Pharma

Reumofan Plus – Why You Should Not Buy Nor Use This Supplement

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BACKGROUND: Reumofan Plus is marketed as a natural dietary supplement for pain relief. Reumofan Plus is labeled in Spanish and promoted for treating arthritis, muscle pain, osteoporosis, bone cancer, and other conditions. The product is manufactured in Mexico by Riger Naturals and sold in some retail outlets, at flea markets, and on various internet sites. FDA has worked closely with the Mexican government on this matter. The Mexican Ministry of Health has issued a health warning to the public and ordered Riger Naturals to recall the product.

Since June 1, 2012, when FDA first warned the public about the dangers of these supplements, the agency has received reports of fatalities, stroke, severe bleeding in the gastrointestinal tract, dizziness, insomnia, high blood sugar levels and problems with liver and kidney functions,as well as corticosteroid withdrawal syndrome

via Safety Alerts for Human Medical Products > Reumofan Plus: Recall – Undeclared Drug Ingredient.

FDA OKs Generic Actos for Type 2 Diabetes

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The FDA today approved the first generic version of Actos to treat adults with type 2 diabetes.

The generic tablets use the same active ingredient as Actos, called pioglitazone, to improve blood glucose control in adults with type 2 diabetes.

via FDA OKs Generic Actos for Type 2 Diabetes.

Ampyra (dalfampridine) – Seizure Risk for Multiple Sclerosis Patients

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BACKGROUND: Ampyra was approved to improve walking in patients with MS. Seizures are a known side effect of Ampyra, and seizure risk increases with higher blood levels of the drug. Ampyra is eliminated from the body through the kidneys, and patients with kidney impairment may develop higher blood levels of the drug, thereby increasing their seizure risk.

via Safety Alerts for Human Medical Products > Ampyra dalfampridine: Drug Safety Communication – Seizure Risk for Multiple Sclerosis Patients.

ADHD Drugs Top Rx for Kids

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Prescription drug use in the pediatric population fell from 2002 to 2010, but the use of birth control and attention-deficit/hyperactivity disorder (ADHD) medications rose, the FDA reported.

Outpatient contraceptive prescriptions jumped 93% from 2002 to 2010 among kids 17 and younger, Grace Chai, PharmD, of the agency’s Center for Drug Evaluation and Research in Silver Spring, Md., and colleagues found.

ADHD drug scripts rose 46% over the same period in the national analysis of prescription databases reported in the July issue of Pediatrics.

via Medical News: FDA: ADHD Drugs Top Rx for Kids – in Pediatrics, General Pediatrics from MedPage Today.

Birth control and chronic sedation have replaced traditional parenting.

Teva’s Adderall 30 mg Tabs – Counterfeit Product – Contains Wrong Active Ingredients

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The counterfeit Adderall tablets are round, white and do not have any type of markings, such as letters or numbers. Authentic Adderall 30 mg tablets produced by Teva are round, orange/peach, and scored tablets with “dp” embossed on one side and “30” on the other side of the tablet.

Adderall contains four active ingredients – dextroamphetamine saccharate, amphetamine aspartate, dextroamphetamine sulfate, and amphetamine sulfate. Instead of these active ingredients, the counterfeit product contained tramadol and acetaminophen, which are ingredients in medicines used to treat acute pain.

via Safety Alerts for Human Medical Products > Teva’s Adderall 30 mg Tablets: Counterfeit Product – Contains Wrong Active Ingredients.

If you or your child is bouncing off the walls AND you bought Adderall off the Internet, check to see if your tablets are white and have no markings.

 

Finasteride Sexual Side Effects Prompt FDA Warning, Label Changes

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Proscar is indicated for treatment of symptoms in men with benign prostatic hyperplasia (BPH) and also is approved to reduce urinary retention risk or the need for surgery related to BPH. Propecia is approved for use only in men as a treatment for male pattern baldness.

Among specific changes the FDA is calling for are:

  • a revision to the Propecia label to add libido disorders, ejaculation disorders and orgasm disorders that continued after the drug was discontinued;
  • a revision to the Proscar label to include decreased libido that continued after the drug was discontinued; and
  • revisions to both drugs’ labels that describe reports of male infertility and/or poor semen quality that normalized or, at least, improved after discontinuing the respective drug.

According to the agency, the changes were based on its review of hundreds of case reports of sexual dysfunction that persisted after patients ceased using the drugs. It should be noted that in 2011, the FDA called for both drugs’ labels to be revised to include erectile dysfunction as a side effect that continued after discontinuation of the drug.

via Finasteride Sexual Side Effects Prompt FDA Warning, Label Changes — AAFP News Now — American Academy of Family Physicians.