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When a Drug's Risks are Not Advertised, it is a Defective Drug

Drug manufacturers have the responsibility to disclose all potential side effects of their products. They must be disclosed to doctors who may prescribe the products to patients and to patients who may take the drugs. By providing this information, drug companies make it possible for doctors to weigh the benefits and potential risks of a particular medication before prescribing it to a patient and patients can consider whether the benefits outweigh the risks before deciding whether or not to take the medication. Without disclosures of potential side effects, doctors and patients cannot make fully informed decisions about their drug use.

When doctors and patients choose not to take a drug because of its risks, drug sales plummet. Thus, it can be quite lucrative for drug manufacturers to downplay or even fail to advertise their products' potential risks despite this being a dishonest act and a violation of their product liability. Drug manufacturers are liable for the damages victims suffer from using their products, which can be sought through defective drug claims.


Abilify is the name brand of the medication aripirazole. Aripirazole is the medicine used to treat mental disorders such as bipolar disorder, severe mental depression and schizophrenia. No evidence has been released that proves that the drug does not do what it is intended to do, but there are some unexpected side effects of taking this medication about which many patients have filed lawsuits. These unexpected side effects primarily include the development or exacerbation of compulsive behavior, according to the British Journal of Psychology, sometimes in patients in whom compulsive behavior had not bee observed prior to taking Abilify.

When the drug first hit the market, the U.S. Food and Drug Administration (FDA) made no warnings that the medicine could induce compulsive behavior. According to the FDA, possible side effects of Abilify included high blood sugar and neuroleptic malignant syndrome (NMS). NMS can result in “high fever, stiff muscles, confusion, sweating, changes in pulse, heart rate, and blood pressure.” Because Abilify functions as an anti-depressant, the FDA also made note that the medicine could lead to increased thoughts of suicide during initial stages of being on the medication.

Yet in 2014, studies began to surface that revealed Abilify, or aripirazole, was linked to an increased risk of compulsive behavior, seen most prominently through proof of pathological gambling in patients who were regularly taking Abilify. Medical professionals thought this was because Abilify acts at the D3 receptor in the limbic system, it may over-stimulate the reward system of the brain. Stimulation of the reward system in your brain is what leads people to compulsive behavior such as pathological gambling.


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A generic drug is an essential option for Americans, as it is sold at a lower cost than a name brand product. In fact, the FDA notes that generic brands can be as much as 85 percent lower in price. However, these lower prices are a direct result of several factors. One of these factors is that generic drug manufacturers are not required to “repeat the costly clinical trials of new drugs.”

With that said, FDA is responsible for protecting public health by “assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.” Under the federal Food, Drug, and Cosmetic Act (FDCA), the “introduction or delivery for introduction” of an any adulterated drug “into interstate commerce” is prohibited. However, there are instances where manufacturers, generic and name brand, circumnavigate the protections in place and thus manufacture, and even distribute, faulty drugs.

One such example of this, according to the FDA, was in 2012, when the United States Department of Justice stepped in to handle several injunctions brought against Ranbaxy, a generic drug manufacturer and Indian corporation. The DOJ, on behalf of the FDA, filed a consent decree of permanent injunction against Ranbaxy and its subsidiary Ranbaxy Inc. for drugs that had been known for non-compliance with U.S. FDA regulations and for falsifying information. The severity of these types of situations was well noted by Stuart F. Delery, the Acting Assistant Attorney General for the Civil Division of the Department of Justice. He stated, “When companies sell adulterated drugs, they undermine the integrity of the FDA's approval process and may cause patients to take drugs that are substandard, ineffective, or unsafe.”


Posted on in Drugs

A recent Health Professional Follow-Up Study (HPFS) has found that erectile dysfunction drugs (such as Viagra) are linked to an increased risk of a dangerous type of cancer. The study showed that men who were taking Viagra were nearly 85 percent more likely to develop melanoma (a fatal type of skin cancer) than those who were not. Men who had previously taken Viagra and had ceased taking the drug were still twice as likely to develop melanoma than men who had never taken it.

The active ingredient, or clinical name for Viagra, is sildenafil. The drug, researchers found, “affects cell pathways that allow melanoma to spread (metastasize) to other parts of the body,” reports Drugwatch.com. This type of skin cancer is responsible for nearly 10,000 deaths annually in the U.S., and an estimated 76,000 cases of melanoma are diagnosed in the same time period.

This, however, has not led physicians to recommend patients cease taking Viagra if they have been on the drug for an extended period of time. Dr. Abrar Qureshi, Chairman of the Dermatology Department at Brown University, told Drugwatch.com that the study was not one that measured cause and effect, but one in which patients self-reported rates of skin cancer.


In June, the Food and Drug Administration (FDA) issued a statement requiring drug-makers who manufacture testosterone to issue a warning label on the drug regarding the potential risk for venous blood clots.

Testosterone replacement drugs are a medicinal therapy for men with erectile dysfunction, though according to WebMD, “inadequate production of testosterone is not a common cause of ED.”

The natural decline of testosterone in a man's body begins after age 30, but there are several causes of lack of testosterone production. Reasons for inadequate testosterone production include (but are not limited to):

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