LAVAL, Quebec, March 24, 2020 /PRNewswire/ -- Bausch Health Companies Inc. (NYSE/TSX: BHC) ("Bausch Health" or the "Company") today outlined several initiatives the Company is taking to contribute to the fight against COVID-19 (coronavirus).
"Bausch Health is actively donating medicines and health care products to assist in the global fight against COVID-19 while also pursuing research to determine if products in our existing portfolio may offer valuable treatment options," said Joseph C. Papa, chairman and CEO, Bausch Health. "In line with our mission of improving people's lives with our health care products, we will continue to seek opportunities to offer support and aid to the institutions, patients and health care providers battling this pandemic."
- In Europe, the Company is ramping up the manufacturing of chloroquine and azithromycin and is seeking emergency access in certain countries with the goal of donating these products where and when needed.
- In Italy, the Bausch Foundation is making available for donation its antiviral VIRAZOLE® (Ribavirin for Inhalation Solution, USP) for nebulization in compassionate use in Italian hospitals.
- In Spain, the Bausch Foundation is making available for donation ARTELAC® Splash™ eye drops for use in local hospitals.
- In the United States, the Company's gastroenterology business Salix Pharmaceuticals is working with key opinion leaders to initiate investigative trials to evaluate XIFAXAN® (rifaximin) in combination with established therapies, supportive care and other investigative therapies to potentially address the symptoms of gastrointestinal distress and pulmonary compromise associated with COVID-19 infection. If the trials demonstrate XIFAXAN is successful in resolving these symptoms or reducing the duration of COVID-19, the Bausch Foundation will donate XIFAXAN to various hospitals.
- In Wuhan, China, health care providers treating patients with COVID-19 reported that they were hindered by fogging eyeglasses while wearing protective gear, such as goggles, face masks and containment suits. The Company's global eye health business Bausch + Lomb responded by donating Biotrue® ONEday daily disposable contact lenses to these health care providers.
- At its Jinan, China production facility, Bausch + Lomb is converting an available production line to produce hand sanitizer that will be donated for health care providers, first responders and volunteers.
- The Bausch Health Patient Assistance Program (PAP) continues to ensure that eligible U.S. patients in need who lack health insurance coverage for certain Bausch Health medicines are able to access their prescription medicines. During this time when many health care offices are not operating on regular schedules, the PAP has increased its efforts to work with patients and physicians' offices to ensure patients have uninterrupted access to their medicines.
VIRAZOLE® (Ribavirin for Inhalation Solution, USP) is indicated for the treatment of hospitalized infants and young children with severe lower respiratory tract infections due to respiratory syncytial virus (RSV). Treatment early in the course of severe lower respiratory tract infection may be necessary to achieve efficacy. Only severe RSV lower respiratory tract infection should be treated with VIRAZOLE. The vast majority of infants and children with RSV infection have disease that is mild, self-limited and does not require hospitalization or antiviral treatment.
Use of aerosolized VIRAZOLE in patients requiring mechanical ventilator assistance should be undertaken only by physicians and support staff familiar with the specific ventilator being used and this mode of administration of the drug. Strict attention must be paid to procedures that have been shown to minimize the accumulation of drug precipitate, which can result in mechanical ventilator dysfunction and associated increased pulmonary pressures.
Sudden deterioration of respiratory function has been associated with initiation of aerosolized VIRAZOLE use in infants. Respiratory function should be carefully monitored during treatment. If initiation of aerosolized VIRAZOLE treatment appears to produce sudden deterioration of respiratory function, treatment should be stopped and reinstituted only with extreme caution, continuous monitoring and consideration of concomitant administration of bronchodilators.
VIRAZOLE is not indicated for use in adults. Physicians and patients should be aware that ribavirin has been shown to produce testicular lesions in rodents and to be teratogenic in all animal species in which adequate studies have been conducted (rodents and rabbits).
IMPORTANT SAFETY INFORMATION (cont.)
- VIRAZOLE is contraindicated in individuals who have shown hypersensitivity to the drug or its components, and in women who are or may become pregnant during exposure to the drug. Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted (rodents and rabbits).
- Deaths during or shortly after treatment with aerosolized VIRAZOLE have been reported in 20 cases of patients treated with VIRAZOLE (12 of these patients were being treated for RSV infections).
- Events associated with aerosolized VIRAZOLE use have included the following: Pulmonary: Worsening of respiratory status, bronchospasm, pulmonary edema, hypoventilation, cyanosis, dyspnea, bacterial pneumonia, pneumothorax, apnea, atelectasis and ventilator dependence. Cardiovascular: Cardiac arrest, hypotension, bradycardia and digitalis toxicity. Bigeminy, bradycardia and tachycardia have been described in patients with underlying congenital heart disease.
- Anemia has been shown to occur frequently with experimental oral and intravenous VIRAZOLE in humans. Also, cases of anemia (type unspecified), reticulocytosis and hemolytic anemia associated with aerosolized VIRAZOLE use have been reported through post-marketing reporting systems.
- Rash and conjunctivitis have been associated with the use of aerosolized VIRAZOLE. Seizures and asthenia associated with experimental intravenous VIRAZOLE therapy have also been reported.
- Adverse Events in Health Care Workers
- Exposure to aerosolized VIRAZOLE in health care workers administering care to patients receiving the drug can cause adverse events which may be severe or serious in nature. Please see Prescribing Information for more detail.
