Tamiflu: Legal Information and Lawsuits

Tamiflu (oseltamivir phosphate) is an antiviral drug to treat the flu in adults, teens, and children over one. Patients should take Tamiflu within 48 hours of noticing flu symptoms.

People also take Tamiflu after being in close contact with someone who has the flu. It’s also helpful to take this medication during a flu outbreak. This decreases the risk of getting the flu virus. This medication can also treat and prevent bird flu or avian influenza.

The U.S. Food and Drug Administration (FDA) approved Tamiflu in 1999. The manufacturer of Tamiflu is Roche Laboratories, Inc.

Here, we’ll provide an overview of Tamiflu, including its side effects and potential health risks.

However, concerns about the drug’s health risks and side effects have prompted FDA action and product liability litigation. This article discusses recent news, research, and lawsuits involving Tamiflu. You’ll also learn what to do if you become sick after taking this medication.

A local attorney can offer targeted legal advice and explain your legal options. If you have a valid legal claim against Roche Labs or another drug company, your attorney will be your fiercest advocate for fair compensation.

What Is Tamiflu?

Tamiflu (oseltamivir) is an antiviral medication that prevents the influenza virus. It’s generally safe for adults and children over the age of 12. Genentech, Inc. and Roche Labs manufacture and sell Tamiflu. People worried about catching influenza A or B can take this drug to prevent illness.

Technically, Tamiflu is an antiviral medication and prophylaxis drug. It’s a neuraminidase inhibitor (NAI) and inhibits the actions of both types of flu. People with the virus can take the drug to help relieve their flu-like symptoms. The medication can also be beneficial in treating influenza.

Tamiflu is available in oral suspension (liquid). You can also choose to take Tamiflu capsules.

Can You Get Tamiflu Over the Counter?

No. According to the Centers for Disease Control and Prevention (CDC), Tamiflu is only available with a prescription. But in 2019, Sanofi signed a deal with Genentech, a subsidiary of the Roche Group, to market an over-the-counter (OTC) version.

But before that happens, Sanofi must conduct clinical studies to determine the safety of an OTC version of Tamiflu. The FDA will want to see if the OTC drug has severe side effects. They’ll also want to know if Tamiflu works as an OTC medication.

Reducing the Spread of the Flu

Tamiflu is taken for flu prevention. But even if you take Tamiflu, you must avoid unnecessary exposure to influenza by taking certain precautions.

Contact your healthcare professional if you develop new symptoms or if your influenza symptoms don’t improve after taking Tamiflu. Some infections can occur with influenza and will require treatment. Ask your doctor if you should get the flu vaccine. The influenza vaccine is a great way to stay healthy during flu season.

Other precautions to take include the following:

• Wash your hands frequently
• Avoid touching your nose, mouth, and eyes
• Avoid sharing silverware and drinks during the flu season
• Stay home from work or school if you are sick to avoid infecting others

Tamiflu may not be enough to prevent hospitalization for people with a weakened immune system. Stay in contact with your healthcare professional if your symptoms worsen. The same applies to pregnant women and patients with a higher risk of contracting influenza.

Will Taking Tamiflu Prevent Me From Spreading the Flu?

Taking Tamiflu can reduce your chances of getting the flu, but it will not stop you from giving it to others. To prevent the spread of the flu, wash your hands frequently and avoid situations such as sharing cups and utensils.

Should I Still Get the Flu Vaccine?

Yes. Tamiflu does not replace the flu vaccine. You should continue to receive your annual flu shot if recommended by your healthcare professional.

What Should I Know Before Taking Tamiflu?

Researchers haven’t assessed Tamiflu’s safety and effectiveness in people with:

• Chronic heart disease
• Chronic lung disease
• Kidney failure
• Underlying high-risk medical conditions

Tamiflu does not help prevent flu-like illnesses caused by viruses other than influenza A and B.

Other infections similar to influenza require different types of treatment. Experts do not recommend Tamiflu for pediatric patients less than one year of age.

What Should I Tell My Doctor Before They Prescribe Tamiflu?

Before you take Tamiflu, talk to your healthcare professional. They need specific information to ensure you don’t have an adverse reaction to the medication.

Specifically, inform your doctor of the following if you:

• Are allergic to Tamiflu or any of its ingredients
• Are allergic to any other medications or substances
• Take (plan to take) any other prescription and nonprescription medications
• Take vitamins, nutritional supplements, and herbal products
• Have taken Tamiflu before
• Are immunocompromised (have HIV or AIDS)
• Take immunosuppressant medications, cancer chemotherapy medications, methotrexate, sirolimus, oral steroids, or tacrolimus
• Have heart, lung, or kidney disease
• Are pregnant, trying to become pregnant, or are breastfeeding

This information will help prevent any adverse drug interactions.

