After a slew of criticism for the deteriorating quality of its products, Johnson and Johnson's new Hepatitis C drug, Simpeprevir, received a positive review from the U.S. Food and Drugs Administration (FDA).
In the past Johnson & Johnson has always been accredited for its superior product quality. However, of late, this has been questioned with the company having to recall more than four of its products in the last two months. Now, seems like the company is working hard to regain its customers' trust.
Johnson and Johnson's new Hepatitis C drug, Simpeprevir, received a positive review from the U.S. Food and Drugs Administration (FDA). The drug was reviewed and compared with two other Hepatitis C drugs, peginterferon-alpha and ribavirin, reports Reuters.
The drug has been labeled "Pregnancy Category C", which means that it is safe for use among pregnant women. FDA reviewers believe that Simpeprevir may have some benefits for pregnant women with Hepatitis C, even though the drug was found to have negative effects on animal fetus.
Clinical trials also reported that the drug has some side effects including photo sensitivity and rashes. The FDA plans on including this information in a warning label on the packet of the drug.
Hepatitis C infection is a leading cause of liver damage, liver cancer, and liver transplants in the United States. Millions of people in the country are infected with hepatitis C and many are unaware of their condition in large part because they may not have any symptoms. Pregnant women can pass on hepatitis C to their children. Statistics show that there is approximately a 1 in 20 chance that it could be passed on to a baby. It is also not recommended that women breast feed their babies if they test positive for hepatitis C.
Screening for hepatitis C can help people infected with the disease live longer, healthier lives. People born between 1945 and 1965 are commonly known as baby boomers, and according to previous reports they are five times more likely to be infected with Hepatitis C. Previous studies have also proven that if the infection is caught in time then treatment helps in lowering the risk of liver cirrhosis, cancer and death.
Last November, the U.S. Preventive Services Task Force (USPSTF) drafted a recommendation suggesting all middle aged adults should get themselves screened for Hepatitis C infection. As a follow up to the draft, the government-backed panel has issued a final recommendation statement in July this year strongly urging people to get tested. The statement also advises doctors to "consider offering screening" to Baby Boomers.