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Pharmaceutical Litigation And Personal Injury Law Blog

Novartis recalls the immunosuppresants Sandimmune and Neoral

The drug manufacturer Novartis recalled both its Neoral capsules and its Sandimmune immunosuppressants last week because of their potentially hazardous packaging. In their recall announcement, Novartis pointed out that they believe that the blister packs that the medications come in may be too easy for children to get into.

Both of the medications that have been recalled are immunodepressants. They are most commonly prescribed to transplant recipients to help reduce their risk of suffering an organ rejection post-surgery.

How the accelerated approval process for drugs works

The path for prescription drugs to get approved and introduced on the market here in the United States is a multi-level process. Its manufacturer must generally get the preliminary go-ahead from the U.S. Food and Drug Administration's (FDA) Center for Drug Evaluation and Research (CDER) before they can move forward with the critical testing stage. Some drugs get fast-tracked though thus bypassing stringent analysis of it though.

FDA guidelines allow for the introduction of some drugs to the market to be expedited. A manufacturer may apply for Accelerated Approval if they can show that the drug may have potential life-saving benefits. This is especially the case if it can help those suffering life-threatening conditions.

The feds say that the weight loss drug lorcaserin causes cancer

The U.S. Food and Drug Administration (FDA) issued a recall of a popularly prescribed weight loss medication last week. The federal agency did so after discovering that lorcaserin, a drug that is more commonly known by its brand name Belviq, may put patients who take it at a higher risk for developing cancer.

Lorcaserin was originally introduced on the market here in the U.S. in 2012. It was touted as a drug that could help obese individuals curb their appetites. It wasn't long after it was made available to patients that the FDA demanded that drug manufacturer conduct clinical trials for the drug.

What happens when the FDA recalls a medical device?

When a medical professional advises a patient to consent to the implantation of a medical device, it is because the doctor believes it will improve the health of the patient. The use of these devices is common, and patients trust that they will help with a specific medical condition. Unfortunately, they are not always safe, and it is necessary for the Food and Drug Administration to issue a recall.

The FDA decides when it is necessary to recall a medical device, drug or food product. There are different levels of recalls, and it can be smart for a patient with a medical device to be aware of how this process works. If you suffered because of a harmful or defective medical device, you could have grounds for a civil claim.

What dangers do inexperienced truckers pose?

Trucking companies have been warning of an impending problem for years. Veteran truck operators are retiring, and there are too few younger drivers looking to fill their spots. This has resulted in recruiters becoming less selective when making hiring decisions. Many of the truckers that they do hire lack experience. This concerns many traffic safety analysts.

Human resources officers at many trucking companies used to not give the resumes of truckers who've had their commercial driver's license (CDL) for two or fewer years a second look. They also used not to hire truckers who've had accidents or tickets. These companies have had to lower their standards to fill their vacancies though.

Johnson & Johnson must pay $340 million to pelvic mesh patients

A San Diego judge ordered the health care company Johnson & Johnson (J&J) to pay a staggering $340 million to the state for false or misleading advertising. The judge pointed that he believes that the J&J's subsidiary Ethicon purposefully neglected to warn both doctors and consumers of the dangers that the company's pelvic mesh product posed when announcing his ruling.

The California judge who presided over the case found that the company purposely left out certain side effects that the mesh posed from their product instructions. J&J also steered clear from referencing them when educating doctors and patients about any benefits and risks associated with having it implanted in them. The judge found that there were serious risks that J&J knew that the mesh posed, yet they intentionally kept such information to themselves.

Lamotrigine is recalled out of cross-contamination concerns

A single lot of Lamotrigine, a prescription medication that doctors prescribe to treat bipolar disorder and epilepsy, was recalled by its manufacturer on the U.S. Food and Drug Administration (FDA)'s urging on Jan. 10. The federal agency ordered the recall after a blood pressure and heart medication was found to have been cross-contaminated with the Lamotrigine tablets.

The cross-contamination of the Lamotrigine 100 milligram (mg) tablets was discovered by a consumer. They noted that the medicine, which also is sold to consumers as Lamictal, was listed as containing Enalapril Maleate on its label. That's the heart medication that's not supposed to be in the Lamotrigine.

What dangers are associated with a trucker having sleep apnea?

Data published recently by the trucking trade publication FreightWaves captures how only four percent of all Americans suffer from sleep apnea (SA). It shows how an alarming 35% of truckers suffer from the same condition though. This sleep disorder affects the quality of an individual's rest and makes them vulnerable to develop heart disease and other related conditions. It's dangerous enough out on the road without motorists being fatigued or unhealthy. This is why the fact that at least one-third of truckers are unwell is so alarming.

There are many different types of SA. Obstructive Sleep Apnea (OSA) is the most common type among truckers. It causes an individual's mouth palate and throat muscles to relax and subsequently collapse. This causes a blockage of an individual's airway.

Federal officials say that Metformin may contain a carcinogen

The U.S. Food and Drug Administration (FDA) confirmed earlier this month that they are looking into reports that researchers in other countries have found trace amounts of the carcinogen N-Nitrosodimethylamine (NDMA) in the prescription drug Metformin. The medication is commonly prescribed to patients who have previously been diagnosed with Type 2 Diabetes. It helps them regulate their blood sugar.

NDMA is a contaminate that is often found in grilled or cured meats, dairy products, water and vegetables. While scientists don't believe that the carcinogen poses any adverse health risk if individuals are exposed to it in small doses, they believe that it is dangerous if a person ingests any amount of the substance above the daily limit for an extended period.

What's the deadline for filing a TDF lawsuit?

TDF, or tenofovir disoproxil fumarate, is a drug designed to treat human immunodeficiency virus (HIV). Marketed by Gilead under the brand name Truvada (along with others), TDF drugs were seen as a first-line treatment for HIV.

The problem is that TDF drugs weren't nearly as safe as Gilead led doctors and patients to believe. Even though Gilead knew that TDF drugs caused osteoporosis, fractures, kidney damage, renal failure and even death, the company continued to promote the drugs to protect its profits -- while simultaneously keeping a much safer treatment, known as TAF drugs, off the market.

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