Tag Archives: hepatitis C drugs

Quick Hits: New Breast Cancer Drugs Have Fewer Side Effects, Antidepressant Use in Pregnancy and Autism & More

A new class of oral drugs for treating the most common type of breast cancer, known as cyclin-dependent kinase (CDK) inhibitors, appears to have fewer adverse events and side effects for most patients compared to other treatments. There are 2 CDK inhibitors currently on the market: Ibrance (palbociclib), approved in February 2015, and Kisqali (ribociclib), which was just approved in March. Both are used to treat hormone receptor-positive (HR+) metastatic breast cancer. A third CDK inhibitor, abemaciclib, is in late-stage development. Researchers examined all publicly available trials for the 3 drugs. The most common side effect was low white blood cells, a condition known as neutropenia that can lead to infection, though it was seen less in abemaciclib. However, neutropenia was usually temporary or resolved with a dose reduction. Other, more common side effects seen with the medications were diarrhea and fatigue. Less common side effects observed were nausea and alopecia (hair loss), though these were mild and treated through a dose reduction or a break from the drug. Posted July 14, 2017. Via The Oncologist.

Children exposed to antidepressants during pregnancy may have a slightly higher risk of developing autism than children of mothers with mental illness who didn’t receive the drugs. Researchers, however, stress that the absolute risk of autism was small, so the results should not be considered alarming. A team at the University of Bristol (UK) analyzed data from 254,610 individuals aged 4-17 of which 5,378 had autism. Of the 3,342 children exposed to antidepressants during pregnancy, 4.1% (136) had a diagnosis of autism compared with 2.9% (353) in 12,325 children not exposed to antidepressants whose mothers had a history of a psychiatric disorder. Researchers noted that overall, 95% of women who took antidepressants did not have a child with autism. An accompanying editorial noted that the results should not dissuade women with depression from using antidepressants in pregnancy since untreated depression can lead to “ substantial health consequences.” Posted July 19, 2017. Via The BMJ.

The FDA has approved a new hepatitis C (HCV) medication, Vosevi. The drug is actually a combination of two existing anti-viral treatments, sofosbuvir and velpatasvir (sold as Epclusa), and a new drug, voxilaprevir. Vosevi is for patients with HCV without liver disease (cirrhosis) or with a mild form of cirrhosis. Results from 2 late-stage trials demonstrated that 96-97% of patients who received Vosevi had no HCV detected in their blood 12 weeks after finishing treatment, an indication the infection has been cured. The most common side effects in patients taking Vosevi were headache, fatigue, diarrhea and nausea. Posted July 18, 2017. Via FDA.


Quick Hits: Teething Tablets Warning, Cutting Back on Opioid Painkiller Production, & More

Parents should avoid giving infants homeopathic teething tablets and gels due to potential risks, including seizures. The FDA, which issued a safety alert about the products in 2010, said that medical attention should be sought immediately if a child experiences seizures, difficulty breathing, lethargy, excessive sleepiness, muscle weakness, skin flushing, constipation, difficulty urinating or agitation while using the pills or gels. The FDA also notes that the products have not been evaluated by the agency for safety and efficacy, and there is no proven health benefit associated with them. In 2010, an FDA analysis found that Hyland’s Teething Tablets contained inconsistent amounts of belladonna, a plant that has sedative properties. The agency noted at the time it had received reports of serious adverse events in children that took the Hyland’s product consistent with belladonna toxicity. Posted September 30, 2016. Via FDA.

The DEA (Drug Enforcement Agency) is mandating a cut in the production of opioid painkillers in the U.S. Beginning in 2017, 25% fewer pills of drugs such as OxyContin (oxycodone), fentanyl and morphine will be manufactured. Vicodin (hydrocodone) production will be reduced by 34%. The DEA noted that although the number of prescriptions for opioids has declined in recent years, abuse of the drugs has increased. The 2015 National Survey on Drug Use and Health, released last month, found 6.5 million Americans aged 12 and older took controlled substance medicines for non-medical purposes in the past month. Posted October 4, 2016. Via DEA.

The FDA is requiring a “black box” warning for certain hepatitis C drugs amid reports that the medications can lead to reactivation of hepatitis B. The agency says it has identified reports of at least 24 people who received the hep C drugs between November 2013 and July of this year who saw a resurgence of hep B that had been eliminated after taking the medications, such as Harvoni (ledipasvir and sofosbuvir), Epclusa (sofosbuvir and velpatasvir) and Viekira. Of these 24 cases, 2 patients died and 1 required a liver transplant. The FDA is recommending that doctors screen patients for current or prior hep B infection before starting hep C therapy and monitor patients on the drugs for hep B flare-ups with blood tests. Posted October 5, 2016. Via FDA.

Adverse drug event data is available: Why isn’t it being used?

According to Brian Overstreet, “there are significant differences in adverse events among the six current Hepatitis C drugs. The rate of hospitalization associated with Incivek, for example, is nearly 21 times higher than treatment with either Harvoni or Sovaldi. This means while the price of Incivek is cheaper, Harvoni and Sovaldi may be safer and ultimately less expensive when you factor in total costs, including what Medicaid may have to pay long term for patients affected by negative side effects.” Via The Hill. Posted July 29, 2015.
–Alanna McCatty