Tamiflu’s Side Effects

As with other medications, Tamiflu carries several adverse side effects. Some of the most common side effects of taking this medication include:

• Skin rash
• Nausea
• Vomiting
• Sore throat
• Diarrhea
• Headaches
• Trouble breathing

Another serious side effect of Tamiflu is thoughts of self-harm. People taking this antiviral medication are at an increased risk of experiencing a risk of self-injury.

Tamiflu and the Risk of Self-Injury

In November 2006, Roche Laboratories and the FDA notified healthcare providers and patients of revisions to the information about Tamiflu provided to patients. The FDA and drugmaker changed the “Precautions/Neuropsychiatric Events and Patient Information” sections of the prescribing information.

The FDA suggested these changes after reports of self-injury and delirium allegedly caused by Tamiflu use. The FDA stated that there isn’t sufficient evidence showing that Tamiflu causes self-injury or hallucinations. But the drug manufacturer, Genentech, advised parents to beware of abnormal behavior in children and adolescents taking the drug.

People, especially children, who already have influenza may be at risk of self-injury and confusion soon after taking Tamiflu. Parents should monitor young people taking Tamiflu for signs of confusion, self-harm, and other unusual behavior.

Many parents still worry about this side effect of Tamiflu. In 2018, a 16-year-old boy in Indiana allegedly killed himself after taking Tamiflu. His parents said he had no suicidal tendencies before taking the drug.

May 2022: Tamiflu May Help Fight COVID-19

In May 2022, the Annals of Medicine and Surgery published a study by Abolfazl Zendehdel et al. showing that oseltamivir phosphate helped increase recovery time for people with COVID-19. The drug decreased hospitalizations for COVID-19 patients as well.

Dec 2020: Questions About Tamiflu and COVID-19

Early studies suggest that Tamiflu does not help with COVID-19. A study in The BMJ reported that experts compared results from using Tamiflu to treat Swine flu (H1N1 Influenza) with those of COVID-19. The researcher argued that the government was selective in the clinical studies it used to support investment in Tamiflu. The claim was that the only studies supporting the use of this medication for the treatment of COVID-19 were clinical trials conducted by pharmaceutical companies. They claim this creates a conflict of interest, especially with controlled trials.

August 3, 2016: FDA Approves Generic Version of Tamiflu

In August 2016, the FDA approved a generic version of Tamiflu (oseltamivir phosphate). The FDA also reiterated that this medication is for people with flu symptoms for less than 48 hours. Beyond that, it will not prove beneficial. The FDA also reminded patients that Tamiflu and its generic versions differ from the flu vaccine.

April 2014: Oxford Study Suggests Tamiflu Cannot Prevent Influenza Pandemic

Researchers at Oxford argue that government stockpiles (strategic national stockpiles) of Tamiflu are senseless as the drug doesn’t help prevent an influenza pandemic. This research was part of the Cochrane Collaboration study. The study suggested that if the government was worried about public health, it needed all data regarding the drug. Once this information was available, researchers found that Tamiflu only shortened flu symptoms by about half a day.

November 27, 2007: Stronger Warnings Urged for Tamiflu

An FDA committee recommended that manufacturer Roche Laboratories, Inc. update Tamiflu labeling to include stronger warnings regarding the risk of psychiatric problems in users of the flu medicine. The FDA Pediatric Advisory Committee made its recommendations after evaluating reports of adverse events associated with prescription influenza medication. These events included delusions, confusion, and self-injury, especially in children and adolescents.

November 13, 2006: Tamiflu Prescribing Information Changed To Reflect Reports of Odd Behavior

Roche Laboratories, Inc. and the FDA notified healthcare professionals of revisions to Tamiflu’s prescribing information. The changes reflect primarily Japanese news reports of self-injury and delirium in patients who took Tamiflu.

Hold Drug Companies Accountable: Get Legal Help With Your Tamiflu Claim

While Tamiflu is popular, there is evidence that it may harm certain patients. If you or a loved one experiences dangerous symptoms or unusual medical conditions while using Tamiflu, contact your doctor. Then, consider meeting with a lawyer to discuss your options and to protect your rights.

Your attorney can help determine if you have a legal claim against your doctor or the manufacturer of Tamiflu. If you pursue legal action, they will help gather medical evidence, documentation, and expert testimony to help prove your claim. Pharmaceutical companies are well-resourced with teams of attorneys on their side. You’ll want expert legal help in your corner, too.

FindLaw’s directory of personal injury attorneys can get you started. Select your state or city to review contact and ratings information for local experts. Your search results will also link you to additional details about the attorneys’ experience with dangerous drug cases. Many law offices offer free case evaluations.