While the pharmaceutical industry has made tremendous advances in new drug development this year, FDA has also had to remove drugs from the market or investigate problem drugs. Here are the top 3 drug warnings and problems so far in 2018.
While the pharmaceutical industry has made tremendous advances in new drug development this year, FDA has also had to remove drugs from the market or investigate problem drugs.
Here are the top 3 drug warnings and issues so far in 2018.
AbbVie and Biogen recalled daclizumab (Zinbryta) worldwide for relapsing MS because “the companies believe that characterizing the complex and evolving benefit/risk profile of Zinbryta will not be possible going forward, given the limited number of patients being treated,” the two companies said in a statement.
The European Medicines Agency (EMA) called for an urgent review of the drug after 7 patients in Germany and 1 patient in Spain experienced encephalitis and/or meningoencephalitis (brain inflammation).
2. FDA said in late April that it is re-examining the safety of a breakthrough Parkinson’s disease drug after reports of hundreds of deaths.
Pimavanserin (Nuplazid, Acadia Pharmaceuticals), the only drug approved to treat hallucinations and delusions associated with Parkinson's disease psychosis, is suspected in hundreds of deaths voluntarily reported by caregivers, doctors and other medical professionals since it hit the market, CNN reported.
"What does it take for a drug like this to be taken off the market?" asked US Rep. Rosa DeLauro, former chair of the congressional subcommittee responsible for funding and overseeing FDA, at a recent Congressional hearing, CNN reported. "How many more adverse events do we have to have reported? How many people, quite frankly, have to die?” DeLauro asked FDA Commissioner Scott Gottlieb, MD, at the hearing.
However, FDA had already begun conducting a new review of the drug because of "potential signals of serious risk/new safety information" in part by using adverse event data, CNN reported.
Death reports citing Nuplazid have typically involved elderly patients with advanced-stage Parkinson's disease who suffered from numerous medical conditions, according to FDA.
3. Earlier this year, FDA added a Boxed Warning, its most prominent warning, on the liver disease medicine obeticholic acid (Ocaliva, Intercept Pharmaceuticals).
Ocaliva has been incorrectly dosed daily, instead of weekly, in patients with moderate to severe primary biliary cholangitis (PBC), a rare chronic liver disease, increasing the risk of serious liver injury, FDA said in a MedWatch Safety Alert.
“FDA is adding the additional warnings to the drug label after receiving reports that Ocaliva is being given to PBC patients with moderate to severe liver impairment more often than is recommended in the prescribing information, resulting in liver decompensation, liver failure, and sometimes death,” FDA said in the Alert.
Read more: FDA reviewing safety of Parkinson’s drug