From FOX News:

The Food and Drug Administration has approved the first generic versions of a drug used to treat schizophrenia, the government organization announced Wednesday.

People who suffer from schizophrenia now have the option of treating their symptoms with the generic version of Seroquel (quetiapine) tablets. Quetiapine is also used to treat or prevent episodes of mania or depression in patients with bipolar disorder.

According to the FDA, the generic tablets are expected to be manufactured in several different strengths.

From The Bellingham Herald:

The Food and Drug Administration is warning patients about a potential mix-up between powerful prescription pain drugs and common over-the-counter medications made at a Novartis manufacturing plant.

The issue stems from manufacturing problems at a Lincoln, Neb., facility which triggered a recall Sunday of 1,645 lots of Novartis' over-the-counter drugs, including Excedrin, Bufferin, NoDoz and Gas-X.  Consumers are advised to stop using the products and contact the company for a refund.

FDA officials warned Monday that some of Novartis' over-the-counter pills may have accidentally been packaged with powerful prescription painkillers made at the same facility. The opioid drugs are sold by Endo Pharmaceuticals as Percocet, Endocet, Opana and Zydone.

Endo Pharmaceuticals Holdings Inc., of Chadds Ford, Pa., said it is not aware of any confirmed product mix-ups that reached patients or caused any injuries. A spokeswoman for Novartis said late Monday that only Gas-X is produced on the same manufacturing line as the opioid drugs.

FDA officials say they are not recalling the painkillers because they are essential medications for many patients and the risks of stray pills are low.

From WebMD:

The FDA has approved the first generic versions of the drugs Zyprexa and Zyprexa Zydis for the treatment of schizophrenia and bipolar disorder.  The generic name for the two drugs is olanzapine.

Keith Webber, PhD, deputy director of the FDA's Office of Pharmaceutical Science, says the approval of generic olanzapine "offers greater access to a widely used treatment for mental illness."

He says that having "affordable treatment options is good for patients with long-term illnesses that must be carefully managed."

Zyprexa can cost more than $300 a month, while generic versions can substantially cut the cost.

The FDA says olanzapine must be dispensed with a medication guide that describes the risks and possible adverse reactions patients may experience. Olanzapine is not approved for treating psychosis in the elderly with dementia.

The drug can have side effects leading to high blood sugar and high blood fat levels and weight gain.

From HealthDay News:

U.S. Food and Drug Administration approval of Afinitor (everolimus) has been expanded to include people with progressive neuroendocrine tumors of the pancreas (PNET) that have spread to other parts of the body or cannot be removed by surgery, the agency said Friday.

PNET is slow-growing and rare, affecting fewer than 1,000 new patients in the United States each year, the FDA said in a news release.

Afinitor was previously FDA-approved for advanced kidney cancer and certain brain tumors that cannot be treated surgically.

From WebMD:

Taking the epilepsy drug topiramate (Topamax) during pregnancy raises the risk of oral cleft birth defects such as cleft lip and cleft palate, according to a new warning issued by the FDA.

New drug registry data show that the risk of oral birth defects is up to 16 times higher among women who took topiramate or its generic equivalents during pregnancy.

Topiramate is approved by the FDA for treating seizures associated with epilepsy and to prevent migraines. But it is also sometimes used on an off-label basis to treat other conditions, such as obesity, bipolar disorder, and alcoholism.

From MedPage Today:

Use of proton pump inhibitors (PPIs) regularly for a year or longer may lead to low levels of circulating magnesium, which may increase the risk of leg spasms, arrhythmias, and seizures, according to an FDA warning.

The latest alert from the FDA says physicians "should consider obtaining serum magnesium levels prior to initiation of prescription PPI treatment in patients expected to be on these drugs for long periods of time."

From Bioscience Technology:

The U.S. Food and Drug Administration (FDA) is warning the public that injectable terbutaline should not be used in pregnant women for prevention or prolonged treatment (beyond 48-72 hours) of preterm labor in either the hospital or outpatient setting because of the potential for serious maternal heart problems and death. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline injection label to warn against this use. In addition, oral terbutaline should not be used for prevention or any treatment of preterm labor because it has not been shown to be effective and has similar safety concerns. The agency is requiring the addition of a Boxed Warning and Contraindication to the terbutaline tablet label to warn against this use.

From Medical News Today:

Two cases of acute liver failure in which the patients taking heart medication dronedarone (Multaq) needed liver transplants have resulted in an FDA communication informing that data on the potential risk of liver injury are being added to the drug's labels.

Dronedarone (Multaq) is used to treat atrial fibrillation and atrial flutter in individuals whose hearts either returned to normal rhythm or who underwent drug therapy for electric shock treatment - the drug helps maintain normal rhythm. The FDA (Food and Drug Administration) approved dronedarone in July 2009, and it is available as 400mg tablets in 60 count bottles. The FDA did not approve the medication for reducing deaths. A study of patients with irregular heartbeats found that Multaq treatment more than doubles the risk of death.

Since its launch, approximately 200,000 people have taken Multaq.

From CNN Health:

Manufacturers of prescription drugs containing acetaminophen are being asked to limit the dosage of the drug and add a liver toxicity warning to product labels, the Food and Drug Administration announced Thursday. This so-called "boxed warning" is the agency's strongest warning for a prescription drug.

Makers of prescription products that include acetaminophen, a popular pain and fever reducer better known under the brand name Tylenol, will be required to limit the amount of the drug to no more than 325 milligrams (mg) per tablet or capsule. Currently some products contain between 500 mg to 750 mg per dose.

"FDA is taking this action to make prescription combination pain medications containing acetaminophen safer for patients to use," said Dr. Sandra Kweder, deputy director of the Office of New Drugs in FDA's Center for Drug Evaluation and research (CDER). "Overdose from prescription combination products containing acetaminophen account for nearly half of all cases of acetaminophen related liver failure in the United States, many of which result in liver transplant or death."

From CounterPunch:

2010 will go down as the year the diet pill Meridia and pain pill Darvon were withdrawn from the market and the heart-attack associated diabetes drug Avandia was severely restricted.

Additionally, here are the drugs which make 2010's Hall of Shame:

• Yaz and Yasmin
• Lyrica, Topamax and Lamictal
• Humira, Prolia and TNF Blockers
• Chantix
• Ambien
• Tamoxifen
• Lipitor and Crestor
• Boniva
• Prempro
• Prozac, Paxil, Zoloft, SSRIs
• Effexor, Cymbalta, Pristiq, SNRIs
• Seroquel, Zyprexa, Geodon, atypical antipsychotics
• Ritalin, Concerta, Strattera, Adderall and ADHD Drugs
• Gardasil and Cervarix Vaccines
• Foradil Aerolizer, Serevent Diskus, Advair and Symbicort
• Singulair and Accolate, leukotriene receptor antagonists