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Fairfield Pharmaceutical Products Law Blog

Selected Paxil batches considered dangerous and defective drugs

Connecticut readers taking prescription medication for depression may be interested to read of a recent recall from GlaxoSmithKline. A letter from the Food and Drug Administration prompted the large drug manufacturer to recall selected batches of the drug Paxil/Seroxat. The letter stated that certain lots of the drug had potentially been contaminated, making them dangerous and defective drugs.

The letter was prompted by an inspection of one of GSK's manufacturing facilities located overseas. It claims that certain batches of Paxil were tainted by pharmaceutical waste. It said that until the problem was corrected the FDA would not approve new applications containing GSK materials.

Viagra one of Connecticut's dangerous and defective drugs?

Connecticut readers of this blog may be interested in a recent study that was conducted at a university in another state. Although this is still an early study and more research is being done, consumers normally prefer to be aware of potentially dangerous and defective drugs. The drug concerned in this instance is Viagra, with the study suggesting that it has been found to multiply the threat of melanoma.

According to the media report, Viagra touches on the identical pathway that permits melanoma to be more invasive. The study revealed that, although Viagra is perfectly effective for erectile dysfunction, the probability of developing melanoma in men taking Viagra was 84 percent higher than in men who did not use Viagra. The study involved almost 26,000 men whose average ages were 65. It was found that men who had used Viagra anytime in their past were twice as likely to develop melanoma, compared to those who have never taken the product.

Johnson & Johnson blamed for defective medical devices

Having a health issue involving incontinence in Connecticut can be discouraging. Some patients have chosen to get vaginal-mesh implants to treat the problem, but some of them have ended up being injured in the long run. When defective medical devices negatively impact a person's quality of life, the injured party has the right to seek justice.

A jury recently decided that Johnson & Jonson should pay more than $1 million in compensatory damages to a woman who claimed that one of the company's vaginal-mesh implants was not designed properly. She claimed that the medical device gradually wore away inside of her and caused her pelvic pain. In 2013, another woman was awarded more than $11 million in damages after alleging that she suffered injuries due to the company's Prolift implant device, which provides support for sagging organs.

Potential for harm causes recall of bee pollen capsules

The manufacturer of several lines of Bella Vi supplements, Pure Edge Nutrition, LLC, recently issued a recall of several lots of bee pollen capsules. The company's voluntary action was in response to findings by the Food and Drug Administration that some of the product contained undeclared, unapproved medications. Officials are concerned about the potential for harm if they are taken by unwary consumers in Connecticut or elsewhere.

Laboratory testing by the FDA revealed the presence of sibutramine and phenophthalein in several different lots of the bee pollen. Sibutramine previously earned approval but was pulled from the market about four years ago when it was deemed unsafe for consumption. Phenophthalein is a powerful laxative. Neither is approved for sale in the United States.

Tampering prompts recall by diet pill manufacturer

Connecticut readers of this blog may be interested to read about a recall issued recently by multinational drug maker GlaxoSmithKline of its weight loss drug, Alli. The drug's manufacturer pulled the product from the shelves, saying an unknown number of bottles contained contaminated product and damaged packaging. The notice was distributed to thousands of stores in several states.

The recall was prompted by customers who bought Alli that, upon closer examination, revealed medication that appeared to have been corrupted. This included mislabeled bottles and lot numbers that did not match up. Some bottles had missing seals and pills that were obviously different from the intended medication.

OTC pain medication recalled to prevent harm to users

Connecticut readers of this blog may be interested to learn of the recall of an over-the-counter pain medication, Reumofan Plus tablets. The distributer of the tablets, Pain Free by Nature, says the medication contains methocarbamol, which could cause harm if consumed by senior citizens. It also contains diclofenac, which can cause serious complications for its users. They are offering a full refund to consumers who purchased this product.

Reumofan Plus is taken to alleviate muscle pain and discomfort associated with conditions like arthritis or osteoporosis, according to literature from the company. It is available for sale online. It comes packaged in lots of 30 tablets.

Manufacturer of Fitbit issues recall, faces lawsuit

Users of a wristband that can monitor and record its users' activity level, whether in Connecticut or elsewhere, are attempting to achieve class-action status for a lawsuit they've initiated. The suit is levied against the manufacturer of Fitbit. The company makes fitness bands that can be worn around the wrist or other parts of the body and monitors the wearer's physical activity, calories burned and sleep cycles.

Fitbit recently recalled the fitness band sold under the name Force. The company learned that just under 2 percent of the people who used the Force band reportedly suffered an allergic reaction when doing so. Skin rash or irritation was the most commonly reported complaint.

Manufacturer of Gaucher disease drug initiates voluntary recall

People with rare diseases sometimes have difficulty with the availability of the prescription drugs approved to treat their condition. This is true if they live in Connecticut or some other state. Sufferers of Gaucher disease may be about to experience that issue. A drug used to combat the rare condition was recalled recently by its manufacturer, Shire.

The drug, Vpriv, was recalled when Shire officials discovered portions had been contaminated with particulate matter. The particulate was located in three different lots of the drug. All came from a single batch, according to Shire representatives.

FDA warns sexual enhancement supplement could cause serious harm

Connecticut readers of this blog may be interested to learn that the Food and Drug Administration has issued a warning that a supplement taken to enhance male sexual performance could be dangerous. They claim the supplement, which is known as Weekend Warrior, has an ingredient similar to what is found in the prescription medication, Viagra. They say this could harm its users, who may take the supplement without understanding the risks involved.

Weekend Warrior is marketed as an effective way to purchase pharmaceutical grade medication from a website or retail store without a prescription. Along with the list of ingredients, the label lists warnings about using the supplement. These include its contraindication for men with high blood pressure or a history of heart disease.

Should listings of dangerous and defective drugs include Zohydro?

Connecticut readers may be interested to learn about the prescription pain killer, Zohydro, which generated mixed response when it received approval from the Food and Drug Administration. Some say the hydrocodone-based pain pill is a godsend for those who suffer. Others say it should be included on rosters listing dangerous and defective drugs.

The FDA approved Zohydro last year. The medication is used to treat those patients who are suffering from chronic pain. It is scheduled to be available for purchase next month.

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