Tagged Articles

accidental exposure 6 articles

Drug company anticipates launch of new oral testosterone treatment

Clarus Therapeutics, an emerging men’s health specialty pharmaceutical company, filed with the Securities and Exchange Commission (SEC) this week to raise up to $86 million in an initial public offering. The biotech company is preparing for the commercial launch of REXTORO, an oral testosterone replacement therapy for which the company has submitted a New Drug Application with the Food and Drug Administration (FDA). If approved, REXTORO will be the first oral testosterone treatment available in the United States. The drug is intended to boost testosterone levels in men with low testosterone levels, also known as hypogonadism. The term “Low T” ... Read More

Five new black box warnings added to long-acting, extended-release opioid painkillers

Five new black box warnings are being added to the safety labels of extended-release and long-acting opioid painkillers, warning that the drugs are addictive, can cause life-threatening problems, and are easily abused and misused, the Food and Drug Administration (FDA) announced. Opioids are a potent class of painkillers that also give patients a feeling of euphoria, making them choice recreational drugs. The following brand-name drugs and their generic counterparts have updated labels reflecting the new warnings: Avinza (morphine sulfate) Extended-Release Capsules,
 Butrans (buprenorphine) Transdermal System, 
Dolophine (methadone hydrochloride) Tablets,
 Duragesic (fentanyl transdermal system), 
Embeda (morphine sulfate and naltrexone hydrochloride) Extended-Release ... Read More

Testosterone therapy linked to increased risk of heart attack, stroke, death

More and more men are using hormone treatments to up their low testosterone levels and enjoy more energy and a stronger libido as they enter midlife; however, the treatment may give them more than they bargained for. A new study of more than 8,700 older men has found that men who use a testosterone supplement were 30 percent more likely to have a stroke, heart attack or die. “Our findings raise some uncertainty regarding the potential safety of testosterone use in men,” authors of the study concluded. “It is important to inform patients that long-term risks are unknown and there ... Read More

FDA orders Fentanyl patches add more visible warnings of deaths from accidental exposure

The Food and Drug Administration (FDA) is requiring makers of Duragesic (fentanyl) pain patches to make warnings of deaths from accidental exposure to the patches more visible to remind patients and caregivers how dangerous the patches can be if they are not disposed of properly. Fentanyl is a powerful narcotic medication that is used to treat severe, ongoing pain that cannot be controlled with other medications. The drug is available in various forms including injection and nasal spray. The warning label requirement applies only to the transdermal patch, which is applied to the skin. The patches contain the medication and ... Read More

Accidental exposure to fentanyl skin patch can be deadly to kids

The Food and Drug Administration (FDA) is warning patients, caregivers and health care providers that accidental exposure to the skin patch containing the powerful painkiller fentanyl can be deadly, especially to young children, and that extra caution should be exercised for storing and disposing of the patches. The agency has received reports of young children who have died or become seriously ill from accidentally coming in contact with these skin patches. “These types of events are tragic; you never want this to happen. We are looking for ways that we can help prevent this from happening in the future,” says ... Read More

Accidental exposure to pain, nicotine, birth control patches can be deadly

Transdermal patches that administer medication through the skin can be dangerous and even deadly if children get their hands on them, according to government records. There are about 60 different kinds of drugs sold as patches in the United States, and they contain medications such as nicotine, painkillers and birth control hormones. Users simply apply the patches to the skin and then discard them after use. The patches work relatively well to deliver medication into the bloodstream without having to be swallowed or received intravenously. However, problems arise when those patches – used or new – get in contact with ... Read More