Adverse Reactions

FDA Warns of Compounding and Dosing Errors with Injectable Semaglutide Products

October 30, 2024 | Lebowitz & Mzhen

The United States has become increasingly heavier over the past half century — overall obesity rates have increased three-fold since the 1960s. Currently, more than two-thirds of U.S. residents are now, by definition, overweight with those individuals qualifying as obese making up more than 40 percent of the population. Even more disturbing is the fact that one in ten individuals meet the medical criteria for a person who is morbidly obese, which can be a life-threatening condition if not counteracted by a change of diet and exercise.

Sadly, this increase in national obesity hasn’t happened overnight; in fact, it’s been a gradual and relentless process that has seen the number of overweight individuals in this country tripling over the past 60 years. Furthermore, the incidence of severe (morbid) obesity has increased ten-fold since the 1960s, and shockingly the figures may actually be an underestimation of this nationwide problem. Here in Maryland, the obesity rate is slightly below the national average at 34.3 percent as of 2021, but that is hardly any consolation.

With such a large number of overweight individuals in the U.S., dieting and nutritional advice has become big business over the past several decades. So many people, hoping to shed excessive weight quickly and with less effort, have fueled an entire industry of weight loss programs, supplements and prescription drugs. Enter Semaglutide, an FDA-approved pharmaceutical marketed by Novo Nordisk under several different brand names, which is being used to help patients with Type 2 diabetes and chronic obesity. This latest answer to the country’s obesity epidemic has shown great promise since its introduction several years ago, but as with many medications there are potential pitfalls and dangers facing those who take advantage of this breakthrough drug.

Maryland Pauses Administration of Johnson & Johnson Vaccine

April 20, 2021 | Lebowitz & Mzhen

Maryland, along with every other state in the U.S., paused the use of Johnson & Johnson’s coronavirus vaccine last week after six recipients of the vaccine in the country experienced a rare blood-clotting disorder. Over seven million people have received Johnson & Johnson’s vaccine in the United States so far. The six people who experienced the clotting disorder were women between 18 and 48 and experienced the disorder within three weeks of receiving the vaccine. In those cases, the blood clots occurred in the brain, and the women all showed low levels of platelets. One woman died from the illness. In a step to reduce Maryland vaccine errors and adverse reactions, Maryland’s Department of Health decided to pause the use of the Johnson & Johnson vaccine in the state “out of an abundance of caution.”

The AstraZeneca vaccine, which has been distributed in Europe, also had cases of individuals with blood clotting, which were “very, very similar” to the Johnson & Johnson clotting cases, one expert noted. Both vaccines use similar technology. A government committee will meet to evaluate further use of the Johnson & Johnson vaccine. The Centers for Disease Control said that individuals who have received the Johnson & Johnson vaccine in the past month should reach out to their doctors if they have abdominal pain, shortness of breath, leg pain, or severe headaches. Health officials reported that the people who experienced the clotting disorder most commonly had a persistent, moderate to severe headache that started six days or later after receiving the shot.

Can Victims of a Vaccine Error Recover Financial Compensation from a Pharmacy?

Yes, individuals who experience vaccine errors or adverse reactions may be able to recover compensation from the administrator or manufacturer of the vaccine in some cases. A Maryland vaccine error claim based on negligence requires a showing that the defendant owed the individual a duty, the defendant failed to meet the relevant standard of care, the defendant’s negligent conduct caused the individual’s injuries, and the individual suffered damages. These cases can be complicated and often must rely on the testimony of experts to explain the link between the error and the injuries the individual suffered. Victims of a vaccine or medication error may be able to receive financial compensation for past and future medical expenses, loss of wages and earning capacity, and other damages depending on their circumstances. A negligence claim in Maryland has to be filed within three years after the date of the injury.

Maryland Patients Should Be Cautious of Adverse Interactions Between Prescription Drugs and Over-the-Counter Supplements

June 26, 2019 | Lebowitz & Mzhen

Prescription drugs are designed to make people feel better. However, each year, thousands of people suffer adverse reactions when they take certain substances at the same time. These events are referred to as adverse interactions. Often, the most dangerous Maryland drug interactions are between two prescription substances; however, as a recent article points out, prescription medication can also interact with over-the-counter supplements.

Supplements exist in a bit of a legal and regulatory gray area in that they are not FDA-approved to treat or diagnose any condition. In fact, the FDA is specifically prohibited from reviewing supplements for safety or efficacy. Thus, what consumers get when they purchase a supplement is somewhat a mystery and can vary depending on the manufacturer.

While the information provided by a supplement manufacturer is likely based on some type of study or belief, it is not scientifically proven. And because the FDA does not regulate supplements, there is no consistency in how they are manufactured. This means supplements that are marketed under the same name but sold by different manufacturers can have drastically different ingredients. There can even be inconsistencies between batches of supplements from the same manufacturer.

Maryland Pharmacy Errors Caused by Medications with Adverse Interactions

June 12, 2019 | Lebowitz & Mzhen

Included among the responsibilities of a Maryland pharmacist is the duty to ensure that the medication provided to a patient does not negatively interact with the patient’s other prescriptions. Prescription medications contain powerful drugs and many prescription medications should not be taken with other prescription medication or even over-the-counter medications.

There are several types of drug interactions, including pharmacodynamic and pharmacokinetic interactions. A pharmacodynamic interaction occurs when two medications that react with the same receptor site are taken at the same time. Pharmacodynamic interactions result in the ingested medications having a greater (synergistic) or decreased (antagonistic) effect, depending on the specific medications involved. Pharmacodynamic interactions can be fatal.

