Late last week the US Food and Drug Administration announced the withdrawal of Permax (pergolide) and Zelnorm (tegaserod) from the US market.

Pergolide is used with levodopa and carbidopa to manage Parkinson's disease. Two new studies showed an increase risk of heart valve damage in patients treated with pergolide versus those patients who did not receive the drug.

The FDA stresses if you are taking pergolide do not stop taking the drug as this can be dangerous. Continue your dosing regimen and consult with your doctor regarding alternative treatments.

Permax (brand name) is manufactured by Valeant Pharmaceuticals. Par and Teva market the generic pergolide products.

For more information, please see the FDA News Article at FDA News - Pergolide

FDA News

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The U.S. Food and Drug Administration (FDA) is advising consumers not to purchase prescription drugs from websites that have orders filled by Mediplan Prescription Plus Pharmacy or Mediplan Global Health in Manitoba, Canada following reports of counterfeit versions of prescription drug products being sold by these companies to U.S. consumers. FDA is investigating these reports and is coordinating with international law enforcement authorities on this matter.

FDA recommends that consumers who have purchased drugs from these websites not use the products because they may be unsafe. Laboratory analyses are underway for intercepted product that was destined for the U.S. market. Preliminary laboratory results to date have found counterfeits of the following drug products from these websites: Lipitor, Diovan, Actonel, Nexium, Hyzaar, Ezetrol (known as Zetia in the United States), Crestor, Celebrex, Arimidex, and Propecia. All of these medications require a prescription from a licensed health care provider to be legally dispensed.

The FDA issued an alert reminding healthcare professionals and caregivers that Phenergan (promethazine) is not to be prescribed for children under two years of age. Caution is also advised for older children.

Seven deaths and twenty two cases of significant respiratory depression have occured in children under two.

All forms of promethazine (syrups, suppositories, tablets or injectables) are contraindicated in children less than two years old.

Complete information is available at the US Food and Drug Administration website: FDA ALERT [4/2006]

Public Citizen, a non-profit consumer advocacy organization, petitioned the Food and Drug Administration to withdraw propoxyphene products (Darvon, Darvocet and generics) from the US market. The petition mentions the phased withdrawal in the United Kingdom which began a year ago. The UK government health authorities stated that the efficacy of this product "...is poorly established and the risk of toxicity in overdose, both accidental and deliberate, is unacceptable."

Friday the US Food and Drug Administration warned consumers not to use two dietary weight loss supplements made in Brazil - Emagrece Sim Dietary Supplement and Herbathin Dietary Supplement. Both supplements may contain the active ingredients chlordiazepoxide and fluoxetine, together with other RX ingredients.

In addition to possibly containing ingredients found in some prescription drugs, both supplements contain fenproporex, a stimulant not approved in the US.

Use of these products may have serious side effects. The FDA also notes that fenproporex can cause a urinalysis to test positive for amphetamines.

For more information see FDA News Release – January 13, 2006

On December 8, 2005, GlaxoSmithKline issued a press release advising of revisions to Paxil labeling. Paxil (paroxetine hydrochloride) and Paxil CR (paroxetine hydrochloride controlled release) labeling is changed from Pregnancy Category C to Pregnancy Category D (indicative of positive evidence of human fetal risk).

The label change is based on further analysis of a previous study "...together with new data from another study utilizing a large medical birth registry..."

For complete information, please see GlaxoSmithKline's Press Release - Paroxetine and FDA News - FDA Advising of Risk of Birth Defects with Paxil.

Paxil is a commonly prescribed antidepressant, and many generics are marketed in the US. For pill identification of Paxil and several generic paroxetine imprints, see Pharmer.org's Imprints of Antidepressants.

GlaxoSmithKline issued a "Dear Healthcare Professional" letter advising doctors that use of Paxil (paroxetine HCL) or Paxil CR Controlled-Release tablets during the first trimester of pregnancy may carry an increased risk of birth defects.

For more information, please refer to the FDA's MedWatch - 2005 Safety Information.

Paxil is a commonly prescribed antidepressant, and many generics are marketed in the US. For pill identification of several Paxil (paroxetine) generics, please see Pharmer.org's Imprints of Antidepressants.

The FDA posted information about using flood-contaminated drugs or drugs subjected to continuous high temperatures.

The FDA's comments can be found at FDA Offers Valuable Information about Drug Use and Safety in the Aftermath of Hurricane Katrina

The FDA annouced a more restrictive distribution program for isotretinoin, a drug used to treat severe acne. The program is called iPledge, and its purpose is to prevent use of isotretinoin during pregnancy since the drug can cause birth defects.

Isotretinoin brand names are Accutane, Amnesteem, Claravis and Sotret.

More information is available at FDA News - August 12, 2005.