FDA adds boxed warning to propylthiouracil label
SILVER SPRING, Md. The Food and Drug Administration has added its strongest possible warning to a drug used to treat thyroid conditions amid reports of severe liver problems in patients using it, the agency announced Wednesday.
The FDA said it added a boxed warning to the label for propylthiouracil, a drug used to treat hyperthyroidism and Graves’ disease, conditions that cause goiters. The agency said it had received numerous reports of severe liver injury and acute liver failure, sometimes resulting in death, in adults and children.
The FDA approved the drug in 1947, and it is marketed as a generic. Pregnant women often use propylthiouracil during the first trimester due to possible risk of birth defects during that time from use of another drug for hyperthyroidism, methimazole, the FDA said. King Pharmaceuticals markets methimazole as Tapazole, though the drug also is available as a generic.
Sandoz to acquire Oriel Therapeutics
HOLZKIRCHEN, Germany Sandoz got its hands on a collection of generic drug candidates Monday as it agreed to acquire privately owned U.S. drug maker Oriel Therapeutics, the generics arm of Swiss drug maker Novartis said. Financial terms of the deal were not disclosed.
Oriel focuses on drugs for respiratory conditions, such as asthma and chronic obstructive pulmonary disease, and the deal gives Sandoz access to development projects such as Solis, a dry powder inhaler that uses Oriel’s FreePath drug-delivery technology.
“Oriel is a strong strategic fit with Sandoz, and the acquisition is expected to support our strategy of increasing the number of differentiated, higher-value products in our development pipeline,” Sandoz division head Jeff George said. “One of our strategic objectives is to offer fully substitutable generic versions of key branded medicines, including respiratory medicines.”
Emdeon affirms e-prescribing for controlled substances is a ‘practical necessity’
NASHVILLE, Tenn. Electronic prescribing network Emdeon is supporting the approval of security standards for e-prescribing of controlled substances, Emdeon said last week.
The company, which calls itself the only e-prescribing network with market-based experience in controlled substances, said it was committed to helping the Drug Enforcement Administration and healthcare industry to implement the interim final rule for e-prescribing the drugs. Controlled substances include prescription drugs for such conditions as chronic pain and psychiatric disorders that are prone to abuse and diversion.
“Our market experience during the Massachusetts Department of Public Health research project indicates that electronic prescribing for controlled substances is safe and a practical necessity,” Emdeon CEO George Lazenby said. “The potential impact is tremendous.”
The Agency for Health Research and Quality, a government agency, funded the MDPH research project with the aim of demonstrating the technological feasibility and potential benefits to patient safety in e-prescribing of controlled substances.