourage manufacturers to issue recalls in the event a problem is identified. A recalled drug not promptly taken off of the market and prevented from getting to patients can lead to serious results from a drug injury to wrongful death. St. Louis area residents may not always know if they have been given a defective drug before it is too late.
With people’s lives literally on the line, one hospital decided to take strong action to help them keep pace with the FDA’s issuing of drug recalls. A new system utilizing Radio Frequency Identification technology allows all medications to be scanned into a system and easily tracked when needed. In a hospital setting, the pharmacy is not the only place that a medication may be when a recall is learned about.

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FDA drug monitoring and reporting under scrutiny

The regulation of medications, both prescription and over-the-counter, is led by the United States Food and Drug Administration. The goal of the FDA’s programs is to ensure public health and safety by preventing defective drugs from either reaching the marketplace or from being further utilized if already being sold and taken. St. Louis citizens trust the FDA every day to be their eyes and ears and prevent harmful drugs from being on the market.
A recently published article discusses the FDA’s process for monitoring drugs and alerting the public about a drug recall. It is rare that the FDA actually issues or requires a recall of any drug. Rather, the safety regulation of pharmaceuticals works by notification to the manufacturer of an identified problem. At that point, any recall issued is done so at the discretion of the pharmaceutical company and is voluntary.

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Overly aggressive use of antibiotics harmful to public

Missouri residents understand the value of ensuring the safety of pharmaceuticals, whether prescription or over the counter, as a vital means of maintaining public health. Drug injuries can cause life-long problems. However, a drug injury may not always result from a defective drug or even from harmful side effects. Being prescribed the wrong medication, especially one that is stronger than what is truly needed, can be damaging down the road as well as at the time.
A report from the University of Utah claims that medical professionals are too quick to prescribe an antiobiotic that is stronger than what is truly needed. The researchers claim that in more than 60 percent of cases, a prescription for a broad-spectrum medication, such as Levaquin, is given. Additionally, the report claims that 25 percent of the time an antiobiotic is prescribed that is not at all appropriate for the condition and will be uneffective in treating it.

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Proposed bill would allow FDA to regulate dietary supplements

The U.S. Food and Drug Administration is responsible for oversight of all prescription drugs. Their drug regulation efforts are aimed at maintaining public safety by preventing a defective medication from harming the public. A defective drug can cause injury, illness or even a wrongful death. However, the FDA has no safety regulation powers over the world of dietary supplements yet these products are also known to have the potential to cause serious problems for people who take them.
Two senators have introduced a new bill that, if passed, would give the FDA regulatory authority over dietary supplements. The bill acknowledges that supplements can be harmful and currently operate under the radar. Problems encountered with supplements are only known by the FDA once an injury or illness actually occurs. One study shows that, between 2004 and 2012, supplements accounted for more than 50% of all recalled drugs in the Class 1 category.

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‘Natural’ not always better in the world of drugs and supplements

The Food and Drug Administration closely monitors prescription drugs to help ensure consumer safety. However, it is not only prescription or over-the-counter pharmaceuticals which may have side effects leading to undesirable drug interactions or even a drug injury. Supplements labelled as “natural” can also be wrought with side effects and, may not necessarily be fully “natural.”
While the FDA has limited control over the supplement market, they can test products and provide consumer warnings. This can be helpful to the public to prevent problems related to defective drugs or defective medication masquerading as supplements. Recently, the FDA has heightened awareness about multiple brands of sexual enhancement supplements after test results showed that the products contained sildenafil, the active ingredient in the prescription drug Viagra.

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Generic drug safety the subject of proposed legislation

The Federal Drug Administration (FDA) monitors drug safety in an effort to keep the public safe. All citizens, including those in the St. Louis area, benefit from the regulations put in place by the FDA. One such regulation that is monitored by the FDA is the requirement of drug manufacturers to report all pharmaceutical information, including drug side effects. However, the law has a loophole for generic drugs where reporting of side effects is not required.

A New York Assemblywoman, Amy Paulin, is working to change the laws pertaining to side effect reporting for generic drugs. She has recently introduced a bill that is not in front of the Assembly Health Committee. It would require that pharmaceutical companies disclose drug safety information including drug interaction and side effects for all generic prescription drugs, just as with non-generic drugs.

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