- 152 health care workers have reported experiencing adverse events through post-marketing surveillance. Of 358 events from these 152-individual health care worker reports, the most common signs and symptoms were headache (51% of reports), conjunctivitis (32%), and rhinitis, nausea, rash, dizziness, pharyngitis, or lacrimation (10 – 20% each). Several cases of bronchospasm and/or chest pain were also reported. Most signs and symptoms reported as having occurred in exposed health care workers resolved within minutes to hours of discontinuing close exposure.
- Ribavirin has demonstrated significant teratogenic and/or embryocidal potential in all animal species in which adequate studies have been conducted. Although clinical studies have not been performed, VIRAZOLE may cause fetal harm in humans. Hospitals are encouraged to conduct training programs to minimize potential occupational exposure to VIRAZOLE. Health care workers who are pregnant should consider avoiding direct care of patients receiving aerosolized VIRAZOLE. If close patient contact cannot be avoided, precautions to limit exposure should be taken.
To report SUSPECTED ADVERSE REACTIONS, contact Bausch Health Companies Inc. at 1-800-321-4576 or the U.S. Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.
Please click here for full Prescribing Information.
XIFAXAN® (rifaximin) 550 mg tablets are indicated for the treatment of irritable bowel syndrome with diarrhea (IBS-D) in adults and for the reduction in risk of overt hepatic encephalopathy (HE) recurrence in adults.
XIFAXAN is not FDA-approved for use in COVID-19 patients.
IMPORTANT SAFETY INFORMATION
- XIFAXAN is contraindicated in patients with a hypersensitivity to rifaximin, rifamycin antimicrobial agents, or any of the components in XIFAXAN. Hypersensitivity reactions have included exfoliative dermatitis, angioneurotic edema, and anaphylaxis.
Clostridium difficile-associated diarrhea (CDAD) has been reported with use of nearly all antibacterial agents, including XIFAXAN, and may range in severity from mild diarrhea to fatal colitis. If CDAD is suspected or confirmed, ongoing antibiotic use not directed against C. difficile may need to be discontinued.
- There is an increased systemic exposure in patients with severe
(Child-Pugh Class C) hepatic impairment. Caution should be exercised
when administering XIFAXAN to these patients.
- Caution should be exercised when concomitant use of XIFAXAN and
P-glycoprotein (P-gp) and/or OATPs inhibitors is needed. Concomitant
administration of cyclosporine, an inhibitor of P-gp and OATPs,
significantly increased the systemic exposure of rifaximin. In patients
with hepatic impairment, a potential additive effect of reduced
metabolism and concomitant P-gp inhibitors may further increase the
systemic exposure to rifaximin.
- In clinical studies, the most common adverse reactions for XIFAXAN in IBS-D (≥2%) were nausea (3%) and ALT increased (2%).
- In clinical studies, the most common adverse reactions for XIFAXAN
in HE (≥10%) were peripheral edema (15%), nausea (14%), dizziness (13%),
fatigue (12%), and ascities (11%).
- INR changes have been reported in patients receiving rifaximin and
warfarin concomitantly. Monitor INR and prothrombin time. Dose
adjustment of warfarin may be required.
- XIFAXAN may cause fetal harm. Advise pregnant women of the potential risk to a fetus.
To report SUSPECTED ADVERSE REACTIONS, contact Salix Pharmaceuticals at 1-800-321-4576.
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch, or call 1-800-FDA-1088.
Please click here for full Prescribing Information.
About the Bausch Foundation
The Bausch Foundation was established in 2017 to improve the lives of patients globally by providing access to safe, effective medicines and by financially supporting health care education and causes around the world. Since its inception, the Bausch Foundation has contributed millions of dollars' worth of financial and product donations to global charitable health organizations.
About Bausch Health
Bausch Health Companies Inc. (NYSE/TSX: BHC) is a global company whose mission is to improve people's lives with our health care products. We develop, manufacture and market a range of pharmaceutical, medical device and over-the-counter products, primarily in the therapeutic areas of eye health, gastroenterology and dermatology. We are delivering on our commitments as we build an innovative company dedicated to advancing global health. More information can be found at www.bauschhealth.com.
This news release contains forward-looking statements, which may generally be identified by the use of the words "anticipates," "expects," "intends," "plans," "should," "could," "would," "may," "believes," "estimates," "potential," "target," or "continue" and variations or similar expressions. These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties discussed in the Company's most recent annual report on Form 10-K and detailed from time to time in Bausch Health's other filings with the U.S. Securities and Exchange Commission and the Canadian Securities Administrators, which factors are incorporated herein by reference. They also include, but are not limited to, risks and uncertainties caused by or relating to the evolving COVID-19 pandemic, and the fear of that pandemic and its potential effects, the severity, duration and future impact of which are highly uncertain and cannot be predicted, and which may have a material adverse impact on the Company, including but not limited to its supply chain, third party suppliers, project development timelines, and costs (which may increase) and revenue and margins (both of which may decrease). Readers are cautioned not to place undue reliance on any of these forward-looking statements. These forward-looking statements speak only as of the date hereof. Bausch Health undertakes no obligation to update any of these forward-looking statements to reflect events or circumstances after the date of this news release or to reflect actual outcomes, unless required by law.