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FDA alert 13 articles

Testing reveals genetic disorder treatment contains wrong drug ingredient

A Food and Drug Administration (FDA) analysis of recalled lots of Medisca’s L-citrulline, a drug used to treat certain urea cycle disorders, a rare genetic disorder primarily diagnosed in children, revealed that the samples contained N-acetyl-leucine, a product used to treat a certain type of dizziness known as acute vestibular vertigo. No L- citrulline was found in the samples tested by the FDA. The recall was initiated last week after the FDA received reports of adverse events associated with subpotent L-citrulliine in patients who were administered the drug. Subpotent L-citurlline in patients with certain urea cycle defects can lead to high ammonia ... Read More

FDA warns parents not to put sunscreen on young infants

Most parents know the importance of slathering their kids in sunscreen, but the Food and Drug Administration (FDA) is advising parents not to put sunscreen on infants younger than 6 months of age. Babies’ skin is thinner than adults’ and children’s and absorbs the active, chemical ingredients in sunscreen easier. Plus, infants have a higher surface-area to body-weight ratio compared to older children and adults, which means they are more sensitive to exposure to the chemicals in sunscreen. Both of these increase their chances of having an allergic reaction or inflammation. The best approach is to keep infants younger than ... Read More

Drug-drug interaction with statins may cause serious muscle injury

Just a week after the Food and Drug Administration (FDA) issued new warnings for an increased risk of diabetes and memory loss with cholesterol-lowering statins, the agency is alerting the public about the risk of muscle injury associated with the drugs if used with certain HIV or hepatitis C medications known as protease inhibitors. The labels for both protease inhibitors and statins has been updated to warn that protease inhibitors and statins, when taken together, may raise blood levels of statins and increase the risk for muscle injury (myopathy). The most serious type of myopathy, called rhabdomyolysis, can damage the ... Read More

Actos bladder cancer lawsuits consolidated in Louisiana

Lawsuits against drug company Takeda claiming its type 2 diabetes drug Actos causes bladder cancer have been consolidated before one judge in federal court in Louisiana. The Federal Judicial Panel on Multidistrict Litigation sent the lawsuits to the Western District of Louisiana in Layfayette. U.S. District Judge Rebecca Doherty will oversee pretrial proceedings including evidence gathering in the lawsuit. The lawsuits claim that patients were put at increased risk for developing bladder cancer by using Actos to treat their type 2 diabetes. The plaintiffs also allege that Takeda and co-defendant Eli Lily & Co. withheld evidence that showed that Actos ... Read More

Bladder cancer victim files lawsuit against Actos maker

An Illinois man is suing the makers of the type 2 diabetes drug Actos, claiming the drug caused him to develop bladder cancer. His lawsuit alleges that the drug company was fully aware that the medication had been linked to bladder cancer but hid the risks from the public. The lawsuit was filed earlier this month in Madison County Circuit Court against Actos makers Takeda Pharmaceuticals America Inc., Takeda Pharmaceuticals North America Inc., Takeda Pharmaceutical Company Limited, and Eli Lilly and Company. The plaintiff was prescribed Actos in 2007 for the long-term control of his high blood sugar. He says he ... Read More

Virus linked to rare but serious brain infection with MS, Crohn’s drug

Testing positive for anti-JC virus (JCV) antibodies has been identified as a risk factor for developing progressive multifocal leukoencephalopathy (PML), a rare but serious brain infection associated with use of Tysabri (natalizumab) for the treatment of Multiple Sclerosis (MS) or Crohn’s disease, the Food and Drug Administration (FDA) said in a safety notice to doctors. The FDA issued a safety alert last April, informing doctors that it was reviewing a possible link between PML and Tysabri. Patients who are prescribed Tysabri are encouraged to be tested for anti-JC virus antibodies. The Stratify JCV Antibody ELISA test, when used with other ... Read More

FDA rejects type 2 diabetes drug based on bladder, breast cancer risks

The Food and Drug Administration (FDA) has rejected the experimental type 2 diabetes drug Dapagliflozin because it poses a risk for bladder and breast cancers. Drug makers Bristol-Myers Squibb and AstraZeneca must provide more data on the drug’s risks and benefits before the FDA would be willing to consider approving the drug for use in the United States. Dapagliflozin works by increasing renal glucose elimination, thereby allowing more sugar to be excreted in the urine. An FDA advisory panel voted in July to recommend the approval for the drug, but raised concerns over the cancer risks that rose out of ... Read More

Judge considers consolidating Actos lawsuits

Judges are considering whether to consolidate tens of thousands of lawsuits filed in the United States against Japanese drug maker Takeda over its type 2 diabetes drug Actos. The lawsuits claim the drug causes bladder cancer. The claims are backed up by an alert issued by the Food and Drug Administration (FDA) earlier this year which warned that studies linked Actos to bladder cancer, and that the risk was even greater in patients who used the drug for more than a year. Actos sales grew considerably early last year after the FDA severely restricted the sale of the type 2 ... Read More

Prediabetes is a diagnosis to take seriously

More than 90 percent of an estimated 60 million Americans are on the verge of getting type 2 diabetes but are completely unaware that they are at risk, according to HealthWomen.org. Many of these people have no symptoms, and many who learn they have the condition known as prediabetes think it’s no big deal. But a diagnosis of prediabetes is nothing to take lightly, says Ann Albright, PhD, RD, director of the Division of Diabetes Translation at the Centers for Disease Control and Prevention. The good news, she says, “is there is something you can do about it.” Prediabetes, as ... Read More