Pharmacokinetic interactions occur when one drug affects the body’s ability to absorb, metabolize, distribute, or eliminate another medication. For example, calcium can bind to some medications, reducing their absorption. Thus, patients are advised not to take the HIV medication Tivicay at the same time as Tums because the calcium in Tums can lower the amount Tivicay that is absorbed into the patient’s system. In this situation, doctors suggest patients take the two medications at staggered times throughout the day.

Statutes of Limitations in Maryland Pharmacy Error Cases

January 23, 2019 | Lebowitz & Mzhen

Maryland personal injury plaintiffs risk having their cases dismissed if they fail to file their claims within the applicable statute of limitations. In a recent case before a state appellate court, the court dismissed the pharmaceutical claim for failing to timely file a claim.

The plaintiff had filed a lawsuit against pharmaceutical companies, alleging that they were liable for his gambling and other losses because he suffered from obsessive-compulsive disorder as a result of taking Mirapex. Mirapex is an FDA-approved medication used to treat Parkinson’s disease, which the plaintiff began taking in 2006 to treat his Parkinson’s disease. After taking it for two years, he told his doctor that he was experiencing increased compulsive behaviors, including gambling. His doctor told him there was a possible association between Mirapex and compulsive behaviors. The plaintiff raised the issue with his doctor several months later. The plaintiff’s family eventually learned of substantial debts resulting from his gambling, at which point the doctor told the plaintiff not to take Mirapex anymore, advising him to use other therapeutic options instead.

When the plaintiff filed the lawsuit against the drug’s manufacturers, the companies claimed that the lawsuit was time-barred, arguing that the plaintiff filed the case after the two-year statute of limitations for personal injury claims under state law. The plaintiff did not dispute that he knew or should have known that he had been wronged by the defendant by April 23, 2008, after discussing the effects of Mirapex with his doctor on more than one occasion. However, he did not file the claim until December 2010. The plaintiff argued that the statute of limitations was tolled until July 2010, because he continued taking Mirapex until that time, and because “continuing violations” are not time-barred. Under that state’s law, a personal injury claim must be filed within two years. However, under what it calls the “continuing accrual” principle, in continuing or recurring liability cases, “a cause of action accrues each time a wrongful act occurs,” which means that the statute of limitations begins again for that act.

How a Physician May Be Responsible for a Maryland Pharmacy Error

April 16, 2018 | Lebowitz & Mzhen

Most Maryland pharmacy errors occur when an overworked pharmacist receives a correct prescription from a physician and makes an error in filling the prescription. Commonly, these errors include filling the wrong dose of the correct medication, providing the patient with the wrong administration instructions, or filling the prescription with the wrong drug. However, some prescription errors result from a negligent or reckless physician.

Both doctors and pharmacists owe a duty of care to their patients when it comes to prescription medication. However, these duties differ slightly, and for good reason. A pharmacist has no control over the medication a doctor prescribes to his patient, and a doctor has no control over the accuracy of the pharmacist. However, in some cases, these duties overlap.

In a recent article, one pharmacist recounts an error that was made just a few years after he had graduated from pharmacy school. The pharmacist, relatively new at the time, was asked by a physician to prescribe an adult dose of medication to a child. When the pharmacist questioned what he believed to be too high a dose for a child, the doctor assured the pharmacist that it was appropriate because the child was “adult-sized.”

The Importance of Adequate Warnings on Prescription Medications in Maryland

February 8, 2018 | Lebowitz & Mzhen

Manufacturers of pharmaceutical drugs – like other products – are responsible for the products they market and release to the public. Some drugs pose a serious health risk due to potential negative interactions with other commonly taken medications, other medications are easily abused and can lead to dependence or addiction, and many pharmaceuticals can have serious side effects when taken improperly.

In general, the manufacturer of a medication is responsible to include an adequate warning, fully disclosing the risks involved with taking the medication. If a drug manufacturer fails to include an adequate warning with their product, they may be held liable for any injuries caused to those who take the medication through a Maryland product liability lawsuit.

Testosterone-Therapy Drugs

Testosterone-therapy drugs have been available for decades, and until recently, they have primarily been prescribed to younger men with low testosterone production. However, over the past few years, doctors have been prescribing testosterone-therapy drugs to older men. These medications, however, are not without their risks.

Adverse Reactions to Prescription Medication

June 8, 2017 | Lebowitz & Mzhen

The availability of prescription medication is restricted and controlled by the government for good reason. In most cases, prescription medications are powerful drugs that, while they do have the power to heal, also have the potential to cause serious adverse effects in some patients.

In some cases, medications are only available through a prescription because that specific medication presents an increased risk of abuse. However, some drugs pose no real potential for abuse but are controlled due to the serious effects they may have on the patient. Of course, this includes situations in which the patient is taking other prescription medication, as well as cases in which the patient is prescribed only one medication. The reality is that even with the advancement of medicine, doctors and pharmacists cannot always know how a patient’s body will react to a certain medication.

In general, doctors and pharmacists have a duty to ensure that the medication they are providing to a patient is not known to be dangerous. This means that a pharmacist should not substitute generic medication for name-brand drugs unless the physician specifically allows for such a substitution. It also means that pharmacists should be double-checking which medications a patient is taking before providing a new medication that may adversely react with an existing one.