Medical Health

Shares of the French drugmaker, which have stumbled in the past week over Lantus concerns, rose 3.1 percent in Paris after the FDA also said patients should not stop taking their therapy without consulting a physician.
In a communication posted on its website, the agency questioned four recently published studies over the cancer [...]

The move comes after a recent, widely publicized study raised the possibility the once-a-day insulin slightly increases risk of cancer.
In a statement, the FDA said patients should not stop taking their insulin without consulting a doctor because of the risk of serious complications, both immediate and long term. Patients with Type 1 diabetes and [...]

The new requirement, called a “Black Box” warning, is based on reports of people experiencing unusual changes in behavior, becoming depressed, or having suicidal thoughts while taking the drugs.
The antidepressant Wellbutrin, which has the same active ingredient as GlaxoSmithKline PLC’s Zyban, already carries such a warning.
The FDA is also requiring an additional study [...]

The panel’s recommendations followed the release of an FDA report last month that found severe liver damage, and even death, can result from a lack of consumer awareness that acetaminophen — which is easier on the stomach than such painkillers as aspirin and ibuprofen — can cause such injury. [...]

Three of four studies published last Friday in Diabetologia showed a potential link between Lantus — an insulin analogue made by French drug company Sanofi-aventis — and increased risks for various tumor types.
But, “the duration of patient follow-up in all four studies was shorter than what is [...]

The Food and Drug Administration has assembled more than 35 experts to discuss ways to prevent overdose with acetaminophen the pain-relieving, fever-reducing ingredient in Tylenol and dozens of other prescription and over-the-counter medications.
Despite years of educational campaigns and other federal actions, acetaminophen is the leading cause of liver failure in the U.S., sending 56,000 [...]

The FDA ordered U.S. Marshals to seize the products from plants run by Caraco Pharmaceutical Laboratories Ltd in Detroit, Farmington Hills, and Wixom, Mich. Caraco manufactures generic drugs, including cardiac, psychiatric and pain medications, the FDA said in a Thursday afternoon press briefing.
“This action follows the company’s continued [...]

Six cases received since its approval in 1983, including two siblings reported to have autism, “raise concerns,” Food and Drug Administration staff wrote in a May 6 memo released on Friday.
Limitations in the reports “make it impossible to definitively conclude” the drug played a role, and genetics or other factors may have [...]

The over-the-counter products contain zinc, an ingredient scientists say may damage nerves in the nose needed for smell. The other products affected by the Food and Drug Administration’s announcement Tuesday are adult and kid-size Zicam Cold Remedy Nasal Swabs.
The FDA says about 130 consumers have reported a loss of smell after using Matrixx Initiatives’ [...]

The increase would give the FDA $3.2 billion in fiscal year 2010, which starts October 1, compared with $2.7 billion in 2009.
The FDA regulates products that make up about one-quarter of the U.S. economy and also deals with food safety issues, tainted drugs and drug side effects.
It has been stretched [...]